quinolones and fluoroquinolones art. 31 phv - annex i for ... · pdf fileaustria actavis group...
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
15 March 2017 EMA/88273/2017 Rev. 2 Human Medicines Evaluation Division
Annex I
List of the names, pharmaceutical forms, strengths of the medicinal
products, routes of administration, marketing authorisation holders in the
member states for quinolones and fluoroquinolones containing medicinal
products
Referral under Article 31 of Directive 2001/83/EC resulting from
pharmacovigilance data
Procedure number: EMEA/H/A-31/1452
Quinsair EMEA/H/A-31/1452/C/002789/0010
Please note that this Annex I may be updated during the procedure to reflect any amended information on concerned products/MAHs
Annex I
EMA/88273/2017 Page 2/151
Nationally authorised medicinal products
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Austria 1a Pharma Gmbh Ciprofloxacin 1a Pharma
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Ciprofloxacin 1a Pharma
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Levofloxacin 1a Pharma
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Levofloxacin 1a Pharma
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Austria 1a Pharma Gmbh Moxifloxacin 1a Pharma Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Austria Actavis Group Ptc Ehf. Ciprofloxacin Actavis Ciprofloxacin Lactate 2.544mg/Ml
Solution For Infusion Intravenous Use
Austria Actavis Group Ptc Ehf. Levofloxacin Actavis
Group Ptc
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Austria Actavis Group Ptc Ehf. Levofloxacin Actavis Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Austria Actavis Group Ptc Ehf. Levofloxacin Actavis Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Austria Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Arzneimittel Gmbh
Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Austria Arcana Arzneimittel Gmbh Ciprofloxacin Mylan Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Austria Arcana Arzneimittel Gmbh Levofloxacin Arcana Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
Austria Arcana Arzneimittel Gmbh Levofloxacin Arcana Arzneimittel
Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Austria Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
Austria Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 500mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 3/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Austria Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.P.A.
Unidrox Prulifloxacin 600mg Tablet
Film-Coated Tablet Oral Use
Austria Bayer Austria Gmbh Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Austria Bayer Austria Gmbh Ciproxin Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Austria Bayer Austria Gmbh Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Austria Bayer Austria Gmbh Ciproxin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Austria Bayer Austria Gmbh Ciproxin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Austria Bayer Austria Gmbh Ciproxin Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Austria Bayer Austria Gmbh Ciproxin Ciprofloxacin Hydrated 250mg/5 Ml
Granules And Solvent For Oral Suspension
Oral Use
Austria Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Austria Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Austria Dr. Friedrich Eberth Arzneimittel Gmbh
Levofloxacin Eberth Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Austria Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Austria Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacin Hydrochloride 582mg
Tablet
Film-Coated Tablet Oral Use
Austria Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacin Hydrochloride 873mg
Tablet
Film-Coated Tablet Oral Use
Austria Fresenius Kabi Austria Gmbh Ciprofloxacin Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Austria Fresenius Kabi Austria Gmbh Levofloxacin Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Austria Fresenius Kabi Austria Gmbh Moxifloxacin Kabi Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 4/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Austria G.E.S. Genéricos Españoles Laboratorio, S.A.
Moxifloxacin G.E.S. Moxifloxacin 400mg/250 Ml
Solution For Infusion Intravenous Use
Austria G.L. Pharma Gmbh Ciflox Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Austria G.L. Pharma Gmbh Ciflox Ciprofloxacin
Hydrochloride
Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Austria G.L. Pharma Gmbh Ciflox Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Austria Genericon Pharma Gesellschaft M.B.H.
Ciprofloxacin Genericon Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Austria Genericon Pharma
Gesellschaft M.B.H.
Ciprofloxacin Genericon Ciprofloxacin
Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
Austria Hexal Pharma Gmbh Ciprofloxacin Hexal Ciprofloxacin Hydrochloride Monohydrate 291mg
Tablet
Film-Coated Tablet Oral Use
Austria Hexal Pharma Gmbh Ciprofloxacin Hexal Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Film-Coated Tablet Oral Use
Austria Hexal Pharma Gmbh Moxifloxacin Hexal Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Austria Hikma Farmacêutica (Portugal), S.A.
Ciprofloxacin Hikma Ciprofloxacin 400mg Bag
Solution For Infusion Intravenous Use
Austria Hikma Farmacêutica (Portugal), S.A.
Levofloxacin Hikma Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Austria Krka, D.D., Novo Mesto Moxifloxacin Krka Moxifloxacin 1600µg/Ml Solution For Infusion Intravenous Injection
Annex I
EMA/88273/2017 Page 5/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Austria Krka, D.D., Novo Mesto Ciprofloxacin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto Ciprofloxacin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto Ciprofloxacin Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto Levofloxacin Krka Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Austria Krka, D.D., Novo Mesto Moxifloxacin Krka Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Austria Luye Pharma Ag Moxifloxacin Acino Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Austria Noridem Enterprises Ltd Ciprofloxacin Noridem Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Austria Noridem Enterprises Ltd Levofloxacin Noridem Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Austria Noridem Enterprises Ltd Moxifloxacin Noridem Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Austria Pfizer Corporation Austria
Gesellschaft M.B.H.
Ciprofloxacin Hospira Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Austria Pfizer Corporation Austria Gesellschaft M.B.H.
Levofloxacin Hospira Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
Austria Pfizer Corporation Austria Gesellschaft M.B.H.
Levofloxacin Hospira Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Austria Pharmathen S.A. Moxifloxacin Pharmathen
Moxifloxacin Hydrochloride 436.37mg Tablet
Film-Coated Tablet Oral Use
Austria Ratiopharm Arzneimittel
Vertriebs-Gmbh
Ciprofloxacin
Ratiopharm
Ciprofloxacin
Hydrochloride
Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Austria Ratiopharm Arzneimittel Vertriebs-Gmbh
Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 583mg
Tablet
Film-Coated Tablet Oral Use
Austria Ratiopharm Arzneimittel Vertriebs-Gmbh
Levofloxacin Ratiopharm
Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Austria Ratiopharm Arzneimittel Vertriebs-Gmbh
Levofloxacin Ratiopharm
Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Austria Ratiopharm Arzneimittel Vertriebs-Gmbh
Moxifloxacin Ratiopharm
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Austria Ratiopharm Arzneimittel Vertriebs-Gmbh
Norfloxacin Ratiopharm Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Austria Ratiopharm Arzneimittel Vertriebs-Gmbh
Ofloxacin Ratiopharm Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Austria Ratiopharm Arzneimittel Vertriebs-Gmbh
Ofloxacin Ratiopharm Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Austria S.Med Handelsgmbh Cipromed Ciprofloxacin 250mg Tablet
Coated Tablet Oral Use
Austria S.Med Handelsgmbh Cipromed Ciprofloxacin 500mg Tablet
Coated Tablet Oral Use
Austria Sandoz Gmbh Moxifloxacin Sandoz Moxifloxacin
400mg/250 Ml
Solution For Infusion Intravenous Use
Austria Sandoz Gmbh Ciprofloxacin Sandoz Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Ciprofloxacin Sandoz Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Ciprofloxacin Sandoz Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Levofloxacin Sandoz Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Levofloxacin Sandoz Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Moxifloxacin Sandoz Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Austria Sandoz Gmbh Norfloxacin Sandoz Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Austria Sanofi-Aventis Gmbh Osterreich
Tavanic Levofloxacin Hemihydrate
5.1246mg/Ml
Solution For Infusion Intravenous Use
Austria Sanofi-Aventis Gmbh Osterreich
Tarivid Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Austria Sanofi-Aventis Gmbh Osterreich
Tavanic Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Austria Sanofi-Aventis Gmbh Osterreich
Tavanic Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Austria Stada Arzneimittel Gmbh Moxifloxacin Stada Moxifloxacin
Hydrochloride
437mg/250 Ml
Solution For Infusion Intravenous Use
Austria Stada Arzneimittel Gmbh Ciprostad Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Austria Stada Arzneimittel Gmbh Ciprostad Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Austria Stada Arzneimittel Gmbh Floxacin Stada Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Austria Stada Arzneimittel Gmbh Moxifloxacin Stada Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Austria Stada Arzneimittel Gmbh Ofloxacin Stada Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Austria Stada Arzneimittel Gmbh Ofloxacin Stada Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Belgium Apotex Europe B.V. Moxifloxacin Apotex Moxifloxacin Hydrochloride 436.33mg Tablet
Film-Coated Tablet Oral Use
Belgium Aurobindo Pharma B.V. Ciprofloxacine Ab Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Belgium Aurobindo Pharma B.V. Ciprofloxacine Ab Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Belgium Aurobindo Pharma B.V. Ciprofloxacine Ab Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Belgium Aurobindo Pharma B.V. Moxifloxacin Ab Moxifloxacin Hydrochloride 436.32µg Tablet
Film-Coated Tablet Oral Use
Belgium B.Braun Melsungen Ag Levofloxacin B. Braun Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Belgium Bayer Sa Nv Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Belgium Bayer Sa Nv Ciproxine Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Belgium Bayer Sa Nv Ciproxine Iv Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Belgium Bayer Sa Nv Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Belgium Bayer Sa Nv Ciproxine Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Belgium Bayer Sa Nv Ciproxine Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Belgium Bayer Sa Nv Ciproxine Ciprofloxacin Hydrated
250mg/5 Ml
Granules And Solvent
For Oral Suspension
Oral Use
Belgium Biocodex Benelux Nv/Sa Logiflox Lomefloxacin Hydrochloride 441.6mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A. Ciprofloxacine Eg Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Belgium Eurogenerics N.V./S.A. Levofloxacine Eg Levofloxacin Hemihydrate 5.12mg/Ml
Solution For Infusion Intravenous Use
Belgium Eurogenerics N.V./S.A. Ciprofloxacine Eg Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A. Ciprofloxacine Eg Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A. Ciprofloxacine Eg Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A. Levofloxacine Eg Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A. Moxifloxacine Eg Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A. Norfloxacine Eg Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A. Ofloxacine Eg Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Belgium Eurogenerics N.V./S.A. Ofloxacine Eg Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Belgium Fresenius Kabi Nv/Sa Ciprofloxacine
Fresenius Kabi
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Belgium Fresenius Kabi Nv/Sa Levofloxacine Fresenius Kabi
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Belgium Fresenius Kabi Nv/Sa Moxifloxacine Fresenius Kabi
Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Belgium Mylan Bvba/Sprl Ciprofloxacine Mylan Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Belgium Mylan Bvba/Sprl Levofloxacin Mylan Levofloxacin
500mg/100 Ml
Tablet Intravenous Use
Belgium Mylan Bvba/Sprl Ciprofloxacine Mylan Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use | Oral Use
Belgium Mylan Bvba/Sprl Ciprofloxacine Mylan Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Belgium Mylan Bvba/Sprl Ciprofloxacine Mylan Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Belgium Mylan Bvba/Sprl Levofloxacine Mylan Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Belgium Mylan Bvba/Sprl Levofloxacine Mylan Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Belgium Mylan Bvba/Sprl Moxifloxacine Mylan Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Belgium Mylan Bvba/Sprl Ofloxacine Mylan Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Belgium Mylan Bvba/Sprl Ofloxacine Mylan Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Belgium Mylan Bvba/Sprl Ciprofloxacine Mylan Ciprofloxacin 200mg/100 Ml
Solution For Infusion Oral Use
Belgium Mylan Bvba/Sprl Moxifloxacine Mylan Moxifloxacin 400mg Tablet
Tablet Oral Use
Belgium Pharmathen S.A. Moxifloxacin Pharmathen
Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Belgium Pharmathen S.A. Moxifloxacin
Pharmathen
Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Levofloxacine Sandoz Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Belgium Sandoz N.V. Moxifloxacin Sandoz Moxifloxacin 400mg/250 Ml
Solution For Infusion Intravenous Use
Belgium Sandoz N.V. Moxifloxacin Sandoz Moxifloxacin 400mg/250ml
Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 10/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Belgium Sandoz N.V. Ciprofloxacine Sandoz Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Ciprofloxacine Sandoz Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Ciprofloxacine Sandoz Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Levofloxacine Sandoz Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Levofloxacine Sandoz Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Moxifloxacin Sandoz Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Belgium Sandoz N.V. Ofloxacine Sandoz Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Belgium Sanofi Belgium Tavanic Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
Belgium Sanofi Belgium Tavanic Levofloxacin
500mg/100 Ml
Solution For Infusion Intravenous Use
Belgium Sanofi Belgium Tavanic Levofloxacin Hemihydrate 5.1246mg/Ml
Solution For Infusion Intravenous Use
Belgium Sanofi Belgium Tarivid Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Belgium Sanofi Belgium Tarivid Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Belgium Sanofi Belgium Tavanic Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Belgium Sanofi Belgium Tavanic Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Levofloxacine Teva Levofloxacin Hemihydrate 512.46mg Tablet
Coated Tablet Oral Use
Belgium Teva Pharma Belgium
N.V./S.A
Ciprofloxacine Teva Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Ciprofloxacine Teva Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium
N.V./S.A
Ciprofloxacine Teva Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Belgium Teva Pharma Belgium N.V./S.A
Levofloxacine Teva Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Levofloxacine Teva Levofloxacin 500mg Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Levofloxacine Teva Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Moxifloxacine Teva Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Ofloxacine Teva Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Belgium Teva Pharma Belgium N.V./S.A
Ofloxacine Teva Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Bulgaria Accord Healthcare Limited Levofloxacin Accord Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Actavis Ead Ciprofloxacin Actavis Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Bulgaria Actavis Ead Ciprofloxacin Actavis Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Actavis Ead нелидикс Nalidixic Acid 500mg Tablet
Tablet Oral Use
Bulgaria Actavis Group Ptc Ehf. Levoxa Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Bulgaria Actavis Group Ptc Ehf. левокса Levofloxacin Hemihydrate 256.23mg
Tablet
Film-Coated Tablet Oral Use
Bulgaria Actavis Group Ptc Ehf. левокса Levofloxacin
Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Adipharm Ead левофлоксацин
адифарм
Levofloxacin
Hemihydrate 500mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Alkaloid Ltd ципрофлоксацин алкалоид
Ciprofloxacin Hydrochloride Monohydrate 291.5mg
Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Bulgaria Alkaloid Ltd ципрофлоксацин алкалоид
Ciprofloxacin Hydrochloride Monohydrate 583mg
Tablet
Film-Coated Tablet Oral Use
Bulgaria Alvogen Ipco S.Ar.L моксиквин Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Antibiotic-Razgrad Ad левофлоксан Levofloxacin
Hemihydrate
5.12mg/Ml
Solution For Infusion Intravenous Use
Bulgaria Antibiotic-Razgrad Ad левофлоксан Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Antibiotic-Razgrad Ad левофлоксан Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Bulgaria Aurobindo Pharma (Malta) Limited
ципрофлоксацин уробиндо
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Aurobindo Pharma (Malta) Limited
ципрофлоксацин уробиндо
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Aurobindo Pharma (Malta) Limited
ципрофлоксацин уробиндо
Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Bayer Pharma Ag авелокс Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Bayer Pharma Ag ципробай Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Bayer Pharma Ag ципробай Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Beximco Pharma Uk Ltd левофлоксацин бексимко
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Beximco Pharma Uk Ltd левофлоксацин бексимко
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Claris Lifesciences (Uk) Limited
Ciprox Ciprofloxacin Lactate 2mg/Ml
Solution For Infusion Intravenous Use
Bulgaria Claris Lifesciences (Uk) Limited
ципрокс Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Bulgaria Ecopharm Group левофлоксацин екофарм
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 13/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Bulgaria Ecopharm Group ципрофлоксацин екофарм
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Fresenius Kabi Bulgaria Eood левофлоксацин каби Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Bulgaria Hikma Farmacêutica (Portugal), S.A.
Ciprofloxacin Hikma Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Bulgaria Krka, D.D., Novo Mesto ципринол Ciprofloxacin
100mg/10 Ml
Concentrate For
Solution For Infusion
Intravenous Use
Bulgaria Krka, D.D., Novo Mesto левалокс Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Bulgaria Krka, D.D., Novo Mesto молоксин Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Bulgaria Krka, D.D., Novo Mesto Nolicin Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto левалокс Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto левалокс Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto молоксин Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto ципринол Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto ципринол Ciprofloxacin 500mg L Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto ципринол Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Bulgaria Krka, D.D., Novo Mesto ципринол Ciprofloxacin 100mg/50 Ml
Solution For Infusion Oral Use
Bulgaria Krka, D.D., Novo Mesto ципринол Ciprofloxacin
200mg/100 Ml
Solution For Infusion Oral Use
Bulgaria Krka, D.D., Novo Mesto ципринол Ciprofloxacin 400mg/200 Ml
Solution For Infusion Oral Use
Bulgaria Medochemie Ltd. медофлоксин Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Bulgaria Mylan S.A.S левофлоксацин майлен
Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
Bulgaria Mylan S.A.S левофлоксацин майлен
Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 14/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Bulgaria Nobel Pharma Co., Ltd. лефлокс Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Pharmacons мокси Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Sandoz Pharmaceuticals D.D. Cimocinox Moxifloxacin 400mg/250 Ml
Solution For Infusion Intravenous Use
Bulgaria Sandoz Pharmaceuticals D.D. флексид Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Bulgaria Sandoz Pharmaceuticals D.D. Cimocinox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Sandoz Pharmaceuticals D.D. флексид Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Sanofi-Aventis Bulgaria Eood таваник Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Sanovel Holding Bv Levofloxacin Sanovel Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Bulgaria Sopharma Ad ципрофлоксацин софарма
Ciprofloxacin Lactate 10mg/Ml
Solution For Infusion Intravenous Use
Bulgaria Sopharma Ad ципрофлоксацин софарма
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Stada Arzneimittel Ag вивекс Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Stada Arzneimittel Ag вивекс Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Stada Arzneimittel Ag моксистад Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Tchaikapharma High Quality Medicines, Inc.
Levor Levofloxacin Hemihydrate 256.23mg Vial
Solution For Infusion Intravenous Use
Bulgaria Tchaikapharma High Quality Medicines, Inc.
Levor Levofloxacin Hemihydrate 512.46mg Vial
Solution For Infusion Intravenous Use
Bulgaria Tchaikapharma High Quality
Medicines, Inc.
Levor Levofloxacin 512.46mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 15/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Bulgaria Teva Pharmaceuticals Bulgaria Eood
левофлоксацин тева Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Bulgaria Teva Pharmaceuticals Bulgaria Eood
левофлоксацин тева Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Warszawskie Zaklady Farmaceutyczne Polfa S.A.
ципрофлав Ciprofloxacin 10mg/Ml Concentrate For Solution For Infusion
Intravenous Use
Bulgaria Zentiva, K.S. Ofloxin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Croatia Alkaloid D.O.O. Citeral Ciprofloxacin 100mg/10 Ml
Concentrate For Solution For Infusion
Intravenous Use
Croatia Alkaloid D.O.O. Citeral Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Croatia Alkaloid D.O.O. Citeral Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Croatia Alpha-Medical D.O.O. Trizolin Uro Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Croatia Alvogen Ipco S.Ar.L Moksifloksacin Alvogen Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Croatia Alvogen Ipco S.Ar.L Mofinacin Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Croatia Bayer Doo Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Croatia Bayer Doo Avelox Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Croatia Belupo D.D. Ciflox Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Croatia Belupo D.D. Ciflox Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Croatia Belupo D.D. Ciflox Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Croatia Belupo D.D. Noflox Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Croatia Double-E Pharma Ltd Moksifloksacin Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Croatia Fresenius Kabi D.O.O. Ciprofloxacin Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Croatia Fresenius Kabi D.O.O. Moxifloxacin Kabi Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 16/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Croatia Jadran-Galenski Laboratorij D.D.
Ciprol Ciprofloxacin Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
Croatia Jadran-Galenski Laboratorij D.D.
Moksacin Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Moloxin Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Injection
Croatia Krka-Farma D.O.O. Ciprinol Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Croatia Krka-Farma D.O.O. Ciprinol Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Croatia Krka-Farma D.O.O. Levalox Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Croatia Krka-Farma D.O.O. Ciprinol Ciprofloxacin
100mg/10 Ml
Concentrate For
Solution For Infusion
Oral Use
Croatia Krka-Farma D.O.O. Ciprinol Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Ciprinol Ciprofloxacin Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Levalox Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Levalox Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Moloxin Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Croatia Krka-Farma D.O.O. Nolicin Norfloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Croatia Pharmas D.O.O. Moksifloksacin Pharmas Moxifloxacin 400mg/250 Ml
Solution For Infusion Intravenous Use
Croatia Pliva Hrvatska D.O.O. Cipromed Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Croatia Pliva Hrvatska D.O.O. Cipromed Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Croatia Pliva Hrvatska D.O.O. Plivamox Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 17/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Croatia Sandoz D.O.O. Ciprofloksacin Sandoz Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Croatia Sandoz D.O.O. Flexid Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Croatia Sandoz D.O.O. Levofloksacin Sandoz Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Croatia Sandoz D.O.O. Ciprofloksacin Sandoz Ciprofloxacin Hydrochloride 583mg
Tablet
Film-Coated Tablet Oral Use
Croatia Sandoz D.O.O. Flexid Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Cyprus Actavis Group Ptc Ehf. Levoxa Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Cyprus Bayer Hellas Sa Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Cyprus Bayer Hellas Sa Ciproxin Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Cyprus Bayer Hellas Sa Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Cyprus Bayer Hellas Sa Ciproxin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Cyprus Codal Synto Ltd Floxasynt Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Cyprus Codal Synto Ltd Floxasynt Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Cyprus Codal Synto Ltd Ofloxin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Cyprus Codal Synto Ltd Ofloxin Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Cyprus Codal Synto Ltd Syntoflox Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Cyprus Codal Synto Ltd Syntoflox Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Cyprus Costakis Tsisios & Co. Ltd Topistin Ciprofloxacin 2mg/Ml Solution For
Injection/Infusion
Intravenous Use
Cyprus Delorbis Pharmaceuticals Ltd Oxacid Ofloxacin 200mg Capsule
Capsule, Hard Oral Use
Annex I
EMA/88273/2017 Page 18/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Cyprus Delorbis Pharmaceuticals Ltd Oxacid Ofloxacin 400mg Capsule
Capsule, Hard Oral Use
Cyprus Delorbis Pharmaceuticals Ltd Floxaval Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Cyprus Delorbis Pharmaceuticals Ltd Floxaval Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Cyprus Delorbis Pharmaceuticals Ltd Viprolox Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Cyprus Delorbis Pharmaceuticals Ltd Viprolox Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Cyprus Delorbis Pharmaceuticals Ltd Viprolox Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Cyprus Demo Abee Ufexil Ciprofloxacin Lactate 2.55mg/Ml
Solution For Infusion Intravenous Use
Cyprus Fresenius Kabi Hellas A.E. Ciprofloxacin Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Cyprus Fresenius Kabi Hellas A.E. Levofloxacin Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Cyprus Medochemie Ltd. Amesol Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Cyprus Medochemie Ltd. Amesol Levofloxacin Hemihydrate 512.46mg
Tablet
Film-Coated Tablet Oral Use
Cyprus Medochemie Ltd. Gyrablock Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Cyprus Medochemie Ltd. Medociprin Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Cyprus Medochemie Ltd. Medociprin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Cyprus Medochemie Ltd. Medofloxine Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Cyprus Mylan S.A.S Levofloxacin Generics Levofloxacin 250mg/50
Ml
Solution For Infusion Intravenous Use
Cyprus Mylan S.A.S Levofloxacin Mylan Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Cyprus Noridem Enterprises Ltd Levofloxacin Noridem Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Cyprus Noridem Enterprises Ltd Moxifloxacin Noridem Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 19/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Cyprus Remedica Ltd Cilox Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Cyprus Remedica Ltd Cilox 200 Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Cyprus Remedica Ltd Trizolin Norfloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Cyprus Remedica Ltd Zindolin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Cyprus Remedica Ltd Zindolin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Cyprus Remedica Ltd Nalidixic Acid Remedica Nalidixic Acid 500mg Tablet
Tablet Oral Use
Cyprus Sanofi-Aventis Cyprus Ltd Tavanic Levofloxacin Hemihydrate
5.1246mg/Ml
Solution For Infusion Intravenous Use
Cyprus Sanofi-Aventis Cyprus Ltd Tabrin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Cyprus Sanofi-Aventis Cyprus Ltd Tavanic Levofloxacin Hemihydrate 512.46mg
Tablet
Film-Coated Tablet Oral Use
Cyprus Sapiens Pharmaceuticals Ltd Ciproflox Iv Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Cyprus Sapiens Pharmaceuticals Ltd Levoxacin Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Cyprus Sapiens Pharmaceuticals Ltd Ciproflox Ciprofloxacin Hydrochloride 291.5mg Tablet
Film Coated Tablet Oral Use
Cyprus Sapiens Pharmaceuticals Ltd Ciproflox Ciprofloxacin Hydrochloride 583mg Tablet
Film Coated Tablet Oral Use
Cyprus Sapiens Pharmaceuticals Ltd Ciproflox Ciprofloxacin Hydrochloride 873mg
Tablet
Film Coated Tablet Oral Use
Cyprus Sapiens Pharmaceuticals Ltd Levoxacin Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Cyprus Sapiens Pharmaceuticals Ltd Levoxacin Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Cyprus Terix Labs Ltd Fairlim Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 20/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Cyprus Terix Labs Ltd Fairlim Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Cyprus The Star Medicines Importers Co Ltd
Ufexil Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Czech Republic +pharma Arzneimittel Gmbh Levofloxacin +pharma Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Czech Republic +pharma Arzneimittel Gmbh Levofloxacin +pharma Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Aziende Chimiche Riunite Angelini Francesco -
A.C.R.A.F. S.P.A.
