acetylsalicylic acid: list of nationally authorised ... · not available r/6840 bayer sp.z.o.o pl...
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Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
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© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.
17 October 2019 EMA/631752/2019 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: acetylsalicylic acid
Procedure no.: PSUSA/00000039/201902
List of nationally authorised medicinal products EMA/382341/2015 Page 2/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
AAS 100 mg comprimidos
not available 42991 SANOFI-AVENTIS, S.A. ES
AAS 500 mg comprimidos
not available 42956 SANOFI-AVENTIS, S.A. ES
Acetylsalicylzuur Apotex cardio 80 mg, tabletten.
not available RVG 26865 APOTEX EUROPE B.V. NL
Acetylsalicylzuur Apotex neuro 30 mg, tabletten.
not available RVG 28359 APOTEX EUROPE B.V. NL
Acetylsalicylzuur cardio 80 mg Pharmachemie
not available RVG 102651 PHARMACHEMIE B.V NL
Acetylsalicylzuur cardio 80 mg Pharmachemie
not available RVG 102648 PHARMACHEMIE B.V NL
Acetylsalicylzuur cardio 80 mg Pharmachemie
not available RVG 102650 PHARMACHEMIE B.V NL
Acetylsalicylzuur cardio 80 mg Pharmachemie, dispergeerbare tabletten
not available RVG 102649 PHARMACHEMIE B.V NL
Acetylsalicylzuur cardio 80 mg, dispergeerbare tabletten
not available RVG 26194 MYLAN B.V. NL
List of nationally authorised medicinal products EMA/382341/2015 Page 3/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Acetylsalicylzuur Cardio Aurobindo 80 mg, dispergeerbare tabletten
not available RVG 102607 AUROBINDO PHARMA B.V. NL
Acetylsalicylzuur Cardio CF 80 mg, tabletten
not available RVG 119589=26865 CENTRAFARM B.V. NL
Acetylsalicylzuur Cardio Teva 80 mg
not available RVG 16466 TEVA NEDERLAND B.V. NL
Acetylsalicylzuur neuro 30 mg Pharmachemie
not available RVG 102653 PHARMACHEMIE B.V NL
Acetylsalicylzuur neuro 30 mg Pharmachemie
not available RVG 102655 PHARMACHEMIE B.V NL
Acetylsalicylzuur neuro 30 mg Pharmachemie
not available RVG 102654 PHARMACHEMIE B.V NL
Acetylsalicylzuur neuro 30 mg, dispergeerbare tabletten
not available RVG 26195 MEDA PHARMA B.V. NL
Acetylsalicylzuur Neuro Aurobindo 30 mg, dispergeerbare tabletten
not available RVG 102604 AUROBINDO PHARMA B.V. NL
Acetylsalicylzuur Neuro CF 30 mg, tabletten
not available RVG 119590=28359 CENTRAFARM B.V. NL
List of nationally authorised medicinal products EMA/382341/2015 Page 4/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Acetylsalicylzuur neuro ratiopharm 30 mg, dispergeerbare tabletten
not available RVG 102652 RATIOPHARM GMBH NL
Acetylsalicylzuur neuro Teva 30 mg, dispergeerbare tabletten.
not available RVG 18116 TEVA NEDERLAND B.V. NL
Acetylsalicylzuur Sandoz 80 mg cardio, tabletten
not available RVG 119637=26865 SANDOZ B.V. NL
Acetylsalicylzuur Sandoz neuro 30 mg, dispergeerbare tabletten
not available RVG 102615 SANDOZ B.V. NL
Ácido acetilsalicílico Bayfarma 100 mg comprimidos gastrorresistentes
not available 62.828 BAYER HISPANIA SL ES
Ácido acetilsalicílico Bayfarma 100 mg comprimidos gastrorresistentes
not available 62.828 BAYER HISPANIA SL ES
Ácido acetilsalicílico Bayfarma 300 mg comprimidos gastrorresistentes
not available 62.826 BAYER HISPANIA SL ES
Ácido acetilsalicílico Bayfarma 300 mg comprimidos gastrorresistentes
not available 62.826 BAYER HISPANIA SL ES
Ácido acetilsalicílico Farmalider 75 mg comprimidos gastrorresistentes
not available 78184 FARMALIDER, S.A. ES
List of nationally authorised medicinal products EMA/382341/2015 Page 5/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Ácido acetilsalicílico Farmoz, 100 mg, comprimidos
not available 17/H/0090/001 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Ácido acetilsalicílico Farmoz, 100 mg, comprimidos
not available 5721816 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Ácido acetilsalicílico Farmoz, 100 mg, comprimidos
not available 17/H/0090/001 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Ácido acetilsalicílico Farmoz, 100 mg, comprimidos