Unidrox Prulifloxacin 600mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Bayer Pharma Ag Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Czech Republic Bayer Pharma Ag Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Cipla (Uk) Limited Ciplox Ciprofloxacin
Hydrochloride Monohydrate 297.5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Cipla (Uk) Limited Ciplox Ciprofloxacin Hydrochloride
Monohydrate 595.5mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Fresenius Kabi S.R.O Ciprofloxacin Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Czech Republic Fresenius Kabi S.R.O Levofloxacin Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Czech Republic Fresenius Kabi S.R.O Moxifloxacin Kabi Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Czech Republic Generics [uk] Limited Levofloxacin Mylan Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Czech Republic Krka, D.D., Novo Mesto Levaxela Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Czech Republic Krka, D.D., Novo Mesto Moflaxa Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 21/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Czech Republic Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 100mg/10 Ml
Concentrate For Solution For Infusion
Oral Use
Czech Republic Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin
Hydrochloride
Monohydrate 582mg/Ml
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto Levaxela Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto Levaxela Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto Moflaxa Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Krka, D.D., Novo Mesto Nolicin Norfloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Czech Republic Lek Pharmaceuticals D.D. Ljubljana
Abaktal Pefloxacin Mesilate Dihydrate 515.3mg/5 Ml
Solution For Infusion Intravenous Use
Czech Republic Lek Pharmaceuticals D.D. Ljubljana
Abaktal Pefloxacin Mesilate Dihydrate 558.56mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Medochemie Ltd. Gyrablock Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Czech Republic Mylan S.A.S Levofloxacin Mylan Levofloxacin
500mg/100 Ml
Solution For Infusion Intravenous Use
Czech Republic Pro.Med.Cs Praha A.S. Cifloxinal Ciprofloxacin Hydrochloride Monohydrate 291mg
Tablet
Film-Coated Tablet Oral Use
Czech Republic Pro.Med.Cs Praha A.S. Cifloxinal Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 22/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Czech Republic Ranbaxy (Uk) Limited Zanocin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Czech Republic Sanofi-Aventis Sro Tavanic Levofloxacin Hemihydrate
5.1246mg/Ml
Solution For Infusion Intravenous Use
Czech Republic Zentiva, K.S. Ofloxin Inf Ofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Czech Republic Zentiva, K.S. Ofloxin 200 Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Denmark Abz-Pharma Gmbh Ciproten Ciprofloxacin Hydrochloride Monohydrate 116.6mg
Tablet
Film-Coated Tablet Oral Use
Denmark Abz-Pharma Gmbh Ciproten Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Abz-Pharma Gmbh Ciproten Ciprofloxacin Hydrochloride
Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Denmark Actavis Group Ptc Ehf. Ciprofloxacin Actavis Ciprofloxacin
Hydrochloride Monohydrate 250mg Tablet
Film-Coated Tablet Oral Use
Denmark Actavis Group Ptc Ehf. Ciprofloxacin Actavis Ciprofloxacin Hydrochloride
Monohydrate 500mg Tablet
Film-Coated Tablet Oral Use
Denmark Actavis Group Ptc Ehf. Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 750mg Tablet
Film-Coated Tablet Oral Use
Denmark Actavis Group Ptc Ehf. Moxifloxacin Actavis Moxifloxacin Hydrochloride 436.37mg Tablet
Film-Coated Tablet Oral Use
Denmark Aliud Pharma Gmbh Ciprotabs Ciprofloxacin 100mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 23/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Denmark Aliud Pharma Gmbh Ciprotabs Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Denmark Aliud Pharma Gmbh Ciprotabs Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Denmark Aliud Pharma Gmbh Ciprotabs Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Denmark Amneal Pharma Europe
Limited
Levofloxacin ”amneal”
Amneal Pharma Europe Limited
Levofloxacin 500mg
Tablet
Film Coated Tablets Oral Use
Denmark Amneal Pharma Europe Limited
Levofloxacin Amneal Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Denmark Amneal Pharma Europe Limited
Levofloxacin Amneal Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Denmark B.Braun Melsungen Ag Levofloxacin ”b. Braun” Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Denmark Bayer Pharma Ag Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Denmark Bayer Pharma Ag Avelox Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Denmark Claris Lifesciences (Uk) Limited
Ciprofloxacin Ciprofloxacin Lactate 2mg/Ml
Solution For Infusion Intravenous Use
Denmark Claris Lifesciences (Uk) Limited
Ciprofloxacin Claris Ciprofloxacin Lactate 2.544mg/Ml
Solution For Infusion Intravenous Use
Denmark Double-E Pharma Ltd Moxifloxacin Double-E Pharma
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Denmark Fresenius Kabi Ab Ciprofloxacin Fresenius Kabi
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Denmark Fresenius Kabi Ab Moxifloxacin Fresenius
Kabi
Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Denmark Generics [uk] Limited Ciprinomyl Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Denmark Hexal A/S Ciprofloxacin Hexal Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Denmark Hexal A/S Ciprofloxacin Hexal Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Denmark Hexal A/S Ciprofloxacin Hexal Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 24/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Denmark Hospira Uk Ltd Ciprofloxacin Hospira Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use | Oral Use
Denmark Krka Sverige Ab Ciprofloxacin Krka Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka Sverige Ab Ciprofloxacin Krka Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Denmark Krka Sverige Ab Ciprofloxacin Krka Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Denmark Krka Sverige Ab Moxifloxacin Krka Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Denmark Mylan Ab Ciprinomyl Ciprofloxacin
200mg/100 Ml
Solution For Infusion Intravenous Use
Denmark Orion Corporation Moxifloxacin Orion Moxifloxacin 400mg Vial
Solution For Infusion Intravenous Use
Denmark Orion Corporation Moxifloxacin Orion Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Denmark Orion Oyj Ciprofloxacin Orion Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Denmark Pharmacodane Aps Cifin Ciprofloxacin 100mg Tablet
Film-Coated Tablet Oral Use
Denmark Pharmacodane Aps Cifin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Denmark Pharmacodane Aps Cifin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Denmark Pharmacodane Aps Cifin Ciprofloxacin Hydrochloride Monohydrate 874.5mg
Tablet
Film-Coated Tablet Oral Use
Denmark Pharmathen S.A. Moxifloxacin
Pharmathen
Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Denmark Pharmathen S.A. Ciprofloxacin Pharmathen
Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 25/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Denmark Pharmathen S.A. Ciprofloxacin Pharmathen
Ciprofloxacin Hydrochloride Monohydrate 583mg
Tablet
Film-Coated Tablet Oral Use
Denmark Pharmathen S.A. Ciprofloxacin Pharmathen
Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Denmark Pharmathen S.A. Moxifloxacin Pharmathen
Moxifloxacin Hydrochloride 436.37mg Tablet
Film-Coated Tablet Oral Use
Denmark Ratiopharm Gmbh Ciprofloxacin Hcl Ratiopharm
Ciprofloxacin Hydrochloride
Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Ratiopharm Gmbh Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride
Monohydrate 100mg Tablet
Film-Coated Tablet Oral Use
Denmark Ratiopharm Gmbh Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Denmark Ratiopharm Gmbh Myrciprox Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Ratiopharm Gmbh Myrciprox Ciprofloxacin Hydrochloride
Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Denmark Sandoz A/S Ciprofloxacin Sandoz Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Denmark Sandoz A/S Ciprofloxacin Sandoz Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Denmark Sandoz A/S Ciprofloxacin Sandoz Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 26/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Denmark Teva Denmark A/S Levofloxacin Teva Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Denmark Teva Denmark A/S Ciprofloxacin Hcl Ratiopharm
Ciprofloxacin Hydrochloride
Monohydrate 874.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Teva Denmark A/S Moxiva Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Denmark Teva Pharma B.V. Ciproscope Ciprofloxacin
Hydrochloride Monohydrate 116.6mg Tablet
Film-Coated Tablet Oral Use
Denmark Teva Pharma B.V. Ciproscope Ciprofloxacin Hydrochloride
Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Denmark Teva Pharma B.V. Ciproscope Ciprofloxacin Hydrochloride
Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Denmark Villerton Invest S.A. Ciprofloxacin Villerton Ciprofloxacin 200mg/100 Ml | Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Estonia +pharma Arzneimittel Gmbh Xyvelam Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Estonia +pharma Arzneimittel Gmbh Xyvelam Levofloxacin
Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Estonia Actavis Group Ptc Ehf. Levoxa Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Estonia Actavis Group Ptc Ehf. Levoxa Levofloxacin
Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 27/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Estonia Actavis Group Ptc Ehf. Velyxa Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Estonia Actavis Group Ptc Ehf. Velyxa Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Estonia Bayer Pharma Ag Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Estonia Bayer Pharma Ag Avelox Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Estonia Jsc Olainfarm Ciprofloxacin Olainfarm Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Estonia Jsc Olainfarm Ciprofloxacin Olainfarm Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto Levnibiot Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Estonia Krka, D.D., Novo Mesto Moflaxa Moxifloxacin 1600µg/Ml Solution For Infusion Intravenous Use
Estonia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin
100mg/10 Ml
Concentrate For
Solution For Infusion
Oral Use
Estonia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 500mg L Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto Levnibiot Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto Levnibiot Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto Moflaxa Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto Nolicin Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Estonia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 100mg/50 Ml
Solution For Infusion Oral Use
Estonia Medochemie Ltd. Medofloxine Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 28/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Estonia Pro.Med.Cs Praha A.S. Cifloxinal Ciprofloxacin Hydrochloride Monohydrate 291mg
Tablet
Film-Coated Tablet Oral Use
Estonia Sandoz Pharmaceuticals D.D. Ciprofloxacin Sandoz Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Estonia Sanofi-Aventis Estonia Oü Tavanic Levofloxacin
Hemihydrate
5.1246mg/Ml
Solution For Infusion Intravenous Use
Estonia Sanofi-Aventis Estonia Oü Tavanic Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Estonia Sanofi-Aventis Estonia Oü Tavanic Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Estonia Zentiva, K.S. Ofloxin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Finland B.Braun Melsungen Ag Levofloxacin B. Braun Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Finland Bayer Pharma Ag Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Finland Bayer Pharma Ag Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Finland Bayer Pharma Ag Ciproxin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Finland Claris Lifesciences (Uk) Limited
Ciprofloxacin Ciprofloxacin Lactate 2mg/Ml
Solution For Infusion Intravenous Use
Finland Double-E Pharma Ltd Moxifloxacin Double-E Pharma
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Finland Fresenius Kabi Ab Ciprofloxacin Fresenius Kabi
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Finland Fresenius Kabi Ab Levofloxacin Fresenius Kabi
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Finland Fresenius Kabi Ab Moxifloxacin Fresenius
Kabi
Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Finland Hexal A/S Ciprofloxacin Hexal Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 29/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Finland Hexal A/S Ciprofloxacin Hexal Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Finland Hexal A/S Ciprofloxacin Hexal Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Finland Krka Sverige Ab Ciprofloxacin Krka Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Finland Krka Sverige Ab Ciprofloxacin Krka Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Finland Krka Sverige Ab Ciprofloxacin Krka Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Finland Krka Sverige Ab Levofloxacin Krka Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Finland Krka Sverige Ab Levofloxacin Krka Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Finland Krka Sverige Ab Moxifloxacin Krka Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Finland Orion Corporation Moxifloxacin Orion Moxifloxacin 400mg
Bottle
Solution For Infusion Intravenous Use
Finland Orion Corporation Moxifloxacin Orion Moxifloxacin 400mg Vial
Solution For Infusion Intravenous Use
Finland Orion Corporation Levofloxacin Orion Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Finland Orion Corporation Moxifloxacin Orion Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Finland Orion Corporation Moxifloxacin Orion Moxifloxacin Hydrochloride
436.37mg Tablet
Film-Coated Tablet Oral Use
Finland Orion Oyj Ciprofloxacin Orion Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Finland Orion Oyj Ciprofloxacin Orion Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Finland Ratiopharm Gmbh Ciprofloxacin
Ratiopharm
Ciprofloxacin
Hydrochloride Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 30/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Finland Ratiopharm Gmbh Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 583mg
Tablet
Film-Coated Tablet Oral Use
Finland Ratiopharm Gmbh Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 874.5mg
Tablet
Film-Coated Tablet Oral Use
Finland Ratiopharm Oy Norfloxacin Ratiopharm Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Finland Sandoz A/S Levofloxacin Sandoz Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Finland Sandoz Gmbh Norfloxacin Sandoz Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Finland Sanofi Oy Tavanic Levofloxacin Hemihydrate 250mg/50 Ml
Solution For Infusion Intravenous Use
Finland Sanofi Oy Tavanic Levofloxacin Hemihydrate 500mg/100 Ml
Solution For Infusion Intravenous Use
Finland Sanofi Oy Tarivid Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Finland Sanofi Oy Tavanic Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Finland Sanofi Oy Tavanic Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Finland Stada Arzneimittel Ag Moxifloxacin Stada Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Finland Teva Sweden Ab Levofloksasiini Teva Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Finland Villerton Invest S.A. Ciprofloxacin Villerton Ciprofloxacin 200mg/100 Ml | Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
France Accord Healthcare France Sas Ciprofloxacine Accord Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
France Accord Healthcare France Sas Ciprofloxacine Accord Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 31/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
France Accord Healthcare France Sas Ciprofloxacine Accord Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
France Accord Healthcare France Sas Levofloxacine Accord Healthcare
Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
France Arrow Generiques Levofloxacine Arrow Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
France Arrow Generiques Levofloxacine Arrow Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
France Arrow Generiques Levofloxacine Arrow Levofloxacin Hemihydrate 5.12mg/Ml
Solution For Infusion Intravenous Use
France Arrow Generiques Levofloxacine Arrow Levofloxacin 500mg
Tablet
Film Coated Tablet Oral Use
France Arrow Generiques Ciprofloxacine Arrow Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
France Arrow Generiques Ciprofloxacine Arrow Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
France Arrow Generiques Ciprofloxacine Arrow Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
France Arrow Generiques Ciprofloxacine Quiver Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
France Arrow Generiques Ciprofloxacine Quiver Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Arrow Generiques Ciprofloxacine Quiver Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
France Arrow Generiques Levofloxacine Arrow Levofloxacin Hemihydrate 500mg
Tablet
Film-Coated Tablet Oral Use
France Arrow Generiques Lévofloxacine Arrow Lab
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Arrow Generiques Norfloxacine Arrow Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
France Arrow Generiques Ofloxacine Arrow Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
France B.Braun Melsungen Ag Levofloxacine B.Braun Levofloxacin
500mg/100 Ml
Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 32/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
France Bayer Healthcare Ciflox Ciprofloxacin 100mg/50 Ml
Solution For Infusion Intravenous Use
France Bayer Healthcare Ciflox Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
France Bayer Healthcare Ciflox Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
France Bayer Healthcare Izilox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
France Bayer Healthcare Ciflox Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
France Bayer Healthcare Ciflox Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Bayer Healthcare Ciflox Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
France Bayer Healthcare Izilox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
France Bayer Healthcare Uniflox Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
France Bayer Healthcare Ciflox Ciprofloxacin Hydrated 250mg/5 Ml
Granules And Solvent For Oral Suspension
Oral Use
France Bayer Healthcare Ciflox Ciprofloxacin Hydrated
500mg/5 Ml
Granules And Solvent
For Oral Suspension
Oral Use
France Bayer Pharma Ag Octegra Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
France Biocodex Benelux Nv/Sa Decalogiflox Lomefloxacin
Hydrochloride 441.6mg Tablet
Film-Coated Tablet Oral Use
France Biogaran Ciprofloxacine Biogaran Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
France Biogaran Ciprofloxacine Biogaran Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
France Biogaran Levofloxacine Biogaran Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Biogaran Moxifloxacine Biogaran Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
France Biogaran Ofloxacine Almus Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 33/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
France Biogaran Ofloxacine Biogaran Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
France Biogaran Norfloxacine Biogaran Norfloxacin 400mg Tablet
Tablet Oral Use
France Claris Lifesciences (Uk) Limited
Ciprofloxacin Ciprofloxacin Lactate 2mg/Ml
Solution For Infusion Intravenous Use
France Claris Lifesciences (Uk)
Limited
Ciprofloxacine Ciprofloxacin Lactate
2mg/Ml
Solution For Infusion Intravenous Use
France Cristers Norfloxacine Cristers Norfloxacin 400mg Tablet
Film Coated Tablets Oral Use
France Cristers Ciprofloxacine Cristers Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
France Cristers Ciprofloxacine Cristers Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Cristers Levofloxacine Cristers Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Cristers Ofloxacine Cristers Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
France Eg Labo Laboratoires Eurogenerics
Levofloxacine Eg Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
France Eg Labo Laboratoires Eurogenerics
Ciprofloxacine Eg Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
France Eg Labo Laboratoires Eurogenerics
Ciprofloxacine Eg Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Eg Labo Laboratoires Eurogenerics
Levofloxacine Eg Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Eg Labo Laboratoires Eurogenerics
Moxifloxacine Eg Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
France Eg Labo Laboratoires Eurogenerics
Norfloxacine Eg Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
France Eg Labo Laboratoires
Eurogenerics
Ofloxacine Eg Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
France Evolupharm Ciprofloxacine Evolugen
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Evolupharm Levofloxacine Evolugen Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
France Evolupharm Ofloxacine Evolugen Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 34/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
France Fresenius Kabi France S.A.S. Ciprofloxacine Kabi Ciprofloxacin 200g/100 Ml
Solution For Infusion Intravenous Use
France Fresenius Kabi France S.A.S. Ciprofloxacine Kabi Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
France Fresenius Kabi France S.A.S. Ciprofloxacine Kabi Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
France Fresenius Kabi France S.A.S. Levofloxacine Kabi Levofloxacin
Hemihydrate 5.125mg/Ml
Solution For Infusion Intravenous Use
France Hospira France Levofloxacine Hospira Levofloxacin Hemihydrate 5.125mg/Ml
Solution For Infusion Intravenous Use
France Krka, D.D., Novo Mesto Levofloxacine Krka Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
France Krka, D.D., Novo Mesto Levofloxacine Krka Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Krka, D.D., Novo Mesto Moxifloxacine Krka Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
France Laboratoires Alter Ciprofloxacine Alter Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
France Laboratoires Alter Ciprofloxacine Alter Ciprofloxacin Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
France Laboratoires Gerda Apurone Flumequine 0.4g Tablet Tablet Oral Use
France Maco Pharma Ciprofloxacine Macopharma
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
France Maco Pharma Ciprofloxacine Macopharma
Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
France Maco Pharma Ofloxacine
Macopharma
Ofloxacin 200mg/40 Ml Solution For Infusion Intravenous Use
France Maco Pharma Ofloxacine Macopharma
Ofloxacin 5mg/Ml Solution For Infusion Intravenous Use
France Mylan S.A.S Ciprofloxacine Mylan Ciprofloxacin
200mg/100 Ml
Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 35/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
France Mylan S.A.S Ciprofloxacine Mylan Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
France Mylan S.A.S Ciprofloxacine Mylan Pharma
Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
France Mylan S.A.S Levofloxacine Mylan Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
France Mylan S.A.S Ofloxacine Mylan Ofloxacin 200mg/40 Ml Solution For Infusion Intravenous Use
France Mylan S.A.S Ofloxacine Mylan Pharma
Ofloxacin 200mg/40 Ml Solution For Infusion Intravenous Use
France Mylan S.A.S Ciprofloxacine Mylan Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
France Mylan S.A.S Ciprofloxacine Mylan Ciprofloxacin
Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
France Mylan S.A.S Ciprofloxacine Mylan Ciprofloxacin Hydrochloride 750mg
Tablet
Film-Coated Tablet Oral Use
France Mylan S.A.S Levofloxacine Mylan Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Mylan S.A.S Moxifloxacine Mylan Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
France Mylan S.A.S Norfloxacine Mylan Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
France Mylan S.A.S Ofloxacine Mylan Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
France Panpharma Ciprofloxacine Panpharma
Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
France Panpharma Ciprofloxacine Panpharma
Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
France Panpharma Ciprofloxacine Panpharma
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Pierre Fabre Medicament Enoxor Enoxacin 200mg Tablet Film-Coated Tablet Oral Use
France Ranbaxy Pharmacie Generiques
Ciprofloxacine Ranbaxy Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
France Ranbaxy Pharmacie Generiques
Ciprofloxacine Ranbaxy Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 36/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
France Ranbaxy Pharmacie Generiques
Levofloxacine Ranbaxy Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
France Ranbaxy Pharmacie Generiques
Norfloxacine Ranbaxy Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
France Ranbaxy Pharmacie Generiques
Ofloxacine Ranbaxy Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
France Ratiopharm Gmbh Ciprofloxacine
Ratiopharm
Ciprofloxacin
Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
France Ratiopharm Gmbh Ciprofloxacine Ratiopharm
Ciprofloxacin Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
France Ratiopharm Gmbh Norfloxacine Ratiopharm
Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
France Ratiopharm Gmbh Ofloxacine Ratiopharm Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
France Sandoz Ciprofloxacine Sandoz Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
France Sandoz Ciprofloxacine Sandoz Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
France Sandoz Levofloxacine Sandoz Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
France Sandoz Moxifloxacine Sandoz Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
France Sandoz Norfloxacine Sandoz Norfloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
France Sandoz Ofloxacine Sandoz Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
France Sanofi-Aventis France Peflacine Pefloxacin Mesilate 3.2mg/Ml
Solution For Infusion Intravenous Use
France Sanofi-Aventis France Peflacine Pefloxacin Mesilate
80mg/Ml
Solution For Infusion Intravenous Use
France Sanofi-Aventis France Tavanic Levofloxacin Hemihydrate 5.1246mg/Ml
Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 37/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
France Sanofi-Aventis France Ciprofloxacine Ciprofloxacin Hydrochloride 291.5mg Tablet
Film-Coated Tablet Oral Use
France Sanofi-Aventis France Ciprofloxacine Ciprofloxacin Hydrochloride 583mg Tablet
Film-Coated Tablet Oral Use
France Sanofi-Aventis France Levofloxacine Levofloxacin
Hemihydrate 512.46mg
Tablet
Film-Coated Tablet Oral Use
France Sanofi-Aventis France Monoflocet Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
France Sanofi-Aventis France Norfloxacine Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
France Sanofi-Aventis France Oflocet Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
France Sanofi-Aventis France Ofloxacine Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
France Sanofi-Aventis France Peflacine Pefloxacin Mesilate 400mg Tablet
Film-Coated Tablet Oral Use
France Sanofi-Aventis France Peflacine Monodose Pefloxacin Mesilate
400mg Tablet
Film-Coated Tablet Oral Use
France Sanofi-Aventis France Pipram Pipemidic Acid 400mg Tablet
Film-Coated Tablet Oral Use
France Sanofi-Aventis France Tavanic Levofloxacin Hemihydrate 256.23mg
Tablet
Film-Coated Tablet Oral Use
France Sanofi-Aventis France Tavanic Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
France Teva Santé Levofloxacine Almus Levofloxacin Hemihydrate 512.46mg Tablet
Coated Tablet Oral Use
France Teva Santé Ciprofloxacin Teva Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
France Teva Santé Ciprofloxacin Teva Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 38/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
France Teva Santé Ciprofloxacine Teva Ciprofloxacin Hydrochloride 750mg Tablet
Film-Coated Tablet Oral Use
France Teva Santé Levofloxacine Teva Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
France Teva Santé Norfloxacin Teva Norfloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
France Teva Santé Ofloxacine Teva Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
France Zydus France Ciprofloxacine Zydus Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
France Zydus France Ciprofloxacine Zydus Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
France Zydus France Levofloxacine Zydus Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Cipro Ciprofloxacin 100mg
Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Cipro Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Cipro Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Cipro Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Levofloxacin 1 A Pharma
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Levofloxacin 1 A Pharma
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Moxifloxacin 1 A Pharma
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Norfloxacin 1 A Pharma Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Ofloxacin 1 A Pharma Ofloxacin 100mg Tablet Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Ofloxacin 1 A Pharma Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Germany 1 A Pharma Gmbh Ofloxacin 1 A Pharma Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 39/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany Abz-Pharma Gmbh Ciproflox Ciprofloxacin Hydrochloride 100mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Ciproflox Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Ciproflox Ciprofloxacin
Hydrochloride 500mg
Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Ciprofloxacin Abz Ciprofloxacin Hydrochloride Monohydrate 116.6mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Ciprofloxacin Abz Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Ciprofloxacin Abz Ciprofloxacin
Hydrochloride Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Levoflox-Ct Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Levoflox-Ct Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Levofloxacin Abz Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Moxifloxacin Abz Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Norfloxacin Abz Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Abz-Pharma Gmbh Ofloxacin Abz Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Germany Actavis Group Ptc Ehf. Moxifloxacin Actavis Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Ciprofloxacin Al Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany Aliud Pharma Gmbh Ciprofloxacin Al Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Ciprofloxacin Al Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Ciprofloxacin Uro Al Ciprofloxacin 100mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Levofloxacin Al Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Levofloxacin Al Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Moxifloxacin Al Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Norfloxacin Al Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Ofloxacin Al Ofloxacin 100mg Tablet Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Ofloxacin Al Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Germany Aliud Pharma Gmbh Ofloxacin Al Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Germany Aristo Pharma Gmbh (Art 57) Ciprofloxacin Aristo Ciprofloxacin Hydrochloride Monohydrate 250mg
Tablet
Film-Coated Tablet Oral Use
Germany Aristo Pharma Gmbh (Art 57) Ciprofloxacin Aristo Ciprofloxacin Hydrochloride Monohydrate 500mg
Tablet
Film-Coated Tablet Oral Use
Germany Aristo Pharma Gmbh (Art 57) Ciprofloxacin Aristo Ciprofloxacin Hydrochloride Monohydrate 750mg Tablet
Film-Coated Tablet Oral Use
Germany Aristo Pharma Gmbh (Art 57) Levofloxacin Aristo Levofloxacin
Hemihydrate 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 41/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany Aristo Pharma Gmbh (Art 57) Levofloxacin Aristo Levofloxacin Hemihydrate 500mg Tablet
Film-Coated Tablet Oral Use
Germany Aurobindo Pharma Gmbh Moxifloxacin Aurobindo Moxifloxacin Hydrochloride 436.32mg Tablet
Film Coated Tablet Oral Use
Germany Aurobindo Pharma Gmbh Levofloxacin Aurobindo Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Germany Aurobindo Pharma Gmbh Levofloxacin Aurobindo Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Axcount Generika Gmbh Ciprofloxacin Axcount Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Axcount Generika Gmbh Ciprofloxacin Axcount Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Basics Gmbh Cipro Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Basics Gmbh Cipro Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Germany Basics Gmbh Cipro Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Germany Basics Gmbh Oflox Ofloxacin 100mg Tablet Film-Coated Tablet Oral Use
Germany Basics Gmbh Oflox Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Germany Basics Gmbh Oflox Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Germany Bayer Vital Gmbh Actira Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Germany Bayer Vital Gmbh Avalox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Germany Bayer Vital Gmbh Ciprobay Ciprofloxacin
100mg/50 Ml
Solution For Infusion Intravenous Use
Germany Bayer Vital Gmbh Ciprobay Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Germany Bayer Vital Gmbh Ciprobay Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Germany Bayer Vital Gmbh Octegra Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Germany Bayer Vital Gmbh Actira Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 42/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany Bayer Vital Gmbh Avalox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Bayer Vital Gmbh Ciprobay Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Bayer Vital Gmbh Ciprobay Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Bayer Vital Gmbh Ciprobay Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Germany Bayer Vital Gmbh Octegra Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Bayer Vital Gmbh Ciprobay Ciprofloxacin 250mg/5
Ml
Granules And Solvent
For Oral Suspension
Oral Use
Germany Bayer Vital Gmbh Ciprobay Ciprofloxacin Hydrated 500mg/5 Ml
Granules And Solvent For Oral Suspension
Oral Use
Germany Betapharm Arzneimittel Gmbh Ciprobeta Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Betapharm Arzneimittel Gmbh Ciprobeta Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Germany Denk Pharma Gmbh & Co. Kg Levofloxacin Denk Pharma Gmbh & Co. Kg
Levofloxacin Hemihydrate
5.13mg/Ml
Solution For Infusion Intravenous Use
Germany Denk Pharma Gmbh & Co. Kg Cipro Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Denk Pharma Gmbh & Co. Kg Cipro Ciprofloxacin
Hydrochloride Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Germany Denk Pharma Gmbh & Co. Kg Levofloxacin Denk Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Denk Pharma Gmbh & Co. Kg Levofloxacin Denk Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Dolorgiet Gmbh & Co Kg Ciprofloxacin Real Ciprofloxacin Hydrochloride 873mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 43/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany Dolorgiet Gmbh & Co Kg Ciprofloxacin Real Ciprofloxacin Hydrochloride Monohydrate 291mg
Tablet
Film-Coated Tablet Oral Use
Germany Dolorgiet Gmbh & Co Kg Ciprofloxacin Real Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Film-Coated Tablet Oral Use
Germany Dolorgiet Gmbh & Co Kg Ciprofloxacin Real Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Germany Double-E Pharma Ltd Moxifloxacin Double-E
Pharma
Moxifloxacin 400mg
Tablet
Film Coated Tablets Oral Use
Germany Dr. Friedrich Eberth Arzneimittel Gmbh
Levofloxacin Dr. Eberth Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
Germany Dr. Friedrich Eberth
Arzneimittel Gmbh
Levofloxacin Eberth Levofloxacin 250mg/50
Ml
Solution For Infusion Intravenous Use
Germany Dr. R. Pfleger Chemische Fabrik Gmbh
Keciflox Ciprofloxacin Hydrochloride 291.5mg Tablet
Film-Coated Tablet Oral Use
Germany Dr. R. Pfleger Chemische
Fabrik Gmbh
Keciflox Ciprofloxacin
Hydrochloride 583mg Tablet
Film-Coated Tablet Oral Use
Germany Dr. R. Pfleger Chemische Fabrik Gmbh
Keciflox Ciprofloxacin Hydrochloride 874.5mg Tablet
Film-Coated Tablet Oral Use
Germany Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Healthcare
Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Germany Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Healthcare
Ciprofloxacin Hydrochloride 582mg
Tablet
Film-Coated Tablet Oral Use
Germany Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Healthcare
Ciprofloxacin Hydrochloride 873mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 44/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany Fresenius Kabi Deutschland Gmbh
Ciprofloxacin Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Germany Fresenius Kabi Deutschland Gmbh
Levofloxacin Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Germany Fresenius Kabi Deutschland Gmbh
Moxifloxacin Kabi Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Germany G.E.S. Genéricos Españoles
Laboratorio, S.A.
Moxifloxacin Eberth Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Germany Hameln Pharma Plus Gmbh Ciprofloxacin Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Germany Hameln Pharma Plus Gmbh Levofloxacin Hameln Levofloxacin Hemihydrate 256.5mg/50 Ml
Solution For Infusion Intravenous Use
Germany Hec Pharm Gmbh Ciprofloxacin Hec Pharm
Ciprofloxacin 100mg Tablet
Film-Coated Tablet Oral Use
Germany Hec Pharm Gmbh Ciprofloxacin Hec Pharm
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Hec Pharm Gmbh Ciprofloxacin Hec Pharm
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Hec Pharm Gmbh Ciprofloxacin Hec Pharm
Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Germany Hec Pharm Gmbh Levofloxacin Hec Pharm Hec Pharm
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Hec Pharm Gmbh Levofloxacin Hec Pharm Hec Pharm
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Hec Pharm Gmbh Moxifloxacin Hec Pharm Hec Pharm
Moxifloxacin Hydrochloride 400mg Tablet
Film-Coated Tablet Oral Use
Germany Hetero Europe S.L. Levofloxacin Hetero Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Germany Hetero Europe S.L. Levofloxacin Hetero Levofloxacin Hemihydrate 512.47mg Tablet
Film-Coated Tablet Oral Use
Germany Heumann Pharma Gmbh &
Co. Generica Kg
Ciprofloxacin Heumann Ciprofloxacin 100mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 45/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany Heumann Pharma Gmbh & Co. Generica Kg
Ciprofloxacin Heumann Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Heumann Pharma Gmbh & Co. Generica Kg
Ciprofloxacin Heumann Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Heumann Pharma Gmbh & Co. Generica Kg
Levofloxacin Heumann Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Heumann Pharma Gmbh &
Co. Generica Kg
Levofloxacin Heumann Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Germany Heumann Pharma Gmbh & Co. Generica Kg
Moxifloxacin Heumann Moxifloxacin Hydrochloride Ph. Eur. 436.37mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Ciprohexal Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Germany Hexal Ag Ciprohexal Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Germany Hexal Ag Cipromedica Ciprofloxacin
200mg/100 Ml
Solution For Infusion Intravenous Use
Germany Hexal Ag Cipromedica Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Germany Hexal Ag Levofloxacin Hexal Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Germany Hexal Ag Moxifloxacin Hexal Moxifloxacin 400mg/250 Ml
Solution For Infusion Intravenous Use
Germany Hexal Ag Ciprohexal Ciprofloxacin 100mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Ciprohexal Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Ciprohexal Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Ciprohexal Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Levofloxacin Hexal Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Levofloxacin Hexal Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 46/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany Hexal Ag Moxifloxacin Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Norflohexal Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Norflox Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Oflohexal Ofloxacin 100mg Tablet Film-Coated Tablet Oral Use
Germany Hexal Ag Oflohexal Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Germany Hexal Ag Oflohexal Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Germany Hexal Ag Oflox Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Germany Hikma Farmacêutica (Portugal), S.A.
Ciprofloxacin Hikma Ciprofloxacin 200mg Vial
Solution For Infusion Intravenous Use
Germany Hikma Farmacêutica (Portugal), S.A.
Levofloxacin Hikma Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Germany Ibigen Srl Levofloxacin Ibisqus Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Germany Ibigen Srl Moxifloxacin Ibisqus Moxifloxacin 400mg/250 Ml
Solution For Infusion Intravenous Use
Germany Iip - Institut Für Industrielle Pharmazie Forschungs- Und Entwicklungsgesellschaft Mbh
Levitis Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Iip - Institut Für Industrielle Pharmazie Forschungs- Und
Entwicklungsgesellschaft Mbh
Levitis Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Infomed Fluids Srl Ciprofloxacin Infomed Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Germany Infomed Fluids Srl Levofloxacin Infomed
Fluids
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Germany Inresa Arzneimittel Gmbh Moxifloxacin Moxifloxacin 400mg/250 Ml
Solution For Infusion Intravenous Use
Germany Laboratorios Normon, S.A. Ciprofloxacin Normon Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Germany Laboratorios Normon, S.A. Levofloxacin Normon Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Germany Lyomark Pharma Gmbh Levofloxacin Lyomark Levofloxacin 250mg/50 Ml
Solution For Infusion Infusion
Annex I
EMA/88273/2017 Page 47/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany Lyomark Pharma Gmbh Ciprofloxacin Lyomark Ciprofloxacin Lactate 2.54mg/Ml
Solution For Infusion Intravenous Use
Germany Macleods Pharma Uk Ltd Levofloxacin Macleods Pharma Uk
Levofloxacin Hemihydrate 256.23mg Tablet
Film Coated Tablets Oral Use
Germany Macleods Pharma Uk Ltd Levofloxacin Macleods Pharma Uk Limited
Levofloxacin 250mg Tablet
Film Coated Tablets Oral Use
Germany Mip Pharma Gmbh Cipro-Saar Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Mip Pharma Gmbh Cipro-Saar Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Mylan Dura Gmbh Levofloxacin Dura Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Germany Mylan Dura Gmbh Levofloxacin Dura Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Mylan Dura Gmbh Moxifloxacin Mylan Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Germany Noridem Enterprises Ltd Ciprofloxacin Noridem Enterprises
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Germany Noridem Enterprises Ltd Levofloxacin Noridem
Enterprises
Levofloxacin
500mg/100 Ml
Solution For Infusion Intravenous Use
Germany Noridem Enterprises Ltd Moxifloxacin Noridem Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Germany Pharma Resources Gmbh Levofloxacin Phares Pharma Resources
Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Germany Pierre Fabre Pharma Gmbh / Germany
Enoxor Enoxacin Sesquihydrate 217mg Tablet
Film-Coated Tablet Oral Use
Germany Puren Pharma Gmbh & Co. Kg Moxifloxacin Puren Moxifloxacin Hydrochloride 436.32mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 116.6mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 48/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany Ratiopharm Gmbh Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 291.5mg
Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 583mg
Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 874.5mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Levofloxacin
Ratiopharm
Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Levofloxacin Ratiopharm
Levofloxacin Hemihydrate 512.46mg
Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Moxifloxacin Ratiopharm
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Norfloxacin Ratiopharm Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Ofloxacin Ratiopharm Ofloxacin 100mg Tablet Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Ofloxacin Ratiopharm Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Germany Ratiopharm Gmbh Ofloxacin Ratiopharm Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Germany Sanofi-Aventis Deutschland
Gmbh
Tarivid Ofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Germany Sanofi-Aventis Deutschland Gmbh
Tavanic Levofloxacin Hemihydrate 5.1246mg/Ml
Solution For Infusion Intravenous Use
Germany Sanofi-Aventis Deutschland Gmbh
Tarivid Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Germany Sanofi-Aventis Deutschland Gmbh
Tavanic Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 49/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany Sanofi-Aventis Deutschland Gmbh
Tavanic Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Sanovel Holding B.V. Levofloxacin Sanovel Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Stada Arzneimittel Ag Norfloxa Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Stadapharm Gmbh Moxifloxacin Stada Moxifloxacin
400mg/250 Ml
Solution For Infusion Intravenous Use
Germany Stadapharm Gmbh Ciprofloxacin Stada Ciprofloxacin 100mg Tablet
Film-Coated Tablet Oral Use
Germany Stadapharm Gmbh Ciprofloxacin Stada Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Germany Stadapharm Gmbh Ciprofloxacin Stada Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Stadapharm Gmbh Ciprofloxacin Stada Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Germany Stadapharm Gmbh Levofloxacin Stada Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Germany Stadapharm Gmbh Levofloxacin Stada Levofloxacin
Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Germany Stadapharm Gmbh Moxifloxacin Stada Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Stadapharm Gmbh Norfloxacin Stada Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Stadapharm Gmbh Ofloxacin Stada Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Germany Stadapharm Gmbh Ofloxacin Stada Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Germany T&d Pharma Gmbh Ciprofloxacin Aiwa Ciprofloxacin Hydrochloride
Monohydrate 291.1mg Tablet
Film-Coated Tablet Oral Use
Germany T&d Pharma Gmbh Ciprofloxacin Aiwa Ciprofloxacin Hydrochloride Monohydrate 582.2mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 50/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany T&d Pharma Gmbh Levofloxacin Aiwa Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Moxifloxacin Tad Moxifloxacin 1600µg/Ml Solution For Infusion Intravenous Injection
Germany Tad Pharma Gmbh Cipro-Saar Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Cipro-Saar Ciprofloxacin Hydrochloride 582mg
Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Cipro-Saar Ciprofloxacin Hydrochloride 873mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Moxifloxacin Tad Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Tad Pharma Gmbh Norflosal Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Germany Teofarma S.R.L. Barazan Norfloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Germany Teva Gmbh Ciprofloxacin Teva Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Germany Teva Gmbh Levofloxacin Teva Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Germany Deutsche Bundeswehr Kommando Sanitätsdienst der
Bundeswehr
Ciprofloxacin Bundeswehr
Ciprofloxacin Hydrochloride 291mg
Tablet
Film-Coated Tablet Oral Use
Germany Deutsche Bundeswehr Kommando Sanitätsdienst der Bundeswehr
Ciprofloxacin Bundeswehr
Ciprofloxacin 2mg/ml Solution For Infusion Intravenous Use
Germany Docpharm Arzneimittelvertrieb GmbH & Co. Kommanditgesellschaft auf Aktien
Ciprodoc Ciprofloxacin Hydrochloride 116,4mg tablet
Film-Coated Tablet Oral Use
Germany Docpharm Arzneimittelvertrieb GmbH &
Co. Kommanditgesellschaft auf Aktien
Ciprodoc Ciprofloxacin Hydrochloride 291mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 51/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Germany Docpharm Arzneimittelvertrieb GmbH & Co. Kommanditgesellschaft
auf Aktien
Ciprodoc Ciprofloxacin Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
Germany Claris Lifesciences (Uk) Limited
Ciprofloxacin Claris Ciprofloxacin Lactate 2mg/ml
Solution For Infusion Intravenous Use
Greece Actavis Group Ptc Ehf. Moxifloxacin Actavis Moxifloxacin
Hydrochloride 400mg
Tablet
Film-Coated Tablet Oral Use
Greece Alet Pharmaceuticals Sa Ciprospes Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Greece Anfarm Hellas Sa Aristin-C Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Greece Anfarm Hellas Sa Aristin - C Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Greece Anfarm Hellas Sa Aristin - C Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Greece Anfarm Hellas Sa Fluseminal Norfloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Greece Angelini Pharma Hellas S.A. Afenoxin Ciprofloxacin 250mg Tablet
Coated Tablet Oral Use
Greece Angelini Pharma Hellas S.A. Afenoxin Ciprofloxacin 500mg
Tablet
Coated Tablet Oral Use
Greece Angelini Pharma Hellas S.A. Prixina Prulifloxacin 600mg / Milli Tablet
Film-Coated Tablet Oral Use
Greece Bayer Hellas Sa Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Greece Bayer Hellas Sa Ciproxin Ciprofloxacin
200mg/100 Ml
Solution For Infusion Intravenous Use
Greece Bayer Hellas Sa Ciproxin Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Greece Bayer Hellas Sa Avelox Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Greece Bayer Hellas Sa Ciproxin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Greece Bayer Hellas Sa Ciproxin Ciprofloxacin Hydrated
250mg/5 Ml
Granules And Solvent
For Oral Suspension
Oral Use
Annex I
EMA/88273/2017 Page 52/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Greece Bayer Hellas Sa Ciproxin Ciprofloxacin Hydrated 500mg/5 Ml
Granules And Solvent For Oral Suspension
Oral Use
Greece Bayer Hellas Sa Ciproxin Xr Ciprofloxacin Hydrochloride 334.8mg Tablet, Ciprofloxacin Hydrated 253mg Tablet
Modified-Release Tablet
Oral Use
Greece Bayer Hellas Sa Ciproxin Xr Ciprofloxacin
Hydrochloride 669.4mg
Tablet, Ciprofloxacin Hydrated 506mg Tablet
Modified-Release
Tablet
Oral Use
Greece Bros Ltd Citrovenot Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Greece Bros Ltd Citrovenot Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Greece Bros Ltd Citrovenot Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Greece Bros Ltd Citrovenot Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Greece Bros Ltd Citrovenot Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Greece Cooper S.A. Pharmaceuticals Levofloxacin Cooper Levofloxacin
Hemihydrate 5.1246mg
Solution For Infusion Intravenous Use
Greece Cooper S.A. Pharmaceuticals Mikrobiel Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Greece Cooper S.A. Pharmaceuticals Nafloxin Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Greece Demo Abee Moxifalon Moxifloxacin 400mg/250 Ml
Solution For Infusion Intravenous Use
Greece Demo Abee Talerin Levofloxacin Hemihydrate 500mg/100 Ml
Solution For Infusion Intravenous Use
Greece Demo Abee Ufexil Ciprofloxacin Lactate 2.55mg/Ml
Solution For Infusion Intravenous Use
Greece Demo Abee Talerin Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 53/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Greece Demo Abee Talerin Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Greece Demo Abee Ufexil Ciprofloxacin Hydrochloride Monohydrate 292mg Tablet
Film-Coated Tablet Oral Use
Greece Demo Abee Ufexil Ciprofloxacin
Hydrochloride Monohydrate 584mg Tablet
Film-Coated Tablet Oral Use
Greece Demo Abee Ufexil Ciprofloxacin Hydrochloride
Monohydrate 876mg Tablet
Film-Coated Tablet Oral Use
Greece Elpen Pharmaceutical Co. Inc. Octegra Moxifloxacin 400mg/250 Ml
Solution For Infusion Intravenous Use
Greece Elpen Pharmaceutical Co. Inc. Topistin Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Greece Elpen Pharmaceutical Co. Inc. Octegra Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Greece Elpen Pharmaceutical Co. Inc. Topistin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Greece Elpen Pharmaceutical Co. Inc. Topistin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Greece Farmellas Enterprises Ltd Cipromycin Ciprofloxacin Hydrochloride Monohydrate 583mg
Tablet
Film-Coated Tablet Oral Use
Greece Finixfarm Ltd Flociprin Ciprofloxacin Lactate 254mg/100 Ml
Solution For Infusion Intravenous Use
Greece Finixfarm Ltd Flociprin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Greece Fresenius Kabi Hellas A.E. Ciprofloxacin Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Greece Fresenius Kabi Hellas A.E. Levofloxacin Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 54/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Greece Gap S.A. ιdrostamin Pefloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Greece Genepharm S.A. Grenis-Cirpo Ciprofloxacin 2mg/Ml Solution For Injection Intravenous Infusion
Greece Genepharm S.A. Grenis-Cirpo Ciprofloxacin Lactate 2mg/Ml
Solution For Injection Intravenous Infusion
Greece Genepharm S.A. Grenis-Cipro Ciprofloxacin 250mg
Tablet
Film Coated Tablet Oral Use
Greece Genepharm S.A. Grenis-Cipro Ciprofloxacin 500mg Tablet
Film Coated Tablet Oral Use
Greece Genepharm S.A. Grenis Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Greece Genepharm S.A. Grenis-Oflo Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Greece Generics [uk] Limited Levofloxacin Generics Levofloxacin Hemihydrate 5.12mg L
Solution For Infusion Intravenous Use
Greece Generics [uk] Limited Levofloxacin Generics Levofloxacin Hemihydrate
500mg/100 Ml
Solution For Infusion Intravenous Use
Greece Generics [uk] Limited Ciprofloxacin Generics Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Greece Generics Pharma Hellas Ltd Ciprofloxacin Generics Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Greece Help Abee Forterra Ciprofloxacin Lactate
127mg/50 Ml
Solution For Infusion Intravenous Use
Greece Help Abee Forterra Ciprofloxacin Lactate 254mg/100 Ml
Solution For Infusion Intravenous Use
Greece Help Abee Forterra Ciprofloxacin
Hydrochloride
Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Greece Help Abee Forterra Ciprofloxacin Hydrochloride Monohydrate 583mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 55/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Greece Help Abee Forterra Ciprofloxacin Hydrochloride Monohydrate 872.7mg
Tablet
Film-Coated Tablet Oral Use
Greece Libytec Pharmaceutical S.A. Flaxidel Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Greece Libytec Pharmaceutical S.A. Flaxidel Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Greece Medichrom A.E. Steinaclox Norfloxacin 400mg Capsule Oral Use
Greece Medicus A.E Floxitard Levofloxacin Hemihydrate 500mg/100 Ml
Solution For Infusion Intravenous Use
Greece Meditrina Pharmaceutical Limited
Glimbax Prulifloxacin 600mg Tablet
Film Coated Tablets Oral Use
Greece Nexus Medicals S.A. Ciprofloxacin Nexus Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Greece Noridem Enterprises Ltd Ciprofloxacin Noridem Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Greece Norma Hellas S.A. Revionorm Ciprofloxacin
200mg/100 Ml
Solution For Infusion Intravenous Use
Greece Norma Hellas S.A. Revionorm Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Greece Norma Hellas S.A. Revionorm Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmanel Commercial Pharmaceutical S.A.
Levofloxacin Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Greece Pharmanel Commercial Pharmaceutical S.A.