not available 5721824 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Ácido acetilsalicílico Farmoz, 100 mg, comprimidos
not available 17/H/0090/001 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Ácido acetilsalicílico Farmoz, 100 mg, comprimidos
not available 17/H/0090/001 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Ácido acetilsalicílico Farmoz, 100 mg, comprimidos
not available 5721832 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Ácido acetilsalicílico Farmoz, 100 mg, comprimidos
not available 17/H/0090/001 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Ácido acetilsalicílico Pentafarma, 100 mg, comprimidos
not available 17/H/0091/001 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
List of nationally authorised medicinal products EMA/382341/2015 Page 6/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Ácido acetilsalicílico Pentafarma, 100 mg, comprimidos
not available 5721840 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Ácido acetilsalicílico Pentafarma, 100 mg, comprimidos
not available 17/H/0091/001 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Ácido acetilsalicílico Pentafarma, 100 mg, comprimidos
not available 5721857 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Ácido acetilsalicílico Pentafarma, 100 mg, comprimidos
not available 17/H/0091/001 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Ácido acetilsalicílico Pentafarma, 100 mg, comprimidos
not available 17/H/0091/001 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Ácido acetilsalicílico Pentafarma, 100 mg, comprimidos
not available 5721865 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Ácido acetilsalicílico Pentafarma, 100 mg, comprimidos
not available 17/H/0091/001 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Albyl minor 250 mg tabletter
not available 4892 MEDA AB SE
Albyl-E 160 mg enterotablett
not available 7616 TAKEDA AS NO
List of nationally authorised medicinal products EMA/382341/2015 Page 7/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Albyl-E 75 mg enterotablett
not available 7905 TAKEDA AS NO
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 300 267 2 4 BAYER HEALTHCARE FR
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 340 648 7 6 BAYER HEALTHCARE FR
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 329 268 7 9 BAYER HEALTHCARE FR
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 329 110 4 2 BAYER HEALTHCARE FR
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 300 266 6 3 BAYER HEALTHCARE FR
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 320 120 7 7 BAYER HEALTHCARE FR
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 329 267 0 1 BAYER HEALTHCARE FR
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 300 267 2 4 BAYER HEALTHCARE FR
List of nationally authorised medicinal products EMA/382341/2015 Page 8/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 340 648 7 6 BAYER HEALTHCARE FR
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 329 268 7 9 BAYER HEALTHCARE FR
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 329 110 4 2 BAYER HEALTHCARE FR
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 300 266 6 3 BAYER HEALTHCARE FR
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 320 120 7 7 BAYER HEALTHCARE FR
ALKA SELTZER 324 mg, comprimé effervescent
not available 34009 329 267 0 1 BAYER HEALTHCARE FR
Alka-Seltzer 324 mg Brausetabletten
not available BE068792 BAYER SA NV BE
Alka-Seltzer 324 mg Brausetabletten
not available 2011081252 BAYER SA NV LU
Alka-Seltzer 324 mg Brausetabletten
not available 2011081252 BAYER SA NV LU
List of nationally authorised medicinal products EMA/382341/2015 Page 9/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Alka-Seltzer 324 mg bruistabletten
not available BE068792 BAYER SA NV BE
ALKA-SELTZER 324 mg comprimate efervescente
not available 7880/2015/01 BAYER SRL RO
Alka-Seltzer 324 mg comprimés effervescents
not available BE068792 BAYER SA NV BE
Alka-Seltzer 324 mg comprimés effervescents
not available 2011081252 BAYER SA NV LU
Alka-Seltzer 324 mg comprimés effervescents
not available 2011081252 BAYER SA NV LU