Bivorilan Ciprofloxacin Hydrochloride
Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmathen Hellas S.A. Evoxil Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Greece Pharmathen Hellas S.A. Ladinin Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Greece Pharmathen Hellas S.A. Ladinin Ciprofloxacin 2mg Solution For Infusion Intravenous Use
Greece Pharmathen Hellas S.A. Ladinin Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 56/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Greece Pharmathen Hellas S.A. Tamvelier Moxifloxacin 400mg/250 Ml
Solution For Infusion Intravenous Use
Greece Pharmathen Hellas S.A. Evoxil Levofloxacin Hemihydrate 250mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmathen Hellas S.A. Evoxil Levofloxacin Hemihydrate 500mg
Tablet
Film-Coated Tablet Oral Use
Greece Pharmathen Hellas S.A. Ladinin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmathen Hellas S.A. Ladinin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmathen Hellas S.A. Ladinin Ciprofloxacin Hydrochloride Monohydrate 750mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmathen Hellas S.A. Tamvelier Moxifloxacin
Hydrochloride 436.37mg Tablet
Film-Coated Tablet Oral Use
Greece Pharmathen S.A. Levofloxacin φαρματεν Levofloxacin Hemihydrate 5.1246mg/Ml
Solution For Infusion Intravenous Use
Greece Proel Epam G Koronis Sa Pharmaceuticals
Ciprofloxacin Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Greece Proel Epam G Koronis Sa Pharmaceuticals
Levoprolin Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Greece Proel Epam G Koronis Sa
Pharmaceuticals
Ciprofloxacin Ciprofloxacin
Hydrochloride 291.5mg Tablet
Film-Coated Tablet Oral Use
Greece Rafarm Sa. Pistofil Norfloxacin 400mg Tablet
Coated Tablet Oral Use
Greece Rafarm Sa. Ravalton Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Greece Rafarm Sa. Ravalton Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 57/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Greece Sandoz Pharmaceuticals D.D. Moxifloxacin Sandoz Moxifloxacin Hydrochloride 400mg Tablet
Film-Coated Tablet Oral Use
Greece Sanofi-Aventis Aebe Tavanic Levofloxacin Hemihydrate 5.1246mg/Ml
Solution For Infusion Intravenous Use
Greece Sanofi-Aventis Aebe Tabrin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Greece Sanofi-Aventis Aebe Tavanic Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Greece Sanofi-Aventis Aebe Tavanic Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Greece Sja Pharm Ltd Labentrol Ciprofloxacin Lactate 2.54mg/Ml
Solution For Infusion Intravenous Use
Greece Sja Pharm Ltd Labentrol Ciprofloxacin Hydrochloride
Monohydrate 583mg
Tablet
Film-Coated Tablet Oral Use
Greece Sja Pharm Ltd Labentrol Ciprofloxacin Hydrochloride Monohydrate 875.3mg Tablet
Film-Coated Tablet Oral Use
Greece Special Medicines Pharmaceutical Products Single-Member Private Company (Pc)
Balepton Ciprofloxacin 500mg Film-Coated Tablet Oral Use
Greece Specifar S.A. Floxator Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Greece Specifar S.A. Floxator Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Greece Specifar S.A. Floxator Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Greece Specifar Sa Floxator Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Greece Specifar Sa Floxator Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 58/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Greece Specifar Sa Floxator Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Greece Specifar Sa Urospes-N Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Greece Terix Labs Ltd Fairlim Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Greece Terix Labs Ltd Fairlim Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Greece Teva Pharma B.V. Ciprofloxacin Teva Ciprofloxacin Hydrochloride 2mg/100 Ml
Solution For Infusion Intravenous Use
Greece Teva Pharma B.V. Levofloxacin Teva Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Greece Teva Pharma B.V. Ciprofloxacin Teva Ciprofloxacin Hydrochloride 750mg Tablet
Film-Coated Tablet Oral Use
Greece Teva Pharma B.V. Moxifloxacin Teva
Pharma
Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Greece Velka Hellas S.A. Cinlevo Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Greece Velka Hellas S.A. Cinlevo Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Greece Venifar Ltd Limox Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Greece Verisfield (Uk) Ltd Cifloxacin Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Greece Verisfield (Uk) Ltd Le-Vof Levofloxacin
Hemihydrate 5.1246mg/Ml
Solution For Infusion Intravenous Use
Greece Verisfield (Uk) Ltd Lexacin Levofloxacin Hemihydrate 5.1246mg/Ml
Solution For Infusion Intravenous Use
Greece Verisfield (Uk) Ltd Rucela Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Greece Verisfield (Uk) Ltd Zoclix Levofloxacin Hemihydrate 5.1276mg/Ml
Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 59/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Greece Vianex S.A. Ciprovian®, 100mg/50ml
Ciprofloxacin Lactate 127.2mg/50 Ml
Solution For Infusion Intravenous Use
Greece Vianex S.A. Ciprovian®, 200mg/100ml
Ciprofloxacin Lactate 254.4mg/100 Ml
Solution For Infusion Intravenous Use
Greece Vianex S.A. Ciprovian®, 400mg/200ml
Ciprofloxacin Lactate 508.8mg/200 Ml
Solution For Infusion Intravenous Use
Greece Vianex S.A. Norocin Norfloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Greece Viofar Ltd Ciprocton Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Greece Viofar Ltd Vetamol Norfloxacin 400mg Tablet
Film Coated Tablet Oral Use
Greece Viofar Ltd Labocton Pefloxacin Mesilate 558.5mg Tablet
Film-Coated Tablet Oral Use
Greece Vocate φαρμακευτικη αε Ciprofal Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Greece Zwitter Pharmaceuticals επε Letrina Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Greece Zwitter Pharmaceuticals επε Letrina Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Hungary 1 A Pharma Gmbh Ciprofloxacin 1 A Pharma
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Hungary 1 A Pharma Gmbh Ciprofloxacin 1 A Pharma
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Hungary 1 A Pharma Gmbh Ciprofloxacin 1a Pharma
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Hungary 1 A Pharma Gmbh Ciprofloxacin 1a Pharma
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Hungary Actavis Group Ptc Ehf. Levoxa Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Hungary Actavis Group Ptc Ehf. Levoxa Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Hungary Actavis Group Ptc Ehf. Levoxa Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Hungary Actavis Group Ptc Ehf. Moxifloxacin Actavis Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Hungary Alvogen Ipco S.Ar.L Moxiquin Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 60/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Hungary Alvogen Ipco S.Ar.L Moxiquin Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Hungary Alvogen Ipco S.Ar.L Prixoter Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Hungary Alvogen Ipco S.Ar.L Prixoter Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Hungary Aziende Chimiche Riunite
Angelini Francesco - A.C.R.A.F. S.P.A.
Unidrox Prulifloxacin 600mg
Tablet
Film-Coated Tablet Oral Use
Hungary Bayer Pharma Ag Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Hungary Bayer Pharma Ag Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Hungary Bayer Pharma Ag Ciprobay Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Hungary Bayer Pharma Ag Ciprobay Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Hungary Egis Pharmaceuticals Plc Cydonin Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Hungary Egis Pharmaceuticals Plc Cydonin Ciprofloxacin Hydrochloride 582mg
Tablet
Film-Coated Tablet Oral Use
Hungary Fresenius Kabi Deutschland Gmbh
Ciprofloxacin Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Hungary Fresenius Kabi Hungary Kft. Levofloxacin Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Hungary Fresenius Kabi Hungary Kft. Moxifloxacin Kabi Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Hungary Gedeon Richter Plc. Savulin Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Hungary Gedeon Richter Plc. Tarivid Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto Moxibiot Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Injection
Hungary Krka, D.D., Novo Mesto Levnibiot Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Hungary Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 61/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Hungary Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 500mg L Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto Levnibiot Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto Levnibiot Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto Moxibiot Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto Nolicin Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto Nolicin-S Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Hungary Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 200mg/100 Ml
Solution For Infusion Oral Use
Hungary Laboratorios Liconsa, S.A. Levofloxacin Liconsa Levofloxacin
Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Hungary Macleods Pharma Uk Ltd Maclevo Levofloxacin Hemihydrate 250mg Tablet
Film-Coated Tablet Oral Use
Hungary Macleods Pharma Uk Ltd Maclevo Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Hungary Macleods Pharma Uk Ltd Maclevo Levofloxacin
Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Hungary Meditop Pharmaceutical Co. Ltd.
Avatac Levofloxacin 250mg Tablet
Film Coated Tablet Oral Use
Hungary Meditop Pharmaceutical Co.
Ltd.
Avatac Levofloxacin 500mg
Tablet
Film Coated Tablet Oral Use
Hungary Meditop Pharmaceutical Co. Ltd.
Avatac Levofloxacin Hemihydrate 256.23mg Tablet
Film Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 62/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Hungary Meditop Pharmaceutical Co. Ltd.
Avatac Levofloxacin Hemihydrate 512.46mg Tablet
Film Coated Tablet Oral Use
Hungary Mylan S.A.S Levofloxacin Mylan Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Hungary Mylan S.A.S Levofloxacin Mylan Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Hungary Pannonpharma Kft. Grenis-Cipro Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
Hungary Pannonpharma Kft. Grenis-Cipro Ciprofloxacin Hydrochloride 583mg
Tablet
Film-Coated Tablet Oral Use
Hungary Pannonpharma Kft. Grenis-Oflo Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Hungary Q Pharma Kft. Levofloxacin Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Hungary Q Pharma Kft. Levofloxacin Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Hungary Q Pharma Kft. Moxifloxacin-Q Pharma Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Hungary Ranbaxy (Uk) Limited Cifran Ciprofloxacin Hydrochloride 291.19mg Tablet
Film-Coated Tablet Oral Use
Hungary Ranbaxy (Uk) Limited Cifran Ciprofloxacin Hydrochloride
582.37mg Tablet
Film-Coated Tablet Oral Use
Hungary Ranbaxy (Uk) Limited Cifran Ciprofloxacin Hydrochloride 873.56mg Tablet
Film-Coated Tablet Oral Use
Hungary Ratiopharm Gmbh Levofloxacin Ratiopharm
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Hungary Sandoz Hungária Kft Cifloxin Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 63/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Hungary Sandoz Hungária Kft Cifloxin Ciprofloxacin Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
Hungary Sandoz Hungária Kft Levofloxacin Sandoz Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Hungary Sandoz Hungária Kft Moxifloxacin Sandoz Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Hungary Sanofi-Aventis Zrt Nevigramon Nalidixic Acid 500mg Capsule
Capsule, Hard Oral Use
Hungary Sanofi-Aventis Zrt Tavanic Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Hungary Teva Gyógyszergyár Zrt Leflokin Levofloxacin 5mg/Ml Film-Coated Tablet Intravenous Use
Hungary Teva Gyógyszergyár Zrt Ciprofloxacin-Human Teva
Ciprofloxacin Lactate 254.4mg/100 Ml
Solution For Infusion Intravenous Use
Hungary Teva Gyógyszergyár Zrt Ciprofloxacin-Human
Teva
Ciprofloxacin Lactate
508.8mg/200 Ml
Solution For Infusion Intravenous Use
Hungary Teva Gyógyszergyár Zrt Leflokin Levofloxacin Hemihydrate 256.2mg/50 Ml
Solution For Infusion Intravenous Use
Hungary Teva Gyógyszergyár Zrt Leflokin Levofloxacin
Hemihydrate 512.5mg/100 Ml
Solution For Infusion Intravenous Use
Hungary Teva Gyógyszergyár Zrt Levofloxacin Teva Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Hungary Teva Gyógyszergyár Zrt Ciprofloxacin Human Ciprofloxacin Hydrochloride 250mg
Tablet
Film-Coated Tablet Oral Use
Hungary Teva Gyógyszergyár Zrt Ciprofloxacin-Human Teva
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Hungary Teva Gyógyszergyár Zrt Ciprofloxacin-Human Teva
Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Hungary Teva Gyógyszergyár Zrt Ciprofloxacin-Human Teva Gyógyszergyár
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Hungary Teva Gyógyszergyár Zrt Ciprofloxacin-Human Teva Gyógyszergyár
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 64/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Hungary Teva Gyógyszergyár Zrt Ciprofloxacin-Human Teva Gyógyszergyár
Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Hungary Teva Gyógyszergyár Zrt Leflokin Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Hungary Teva Gyógyszergyár Zrt Leflokin Levofloxacin Hemihydrate 512.46mg
Tablet
Film-Coated Tablet Oral Use
Hungary Teva Gyógyszergyár Zrt Moxifloxacin Ratiopharm
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Iceland Actavis Group Ptc Ehf. Levofloxacin Actavis Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Iceland Actavis Group Ptc Ehf. Levofloxacin Actavis Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Iceland Actavis Hf. Síprox Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Iceland Actavis Hf. Síprox Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Iceland Alvogen Ehf Ciprofloxacin Alvogen Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Iceland Alvogen Ehf Ciprofloxacin Alvogen Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Iceland Alvogen Ehf Ciprofloxacin Alvogen Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Iceland Alvogen Ipco S.Ar.L Moxiquin Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Iceland Bayer Pharma Ag Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Iceland Bayer Pharma Ag Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Iceland Villerton Invest S.A. Ciprofloxacin Villerton Ciprofloxacin Lactate 2.544mg/Ml
Solution For Infusion Intravenous Use
Ireland Actavis Group Ptc Ehf. Ciplox Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Ireland Actavis Group Ptc Ehf. Ciplox Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Ireland Actavis Group Ptc Ehf. Ciplox Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 65/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Ireland Bayer Ltd Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Ireland Bayer Ltd Ciproxin Ciprofloxacin 100mg/50 Ml
Solution For Infusion Intravenous Use
Ireland Bayer Ltd Ciproxin Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Ireland Bayer Ltd Ciproxin Ciprofloxacin
400mg/200 Ml
Solution For Infusion Intravenous Use
Ireland Bayer Ltd Ciproxin Iv Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Ireland Bayer Ltd Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Ireland Bayer Ltd Ciproxin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Ireland Bayer Ltd Ciproxin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Ireland Bayer Ltd Ciproxin Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Ireland Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Ireland Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Ireland Clonmel Healthcare Ltd. Profloxin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Ireland Clonmel Healthcare Ltd. Profloxin Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Ireland Fannin Ltd Ciprofloxacin Fannin Limited
Ciprofloxacin Hydrochloride 250mg
Tablet
Film-Coated Tablet Oral Use
Ireland Fannin Ltd Ciprofloxacin Fannin
Limited
Ciprofloxacin
Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
Ireland Fresenius Kabi Limited Levofloxacin Fresenius Kabi
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Ireland Fresenius Kabi Limited Moxifloxacin Fresenius Kabi
Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 66/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Ireland Generics [uk] Limited Ciprofloxacin Mylan Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Ireland Generics [uk] Limited Levofloxacin Generics Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Ireland Hikma Farmacêutica (Portugal), S.A.
Levofloxacin Hikma Farmacêutica (Portugal), S.A.
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Ireland Hikma Farmacêutica (Portugal), S.A.
Truoxin Iv Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Ireland Hospira Uk Ltd Ciprofloxacin Hospira Uk
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Ireland Krka, D.D., Novo Mesto Ciprofloxacin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto Ciprofloxacin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto Ciprofloxacin Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto Levofloxacin Krka Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Ireland Krka, D.D., Novo Mesto Levofloxacin Krka Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Ireland Mcdermott Laboratories Ltd Cifloxager Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Ireland Mcdermott Laboratories Ltd Cifloxager Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Ireland Mcdermott Laboratories Ltd Tavager Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Ireland Noridem Enterprises Ltd Ciprofloxacin Noridem
Enterprises
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Ireland Noridem Enterprises Ltd Levofloxacin Noridem
Enterprises
Levofloxacin
500mg/100 Ml
Solution For Infusion Intravenous Use
Ireland Pharmathen S.A. Refaz Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Ireland Pharmathen S.A. Refaz Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 67/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Ireland Rowex Ltd Cifox Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Ireland Rowex Ltd Cifox Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Ireland Rowex Ltd Cifox Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Ireland Rowex Ltd Cifox Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Ireland Sanofi-Aventis Ireland Ltd Tarivid Ofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Ireland Sanofi-Aventis Ireland Ltd Tavanic Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
Ireland Sanofi-Aventis Ireland Ltd Tavanic Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Ireland Sanofi-Aventis Ireland Ltd Tarivid Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Ireland Sanofi-Aventis Ireland Ltd Tavanic Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Ireland Sanofi-Aventis Ireland Ltd Tavanic Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Ireland Teva Pharma B.V. Ciprofloxacin Teva Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Ireland Teva Pharma B.V. Levofloxacin Teva Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Ireland Teva Pharma B.V. Ciprofloxacin Teva Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
Ireland Teva Pharma B.V. Ciprofloxacin Teva Ciprofloxacin Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
Italy Abc Farmaceutici S.P.A. Norfloxacina Abc Norfloxacin 400mg
Capsule
Capsule Oral Use
Italy Abc Farmaceutici S.P.A. Ciprofloxacina Abc Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Italy Abc Farmaceutici S.P.A. Ciprofloxacina Abc Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 68/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Abc Farmaceutici S.P.A. Ciprofloxacina Abc Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Italy Abc Farmaceutici S.P.A. Levofloxacina Abc Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy Abc Farmaceutici S.P.A. Levofloxacina Abc Levofloxacin
Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited Ciprofloxacina Accord Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited Ciprofloxacina Accord Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited Ciprofloxacina Accord Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited Levofloxacina Accord Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy Accord Healthcare Limited Levofloxacina Accord Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Italy Agips Farmaceutici S.R.L. Samper Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Agips Farmaceutici S.R.L. Samper Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Agips Farmaceutici S.R.L. Samper Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Italy Agips Farmaceutici S.R.L. Summaflox Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Agips Farmaceutici S.R.L. Summaflox Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Almus S.R.L Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 69/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Almus S.R.L Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Film-Coated Tablet Oral Use
Italy Almus S.R.L Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Italy Almus S.R.L Levofloxacina Almus Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Almus S.R.L Levofloxacina Almus Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Levofloxacina Aurobindo Pharma Italia
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Italy Aurobindo Pharma (Italia) S.R.L.
Ciprofloxacina Aurobindo
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral
Italy Aurobindo Pharma (Italia) S.R.L.
Ciprofloxacina Aurobindo
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Ciprofloxacina Aurobindo
Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Ciprofloxacina Aurobindo Italia
Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Ciprofloxacina Aurobindo Italia
Ciprofloxacin Hydrochloride
Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Ciprofloxacina Aurobindo Italia
Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Levofloxacina Aurobindo
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Aurobindo Pharma (Italia) S.R.L.
Levofloxacina Aurobindo
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 70/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Aurobindo Pharma (Italia) S.R.L.
Moxifloxacina Aurobindo
Moxifloxacin Hydrochloride 436.32mg Tablet
Film-Coated Tablet Oral Use
Italy Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.P.A.
Levofloxacina Angelini Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Aziende Chimiche Riunite
Angelini Francesco -
A.C.R.A.F. S.P.A.
Levofloxacina Angelini Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Italy Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.P.A.
Unidrox Prulifloxacin 600mg Tablet
Film-Coated Tablet Oral Use
Italy B.Braun Melsungen Ag Levofloxacina B. Braun Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Italy Bayer Pharma Ag Octegra Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Italy Bayer Spa Avalox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Italy Bayer Spa Ciproxin Ciprofloxacin 100mg/50 Ml
Solution For Infusion Intravenous Use
Italy Bayer Spa Ciproxin Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Italy Bayer Spa Ciproxin Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Italy Bayer Spa Actira Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Italy Bayer Spa Avalox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Italy Bayer Spa Ciproxin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Bayer Spa Ciproxin Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Italy Bayer Spa Ciproxin Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Italy Bayer Spa Ciproxin Ciprofloxacin Hydrated
250mg/5 Ml
Granules And Solvent
For Oral Suspension
Oral Use
Annex I
EMA/88273/2017 Page 71/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Bayer Spa Ciproxin Ciprofloxacin Hydrated 500mg/5 Ml
Granules And Solvent For Oral Suspension
Oral Use
Italy Bayer Spa Ciproxin Ciprofloxacin Hydrochloride 334.8mg Tablet
Modified-Release Tablet
Oral Use
Italy Bayer Spa Ciproxin Ciprofloxacin Hydrochloride 669.4mg
Tablet
Modified-Release Tablet
Oral Use
Italy Benedetti & Co. S.P.A. Urocinox Cinoxacin 500mg Capsule
Capsule, Hard Oral Use
Italy Bioakos Farma Laboratori S.R.L.
Chinocid Ciprofloxacin Hydrochloride
Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Italy Bioakos Farma Laboratori S.R.L.
Chinocid Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Film-Coated Tablet Oral Use
Italy Bioakos Farma Laboratori S.R.L.
Chinocid Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Italy Bioindustria Lim Laboratorio Italiano Medicinali Spa
Ciprofloxacina Bioindustria L.I.M.
Ciprofloxacin Lactate 254.4mg Vial
Solution For Infusion Intravenous Use
Italy Bioindustria Lim Laboratorio Italiano Medicinali Spa
Ciprofloxacina Bioindustria L.I.M.
Ciprofloxacin Lactate 508.8mg Vial
Solution For Infusion Intravenous Use
Italy Bioindustria Lim Laboratorio
Italiano Medicinali Spa
Levofloxacina
Bioindustria L.I.M.
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Italy C&g Farmaceutici Ciprofloxacina Pharmacare
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy C&g Farmaceutici Ciprofloxacina
Pharmacare
Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Italy C&g Farmaceutici Ciprofloxacina Pharmacare
Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Italy Crinos S.P.A. Aranda Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 72/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Crinos S.P.A. Aranda Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Crinos S.P.A. Keraflox Prulifloxacin 600mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Ciprofloxacina Doc Generici
Ciprofloxacin Hydrochloride 291.5mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Ciprofloxacina Doc Generici
Ciprofloxacin Hydrochloride 583mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Ciprofloxacina Doc Generici
Ciprofloxacin Hydrochloride 873mg
Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Levofloxacina Doc Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Levofloxacina Doc Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Levofloxacina Doc Generics
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Doc Generici S.R.L. Levofloxacina Doc Generics
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Double-E Pharma Ltd Moxifloxacina Double-E Pharma
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Italy Eg S.P.A. Iasar Ciprofloxacin Lactate 2.544mg/Ml
Solution For Infusion Intravenous Use
Italy Eg S.P.A. Acido Pipemidico Eg Pipemidic Acid 400mg Capsule
Capsule, Hard Oral Use
Italy Eg S.P.A. Ciprofloxacina Eg Ciprofloxacin Hydrochloride Monohydrate
296.95mg Tablet
Film-Coated Tablet Oral Use
Italy Eg S.P.A. Ciprofloxacina Eg Ciprofloxacin Hydrochloride Monohydrate 593.9mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 73/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Eg S.P.A. Ciprofloxacina Eg Ciprofloxacin Hydrochloride Monohydrate
890.85mg Tablet
Film-Coated Tablet Oral Use
Italy Eg S.P.A. Levofloxacina Eg Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy Eg S.P.A. Levofloxacina Eg Levofloxacin
Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Italy Eg S.P.A. Norfloxacina Eg Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Italy Epifarma S.R.L. Epifloxin Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Epifarma S.R.L. Prociflor Ciprofloxacin Hydrochloride Monohydrate 291mg
Tablet
Film-Coated Tablet Oral Use
Italy Epifarma S.R.L. Prociflor Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Italy Epifarma S.R.L. Prociflor Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Italy Euro-Pharma S.R.L. Allgram Levofloxacin 500mg
Tablet
Film Coated Tablet Oral Use
Italy Euro-Pharma S.R.L. Allgram Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Farto S.R.L. Farmaco Biochimico Toscano
Cuspis Ciprofloxacin Hydrochloride
Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 74/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Farto S.R.L. Farmaco Biochimico Toscano
Cuspis Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Film-Coated Tablet Oral Use
Italy Farto S.R.L. Farmaco Biochimico Toscano
Cuspis Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Italy Farto S.R.L. Farmaco Biochimico Toscano
Klektica Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy Farto S.R.L. Farmaco Biochimico Toscano
Klektica Levofloxacin Hemihydrate 500mg
Tablet
Film-Coated Tablet Oral Use
Italy Francia Farmaceutici Industria Farmaco Biologica S.R.L.
Diperpen Pipemidic Acid 400mg Capsule
Capsule Oral Use
Italy Fresenius Kabi Italia S.R.L. Ciprofloxacina Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Italy Fresenius Kabi Italia S.R.L. Levofloxacina Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Italy Fresenius Kabi Italia S.R.L. Moxifloxacina Kabi Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Italy Genetic Spa Bosix Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Italy Genetic Spa Bosix Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Film-Coated Tablet Oral Use
Italy Genetic Spa Bosix Ciprofloxacin Hydrochloride
Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Italy Genetic Spa Findatur Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 75/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Genetic Spa Findatur Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Italy Germed Pharma S.R.L. Ciprofloxacina Germed Pharma
Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Italy Germed Pharma S.R.L. Ciprofloxacina Germed
Pharma
Ciprofloxacin
Hydrochloride Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Italy Germed Pharma S.R.L. Ciprofloxacina Germed Pharma
Ciprofloxacin Hydrochloride
Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Italy Germed Pharma S.R.L. Levofloxacina Germed Levofloxacin Hemihydrate 256.23mg
Tablet
Film-Coated Tablet Oral Use
Italy Germed Pharma S.R.L. Levofloxacina Germed Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Italy Glaxosmithkline S.P.A. Levoxacin Levofloxacin Hemihydrate
500mg/100 Ml
Solution For Infusion Intravenous Use
Italy Glaxosmithkline S.P.A. Levoxacin Levofloxacin Hemihydrate 250mg Tablet
Film-Coated Tablet Oral Use
Italy Glaxosmithkline S.P.A. Levoxacin Levofloxacin
Hemihydrate 500mg Tablet
Film-Coated Tablet Oral Use
Italy Grünenthal Italia S.R.L. Peflox Pefloxacin Mesilate 400mg Tablet
Film-Coated Tablet Oral Use
Italy Hikma Farmacêutica (Portugal), S.A.
Ciprofloxacina Hikma Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Italy Hikma Farmacêutica (Portugal), S.A.
Levofloxacina Hikma Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 76/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy I.B.N. Savio S.R.L. Flontalexin Ciprofloxacin Hydrochloride Monohydrate 291mg
Tablet
Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Flontalexin Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Flontalexin Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Alvand Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Italy I.B.N. Savio S.R.L. Alvand Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Ibi G. Lorenzini Spa Ibixacin Ciprofloxacin
Hydrochloride
Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Italy Ibi G. Lorenzini Spa Ibixacin Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Film-Coated Tablet Oral Use
Italy Ibi G. Lorenzini Spa Ibixacin Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Italy Ibigen Srl Ciprofloxacina Ibigen Ciprofloxacin Lactate 127.2mg/50 Ml
Solution For Infusion Intravenous Use
Italy Ibigen Srl Ciprofloxacina Ibigen Ciprofloxacin Lactate 254.4mg/100 Ml
Solution For Infusion Intravenous Use
Italy Ibigen Srl Ciprofloxacina Ibigen Ciprofloxacin Lactate 508.8mg/200 Ml
Solution For Infusion Intravenous Use
Italy Infomed Fluids Srl Ciprofloxacina Infomed Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 77/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Istituto Chimico Internazionale Dr. Giuseppe Rende S.R.L.
Ciperus Ciprofloxacin Hydrochloride Monohydrate 291mg
Tablet
Film-Coated Tablet Oral Use
Italy Istituto Chimico Internazionale Dr. Giuseppe Rende S.R.L.
Ciperus Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Film-Coated Tablet Oral Use
Italy Istituto Chimico Internazionale Dr. Giuseppe Rende S.R.L.
Ciperus Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Italy Istituto Chimico
Internazionale Dr. Giuseppe Rende S.R.L.
Lemaxil Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy Istituto Chimico Internazionale Dr. Giuseppe
Rende S.R.L.
Lemaxil Levofloxacin Hemihydrate 512.46mg
Tablet
Film-Coated Tablet Oral Use
Italy Istituto Luso Farmaco D'italia S.P.A.
Chimono Lomefloxacin Hydrochloride 441.6mg Tablet
Film-Coated Tablet Oral Use
Italy Keironpharma S.R.L. Ciprofloxacina Keironpharma
Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Italy Keironpharma S.R.L. Ciprofloxacina Keironpharma
Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Italy Keironpharma S.R.L. Levofloxacina Keironpharma
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Italy Konpharma S.R.L. Agilev Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy Konpharma S.R.L. Agilev Levofloxacin Hemihydrate 512.46mg
Tablet
Film-Coated Tablet Oral Use
Italy Krka, D.D., Novo Mesto Ciprofloxacina Krka Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 78/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Krka, D.D., Novo Mesto Ciprofloxacina Krka Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Film-Coated Tablet Oral Use
Italy Krka, D.D., Novo Mesto Ciprofloxacina Krka Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Italy Krka, D.D., Novo Mesto Levofloxacina Krka Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Krka, D.D., Novo Mesto Levofloxacina Krka Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Krka, D.D., Novo Mesto Moxifloxacina Krka Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratori Alter S.R.L. Ciprofloxacina Alter Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratori Alter S.R.L. Ciprofloxacina Alter Ciprofloxacin Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratori Alter S.R.L. Levofloxacina Alter Levofloxacin Hemihydrate 250mg
Tablet
Film-Coated Tablet Oral Use
Italy Laboratori Alter S.R.L. Levofloxacina Alter Levofloxacin Hemihydrate 500mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratorio Farmaceutico Ct
Srl
Uropimid Pipemidic Acid 400mg
Capsule
Capsule Oral Use
Italy Laboratorio Farmaceutico Ct Srl
Eoxin Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratorio Farmaceutico Ct Srl
Eoxin Ciprofloxacin Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratorio Farmaceutico Ct Srl
Eoxin Ciprofloxacin Hydrochloride 873mg Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Laboratorio Farmaceutico Ct Srl
Sineflox Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy Laboratorio Farmaceutico Ct Srl
Sineflox Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Italy Lanova Farmaceutici S.R.L. Monos Rufloxacin
Hydrochloride 200mg
Tablet
Film-Coated Tablet Oral Use
Italy Macleods Pharma Uk Ltd Levofloxacin Macleods Levofloxacin Hemihydrate 256.23mg Tablet
Film Coated Tablets Oral Use
Italy Macleods Pharma Uk Ltd Levofloxacin Macleods Levofloxacin Hemihydrate 512.46mg Tablet
Film Coated Tablets Oral Use
Italy Macleods Pharma Uk Ltd Levofloxacina Macleods Levofloxacin Hemihydrate 256.23mg
Tablet
Film-Coated Tablet Oral Use
Italy Magis Farmaceutici S.P.A. Levoxigram Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Magis Farmaceutici S.P.A. Levoxigram Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Magis Farmaceutici Srl Levoxigram Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Magis Farmaceutici Srl Levoxigram Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Meda Pharma S.P.A. Maxaquin Lomefloxacin
Hydrochloride 400mg Tablet
Film-Coated Tablet Oral Use
Italy Meda Pharma S.P.A. Uniquin Lomefloxacin Hydrochloride 441.6mg
Tablet
Film-Coated Tablet Oral Use
Italy Mediolanum Farmaceutici Spa Qari Rufloxacin Hydrochloride 200mg Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Mylan S.P.A. Ciprofloxacina Mylan Generics Italia
Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Italy Mylan S.P.A. Ciprofloxacina Mylan Generics Italia
Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Italy Mylan S.P.A. Levofloxacin Mylan Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Italy Mylan S.P.A. Ciprofloxacina Mylan
Generics
Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Ciprofloxacina Mylan Generics
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Ciprofloxacina Mylan
Generics
Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Levofloxacina Mylan Generics
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Levofloxacina Mylan Generics Italia
Levofloxacin 200mg Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Levofloxacina Mylan
Generics Italia
Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Italy Mylan S.P.A. Levofloxacina Mylan Generics Italia
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Neapharma Srl Gray Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy Neapharma Srl Gray Levofloxacin
Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Italy Neopharmed Gentili S.R.L. Refrain Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy Neopharmed Gentili S.R.L. Refrain Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Italy Pensa Pharma S.P.A. Ciprofloxacina Pensa Ciprofloxacin Hydrochloride
Monohydrate 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Pensa Pharma S.P.A. Ciprofloxacina Pensa Ciprofloxacin Hydrochloride Monohydrate 500mg
Tablet
Film-Coated Tablet Oral Use
Italy Pensa Pharma S.P.A. Ciprofloxacina Pensa Ciprofloxacin Hydrochloride Monohydrate 750mg
Tablet
Film-Coated Tablet Oral Use
Italy Pensa Pharma S.P.A. Levofloxacina Pensa Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Pensa Pharma S.P.A. Levofloxacina Pensa Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Pensa Pharma S.P.A. Levofloxacina Pensa Pharma
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Pensa Pharma S.P.A. Levofloxacina Pensa Pharma
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Pharmathen S.A. Moxifloxacin
Pharmathen
Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Italy Pharmeg S.R.L. Levobat Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Piam Farmaceutici S.P.A. Trissil Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy Piam Farmaceutici S.P.A. Trissil Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Italy Ranbaxy Italia S.P.A. Ciprofloxacina Ranbaxy Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Italy Ranbaxy Italia S.P.A. Ciprofloxacina Ranbaxy Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Italy Ranbaxy Italia S.P.A. Ciprofloxacina Ranbaxy Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
Italy Ranbaxy Italia S.P.A. Ciprofloxacina Ranbaxy Ciprofloxacin Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Ranbaxy Italia S.P.A. Ciprofloxacina Ranbaxy Ciprofloxacin Hydrochloride 750mg Tablet
Film-Coated Tablet Oral Use
Italy Ranbaxy Italia S.P.A. Levofloxacina Ranbaxy Levofloxacin Hemihydrate 250mg Tablet
Film-Coated Tablet Oral Use
Italy Ranbaxy Italia S.P.A. Levofloxacina Ranbaxy Levofloxacin
Hemihydrate 500mg
Tablet
Film-Coated Tablet Oral Use
Italy Ratiopharm Gmbh Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Italy Ratiopharm Gmbh Ciprofloxacina Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Italy Ratiopharm Gmbh Ciprofloxacina
Ratiopharm
Ciprofloxacin
Hydrochloride Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Italy Ro-Farm Di Salvatore De Maio & C. S.A.S.
Gerbat Ciprofloxacin Hydrochloride
Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Italy Ro-Farm Di Salvatore De Maio & C. S.A.S.
Gerbat Ciprofloxacin Hydrochloride
Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Italy Ro-Farm Di Salvatore De Maio & C. S.A.S.
Gerbat Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Italy S.F. Group Srl Batiflox Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy S.F. Group Srl Batiflox Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Italy S.F. Group Srl Battizer Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Italy S.F. Group Srl Battizer Ciprofloxacin
Hydrochloride Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Italy S.F. Group Srl Battizer Ciprofloxacin Hydrochloride
Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Italy S.F. Group Srl Kinox Ciprofloxacin Hydrochloride
Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Italy S.F. Group Srl Kinox Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Italy S.F. Group Srl Kinox Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Italy S.F. Group Srl Macar Ciprofloxacin Hydrochloride
Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Italy S.F. Group Srl Macar Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 84/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy S.F. Group Srl Macar Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Italy S.F. Group Srl Ullax Ciprofloxacin Hydrochloride Monohydrate 291mg
Tablet
Film-Coated Tablet Oral Use
Italy S.F. Group Srl Ullax Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Italy S.F. Group Srl Ullax Ciprofloxacin
Hydrochloride Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz Gmbh Ciprofloxacina Sandoz
Gmbh
Ciprofloxacin
Hydrochloride Monohydrate
222mg/100 Ml
Solution For Infusion Intravenous Use
Italy Sandoz Gmbh Ciprofloxacina Sandoz Gmbh
Ciprofloxacin Hydrochloride Monohydrate 443mg/200 Ml
Solution For Infusion Intravenous Use
Italy Sandoz S.P.A. Ciprofloxacina Sandoz Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Ciprofloxacina Sandoz Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Ciprofloxacina Sandoz Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Levofloxacina Sandoz Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Levofloxacina Sandoz Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Sandoz S.P.A. Norfloxacina Sandoz Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 85/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Sanofi Spa Tavanic Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
Italy Sanofi Spa Tavanic Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Italy Sanofi Spa Prixar Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy Sanofi Spa Prixar Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Italy Sanofi Spa Tavanic Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Sanofi Spa Tavanic Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy So.Se.Pharm S.R.L. Generflon Ciprofloxacin Hydrochloride 291mg
Tablet
Film-Coated Tablet Oral Use
Italy So.Se.Pharm S.R.L. Generflon Ciprofloxacin Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
Italy So.Se.Pharm S.R.L. Generflon Ciprofloxacin Hydrochloride 873mg Tablet
Film-Coated Tablet Oral Use
Italy Spa – Società Prodotti Antibiotici S.P.A.
Chinoplus Prulifloxacin 600mg Tablet
Film-Coated Tablet Oral Use
Italy Tecnigen S.R.L. Ciprofloxacina Tecnigen Ciprofloxacin
Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Italy Tecnigen S.R.L. Ciprofloxacina Tecnigen Ciprofloxacin
Hydrochloride Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 86/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Tecnigen S.R.L. Ciprofloxacina Tecnigen Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Italy Tecnigen S.R.L. Levofloxacina Tecnigen Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Italy Tecnigen S.R.L. Levofloxacina Tecnigen Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Italy Tecnigen S.R.L. Levofloxacina Tecnigen Italia
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Italy Teofarma S.R.L. Pipram Pipemidic Acid 400mg Capsule
Capsule, Hard Oral Use
Italy Teofarma S.R.L. Urotractin Pipemidic Acid Trihydrate 235.63mg Capsule
Capsule, Hard Oral Use
Italy Teofarma S.R.L. Urotractin Pipemidic Acid Trihydrate 471.25mg
Capsule
Capsule, Hard Oral Use
Italy Teva Italia S.R.L. Fovex Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Italy Teva Italia S.R.L. Levofloxacina Teva Italia
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Italy Teva Italia S.R.L. Ciprofloxacina Teva Ciprofloxacin Hydrochloride 750mg Tablet
Film-Coated Tablet Oral Use
Italy Teva Italia S.R.L. Levofloxacina Teva Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Italy Teva Italia S.R.L. Levofloxacina Teva Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Italy Teva Italia S.R.L. Moxifloxacina Teva Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Italy Villerton Invest S.A. Ciprofloxacina Villerton Invest
Ciprofloxacin Lactate 127.2mg/50 Ml
Solution For Infusion Intravenous Use
Italy Villerton Invest S.A. Ciprofloxacina Villerton
Invest
Ciprofloxacin Lactate
254.4mg/100 Ml
Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 87/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Italy Villerton Invest S.A. Ciprofloxacina Villerton Invest
Ciprofloxacin Lactate 508.8mg/200 Ml
Solution For Infusion Intravenous Use
Italy Visufarma Spa Pipemid Pipemidic Acid Trihydrate 471.22mg Capsule
Capsule Oral Use
Italy Zentiva Italia Srl Ciprofloxacina Zentiva Ciprofloxacin Hydrochloride
Monohydrate 291.5mg
Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Ciprofloxacina Zentiva Ciprofloxacin Hydrochloride Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Ciprofloxacina Zentiva Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Levofloxacina Zentiva Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Italy Zentiva Italia Srl Levofloxacina Zentiva Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Latvia Aurobindo Pharma (Malta)
Limited
Ciprofloxacin Aurobindo Ciprofloxacin 500mg
Tablet
Tablet Oral Use
Latvia Bayer Pharma Ag Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Latvia Bayer Pharma Ag Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Latvia Cipla (Uk) Limited Ciplox Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Latvia Cipla (Uk) Limited Norflox Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Latvia Jsc Olainfarm Ciprofloxacin Olainfarm Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Latvia Jsc Olainfarm Ciprofloxacin Olainfarm Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto Levalox Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Latvia Krka, D.D., Novo Mesto Moloxin Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use | Oral Use
Latvia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 100mg/10 Ml
Concentrate For Solution For Infusion
Oral Use
Latvia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 500mg L Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto Levalox Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto Levalox Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto Moloxin Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto Nolicin Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Latvia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin
200mg/100 Ml
Solution For Infusion Oral Use
Latvia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 400mg/200 Ml
Solution For Infusion Oral Use
Latvia Lek Pharmaceuticals D.D.
Ljubljana
Palin Pipemidic Acid 200mg
Capsule
Capsule, Hard Oral Use
Latvia Medochemie Ltd. Medofloxine Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Latvia Pharmaswiss česká Republika S.R.O.
Oroflocina Levofloxacin Hemihydrate 250mg Tablet
Film Coated Tablet Oral Use
Latvia Pharmaswiss česká Republika
S.R.O.
Oroflocina Levofloxacin
Hemihydrate 500mg Tablet
Film Coated Tablet Oral Use
Latvia Pro.Med.Cs Praha A.S. Cifloxinal Ciprofloxacin Hydrochloride
Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Latvia Ranbaxy (Uk) Limited Cifran Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Latvia Ranbaxy (Uk) Limited Zanocin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Latvia Sandoz Pharmaceuticals D.D. Ciprofloxacin Sandoz Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Latvia Sandoz Pharmaceuticals D.D. Moxifloxacin Sandoz Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Latvia Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Cipronex Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Latvia Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Cipronex Ciprofloxacin Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
Latvia Zentiva, K.S. Ofloxin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Lithuania Actavis Nordic A/S Ciprofloxacin Actavis Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Lithuania Aurobindo Pharma (Malta) Limited
Ciprofloxacin Aurobindo Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Lithuania Bayer Pharma Ag Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Lithuania Bayer Pharma Ag Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto Moflaxa Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Injection
Lithuania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 100mg/50 Ml
Solution For Infusion Intravenous Use
Lithuania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Lithuania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Lithuania Krka, D.D., Novo Mesto Levalox Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Lithuania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 100mg/10 Ml
Concentrate For Solution For Infusion
Oral Use
Lithuania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 500mg L Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto Levalox Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto Levalox Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Lithuania Krka, D.D., Novo Mesto Moflaxa Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Lithuania Krka, D.D., Novo Mesto Nolicin Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Lithuania Lek Pharmaceuticals D.D. Ljubljana
Palin Pipemidic Acid 200mg Capsule
Capsule, Hard Oral Use
Lithuania Mepha Lda Bactiflox Lactab Ciprofloxacin
Hydrochloride 583mg Tablet
Film-Coated Tablet Oral Use
Lithuania Pharmaswiss česká Republika S.R.O.
Oroflocina Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Lithuania Pharmaswiss česká Republika S.R.O.
Oroflocina Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Lithuania Pro.Med.Cs Praha A.S. Cifloxinal Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Lithuania Ranbaxy (Uk) Limited Cifran Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Lithuania Ranbaxy (Uk) Limited Zanocin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Lithuania Sandoz Pharmaceuticals D.D. Ciprofloxacin Sandoz Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Lithuania Sandoz Pharmaceuticals D.D. Moxifloxacin Sandoz Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Lithuania Torrent Pharma Gmbh Quintor Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Lithuania Torrent Pharma Gmbh Quintor Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Lithuania Uab Sanofi-Aventis Lietuva Tavanic Levofloxacin
Hemihydrate 5.1246mg/Ml
Solution For Infusion Intravenous Use
Lithuania Uab Sanofi-Aventis Lietuva Tavanic Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Lithuania Uab Sanofi-Aventis Lietuva Tavanic Levofloxacin Hemihydrate 512.46mg
Tablet
Film-Coated Tablet Oral Use
Lithuania Zentiva, K.S. Ofloxin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 91/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Luxembourg Apotex Europe B.V. Moxifloxacin Apotex Moxifloxacin Hydrochloride 436.33mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Bayer Sa Nv Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Luxembourg Bayer Sa Nv Ciproxine Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Luxembourg Bayer Sa Nv Ciproxine Iv Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Luxembourg Bayer Sa Nv Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Bayer Sa Nv Ciproxine Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Bayer Sa Nv Ciproxine Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Bayer Sa Nv Ciproxine Ciprofloxacin Hydrated 250mg/5 Ml
Granules And Solvent For Oral Suspension
Oral Use
Luxembourg Eurogenerics N.V./S.A. Levofloxacine Eg Levofloxacin Hemihydrate 5.12mg/Ml
Solution For Infusion Intravenous Drip
Luxembourg Eurogenerics N.V./S.A. Ciprofloxacine Eg Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Luxembourg Eurogenerics N.V./S.A. Ciprofloxacine Eg Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A. Ciprofloxacine Eg Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A. Ciprofloxacine Eg Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A. Moxifloxacine Eg Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A. Norfloxacine Eg Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A. Ofloxacine Eg Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Luxembourg Eurogenerics N.V./S.A. Ofloxacine Eg Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Luxembourg Fresenius Kabi Deutschland Gmbh
Ciprofloxacin Kabi Ciprofloxacin 100mg/50 Ml
Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 92/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Luxembourg Fresenius Kabi Deutschland Gmbh
Ciprofloxacin Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Luxembourg Fresenius Kabi Deutschland Gmbh
Ciprofloxacin Kabi Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Luxembourg Fresenius Kabi Deutschland Gmbh
Levofloxacine Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Luxembourg Fresenius Kabi Deutschland
Gmbh
Moxifloxacin Kabi Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Luxembourg Mylan Bvba/Sprl Ciprofloxacina Mylan Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Mylan Bvba/Sprl Ciprofloxacina Mylan Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Luxembourg Mylan Bvba/Sprl Moxifloxacine Mylan Moxifloxacin Hydrochloride 400mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Mylan Bvba/Sprl Ofloxacine Mylan Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Luxembourg Mylan Bvba/Sprl Ofloxacine Mylan Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Luxembourg Ratiopharm Gmbh Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Ratiopharm Gmbh Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Ratiopharm Gmbh Ciprofloxacin
Ratiopharm
Ciprofloxacin
Hydrochloride Monohydrate 874.5mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Ratiopharm Gmbh Moxifloxacin Ratiopharm
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Sandoz N.V. Ciprofloxacine Sandoz Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Sandoz N.V. Ciprofloxacine Sandoz Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 93/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Luxembourg Sandoz N.V. Ciprofloxacine Sandoz Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Sanofi Belgium Tavanic Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
Luxembourg Sanofi Belgium Tarivid Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Luxembourg Sanofi Belgium Tarivid Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Luxembourg Sanofi Belgium Tavanic Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Sanofi Belgium Tavanic Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Teva Pharma Belgium N.V./S.A
Levofloxacine Teva Levofloxacin Hemihydrate 256.23mg
Tablet
Film-Coated Tablet Oral Use
Luxembourg Teva Pharma Belgium N.V./S.A
Levofloxacine Teva Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Malta Actavis Group Ptc Ehf. Levofloxacin Actavis Group Ptc Ehf.
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Malta Actavis Group Ptc Ehf. Levoxa Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Malta Actavis Group Ptc Ehf. Levoxa Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Malta Actavis Group Ptc Ehf. Siprox Ciprofloxacin Hydrochloride
Monohydrate 250mg Tablet
Film-Coated Tablet Oral Use
Malta Actavis Group Ptc Ehf. Siprox Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Film-Coated Tablet Oral Use
Malta Bayer Plc Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Malta Bayer Plc Ciproxin Ciprofloxacin 100mg/50 Ml
Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 94/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Malta Bayer Plc Ciproxin Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Malta Bayer Plc Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Malta Bayer Plc Ciproxin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Malta Bayer Plc Ciproxin Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Malta Beacon Pharmaceuticals Limited
Evoxil Levofloxacin Hemihydrate 5mg/Ml
Solution For Infusion Intravenous Use
Malta Beacon Pharmaceuticals
Limited
Evoxil Levofloxacin
Hemihydrate 500mg Tablet
Film-Coated Tablet Oral Use
Malta Beximco Pharma Uk Ltd Levofloxacin Beximco Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Malta Beximco Pharma Uk Ltd Levofloxacin Beximco Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Malta Cooper S.A. Pharmaceuticals Levofloxacin Cooper Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Malta Cooper S.A. Pharmaceuticals Nafloxin Ciprofloxacin 2mg/Ml Solution For Injection/Infusion
Intravenous Use
Malta Delorbis Pharmaceuticals Ltd Viprolox Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Malta Delorbis Pharmaceuticals Ltd Viprolox Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Malta Demo Abee Ufexil Ciprofloxacin Lactate 2.55mg/Ml
Solution For Infusion Intravenous Use
Malta Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacin
Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Malta Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacin Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
Malta Fresenius Kabi Limited Levofloxacin Fresenius Kabi
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Malta Ibigen Srl Ciprofloxacin Ibigen Ciprofloxacin Lactate 127.2mg/50 Ml
Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 95/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Malta Ibigen Srl Ciprofloxacin Ibigen Ciprofloxacin Lactate 254.4mg/100 Ml
Solution For Infusion Intravenous Use
Malta Ibigen Srl Ciprofloxacin Ibigen Ciprofloxacin Lactate 508.8mg/200 Ml
Solution For Infusion Intravenous Use
Malta Ibigen Srl Levofloxacin Ibigen Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Malta Medochemie Ltd. Medociprin Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Malta Medochemie Ltd. Medociprin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Malta Mylan S.A.S Levofloxacin Mylan Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Malta Piam Farmaceutici S.P.A. Trissil Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Malta Remedica Ltd Zindolin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Malta Sanofi Malta Ltd Tavanic Levofloxacin Hemihydrate 512.46mg
Tablet
Film-Coated Tablet Oral Use
Malta Tad Pharma Gmbh Norflosal Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Malta Villerton Invest S.A. Ciprofloxacin Villerton Invest
Ciprofloxacin 100mg/50 Ml |
Ciprofloxacin 200mg/100 Ml | Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Netherlands Accord Healthcare Limited Ciprofloxacine Accord Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Netherlands Accord Healthcare Limited Ciprofloxacine Accord Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Netherlands Accord Healthcare Limited Ciprofloxacine Accord Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Netherlands Amneal Pharma Europe Limited
Ciprofloxacine Amneal Ciprofloxacin Lactate 2.544mg/Ml
Solution For Infusion Intravenous Use
Netherlands Apotex Europe B.V. Ciprofloxacine Apotex Ciprofloxacin 250mg Tablet
Tablet Oral Use
Annex I
EMA/88273/2017 Page 96/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Netherlands Apotex Europe B.V. Ciprofloxacine Apotex Ciprofloxacin 500mg Tablet
Tablet Oral Use
Netherlands Apotex Europe B.V. Ciprofloxacine Apotex Ciprofloxacin 750mg Tablet
Tablet Oral Use
Netherlands Aurobindo Pharma B.V. Ciprofloxacine Aurobindo
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V. Ciprofloxacine
Aurobindo
Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V. Ciprofloxacine Aurobindo
Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V. Levofloxacin Aurobindo Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V. Levofloxacin Aurobindo Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V. Levofloxacine Aurobindo
Levofloxacin Hemihydrate 512.46mg
Units
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V. Moxifloxicine Aurobindo Moxifloxacin Hydrochloride 436.37mg Tablet
Film-Coated Tablet Oral Use
Netherlands Aurobindo Pharma B.V. Norfloxacine Aurobindo Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Netherlands B.Braun Melsungen Ag Levofloxacine B. Braun Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Netherlands Bayer Bv Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Netherlands Bayer Bv Avelox Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Netherlands Bayer Bv Ciproxin Ciprofloxacin Hydrated 250mg/5 Ml
Granules And Solvent For Oral Suspension
Oral Use
Netherlands Bayer Bv Ciproxin Ciprofloxacin Hydrated 500mg/5 Ml
Granules And Solvent For Oral Suspension
Oral Use
Netherlands Beximco Pharma Uk Ltd Levofloxacine Beximco Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Netherlands Beximco Pharma Uk Ltd Levofloxacine Beximco Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Netherlands Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 97/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Netherlands Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Ciprofloxacine Cf Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Netherlands Centrafarm B.V. Ciprofloxacine Cf Ciprofloxacin 100mg Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Ciprofloxacine Cf Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Ciprofloxacine Cf Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Ciprofloxacine Cf Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Levofloxacine Cf Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Levofloxacine Cf Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Netherlands Centrafarm B.V. Norfloxacine Norfloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Netherlands Claris Lifesciences (Uk) Limited
Ciprofloxacin Ciprofloxacin Lactate 2mg/Ml
Solution For Infusion Intravenous Use
Netherlands Claris Lifesciences (Uk)
Limited
Ciprofloxacin Claris Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Netherlands Double-E Pharma Ltd Moxifloxacine Double-E Pharma
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Netherlands Fairmed Healthcare Gmbh Ciprofloxacine Fair-Med Ciprofloxacin
Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Netherlands Fairmed Healthcare Gmbh Ciprofloxacine Fair-Med Ciprofloxacin
Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
Netherlands Fairmed Healthcare Gmbh Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 873mg Tablet
Film-Coated Tablet Oral Use
Netherlands Fresenius Kabi Nederland B.V. Ciprofloxacine Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Netherlands Fresenius Kabi Nederland B.V. Levofloxacine Fresenius
Kabi
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 98/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Netherlands Fresenius Kabi Nederland B.V. Moxifloxacine Fresenius Kabi
Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Netherlands Hameln Pharma Plus Gmbh Ciprofloxacin Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Netherlands Hexal Ag Ciprofloxacine Hexal Ag
Ciprofloxacin 100mg Tablet
Film-Coated Tablet Oral Use
Netherlands Hexal Ag Ciprofloxacine Hexal
Ag
Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Netherlands Hexal Ag Ciprofloxacine Hexal Ag
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Netherlands Hexal Ag Ciprofloxacine Hexal Ag
Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Netherlands Hexal Ag Ciprofloxacine Hexal Ag Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Netherlands Hikma Farmacêutica (Portugal), S.A.