Alka-Seltzer 324 mg šnypščiosios tabletės
not available LT/1/94/0845/001 BAYER UAB LT
Alka-Seltzer 324 mg šnypščiosios tabletės
not available LT/1/94/0845/001 BAYER UAB LT
Alka-Seltzer 324mg pezsgőtabletta
not available OGYI-T-8081/01 BAYER HUNGARIA KFT HU
Alka-Seltzer 324mg pezsgőtabletta
not available OGYI-T-8081/01 BAYER HUNGARIA KFT HU
List of nationally authorised medicinal products EMA/382341/2015 Page 10/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Alka-Seltzer Original not available MA 513/00202 BAYER PLC MT
Alka-Seltzer Original not available MA 513/00202 BAYER PLC MT
Alka-Seltzer Original not available PL 00010/0511 BAYER PLC UK
Alka-Seltzer Original not available PL 00010/0511 BAYER PLC UK
Alka-Seltzer, 324 mg, tabletki musujące
not available R/1927 BAYER SP.Z.O.O PL
Alka-Seltzer, 324 mg, tabletki musujące
not available R/1927 BAYER SP.Z.O.O PL
Alka-Seltzer, bruistabletten 324 mg
not available RVG 01147 BAYER BV NL
Alka-Seltzer, bruistabletten 324 mg
not available RVG 01147 BAYER BV NL
Alka-Seltzer® - Brausetabletten
not available 8.050 BAYER AUSTRIA GMBH AT
List of nationally authorised medicinal products EMA/382341/2015 Page 11/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Alka-Seltzer® - Brausetabletten
not available 8.050 BAYER AUSTRIA GMBH AT
Asaflow 160 mg, comprimés gastro-résistants
not available 2001116613 TAKEDA BELGIUM SCA/CVA LU
Asaflow 160 mg, maagsapresistente tabletten
not available BE152695 TAKEDA BELGIUM SCA/CVA BE
Asaflow 160 mg, magensaftresistente Tabletten
not available BE152695 TAKEDA BELGIUM SCA/CVA BE
Asaflow 80 mg maagsapresistente tabletten
not available BE187512 TAKEDA BELGIUM SCA/CVA BE
Asaflow 80 mg maagsapresistente tabletten
not available BE429457 TAKEDA BELGIUM SCA/CVA BE
Asaflow 80 mg, comprimés gastro-résistants
not available 2000075786 TAKEDA BELGIUM SCA/CVA LU
Asaflow 80 mg, magensaftresistente Tabletten
not available BE187512 TAKEDA BELGIUM SCA/CVA BE
Asaflow 80 mg, magensaftresistente Tabletten
not available BE429457 TAKEDA BELGIUM SCA/CVA BE
List of nationally authorised medicinal products EMA/382341/2015 Page 12/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspiricor® 100 mg - Filmtabletten
not available 1-20088 BAYER AUSTRIA GMBH AT
Aspiricor® 100 mg - Filmtabletten
not available 1-20088 BAYER AUSTRIA GMBH AT
Aspirin ® 300 mg Tablette mit 300 mg Acetylsalicylsäure
not available 30.00.00 BAYER VITAL GMBH DE
Aspirin ® 300 mg Tablette mit 300 mg Acetylsalicylsäure
not available 30.00.00 BAYER VITAL GMBH DE
ASPIRIN 300, 300 mg, tabletki powlekane
not available R/6840 BAYER SP.Z.O.O PL
ASPIRIN 300, 300 mg, tabletki powlekane
not available R/6840 BAYER SP.Z.O.O PL
Aspirin 300mg Effervescent tablets.
not available PA 1410/37/1 BAYER LTD IE
Aspirin 300mg Effervescent tablets.
not available PA 1410/37/1 BAYER LTD IE
Aspirin 300mg Gastro-resistant Tablets
not available PL 20046/0033 FOCUS PHARMACEUTICALS LIMITED
UK
List of nationally authorised medicinal products EMA/382341/2015 Page 13/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin 300mg Gastro-resistant Tablets
not available PL 16853/0063 ALLIANCE PHARMACEUTICALS LTD
UK
Aspirin 300mg Tablets not available PL 16028/0046 GALPHARM HEALTHCARE LIMITED
UK
Aspirin 300mg Tablets BP
not available PL 17907/0152 BRISTOL LABORATORIES LTD (BERKHAMSTED)
UK
Aspirin 300mg Tablets BP
not available PL 17907/0153 BRISTOL LABORATORIES LTD (BERKHAMSTED)
UK
ASPIRIN 500 mg comprimate
not available 10166/2017/01 BAYER SRL RO
ASPIRIN 500 mg comprimate
not available 10166/2017/02 BAYER SRL RO
Aspirin 500 mg dragerade tabletter
not available 52876 BAYER AB SE
Aspirin 500 mg dragerade tabletter
not available 52876 BAYER AB SE
Aspirin 500 mg drajeuri FR/H/0482/001 11322/2019/04 BAYER SRL RO
List of nationally authorised medicinal products EMA/382341/2015 Page 14/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin 500 mg drajeuri FR/H/0482/001 11322/2019/01 BAYER SRL RO
Aspirin 500 mg drajeuri FR/H/0482/001 11322/2019/03 BAYER SRL RO
Aspirin 500 mg drajeuri FR/H/0482/001 11322/2019/02 BAYER SRL RO