Ciprofloxacine Hikma Ciprofloxacin 200mg Vial
Solution For Infusion Intravenous Use
Netherlands Hikma Farmacêutica
(Portugal), S.A.
Levofloxacine Hikma Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Netherlands Hospira Benelux Bvba Levofloxacine Hospira Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
Netherlands Jubilant Pharmaceuticals Nv Levofloxacine Jubilant Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Netherlands Jubilant Pharmaceuticals Nv Levofloxacine Jubilant Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Netherlands Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Netherlands Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Netherlands Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Netherlands Krka, D.D., Novo Mesto Ciprofloxacine Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Netherlands Krka, D.D., Novo Mesto Ciprofloxacine Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 99/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Netherlands Krka, D.D., Novo Mesto Ciprofloxacine Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Netherlands Mylan B.V. Ciprofloxacine Mylan Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Netherlands Mylan B.V. Levofloxacin Mylan Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Netherlands Mylan B.V. Ciprofloxacine Mylan Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Netherlands Mylan B.V. Ciprofloxacine Mylan Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Netherlands Mylan B.V. Levofloxacine Mylan Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Netherlands Mylan B.V. Levofloxacine Mylan Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Netherlands Mylan B.V. Norfloxacine Mylan Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Netherlands Mylan B.V. Ofloxacine Mylan Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Netherlands Mylan B.V. Ofloxacine Mylan Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Netherlands Pharma Resources Gmbh Levofloxacine Pharma Resources
Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Netherlands Pharmachemie B.V Ciprofloxacine Pch Ciprofloxacin Lactate 2mg/Ml
Solution For Infusion Intravenous Use
Netherlands Pharmachemie B.V Ciprofloxacin Pch Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Netherlands Pharmachemie B.V Ciprofloxacin Pch Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Netherlands Pharmachemie B.V Ciprofloxacine Pch Ciprofloxacin
Hydrochloride Monohydrate 750mg Tablet
Film-Coated Tablet Oral Use
Netherlands Pharmachemie B.V Levofloxacine Pch Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Netherlands Pharmachemie B.V Levofloxacine Pch Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 100/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Netherlands Pharmachemie B.V Ofloxacine 200 Pch Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Netherlands Pharmachemie B.V Ofloxacine 400 Pch Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Netherlands Pharmathen S.A. Moxifloxacin
Pharmathen
Moxifloxacin
Hydrochloride 400mg Tablet
Film-Coated Tablet Oral Use
Netherlands Ratiopharm Nederland B.V Ciprofloxacine
Ratiopharm
Ciprofloxacin
Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
Netherlands Ratiopharm Nederland B.V Ciprofloxacine Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Netherlands Ratiopharm Nederland B.V Ciprofloxacine
Ratiopharm
Ciprofloxacin
Hydrochloride Monohydrate 874.5mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Levofloxacine Sandoz Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Netherlands Sandoz B.V. Ciprofloxacine Sandoz Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Ciprofloxacine Sandoz Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Ciprofloxacine Sandoz Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Levofloxacine Sandoz Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Levofloxacine Sandoz Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Moxifloxacine Sandoz Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Norfloxacine Sandoz Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Ofloxacine Sandoz Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Netherlands Sandoz B.V. Ofloxacine Sandoz Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
Netherlands Sanofi-Aventis Netherlands B.V.
Tavanic Iv Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 101/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Netherlands Sanofi-Aventis Netherlands B.V.
Tavanic Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sanofi-Aventis Netherlands B.V.
Tavanic 500 Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Netherlands Sanovel Holding B.V. Levofloxacine Sanovel Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Netherlands Teva Nederland B.V. Norfloxacine Teva Norfloxacin 400mg Tablet
Film-Coated Tablet Gastroenteral Use | Oral Use
Netherlands Teva Nederland B.V. Moxifloxacine Teva Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Netherlands Torrent Pharma Gmbh Levofloxacin Torrent Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Netherlands Torrent Pharma Gmbh Levofloxacin Torrent Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Norway Actavis Group Hf. Ciprofloxacin Actavis Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Norway Actavis Group Hf. Ciprofloxacin Actavis Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Norway Actavis Group Hf. Ciprofloxacin Actavis Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Norway Bayer Pharma Ag Ciproxin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Norway Bayer Pharma Ag Ciproxin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Norway Hospira Uk Ltd Ciprofloxacin Hospira Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use | Oral
Use
Norway Sanofi-Aventis Norge As Tarivid Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Norway Teva Sweden Ab Ciprofloxacin Teva Ciprofloxacin 100mg Tablet
Film-Coated Tablet Oral Use
Norway Teva Sweden Ab Ciprofloxacin Teva Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Norway Teva Sweden Ab Ciprofloxacin Teva Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 102/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Norway Teva Sweden Ab Ciprofloxacin Teva Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Norway Villerton Invest S.A. Ciprofloxacin Villerton Ciprofloxacin 200mg/100 Ml | Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Poland +pharma Arzneimittel Gmbh Xyvelam Levofloxacin
Hemihydrate 256.23mg
Tablet
Film-Coated Tablet Oral Use
Poland +pharma Arzneimittel Gmbh Xyvelam Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Poland Actavis Group Ptc Ehf. Levoxa Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Poland Actavis Group Ptc Ehf. Levoxa Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Poland Actavis Group Ptc Ehf. Levoxa Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Poland Alvogen Ipco S.Ar.L Proxacin Ciprofloxacin 10mg/Ml Solution For Infusion Intravenous Use
Poland Alvogen Ipco S.Ar.L Proxacin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Poland Alvogen Ipco S.Ar.L Proxacin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Poland Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.P.A.
Chinoplus Prulifloxacin 600mg Film-Coated Tablet Oral Use
Poland Aziende Chimiche Riunite
Angelini Francesco - A.C.R.A.F. S.P.A.
Prixina Prulifloxacin 600mg
Tablet
Film-Coated Tablet Oral Use
Poland B.Braun Melsungen Ag Levofloxacinum B. Braun
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Poland Bayer Pharma Ag Avelox Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Poland Bayer Pharma Ag Ciprobay Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 103/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Poland Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Poland Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacin Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
Poland Fresenius Kabi Deutschland
Gmbh
Ciprofloxacin Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Poland Fresenius Kabi Polska Sp. Z O.O.
Levofloxacin Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Poland Fresenius Kabi Polska Sp. Z O.O.
Moxifloxacin Kabi Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Poland Gedeon Richter Polska Sp. Z. O.O.
Cipropol Ciprofloxacin 250mg Film-Coated Tablet Oral Use
Poland Gedeon Richter Polska Sp. Z. O.O.
Cipropol Ciprofloxacin 500mg Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto Moloxin Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Injection
Poland Krka, D.D., Novo Mesto Levalox Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Poland Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 100mg/10 Ml
Concentrate For Solution For Infusion
Oral Use
Poland Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 500mg L Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto Levalox Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto Levalox Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto Moloxin Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Poland Krka, D.D., Novo Mesto Nolicin Norfloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Poland Noridem Enterprises Ltd Moxifloxacin Noridem Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A.
Norsept Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 104/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Poland Pharmaswiss česká Republika S.R.O.
Oroflocina Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Poland Pharmaswiss česká Republika S.R.O.
Oroflocina Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Poland Sandoz Gmbh Abaktal Pefloxacin 400mg/5 Ml Solution For Infusion Intravenous Use
Poland Sandoz Gmbh Levofloxacin Sandoz Levofloxacin
Hemihydrate 5.12mg/Ml
Solution For Infusion Intravenous Use
Poland Sandoz Gmbh Palin Pipemidic Acid 200mg Capsule
Capsule, Hard Oral Use
Poland Sandoz Gmbh Abaktal Pefloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Poland Sandoz Gmbh Floxitrat Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Poland Sanofi-Aventis Deutschland Gmbh
Tavanic Levofloxacin Hemihydrate
5.1246mg/Ml
Solution For Infusion Intravenous Use
Poland Sanofi-Aventis Deutschland Gmbh
Tarivid Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Poland Synoptis Pharma Sp Z O O Levofloxacin Genoptim Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Poland Synoptis Pharma Sp Z O O Levofloxacin Genoptim Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Cipronex Ciprofloxacin 100mg/50 Ml
Solution For Infusion Intravenous Use
Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Cipronex Ciprofloxacin Hydrochloride 291mg
Tablet
Film-Coated Tablet Oral Use
Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Cipronex Ciprofloxacin Hydrochloride 582mg
Tablet
Film-Coated Tablet Oral Use
Poland Zentiva, A.S. Ciphin Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 105/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Accord Healthcare Limited Levofloxacina Combino Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Portugal Almus, Lda Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Portugal Almus, Lda Levofloxacina Almus Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Portugal Almus, Lda Levofloxacina Almus Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Alter, S.A. Ciprofloxacina Alter Ciprofloxacin Hydrochloride 250mg
Tablet
Coated Tablet Oral Use
Portugal Alter, S.A. Ciprofloxacina Alter Ciprofloxacin Hydrochloride 500mg Tablet
Coated Tablet Oral Use
Portugal Alter, S.A. Ciprofloxacina Alter Ciprofloxacin
Hydrochloride 750mg Tablet
Coated Tablet Oral Use
Portugal Alter, S.A. Ciprofloxacina Alter Ciprofloxacin Hydrochloride Monohydrate 291mg
Tablet
Coated Tablet Oral Use
Portugal Alter, S.A. Ciprofloxacina Alter Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Coated Tablet Oral Use
Portugal Alter, S.A. Ciprofloxacina Alter Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Coated Tablet Oral Use
Portugal Angelini Farmacêutica, Lda Unidrox Prulifloxacin 600mg
Tablet
Film-Coated Tablet Oral Use
Portugal Apotex Europe B.V. Moxifloxacin Apotex Moxifloxacin Hydrochloride 436.33mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 106/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Aristo Pharma Iberia, S.L. Nivoflox Ciprofloxacin Hydrochloride Monohydrate 291mg
Capsule
Capsule Oral Use
Portugal Aristo Pharma Iberia, S.L. Nivoflox Ciprofloxacin Hydrochloride Monohydrate 582mg
Capsule
Capsule Oral Use
Portugal Aristo Pharma Iberia, S.L. Levofloxacina Aristo Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Aristo Pharma Iberia, S.L. Levofloxacina Aristo Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Aurobindo Pharma (Portugal), Unipessoal Lda
Ciprofloxacina Aurobindo
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Aurobindo Pharma (Portugal), Unipessoal Lda
Ciprofloxacina Aurobindo
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Aurobindo Pharma (Portugal),
Unipessoal Lda
Ciprofloxacina
Aurobindo
Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Portugal Aurobindo Pharma (Portugal), Unipessoal Lda
Levofloxacina Aurobindo
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Aurobindo Pharma (Portugal),
Unipessoal Lda
Levofloxacina
Aurobindo
Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Portugal Aurobindo Pharma (Portugal), Unipessoal Lda
Moxifloxacina Aurobindo
Moxifloxacin Hydrochloride 436.32mg Tablet
Film-Coated Tablet Oral Use
Portugal Aurovitas Unipessoal, Lda. Levofloxacina Ritisca Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Portugal Aurovitas Unipessoal, Lda. Ciprofloxacina Actavis Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Portugal Aurovitas Unipessoal, Lda. Ciprofloxacina Actavis Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Aurovitas Unipessoal, Lda. Ciprofloxacina Actavis Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Portugal Aurovitas Unipessoal, Lda. Ciprofloxacina Aurovitas
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Aurovitas Unipessoal, Lda. Ciprofloxacina Aurovitas
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 107/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Aurovitas Unipessoal, Lda. Ciprofloxacina Aurovitas
Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Portugal Aurovitas Unipessoal, Lda. Levofloxacina Ritisca Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Aurovitas Unipessoal, Lda. Levofloxacina Ritisca Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Aurovitas Unipessoal, Lda. Moxifloxacina Aurovitas Moxifloxacin
Hydrochloride 436.32mg Tablet
Film-Coated Tablet Oral Use
Portugal Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.P.A.
Keraflox Prulifloxacin 600mg Tablet
Film-Coated Tablet Oral Use
Portugal B. Braun Medical, Lda. Levofloxacina B.Braun Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Portugal Baldacci - Portugal, S.A. Megaflox Ciprofloxacin Hydrochloride 528mg Tablet
Coated Tablet Oral Use
Portugal Bayer Portugal Lda Ciproxina Ciprofloxacin
400mg/200 Ml
Solution For Infusion Intravenous Use
Portugal Bayer Portugal Lda Ciproxina Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Bayer Portugal Lda Ciproxina Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Portugal Bayer Portugal Lda Ciproxina Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Portugal Bayer Portugal Lda Ciproxina Od Ciprofloxacin
Hydrochloride 669.4mg Tablet, Ciprofloxacin
Hydrated 506mg Tablet
Modified-Release
Tablet
Oral Use
Portugal Bayer Portugal Lda Ciproxina Od Ciprofloxacin Hydrochloride Monohydrate 334.8mg
Tablet, Ciprofloxacin Hydrated 253mg Tablet
Modified-Release Tablet
Oral Use
Portugal Bayhealth Lda. Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Portugal Bayhealth Lda. Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 108/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Bialfar - Produtos Farmacêuticos, S.A.
Uroflox Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Portugal Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Bluepharma Genéricos -
Comércio De Medicamentos, S.A.
Ciprofloxacina
Bluepharma
Ciprofloxacin
Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Portugal Bluepharma Genéricos - Comércio De Medicamentos,
S.A.
Ciprofloxacina Bluepharma
Ciprofloxacin Hydrochloride
Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Portugal Bluepharma Genéricos - Comércio De Medicamentos, S.A.
Ciprofloxacina Bluepharma
Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Portugal Bluepharma Genéricos - Comércio De Medicamentos, S.A.
Levofloxacina Bluepharma
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Bluepharma Genéricos -
Comércio De Medicamentos, S.A.
Levofloxacina
Bluepharma
Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Portugal Bluepharma Genéricos - Comércio De Medicamentos, S.A.
Moxifloxacina Bluepharma
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Portugal Bluepharma Indústria Farmacêutica S.A.
Moxifloxacina Bloza Bluepharma - Indústria Farmacêutica
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Portugal Bluepharma Indústria Farmacêutica S.A.
Moxifloxacina Bluesar Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Portugal Bluepharma Indústria Farmacêutica S.A.
Moxifloxacina Oara Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Portugal Centrofarma Lda Proflox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 109/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Centrofarma Lda Proflox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda. Levofloxacina Ciclum Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Portugal Ciclum Farma Unipessoal Lda. Ciprofloxacina Ciclum Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda. Ciprofloxacina Ciclum Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda. Levofloxacina Ciclum Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda. Levofloxacina Ciclum Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Ciclum Farma Unipessoal Lda. Moxifloxacina Ciclum Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Ciprofloxacina Cinfa Ciprofloxacin 250mg Tablet
Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Ciprofloxacina Cinfa Ciprofloxacin 500mg
Tablet
Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Ciprofloxacina Cinfa Ciprofloxacin 750mg Tablet
Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Norfloxacina Cinfa Norfloxacin 400mg
Tablet
Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Levofloxacina Cinfa Levofloxacin 250mg Tablet
Film Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Levofloxacina Cinfa Levofloxacin 500mg
Tablet
Film Coated Tablet Oral Use
Portugal Cinfa Portugal, Lda. Moxifloxacina Cinfa Moxifloxacin Hydrochloride 436.8mg
Tablet
Film-Coated Tablet Oral Use
Portugal Double-E Pharma Ltd Moxifloxacina Generis Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral
Portugal Double-E Pharma Ltd Moxifloxacina Generis Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico
Medicinal, S.A.
Ciprofloxacina Farmoz Ciprofloxacin
200mg/100 Ml
Solution For Infusion Intravenous Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Levofloxacina Farmoz Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 110/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Ofloxacina Farmoz Ofloxacin Hydrochloride 220mg/100 Ml
Solution For Infusion Intravenous Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Ciprofloxacina Farmoz Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico
Medicinal, S.A.
Ciprofloxacina Farmoz Ciprofloxacin
Hydrochloride
Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Levofloxacina Farmoz Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Farmoz - Sociedade Técnico Medicinal, S.A.
Levofloxacina Farmoz Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Fresenius Kabi Pharma Portugal Lda.
Ciprofloxacina Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Portugal Fresenius Kabi Pharma
Portugal, Lda.
Ciprofloxacina Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Portugal Fresenius Kabi Pharma Portugal, Lda.
Levofloxacina Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Portugal Generis Farmacêutica, S.A. Ciprofloxacina Generis Ciprofloxacin
200mg/100 Ml
Solution For Infusion Intravenous Use
Portugal Generis Farmacêutica, S.A. Ciprofloxacina Generis Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A. Ciprofloxacina Generis Ciprofloxacin
Hydrochloride 582mg
Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A. Ciprofloxacina Generis Ciprofloxacin Hydrochloride 873mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A. Ciprofloxacina Labesfal Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 111/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Generis Farmacêutica, S.A. Ciprofloxacina Labesfal Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A. Ciprofloxacina Labesfal Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A. Levofloxacina Generis Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A. Levofloxacina Generis Levofloxacin Hemihydrate 512.46mg
Tablet
Film-Coated Tablet Oral Use
Portugal Generis Farmacêutica, S.A. Ciprofloxacina Generis Ciprofloxacin 250mg/2.5 Ml
Oral Suspension Oral Use
Portugal Generis Farmacêutica, S.A. Ciprofloxacina Generis Ciprofloxacin 500mg/5
Ml
Oral Suspension Oral Use
Portugal Germed Farmacêutica, Lda. Ciprofloxacina Germed Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Portugal Germed Farmacêutica, Lda. Ciprofloxacina Germed Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Portugal Germed Farmacêutica, Lda. Ciprofloxacina Germed Ciprofloxacin
Hydrochloride
Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Portugal Germed Farmacêutica, Lda. Levofloxacina Germed Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Portugal Germed Farmacêutica, Lda. Levofloxacina Germed Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 112/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Gold Farma Ciprofloxacina Wynn Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Portugal Gold Farma Ciprofloxacina Wynn Ciprofloxacin Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
Portugal Gold Farma Ciprofloxacina Wynn Ciprofloxacin
Hydrochloride 291mg
Tablet, Opadry Y-1-7000 White 10mg Tablet
Tablet Oral Use
Portugal Gold Farma Ciprofloxacina Wynn Ciprofloxacin Hydrochloride 582mg
Tablet, Opadry Y-1-7000 White 20mg Tablet
Tablet Oral Use
Portugal Gp – Genéricos Portugueses,
Lda.
Ciprofloxacina Gp Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Portugal Gp – Genéricos Portugueses, Lda.
Ciprofloxacina Gp Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Gp – Genéricos Portugueses, Lda.
Ciprofloxacina Gp Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Portugal Hetero Europe S.L. Levofloxacina Hetero Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Portugal Hetero Europe S.L. Levofloxacina Hetero Levofloxacin Hemihydrate 512.47mg
Tablet
Film-Coated Tablet Oral Use
Portugal Hetero Europe S.L. Levofloxacina Hetero Europe
Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Portugal Hetero Europe S.L. Levofloxacina Hetero
Europe
Levofloxacin
Hemihydrate 512.47mg Tablet
Film-Coated Tablet Oral Use
Portugal Hetero Europe S.L. Moxifloxacina Hetero Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 113/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Hetero Europe S.L. Moxifloxacina Hetero Moxifloxacin Hydrochloride 436.8mg Tablet
Film-Coated Tablet Oral Use
Portugal Hikma Farmacêutica (Portugal), S.A.
Ciprofloxacina Hikma Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Portugal Hikma Farmacêutica (Portugal), S.A.
Levofloxacina Hikma Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Portugal Hikma Farmacêutica (Portugal), S.A.
Ciprofloxacina Hikma Ciprofloxacin Hydrochloride Monohydrate 291.1mg Tablet
Film-Coated Tablet Oral Use
Portugal Hikma Farmacêutica
(Portugal), S.A.
Ciprofloxacina Hikma Ciprofloxacin
Hydrochloride Monohydrate 582.2mg Tablet
Film-Coated Tablet Oral Use
Portugal Hikma Farmacêutica (Portugal), S.A.
Ciprofloxacina Hikma Ciprofloxacin Hydrochloride
Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Portugal Hospira Portugal Lda Levofloxacina Hospira Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Portugal Jaba Recordati, S.A. Ciprofloxacina Jaba Ciprofloxacin Hydrochloride Monohydrate 291mg
Tablet
Film-Coated Tablet Oral Use
Portugal Jaba Recordati, S.A. Ciprofloxacina Jaba Ciprofloxacin Hydrochloride Monohydrate 582mg
Tablet
Film-Coated Tablet Oral Use
Portugal Jaba Recordati, S.A. Ciprofloxacina Jaba Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Portugal Krka Farmacêutica,
Unipessoal Lda.
Ciprofloxacina Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Portugal Krka Farmacêutica, Unipessoal Lda.
Ciprofloxacina Ciprofloxacin 500mg L Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 114/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Krka Farmacêutica, Unipessoal Lda.
Ciprofloxacina Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Portugal Krka Farmacêutica, Unipessoal Lda.
Moxifloxacina Eulex Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Portugal Krka, D.D., Novo Mesto Levofloxacina Krka Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Krka, D.D., Novo Mesto Levofloxacina Krka Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Portugal Krka, D.D., Novo Mesto Moxifloxacin Krka Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Portugal Labesfal Laboratorios Almiro,
S.A.
Quinox Ciprofloxacin
100mg/50 Ml
Solution For Infusion Intravenous Use
Portugal Labesfal Laboratorios Almiro, S.A.
Quinox Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Portugal Labesfal Laboratorios Almiro, S.A.
Quinox Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Portugal Laboratórios Atral, S.A. Bioquil Ofloxacin 200mg Tablet Coated Tablet Oral Use
Portugal Laboratórios Atral, S.A. Bioquil Ofloxacin 400mg Tablet Coated Tablet Oral Use
Portugal Laboratórios Atral, S.A. Ciplox Ciprofloxacin Hydrochloride Monohydrate 582.4mg
Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Atral, S.A. Ciplox Ciprofloxacin Hydrochloride Monohydrate 873.6mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Ciprofloxacina Azevedos
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Ciprofloxacina Azevedos
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Ciprofloxacina Azevedos
Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Ciprofloxacina Azevedos
Ciprofloxacin Hydrochloride Monohydrate 291mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 115/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Laboratórios Basi – Indústria Farmacêutica, S.A.
Levofloxacina Basi Levofloxacin 250mg Bag
Solution For Infusion Intravenous Use
Portugal Laboratórios Basi – Indústria Farmacêutica, S.A.
Levofloxacina Basi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Portugal Laboratórios Basi – Indústria Farmacêutica, S.A.
Ciprofloxacina Basi Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Basi – Indústria
Farmacêutica, S.A.
Ciprofloxacina Basi Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Basi – Indústria Farmacêutica, S.A.
Ciprofloxacina Basi Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Basi – Indústria
Farmacêutica, S.A.
Levofloxacina Basi Levofloxacin
Hemihydrate 256.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Basi – Indústria Farmacêutica, S.A.
Levofloxacina Basi Levofloxacin Hemihydrate 513mg Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Delta, S.A. Oliflox Prulifloxacin 600mg
Tablet
Film-Coated Tablet Oral Use
Portugal Laboratórios Normon, S.A. Ciprofloxacina Normon Ciprofloxacin 254.4mg/100 Ml
Solution For Infusion Intravenous Use
Portugal Laboratórios Normon, S.A. Ciprofloxacina Normon Ciprofloxacin 508.8mg/200 Ml
Solution For Infusion Intravenous Use
Portugal Laboratórios Normon, S.A. Estecina Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Portugal Laboratórios Normon, S.A. Estecina Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Portugal Laboratórios Normon, S.A. Levofloxacina Normon Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Portugal Luye Pharma Ag Nixin Ciprofloxacin Hydrochloride Monohydrate 291.5mg
Tablet
Film-Coated Tablet Oral Use
Portugal Luye Pharma Ag Nixin Ciprofloxacin Hydrochloride Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 116/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Luye Pharma Ag Nixin Ciprofloxacin Hydrochloride Monohydrate 873.3mg
Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Levofloxacina Mylan Levofloxacin Hemihydrate 5.12mg Tablet
Solution For Infusion Intravenous Use
Portugal Mylan, Lda Levofloxacina Mylan Levofloxacin
Hemihydrate 5mg L
Solution For Infusion Intravenous Use
Portugal Mylan, Lda Ciprofloxacina Mylan Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Ciprofloxacina Mylan Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Ciprofloxacina Mylan Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Levofloxacina Mylan Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Levofloxacina Mylan Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Moxifloxacina Mylan Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Portugal Mylan, Lda Ofloxacina Mylan Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Bactoflox Ofloxacin 200mg Tablet Coated Tablet Oral Use
Portugal Pentafarma - Sociedade
Tecnico-Medicinal S.A.
Ciprofloxacina
Pentafarma
Ciprofloxacin
Hydrochloride Monohydrate 291.5mg
/ Pico Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Ciprofloxacina Pentafarma
Ciprofloxacin Hydrochloride Monohydrate 291.5mg
Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Ciprofloxacina Pentafarma
Ciprofloxacin Hydrochloride Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 117/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Ciprofloxacina Pentafarma
Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.
Loxadin Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Pentafarma - Sociedade
Tecnico-Medicinal S.A.
Loxadin Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Ciprofloxacina Pharmakern
Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Portugal Pharmakern Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Levofloxacina Pharmakern
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Pharmakern Portugal – Produtos Farmacêuticos,
Sociedade Unipessoal, Lda.
Levofloxacina Pharmakern
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm Lda Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 291.5µg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm Lda Ciprofloxacina Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm Lda Ciprofloxacina
Ratiopharm
Ciprofloxacin
Hydrochloride
Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm Lda Ciprofloxacina Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 874.5mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 118/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Ciprofloxacin Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 874.5mg
Tablet
Film-Coated Tablet Oral Use
Portugal Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda
Ciprofloxacina Ratiopharm
Ciprofloxacin Hydrochloride Monohydrate 874.5mg
Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda. Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda. Ciprofloxacina Sandoz Ciprofloxacin
Hydrochloride Monohydrate 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda. Ciprofloxacina Sandoz Ciprofloxacin
Hydrochloride Monohydrate 750mg
Tablet
Film-Coated Tablet Oral Use
Portugal Sandoz Farmacêutica Lda. Levofloxacina Sandoz Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos
Farmaceuticos Lda
Tavanic Levofloxacin 250mg/50
Ml
Solution For Infusion Intravenous Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Tavanic Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Portugal Sanofi - Produtos
Farmaceuticos Lda
Oflocet Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Tavanic Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Tavanic Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Sanofi - Produtos Farmaceuticos Lda
Tavanic Levofloxacin 512.46mg Tablet
Film-Coated Tablet Oral Use
Portugal Tecnimede - Sociedade Técnico-Medicinal, Sa
Giroflox Ciprofloxacin 2mg/Ml Solution For Infusion Injection
Annex I
EMA/88273/2017 Page 119/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Tecnimede - Sociedade Técnico-Medicinal, Sa
Giroflox Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Portugal Tetrafarma- Produtos Farmacêuticos, Lda.
Ciprofloxacina Tetrafarma
Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
Portugal Tetrafarma- Produtos
Farmacêuticos, Lda.
Ciprofloxacina
Tetrafarma
Ciprofloxacin
Hydrochloride
Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Portugal Tetrafarma- Produtos Farmacêuticos, Lda.
Ciprofloxacina Tetrafarma
Ciprofloxacin Hydrochloride Monohydrate 873mg
Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Ciprofloxacina Teva Ciprofloxacin Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos
Farmacêuticos Lda
Ciprofloxacina Teva Ciprofloxacin
Hydrochloride Monohydrate 291mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Ciprofloxacina Teva Ciprofloxacin Hydrochloride
Monohydrate 582mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Ciprofloxacina Teva Ciprofloxacin Hydrochloride
Monohydrate 873mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos Farmacêuticos Lda
Levofloxacina Teva Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Portugal Teva Pharma – Produtos
Farmacêuticos Lda
Levofloxacina Teva Levofloxacin
Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Ciprofloxacina Tolife Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 120/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Portugal Tolife - Produtos Farmacêuticos, S.A.
Ciprofloxacina Tolife Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Portugal Tolife - Produtos Farmacêuticos, S.A.
Ciprofloxacina Tolife Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Romania Ac Helcor Ciprolen Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Romania Ac Helcor Ciprolen Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Romania Ac Helcor Pharma Norfloxacin Norfloxacin Hydrochloride 400mg Tablet
Film-Coated Tablet Oral Use
Romania Actavis Group Ptc Ehf. Levofloxacină Actavis Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Romania Actavis Group Ptc Ehf. Levofloxacina Actavis Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Romania Actavis Group Ptc Ehf. Levofloxacina Actavis Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Romania Actavis Group Ptc Ehf. Mofil Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Romania Alvogen Ipco S.Ar.L Mofinacin Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Romania Alvogen Ipco S.Ar.L Mofinacin Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Romania Antibiotice Sa Cipro Quin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Romania Antibiotice Sa Norfloxacină Atb Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Romania Arena Group S.A Norfloxacina Arena Norfloxacin 400mg
Capsule
Capsule, Hard Oral Use
Romania Arena Group S.A Ciprofloxacină Arena Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Romania Arena Group S.A Ciprofloxacină Arena Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Romania Arena Group S.A Ciprofloxacină Arena Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Romania Arena Group S.A Ciprofloxacină Arena Ciprofloxacin Hydrochloride 116.4mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 121/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Romania Arena Group S.A Levofloxacina Arena Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Romania Arena Group S.A Levofloxacina Arena Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Romania Aurobindo Pharma (Malta)
Limited
Ciprofloxacina
Aurobindo
Ciprofloxacin
Hydrochloride 500mg
Tablet
Film Coated Tablet Oral Use
Romania Aurobindo Pharma (Malta) Limited
Ciprofloxacina Aurobindo
Ciprofloxacin Hydrochloride 750mg Tablet
Film Coated Tablet Oral Use
Romania Aurobindo Pharma (Malta) Limited
Ciprofloxacină Aurobindo
Ciprofloxacin Hydrochloride 250mg Tablet
Film Coated Tablet Oral Use
Romania Aurobindo Pharma (Malta) Limited
Ciprofloxacina Aurobindo
Ciprofloxacin Hydrochloride 250mg
Tablet
Film-Coated Tablet Oral Use
Romania Aurobindo Pharma (Malta) Limited
Ciprofloxacină Aurobindo
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Romania Aurobindo Pharma (Malta) Limited
Ciprofloxacină Aurobindo
Ciprofloxacin Hydrochloride 250mg
Tablet
Film-Coated Tablet Oral Use
Romania Aurobindo Pharma (Malta) Limited
Ciprofloxacină Aurobindo
Ciprofloxacin Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
Romania Aurobindo Pharma (Malta)
Limited
Ciprofloxacină
Aurobindo
Ciprofloxacin
Hydrochloride 750mg Tablet
Film-Coated Tablet Oral Use
Romania Aurobindo Pharma (Malta) Limited
Moxifloxacina Aurobindo
Moxifloxacin Hydrochloride 436.32mg Tablet
Film-Coated Tablet Oral Use
Romania Bayer Pharma Ag Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Romania Bayer Pharma Ag Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 122/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Romania Bayer Pharma Ag Ciprobay Xr Ciprofloxacin Hydrochloride 334.8mg Tablet, Ciprofloxacin
Hydrated 253mg Tablet
Modified-Release Tablet
Oral Use
Romania Bayer Pharma Ag Ciprobay Xr Ciprofloxacin Hydrochloride 669.4mg Tablet, Ciprofloxacin
Hydrated 506mg Tablet
Modified-Release Tablet
Oral Use
Romania Dr. Reddy's Laboratories Romania Srl
Ciprofloxacina Dr. Reddy`s
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Romania Dr. Reddy's Laboratories Romania Srl
Fleraday Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Romania Dr. Reddy's Laboratories Romania Srl
Fleraday Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Romania Gedeon Richter România S.A. Cuminol Ciprofloxacin Hydrochloride 291.5mg Tablet
Film-Coated Tablet Oral Use
Romania Gedeon Richter România S.A. Cuminol Ciprofloxacin Hydrochloride 583mg Tablet
Film-Coated Tablet Oral Use
Romania Infomed Fluids Srl Cipro Inf Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Romania Infomed Fluids Srl Levofloxacin Infomed Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Romania Krka, D.D., Novo Mesto Moflaxa Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Injection
Romania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 100mg/10 Ml
Concentrate For Solution For Infusion
Intravenous Use
Romania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin
100mg/50 Ml
Solution For Infusion Intravenous Use
Romania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Romania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Romania Krka, D.D., Novo Mesto Levalox Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Romania Krka, D.D., Novo Mesto Moflaxa Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Romania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 123/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Romania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 500mg L Film-Coated Tablet Oral Use
Romania Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Romania Krka, D.D., Novo Mesto Levalox Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Romania Krka, D.D., Novo Mesto Levalox Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Romania Krka, D.D., Novo Mesto Moflaxa Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Romania Krka, D.D., Novo Mesto Nolicin Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Romania Labormed Pharma S.A. Norfloxacină Lph Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Romania Laropharm Srl Norfloxacin Laropharm Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Romania Laropharm Srl Ofloxacină Laropharm Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Romania Laropharm Srl Pefloxacin Laropharm Pefloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Romania Macleods Pharma Uk Ltd Levofloxacin Macleods Pharma Uk Limited
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Romania Macleods Pharma Uk Ltd Levofloxacin Macleods Pharma Uk Limited
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Romania Mylan S.A.S Levofloxacină Mylan Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
Romania Mylan S.A.S Levofloxacină Mylan Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Romania Ranbaxy (Uk) Limited Cifran Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Romania Ranbaxy (Uk) Limited Cifran Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Romania Ranbaxy (Uk) Limited Zanocin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Romania S.C. Fresenius Kabi România S.R.L.
Levofloxacin Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Romania S.C. Fresenius Kabi România S.R.L.
Moxifloxacina Kabi Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 124/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Romania S.C. Sandoz S.R.L. Levofloxacină Sandoz Levofloxacin Hemihydrate 5.12mg/Ml
Solution For Infusion Intravenous Use
Romania S.C. Sandoz S.R.L. Moxifloxacina Sandoz Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Romania S.C. Zentiva S.A. Ciprofloxacina Zentiva Ciprofloxacin Lactate 10mg/Ml
Concentrate For Solution For Infusion
Intravenous Use
Romania S.C. Zentiva S.A. Nalixid Nalidixic Acid 500mg Capsule
Capsule Oral Use
Romania Stada Arzneimittel Ag Cenomar Levofloxacin Hemihydrate 5.12mg/Ml
Solution For Infusion Intravenous Use
Romania Terapia S.A. Tavanic I.V. Levofloxacin 250mg/50 Ml
Solution For Infusion Intravenous Use
Romania Terapia S.A. Tavanic I.V. Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Romania Terapia S.A. Tavanic Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Romania Terapia S.A. Tavanic Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Romania Terapia S.A. Tavanic Levofloxacin 512.46mg Tablet
Film-Coated Tablet Oral Use
Romania Teva Pharmaceuticals S.R.L Evolox Levofloxacin 5mg/100 Ml
Solution For Infusion Intravenous Use
Romania Torrent Pharma Srl Levotor Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Romania Torrent Pharma Srl Levotor Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Romania Torrent Pharma Srl Moxifloxacina Torrent Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Romania Torrent Pharma Srl Moxitor Moxifloxacin Hydrochloride 436.37mg Tablet
Film-Coated Tablet Oral Use
Romania Zentiva, K.S. Ofloxin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Slovakia Actavis Group Ptc Ehf. Levofloxacin Actavis Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 125/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Slovakia Bayer Pharma Ag Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Slovakia Bayer Pharma Ag Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Slovakia Cipla (Uk) Limited Ciplox Ciprofloxacin Hydrochloride Monohydrate 297.5mg
Tablet
Film-Coated Tablet Oral Use
Slovakia Cipla (Uk) Limited Ciplox Ciprofloxacin
Hydrochloride Monohydrate 595mg Tablet
Film-Coated Tablet Oral Use
Slovakia Fresenius Kabi S.R.O Ciprofloxacin Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Slovakia Fresenius Kabi S.R.O Levofloxacin Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Slovakia Fresenius Kabi S.R.O Moxifloxacin Kabi Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Slovakia Hikma Farmacêutica (Portugal), S.A.
Ciprolon Ciprofloxacin Lactate 254mg/100 Ml
Solution For Infusion Intravenous Use
Slovakia Hikma Farmacêutica (Portugal), S.A.
Ciprolon Ciprofloxacin Hydrochloride 586mg
Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto Moloxin Moxifloxacin 1600µg/Ml Solution For Infusion Intravenous Injection
Slovakia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Slovakia Krka, D.D., Novo Mesto Levalox Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Slovakia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin Lactate 100mg/10 Ml
Concentrate For Solution For Infusion
Oral Use
Slovakia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 500mg L Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto Levalox Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto Levalox Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Slovakia Krka, D.D., Novo Mesto Moloxin Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Slovakia Krka, D.D., Novo Mesto Nolicin Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Slovakia Medochemie Ltd. Gyrablock Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Slovakia Medochemie Ltd. Medociprin Ciprofloxacin Hydrochloride Monohydrate 291.5mg
Tablet
Film-Coated Tablet Oral Use
Slovakia Medochemie Ltd. Medociprin Ciprofloxacin Hydrochloride Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
Slovakia Medochemie Ltd. Medofloxine Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Slovakia Pro.Med.Cs Praha A.S. Cifloxinal Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
Slovakia Ranbaxy (Uk) Limited Zanocin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Slovakia Sandoz Pharmaceuticals D.D. Abaktal Pefloxacin Mesilate
Dihydrate 515.3mg/5 Ml
Concentrate For
Solution For Infusion
Intravenous Use
Slovakia Sandoz Pharmaceuticals D.D. Abaktal Pefloxacin Mesilate Dihydrate 558.5mg Tablet
Film-Coated Tablet Oral Use
Slovakia Sandoz Pharmaceuticals D.D. Ciprofloxacín Sandoz Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Slovakia Sandoz Pharmaceuticals D.D. Ciprofloxacín Sandoz Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Slovakia Sanofi-Aventis Slovakia Sro Taroflox Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Slovakia Sanofi-Aventis Slovakia Sro Tavanic Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Slovakia Teva Pharmaceuticals Cr,
S.R.O.
Ciprofloxacin Teva Ciprofloxacin
Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Slovakia Teva Pharmaceuticals Cr, S.R.O.
Ciprofloxacin Teva Ciprofloxacin Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
Slovakia Teva Pharmaceuticals Cr, S.R.O.
Ciprofloxacin Teva Ciprofloxacin Hydrochloride 750mg Tablet
Film-Coated Tablet Oral Use
Slovakia Zentiva, A.S. Ciphin Ciprofloxacin
Hydrochloride
Monohydrate 500mg Tablet
Film-Coated Tablet Oral Use
Slovakia Zentiva, K.S. Ofloxin Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Slovenia Actavis Group Ptc Ehf. Levoxa Levofloxacin Hemihydrate 250mg
Tablet
Film-Coated Tablet Oral Use
Slovenia Actavis Group Ptc Ehf. Levoxa Levofloxacin Hemihydrate 500mg Tablet
Film-Coated Tablet Oral Use
Slovenia Actavis Group Ptc Ehf. Moxifloxacin Actavis Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Slovenia B.Braun Melsungen Ag Levofloksacin B. Braun Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Slovenia B.Braun Melsungen Ag Levofloksacin B. Braun Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Slovenia Bayer D.O.O Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Slovenia Bayer D.O.O Ciprobay Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
Slovenia Bayer D.O.O Ciprobay Ciprofloxacin
400mg/200 Ml
Solution For Infusion Intravenous Use
Slovenia Bayer D.O.O Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Slovenia Bayer D.O.O Ciprobay Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Slovenia Bayer D.O.O Ciprobay Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Slovenia Bayer D.O.O Ciprobay Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Slovenia Fresenius Kabi Deutschland Gmbh
Levofloksacin Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Slovenia Fresenius Kabi Deutschland Gmbh
Moksifloksacin Kabi Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Slovenia Infomed Fluids Srl Ciprofloksacin Infomed Fluids
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Slovenia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin
100mg/10 Ml
Concentrate For
Solution For Infusion
Intravenous Use
Slovenia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 100mg/50 Ml
Solution For Infusion Intravenous Use
Slovenia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin
200mg/100 Ml
Solution For Infusion Intravenous Use
Slovenia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Slovenia Krka, D.D., Novo Mesto Leviaben Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Slovenia Krka, D.D., Novo Mesto Moloxin Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use | Oral
Use
Slovenia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 500mg L Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto Ciprinol Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto Leviaben Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto Leviaben Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto Moloxin Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Slovenia Krka, D.D., Novo Mesto Nolicin Norfloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Slovenia Lek Pharmaceuticals D.D. Ljubljana
Ciprofloksacin Lek Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
Slovenia Lek Pharmaceuticals D.D.
Ljubljana
Ciprofloksacin Lek Ciprofloxacin
Hydrochloride Monohydrate 222mg/100 Ml
Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 129/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Slovenia Lek Pharmaceuticals D.D. Ljubljana
Levofloksacin Lek Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Slovenia Lek Pharmaceuticals D.D. Ljubljana
Abaktal Pefloxacin Mesilate 400mg Tablet
Film-Coated Tablet Oral Use
Slovenia Lek Pharmaceuticals D.D. Ljubljana
Ciprofloksacin Lek Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Slovenia Lek Pharmaceuticals D.D.
Ljubljana
Ciprofloksacin Lek Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Slovenia Lek Pharmaceuticals D.D. Ljubljana
Ciprofloksacin Lek Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Slovenia Lek Pharmaceuticals D.D.
Ljubljana
Levofloksacin Lek Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Slovenia Lek Pharmaceuticals D.D. Ljubljana
Levofloksacin Lek Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Slovenia Lek Pharmaceuticals D.D. Ljubljana
Moksifloksacin Lek Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Slovenia Lek Pharmaceuticals D.D.
Ljubljana
Abaktal Pefloxacin Mesilate
400mg/5 Ml
Solution For Injection Oral Use
Slovenia Sanofi-Aventis D.O.O. Tavanic Levofloxacin Hemihydrate
5.1246mg/Ml
Solution For Infusion Intravenous Use
Slovenia Sanofi-Aventis D.O.O. Tavanic Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Slovenia Stada Arzneimittel Ag Moksifloksacin Stada Moxifloxacin 400mg/250 Ml
Solution For Infusion Intravenous Use
Slovenia Stada Arzneimittel Ag Moksifloksacin Stada Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Spain Accord Healthcare S.L.U. Levofloxacino Accord Levofloxacin
Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Spain Actavis Group Ptc Ehf. Levofloxacino Actavis Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Spain Actavis Group Ptc Ehf. Levofloxacino Actavis Group Ptc
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 130/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Spain Actavis Group Ptc Ehf. Moxifloxacino Actavis Moxifloxacin Hydrochloride 400mg Tablet
Film-Coated Tablet Oral Use
Spain Almus Farmaceutica S.A Levofloxacino Almus Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Amneal Pharma Europe Limited
Levofloxacino Amneal Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Amneal Pharma Europe Limited
Levofloxacino Amneal Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Apotex Europe B.V. Levofloxacino Apotex Ag
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Apotex Europe B.V. Moxifloxacino Apotex Moxifloxacin Hydrochloride 436.33mg Tablet
Film-Coated Tablet Oral Use
Spain Arafarma Group, S.A Araxacina Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Arafarma Group, S.A Araxacina Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Spain Arafarma Group, S.A Araxacina Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Spain Aristo Pharma Iberia, S.L. Ciprofloxacino Aristo Ciprofloxacin 250mg Film-Coated Tablet Oral Use
Spain Aristo Pharma Iberia, S.L. Ciprofloxacino Aristo Ciprofloxacin 750mg Film-Coated Tablet Oral Use
Spain Aristo Pharma Iberia, S.L. Ciprofloxacino Aristo Ciprofloxacin Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
Spain Aurovitas Spain,s.A.U. Levofloxacino Aurovitas Levofloxacin
Hemihydrate 500mg Tablet
Film-Coated Tablet Oral Use
Spain Aurovitas Spain,s.A.U. Levofloxacino Aurovitas Spain
Levofloxacin Hemihydrate 500mg Tablet
Film-Coated Tablet Oral Use
Spain B.Braun Medical, S.A. Levofloxacino B. Braun Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Spain Bayer Hispania Sl Actira Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Spain Bayer Hispania Sl A C T I R A Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Spain Bayer Hispania Sl Baycip Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Cipla Europe Nv Levofloxacino Cipla Levofloxacin
Hemihydrate 512.47mg Tablet
Film-Coated Tablet Oral Use
Spain Dermogen Farma, S.A. Ciprofloxacino Dermogen
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Dermogen Farma, S.A. Ciprofloxacino Dermogen
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Dermogen Farma, S.A. Ciprofloxacino Dermogen
Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Spain Dermogen Farma, S.A. Levofloxacino
Dermogen
Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Spain Dermogen Farma, S.A. Levofloxacino Dermogen
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Especialidades Farmaceuticas
Centrum, S.A
Asey Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Spain Fresenius Kabi España S.A.U. Ciprofloxacino Fresenius Kabi
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Spain Fresenius Kabi España S.A.U. Ciprofloxacino Kabi Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Spain Fresenius Kabi España S.A.U. Levofloxacino Kabi Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Spain Fresenius Kabi España S.A.U. Moxifloxacino Kabi Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Spain G.E.S. Genéricos Españoles Laboratorio, S.A.
Ciprofloxacino Anages Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Spain G.E.S. Genéricos Españoles Laboratorio, S.A.
Ciprofloxacino G.E.S. Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Spain G.E.S. Genéricos Españoles Laboratorio, S.A.
Levofloxacino G.E.S. Levofloxacin 500mg Bag
Solution For Infusion Intravenous Use
Spain G.E.S. Genéricos Españoles Laboratorio, S.A.
Moxifloxacino G.E.S. Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Spain G.E.S. Genéricos Españoles Laboratorio, S.A.
Ofloxacino G.E.S. Ofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Spain Helm Iberica Sa Levofloxacino Hibrel Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Hetero Europe S.L. Moxifloxacino Hetero Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Spain Hospira Uk Ltd Levofloxacino Hospira Levofloxacin 250mg/50
Ml
Solution For Infusion Intravenous Use
Spain Industria Química Y Farmacéutica Vir, S.A.
Ciprofloxacino Vir Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Industria Química Y
Farmacéutica Vir, S.A.
Ciprofloxacino Vir Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Spain Industria Química Y Farmacéutica Vir, S.A.
Doriman Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Industria Química Y Farmacéutica Vir, S.A.
Doriman Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Industria Química Y
Farmacéutica Vir, S.A.
Oflovir Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Spain Kern Pharma, S.L. Ciprofloxacino Kern Pharma
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Spain Kern Pharma, S.L. Levofloxacino Kern Pharma
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Spain Kern Pharma, S.L. Moxifloxacino Kern Pharma
Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Spain Kern Pharma, S.L. Levofloxacino Kern Pharma
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Kern Pharma, S.L. Moxifloxacino Kern
Pharma
Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Spain Korhispana, S.L. Ciprofloxacino Korhispana
Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
Spain Korhispana, S.L. Ciprofloxacino Korhispana
Ciprofloxacin Hydrochloride 500mg
Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Spain Korhispana, S.L. Ciprofloxacino Korhispana
Ciprofloxacin Hydrochloride 750mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto Levofloxacino Krka Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Krka, D.D., Novo Mesto Moxifloxacino Krka Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L. Ciprofloxacino Stada Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L. Levofloxacino Stada Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L. Moxifloxacino Stada Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorio Stada, S.L. Norfloxacino Stada Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A. Ciprofloxacino Alter Ciprofloxacin
Hydrochloride 250mg
Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A. Ciprofloxacino Alter Ciprofloxacin Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A. Ciprofloxacino Alter Ciprofloxacin Hydrochloride 750mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Alter, S.A. Levofloxacino Alter Levofloxacin Hemihydrate 500mg
Tablet
Tablet Oral Use
Spain Laboratorios Aurobindo S.L.U.
Levofloxacino Aurobindo
Levofloxacin 250mg Tablet
Film Coated Tablet Oral Use
Spain Laboratorios Aurobindo
S.L.U.
Ciprofloxacino
Aurobindo
Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Aurobindo S.L.U.
Ciprofloxacino Aurobindo
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Aurobindo
S.L.U.
Ciprofloxacino
Aurobindo
Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 134/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Spain Laboratorios Aurobindo S.L.U.
Levofloxacino Aurobindo
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Aurobindo S.L.U.
Moxifloxacino Aurobindo
Moxifloxacin Hydrochloride 436.32mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Berenguer Infale, S.L.
Galusan Pipemidic Acid 400mg Capsule
Capsule, Hard Oral Use
Spain Laboratorios Biomed Piprol Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Cinfa, S.A. Ciprofloxacino Cinfa Ciprofloxacin 250mg Tablet
Coated Tablet Oral Use
Spain Laboratorios Cinfa, S.A. Ciprofloxacino Cinfa Ciprofloxacin 500mg Tablet
Coated Tablet Oral Use
Spain Laboratorios Cinfa, S.A. Ciprofloxacino Cinfa Ciprofloxacin 750mg Tablet
Coated Tablet Oral Use
Spain Laboratorios Cinfa, S.A. Levofloxacino Cinfa Levofloxacin
Hemihydrate 512.45mg
Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Cinfa, S.A. Moxifloxacino Cinfa Moxifloxacin Hydrochloride 436.8mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Cinfa, S.A. Norfloxacino Cinfa Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Combix, S.L.U. Ciprofloxacino Combix Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Combix, S.L.U. Levofloxacino Combix Levofloxacin Hemihydrate 512.46mg
Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Combix, S.L.U. Levofloxacino Pharma Combix
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Lesvi, S.L. Rigoran Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A. Ciprofloxacino Normon Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Spain Laboratorios Normon, S.A. Levofloxacino Normon Levofloxacin
500mg/100 Ml
Solution For Infusion Intravenous Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Spain Laboratorios Normon, S.A. Norfloxacino Normon Norfloxacin 400mg Tablet
Coated Tablet Oral Use
Spain Laboratorios Normon, S.A. Moxifloxaxino Normon Moxifloxacin 400mg Units
Film Coated Tablet Oral Use
Spain Laboratorios Normon, S.A. Levofloxacino Normon Levofloxacin Hemihydrate 513mg Tablet
Film Coated Tablets Oral Use
Spain Laboratorios Normon, S.A. Ciprofloxacino Normon Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A. Ciprofloxacino Normon Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Normon, S.A. Ciprofloxacino Normon Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Ranbaxy S.L. Ciprofloxacino Ranbaxy Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Ranbaxy S.L. Levofloxacino Ranbaxy Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Ranbaxy S.L. Norfloxacino Ranbaxy Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Spain Laboratorios Ranbaxy S.L. Ofloxacino Ranbaxy Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
Spain Laboratorios Salvat, S.A. Cetraxal Ciprofloxacin 500mg Tablet
Coated Tablet Oral Use
Spain Laboratorios Salvat, S.A. Cetraxal Ciprofloxacin 750mg Tablet
Coated Tablet Oral Use
Spain Laboratorios Salvat, S.A. Cetraxal Ciprofloxacin 500mg/5 Ml
Oral Suspension Oral Use
Spain Laboratorios Salvat, S.A. Cetraxal Ciprofloxacin 500mg
Sachet
Oral Suspension In
Sachet
Oral Use
Spain Laboratorios Serra Pamies
S.A.
Levofloxacino
Serraclinics
Levofloxacin 500mg
Bag
Solution For Infusion Intravenous Use
Spain Laboratorios Tecnobío, S.A. Nuril Pipemidic Acid 400mg Capsule
Capsule, Hard Oral Use
Spain Mabo-Farma, S.A. Ciprofloxacino Mabo Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Spain Mabo-Farma, S.A. Ciprofloxacino Mabo Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Annex I
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Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Spain Mabo-Farma, S.A. Ciprofloxacino Mabo Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Spain Mabo-Farma, S.A. Levofloxacino Mabo Levofloxacin Hemihydrate 500mg Tablet
Film-Coated Tablet Oral Use
Spain Macleods Pharma Uk Ltd Levofloxacin Macleods Levofloxacin 512.46mg Tablet
Film-Coated Tablet Oral Use
Spain Mylan Pharmaceuticals S.L. Levofloxacin Mylan Levofloxacin 500mg/100 Ml
Solution For Injection Intravenous Use
Spain Mylan Pharmaceuticals S.L. Levofloxacino Mylan Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Mylan Pharmaceuticals S.L. Moxifloxacino Mylan Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Spain Onedose Pharma Ciprofloxacino Bluepharma
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Onedose Pharma Ciprofloxacino
Bluepharma
Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Spain Onedose Pharma Levofloxacino Bluepharma
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A Ciprofloxacino Pensa Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A Ciprofloxacino Pensa Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A Levofloxacino Pensa Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Spain Pensa Pharma, S.A Norfloxacino Pensa Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Spain Qualigen, S.L. Ciprofloxacino Qualigen Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Qualigen, S.L. Ciprofloxacino Qualigen Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Qualigen, S.L. Levofloxacino Qualigen Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Qualigen, S.L. Moxifloxacino Qualigen Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 137/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Spain Qualigen, S.L. Norfloxacino Qualigen Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm Espana Sa Ciprofloxacino Ratio Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm Espana Sa Ciprofloxacino Ratio Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm Espana Sa Ciprofloxacino Ratio Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm Espana Sa Levofloxacino Ratiopharm
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Ratiopharm Espana Sa Moxifloxacino
Ratiopharm
Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A. Ciprofloxacino Sandoz Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A. Levofloxacino Sandoz Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A. Moxifloxacino Sandoz Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Spain Sandoz Farmacéutica, S.A. Norfloxacino Sandoz Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Spain Sanofi-Aventis, S.A. Tavanic Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
Spain Sanofi-Aventis, S.A. Tavanic Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Sigma Tau España, S.A. Globuce Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Sigma Tau España, S.A. Globuce Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Spain Sigma Tau España, S.A. Globuce Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Spain Sigma Tau España, S.A. Taucip Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Sigma Tau España, S.A. Taucip Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Stada Genéricos, S.L. Xasmun Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 138/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Spain Tarbis Farma, S.L. Ciprofloxacino Tarbis Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Tarbis Farma, S.L. Ciprofloxacino Tarbis Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Tarbis Farma, S.L. Ciprofloxacino Tarbis Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Spain Tarbis Farma, S.L. Levofloxacino Tarbis Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Spain Tecnimede España Ind. Fca., S.A.
Levofloxacino Tecnigen Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Spain Tecnimede España Ind. Fca.,
S.A.
Levofloxacino
Tecnimede España
Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Spain Tedec-Meiji Farma, S.A. Urisan Pipemidic Acid 400mg Capsule
Capsule Oral Use
Spain Teva Pharma S.L.U Ciprofloxacino Tevagen Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Spain Teva Pharma S.L.U Ciprofloxacino Tevagen Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Spain Teva Pharma S.L.U Ciprofloxacino Tevagen Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Spain Teva Pharma S.L.U Levofloxacino Efg Teva Levofloxacin Hemihydrate 500mg Tablet
Film-Coated Tablet Oral Use
Spain Teva Pharma S.L.U Moxifloxacino Tevagen Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Spain Vegal Farmaceutica, S.L. Moxifloxacino Depronal Vegal Farmacéutica,
S.L.
Moxifloxacin 400mg Tablet
Film Coated Tablet Oral Use
Spain Vegal Farmaceutica, S.L. Moxifloxacino Gadur
Vegal Farmacéutica, S.L.
Moxifloxacin 400mg
Tablet
Film Coated Tablet Oral Use
Spain Vegal Farmaceutica, S.L. Levofloxacino Vegal Levofloxacin Hemihydrate 513mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 139/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Spain Zentiva, K.S. Moxifloxacino Moxifloxacin Hydrochloride 436.37mg Container
Solution For Infusion Intravenous Use
Spain Zentiva, K.S. Moxifloxacino Moxifloxacin Hydrochloride 436.37mg Tablet
Film-Coated Tablet Oral Use
Sweden Accord Healthcare Limited Ciprofloxacin Accord Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Sweden Accord Healthcare Limited Ciprofloxacin Accord Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Sweden Accord Healthcare Limited Ciprofloxacin Accord Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Sweden Actavis Group Hf. Ciprofloxacin Actavis Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Sweden Actavis Group Hf. Ciprofloxacin Actavis Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Sweden Actavis Group Hf. Ciprofloxacin Actavis Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Sweden Amneal Pharma Europe Limited
Ciprofloxacin Amneal Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
Sweden Amneal Pharma Europe Limited
Ciprofloxacin Amneal Ciprofloxacin Hydrochloride 500mg Tablet
Film-Coated Tablet Oral Use
Sweden Amneal Pharma Europe Limited
Ciprofloxacin Amneal Ciprofloxacin Hydrochloride 750mg
Tablet
Film-Coated Tablet Oral Use
Sweden Amneal Pharma Europe Limited
Levofloxacin Amneal Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Sweden Amneal Pharma Europe
Limited
Levofloxacin Amneal Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Sweden B.Braun Melsungen Ag Levofloxacin B. Braun Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Sweden Bayer Pharma Ag Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Sweden Bayer Pharma Ag Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 140/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Sweden Bayer Pharma Ag Ciproxin Ciprofloxacin Hydrated 250mg/5 Ml
Granules And Solvent For Oral Suspension
Oral Use
Sweden Bayer Pharma Ag Ciproxin Ciprofloxacin Hydrated 500mg/5 Ml
Granules And Solvent For Oral Suspension
Oral Use
Sweden Bluefish Pharmaceuticals Ab Ciprofloxacin Bluefish Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Sweden Bluefish Pharmaceuticals Ab Ciprofloxacin Bluefish Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Sweden Bluefish Pharmaceuticals Ab Ciprofloxacin Bluefish Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Sweden Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Sweden Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Sweden Double-E Pharma Ltd Moxifloxacin Double-E Pharma
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral
Sweden Fresenius Kabi Ab Ciprofloxacin Fresenius
Kabi
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
Sweden Fresenius Kabi Ab Moxifloxacin Fresenius Kabi
Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
Sweden Hexal A/S Ciprofloxacin Hexal Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Sweden Hexal A/S Ciprofloxacin Hexal Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Sweden Hexal A/S Ciprofloxacin Hexal Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Sweden Hospira Uk Ltd Ciprofloxacin Hospira Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use | Oral
Use
Sweden Krka Sverige Ab Ciprofloxacin Krka Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Sweden Krka Sverige Ab Ciprofloxacin Krka Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Sweden Krka Sverige Ab Ciprofloxacin Krka Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
Sweden Krka Sverige Ab Levofloxacin Krka Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 141/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Sweden Krka Sverige Ab Moxifloxacin Krka Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Sweden Krka Sverige Ab Norfloxacin Krka Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
Sweden Mylan Ab Ciprofloxacin Mylan Ciprofloxacin 100mg Tablet
Film-Coated Tablet Oral Use
Sweden Mylan Ab Ciprofloxacin Mylan Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
Sweden Mylan Ab Ciprofloxacin Mylan Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Sweden Mylan Ab Ciprofloxacin Mylan Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
Sweden Mylan Ab Levofloxacin Mylan Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Sweden Mylan Ab Levofloxacin Mylan Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Sweden Orion Corporation Moxifloxacin Orion Moxifloxacin 400mg
Vial
Solution For Infusion Intravenous Use
Sweden Orion Corporation Moxifloxacin Orion Moxifloxacin 400mg/250 Ml
Solution For Infusion Intravenous Use
Sweden Orion Corporation Levofloxacin Orion Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Sweden Orion Corporation Moxifloxacin Orion Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
Sweden Orion Oyj Ciprofloxacin Orion Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Sweden Ranbaxy (Uk) Limited Ciprofloxacin Ranbaxy Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
Sweden Sanofi Ab Tavanic Levofloxacin Hemihydrate 5.1246mg/Ml
Solution For Infusion Intravenous Use
Sweden Sanofi Ab Tavanic Levofloxacin
Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 142/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
Sweden Sanofi Ab Tavanic Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Sweden Villerton Invest S.A. Ciprofloxacin Villerton Ciprofloxacin 200mg/100 Ml | Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
United Kingdom Accord Healthcare Limited Levofloxacin Accord Levofloxacin 250mg/50
Ml
Solution For Infusion Intravenous Use
United Kingdom Accord Healthcare Limited Levofloxacin Accord Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
United Kingdom Accord Healthcare Limited Ciprofloxacin Accord
Healthcare
Ciprofloxacin
Hydrochloride 291.1mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited Ciprofloxacin Accord Healthcare
Ciprofloxacin Hydrochloride 582.2mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited Ciprofloxacin Accord Healthcare
Ciprofloxacin Hydrochloride 873.3mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited Levofloxacin Accord Levofloxacin Hemihydrate 512.46mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Accord Healthcare Limited Levofloxacin Accord Healthcare
Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Actavis Group Ptc Ehf. Levofloxacin Actavis
Group Ptc
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
United Kingdom Actavis Group Ptc Ehf. Levofloxacin Actavis Group Ptc
Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Actavis Group Ptc Ehf. Levofloxacin Actavis Group Ptc
Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Actavis Group Ptc Ehf. Moxifloxacin Actavis Group
Moxifloxacin Hydrochloride 400mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 143/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
United Kingdom Amneal Pharma Europe Limited
Levofloxacin Amneal Pharma Europe
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
United Kingdom Amneal Pharma Europe Limited
Ciprofloxacin Amneal Pharma Europe
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Aventis Pharma Ltd Tarivid Ofloxacin 2mg/Ml Solution For Infusion Intravenous Use
United Kingdom Aventis Pharma Ltd Tarivid Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
United Kingdom Aventis Pharma Ltd Tarivid Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
United Kingdom Aventis Pharma Ltd Tavanic Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Aventis Pharma Ltd Tavanic Levofloxacin Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Bayer Plc Avelox Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
United Kingdom Bayer Plc Ciproxin Ciprofloxacin 100mg/50 Ml
Solution For Infusion Intravenous Use
United Kingdom Bayer Plc Ciproxin Ciprofloxacin 200mg/100 Ml
Solution For Infusion Intravenous Use
United Kingdom Bayer Plc Ciproxin Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
United Kingdom Bayer Plc Avelox Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Bayer Plc Ciproxin Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Bayer Plc Ciproxin Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Bayer Plc Ciproxin Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Bayer Plc Ciproxin Ciprofloxacin 250mg/5 Ml
Granules And Solvent For Oral Suspension
Oral Use
United Kingdom Beacon Pharmaceuticals
Limited
Evoxil Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
United Kingdom Beacon Pharmaceuticals Limited
Evoxil Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Beacon Pharmaceuticals
Limited
Evoxil Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 144/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
United Kingdom Bristol Laboratories Ltd (Berkhamsted)
Levofloxacin Bristol Laboratories
Levofloxacin 250mg Tablet
Film Coated Tablet Oral Use
United Kingdom Bristol Laboratories Ltd (Berkhamsted)
Levofloxacin Bristol Laboratories
Levofloxacin 500mg Tablet
Film Coated Tablet Oral Use
United Kingdom Bristol Laboratories Ltd (Berkhamsted)
Ciprofloxacin Bristol Laboratories
Ciprofloxacin 100mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Bristol Laboratories Ltd
(Berkhamsted)
Ciprofloxacin Bristol
Laboratories
Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Bristol Laboratories Ltd (Berkhamsted)
Ciprofloxacin Bristol Laboratories
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Bristol Laboratories Ltd
(Berkhamsted)
Ciprofloxacin Bristol
Laboratories
Ciprofloxacin 750mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Bristol Laboratories Ltd (Berkhamsted)
Ofloxacin Bristol Laboratories
Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
United Kingdom Bristol Laboratories Ltd (Berkhamsted)
Ofloxacin Bristol Laboratories
Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
United Kingdom Chelonia Healthcare Limited Nalidixic Acid Chelonia
Healthcare
Nalidixic Acid Bp
500mg Tablet
Tablet Oral Use
United Kingdom Cipla (Eu) Limited Ciprofloxacin Cipla (Eu) Ciprofloxacin Hydrochloride
116.43mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Cipla (Eu) Limited Ciprofloxacin Cipla (Eu) Ciprofloxacin Hydrochloride 291.08mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Cipla (Eu) Limited Ciprofloxacin Cipla (Eu) Ciprofloxacin Hydrochloride 582.16mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Cipla (Eu) Limited Ciprofloxacin Cipla (Eu) Ciprofloxacin Hydrochloride 873.24mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Claris Lifesciences (Uk) Limited
Ciprofloxacin Claris Lifesciences (Uk)
Ciprofloxacin Lactate 2mg/Ml
Solution For Infusion Intravenous Use
United Kingdom Claris Lifesciences (Uk) Limited
Ciprofloxacin Claris Lifesciences Uk
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
United Kingdom Claris Lifesciences (Uk) Limited
Levofloxacin Claris Lifesciences Uk
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
Annex I
EMA/88273/2017 Page 145/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
United Kingdom Double-E Pharma Ltd Moxifloxacin Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral
United Kingdom Double-E Pharma Ltd Moxifloxacin Double-E Pharma
Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Dr. Reddy's Laboratories (Uk) Ltd.
Ciprofloxacin Dr. Reddy's Laboratories (Uk)
Ciprofloxacin 100mg Film-Coated Tablet Oral Use
United Kingdom Dr. Reddy's Laboratories (Uk) Ltd.
Ciprofloxacin Dr. Reddy's Laboratories (Uk)
Ciprofloxacin 250mg Film-Coated Tablet Oral Use
United Kingdom Dr. Reddy's Laboratories (Uk) Ltd.
Ciprofloxacin Dr. Reddy's Laboratories
(Uk)
Ciprofloxacin 500mg Film-Coated Tablet Oral Use
United Kingdom Dr. Reddy's Laboratories (Uk) Ltd.
Ciprofloxacin Dr. Reddy's Laboratories (Uk)
Ciprofloxacin 750mg Film-Coated Tablet Oral Use
United Kingdom Farmaprojects S.A Levofloxacin
Farmaprojects
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
United Kingdom Farmaprojects S.A Levofloxacin Farmaprojects
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Fresenius Kabi Limited Ciprofloxacin Fresenius
Kabi
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
United Kingdom Fresenius Kabi Limited Levofloxacin Fresenius Kabi
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
United Kingdom Fresenius Kabi Limited Moxifloxacin Fresenius Kabi
Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
United Kingdom Generics [uk] Limited Ciprofloxacin Arcana
Arzneimittel Gmbh
Ciprofloxacin
200mg/100 Ml
Solution For Infusion Intravenous Use
United Kingdom Generics [uk] Limited Ciprofloxacin Arcana Arzneimittel Gmbh
Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
United Kingdom Generics [uk] Limited Levofloxacin Mylan Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
United Kingdom Generics [uk] Limited Levofloxacin Mylan Levofloxacin 500mg/100 Ml
Solution For Injection Intravenous Use
United Kingdom Generics [uk] Limited Ciprofloxacin Generics [uk]
Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 146/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
United Kingdom Generics [uk] Limited Ciprofloxacin Generics [uk]
Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Generics [uk] Limited Levofloxacin Generics (Uk)
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Generics [uk] Limited Levofloxacin Generics (Uk)
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Generics [uk] Limited Ofloxacin Generics Uk Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
United Kingdom Generics [uk] Limited Ofloxacin Generics Uk Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
United Kingdom Hikma Farmacêutica (Portugal), S.A.
Ciprofloxacin Hikma Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
United Kingdom Hikma Farmacêutica (Portugal), S.A.
Levofloxacin Hikma Farmacêutica
(Portugal), S.A.
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
United Kingdom Hospira Uk Ltd Ciprofloxacin Hospira Uk
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
United Kingdom Hospira Uk Ltd Levofloxacin Hospira
Uk
Levofloxacin 250mg/50
Ml
Solution For Infusion Intravenous Use
United Kingdom Hospira Uk Ltd Levofloxacin Hospira Uk
Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
United Kingdom Ibigen Srl Levofloxacin Ibigen Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
United Kingdom Infomed Fluids Srl Ciprofloxacin Infomed
Fluids
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
United Kingdom Infomed Fluids Srl Levofloxacin Infomed Fluids
Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
United Kingdom Ipca Productos Farmaceuticos
Unipessoal Lda
Levofloxacin Ipca
Laboratories Uk
Levofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Ipca Productos Farmaceuticos Unipessoal Lda
Levofloxacin Ipca Laboratories Uk
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Jelfa Sa Levofloxacin Jelfa Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Jelfa Sa Levofloxacin Jelfa Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Macleods Pharma Uk Ltd Levofloxacin Macleods Pharma Uk
Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 147/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
United Kingdom Macleods Pharma Uk Ltd Levofloxacin Macleods Pharma Uk
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Medreich Plc Ciprofloxacin Medreich Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Medreich Plc Ciprofloxacin Medreich Ciprofloxacin Hydrochloride 582mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Medreich Plc Ciprofloxacin Medreich Ciprofloxacin Hydrochloride 873mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Milpharm Limited Ciprofloxacin Milpharm Ciprofloxacin 250mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Milpharm Limited Ciprofloxacin Milpharm Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Milpharm Limited Ciprofloxacin Milpharm Ciprofloxacin 750mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Noridem Enterprises Ltd Ciprofloxacin Noridem Enterprises
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
United Kingdom Noridem Enterprises Ltd Levofloxacin Noridem Enterprises
Levofloxacin 500mg/100 Ml
Solution For Infusion Intravenous Use
United Kingdom Noridem Enterprises Ltd Moxifloxacin Noridem Enterprises
Moxifloxacin 1.6mg/Ml Solution For Infusion Intravenous Use
United Kingdom Noumed Life Sciences Ciprofloxacin Noumed Life Sciences
Ciprofloxacin Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Pharma Resources Gmbh Levofloxacin Pharma
Resources
Levofloxacin
500mg/100 Ml
Solution For Infusion Intravenous Use
United Kingdom Pharmathen S.A. Ciprofloxacin Pharmathen
Ciprofloxacin 2mg/Ml Solution For Infusion Intravenous Use
United Kingdom Pharmathen S.A. Bacital Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Pharmathen S.A. Bacital Levofloxacin
Hemihydrate 512.46mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 148/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
United Kingdom Pharmathen S.A. Prixoter Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Pharmathen S.A. Prixoter Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Ranbaxy (Uk) Limited Ciprofloxacin Ranbaxy Ciprofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Ranbaxy (Uk) Limited Ciprofloxacin Ranbaxy Ciprofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Ratiopharm Gmbh Levofloxacin Ratiopharm
Levofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Ratiopharm Gmbh Levofloxacin
Ratiopharm
Levofloxacin
Hemihydrate 250mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Ratiopharm Gmbh Norfloxacin Ratiopharm Norfloxacin 400mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Rivopharm Uk Ltd Moxifloxacin Rivopharm Moxifloxacin 400mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Sandoz Ltd Levofloxacin Sandoz Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Sandoz Ltd Levofloxacin Sandoz Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Special Concept Development (Uk) Ltd
Ciprofloxacin Special Concept Development (Uk)
Ciprofloxacin Hydrochloride 291mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Special Concept Development (Uk) Ltd
Ciprofloxacin Special Concept Development (Uk)
Ciprofloxacin Hydrochloride 582mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Special Concept Development (Uk) Ltd
Ciprofloxacin Special Concept Development (Uk)
Ciprofloxacin Hydrochloride 873mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Stada Arzneimittel Ag Levofloxacin Stada Arzneimittel
Levofloxacin Hemihydrate 5.12mg/Ml
Solution For Infusion Intravenous Use
United Kingdom Strides Shasun Uk Limited Ciprofloxacin Co-
Pharma Limited
Ciprofloxacin 250mg
Tablet
Tablet Oral Use
Annex I
EMA/88273/2017 Page 149/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
United Kingdom Strides Shasun Uk Limited Ciprofloxacin Co-Pharma Limited
Ciprofloxacin 500mg Tablet
Tablet Oral Use
United Kingdom Strides Shasun Uk Limited Ciprofloxacin Co-Pharma Limited
Ciprofloxacin 750mg Tablet
Tablet Oral Use
United Kingdom Teva Pharma B.V. Levofloxacin Teva Levofloxacin 250mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Pharma B.V. Levofloxacin Teva
Pharma B.V.
Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Pharma B.V. Ofloxacin Teva Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
United Kingdom Teva Pharma B.V. Ofloxacin Teva Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Ciprofloxacin Teva Uk Ciprofloxacin Lactate 2mg/Ml
Solution For Infusion Intravenous Use
United Kingdom Teva Uk Limited Levofloxacin Teva Uk Levofloxacin 5mg/Ml Solution For Infusion Intravenous Use
United Kingdom Teva Uk Limited Ciprofloxacin Teva Ciprofloxacin 500mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Ciprofloxacin Teva Ciprofloxacin
Hydrochloride 750mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Ciprofloxacin Teva Uk Ciprofloxacin Hydrochloride 100mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Ciprofloxacin Teva Uk Ciprofloxacin Hydrochloride 250mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Ciprofloxacin Teva Uk Ciprofloxacin Hydrochloride 500mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Ciprofloxacin Teva Uk Ciprofloxacin Hydrochloride 750mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Levofloxacin Teva Uk Levofloxacin 500mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Levofloxacin Teva Uk Levofloxacin Hemihydrate 256.23mg Tablet
Film-Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 150/151
Member State in EEA
Marketing authorisaton holder
Short name of the Medicinal Product
Active substance + Strength
Pharmaceutical form Route of Administration
United Kingdom Teva Uk Limited Moxifloxacin Teva Uk Moxifloxacin 400mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Ofloxacin Teva Uk Ofloxacin 200mg Tablet Film-Coated Tablet Oral Use
United Kingdom Teva Uk Limited Ofloxacin Teva Uk Ofloxacin 400mg Tablet Film-Coated Tablet Oral Use
United Kingdom Tillomed Laboratories Ltd Ciprofloxacin Tillomed Laboratories
Ciprofloxacin Hydrochloride
Monohydrate 116.6mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Tillomed Laboratories Ltd Ciprofloxacin Tillomed Laboratories
Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Tillomed Laboratories Ltd Ciprofloxacin Tillomed
Laboratories
Ciprofloxacin
Hydrochloride Monohydrate 583mg Tablet
Film-Coated Tablet Oral Use
United Kingdom Tillomed Laboratories Ltd Ciprofloxacin Tillomed Laboratories
Ciprofloxacin Hydrochloride Monohydrate 874.5mg
Tablet
Film-Coated Tablet Oral Use
United Kingdom Villerton Invest S.A. Ciprofloxacin Villerton Invest
Ciprofloxacin 100mg/50 Ml | Ciprofloxacin 200mg/100 Ml |
Ciprofloxacin 400mg/200 Ml
Solution For Infusion Intravenous Use
United Kingdom Wockhardt Uk Ltd Ciprofloxacin
Wockhardt Uk
Ciprofloxacin 250mg
Tablet
Coated Tablet Oral Use
United Kingdom Wockhardt Uk Ltd Ciprofloxacin
Wockhardt Uk
Ciprofloxacin 500mg
Tablet
Coated Tablet Oral Use
Annex I
EMA/88273/2017 Page 151/151
Centrally authorised medicinal products
MA (EU) number
(Invented) name
Strength
Pharmaceutical Form
Route of Administration
Immediate Packaging
Content (concentration)
Pack size
EU/1/14/973/001
Quinsair 240 mg Nebuliser solution
Inhalation use ampoule (LDPE) 2.4 ml (100 mg/ml)
56 ampoules + 1 nebuliser handset