Aspirin 500 mg granulat not available 15-10696 BAYER AB NO
Aspirin 500 mg granulat not available 15-10696 BAYER AB NO
Aspirin 500 mg granulat not available 53040 BAYER AB SE
Aspirin 500 mg granulat not available 53040 BAYER AB SE
Aspirin 500 mg obalené tablety
FR/H/0482/001 07/480/13-C BAYER SRO CZ
Aspirin 500 mg obložene tablete
FR/H/0482/001 H/14/01909/001 BAYER D.O.O SI
List of nationally authorised medicinal products EMA/382341/2015 Page 15/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin 500 mg obložene tablete
FR/H/0482/001 H/14/01909/008 BAYER D.O.O SI
Aspirin 500 mg obložene tablete
FR/H/0482/001 H/14/01909/006 BAYER D.O.O SI
Aspirin 500 mg obložene tablete
FR/H/0482/001 H/14/01909/003 BAYER D.O.O SI
Aspirin 500 mg obložene tablete
FR/H/0482/001 H/14/01909/005 BAYER D.O.O SI
Aspirin 500 mg obložene tablete
FR/H/0482/001 H/14/01909/007 BAYER D.O.O SI
Aspirin 500 mg obložene tablete
FR/H/0482/001 H/14/01909/004 BAYER D.O.O SI
Aspirin 500 mg obložene tablete
FR/H/0482/001 H/14/01909/002 BAYER D.O.O SI
Aspirin 500 mg tablete not available H/92/00220/001 BAYER D.O.O SI
Aspirin 500 mg tablete not available H/92/00220/002 BAYER D.O.O SI
List of nationally authorised medicinal products EMA/382341/2015 Page 16/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin 500 mg tablete not available H/92/00220/001 BAYER D.O.O SI
Aspirin 500 mg tablete not available H/92/00220/002 BAYER D.O.O SI
Aspirin 500 mg tabletės not available LT/1/94/0846/002 BAYER UAB LT
Aspirin 500 mg tabletės not available LT/1/94/0846/001 BAYER UAB LT
Aspirin 500 mg tabletės not available LT/1/94/0846/002 BAYER UAB LT
Aspirin 500 mg tabletės not available LT/1/94/0846/001 BAYER UAB LT
Aspirin 500 mg tabletta not available OGYI-T-1505/07 BAYER HUNGARIA KFT HU
Aspirin 500 mg tabletta not available OGYI-T-1505/03 BAYER HUNGARIA KFT HU
Aspirin 500 mg tabletta not available OGYI-T-1505/02 BAYER HUNGARIA KFT HU
List of nationally authorised medicinal products EMA/382341/2015 Page 17/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin 500 mg tabletta not available OGYI-T-1505/07 BAYER HUNGARIA KFT HU
Aspirin 500 mg tabletta not available OGYI-T-1505/03 BAYER HUNGARIA KFT HU
Aspirin 500 mg tabletta not available OGYI-T-1505/02 BAYER HUNGARIA KFT HU
Aspirin 500 mg tabletter
not available 95/01663 BAYER AB NO
Aspirin 500 mg tabletter
not available 95/01663 BAYER AB NO
Aspirin 500 mg tabletter
not available 0137 BAYER AB SE
Aspirin 500 mg tabletter
not available 0137 BAYER AB SE
Aspirin 500 mg tabletter, drasjerte
not available 15-10667 BAYER AB NO
Aspirin 500 mg tabletter, drasjerte
not available 15-10667 BAYER AB NO
List of nationally authorised medicinal products EMA/382341/2015 Page 18/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin 500 mg tablety not available 07/0136/91-CS BAYER SPOL SRO SK
Aspirin 500 mg tablety not available 07/0136/91-CS BAYER SPOL SRO SK
Aspirin 500 mg überzogene Tabletten
FR/H/0482/001 86750.00.00 BAYER VITAL GMBH DE
Aspirin 75 mg Gastro-resistant Tablets
not available PA0126/246/001 CLONMEL HEALTHCARE LTD.
IE
Aspirin 75 mg Gastro-Resistant Tablets
not available PL 16028/0026 GALPHARM HEALTHCARE LIMITED
UK
Aspirin 75 mg Gastro-resistant Tablets
not available PL 36687/0257 TORRENT PHARMA (UK) LTD.
UK
Aspirin Akut 500 mg Brausetabletten
DE/H/0249/001 1-24114 BAYER AUSTRIA GMBH AT
Aspirin Cardio 100 mg enterotabletter
not available 12236 BAYER OY FI
Aspirin Cardio 100 mg enterotabletter
not available 12236 BAYER OY FI
List of nationally authorised medicinal products EMA/382341/2015 Page 19/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin Cardio 100 mg enterotabletti
not available 12236 BAYER OY FI
Aspirin Cardio 100 mg enterotabletti
not available 12236 BAYER OY FI
Aspirin Cardio 100 mg skrandyje neirios tabletės
not available LT/1/10/2038/003 BAYER UAB LT
Aspirin Cardio 100 mg skrandyje neirios tabletės
not available LT/1/10/2038/001 BAYER UAB LT
Aspirin Cardio 100 mg skrandyje neirios tabletės
not available LT/1/10/2038/003 BAYER UAB LT
Aspirin Cardio 100 mg skrandyje neirios tabletės
not available LT/1/10/2038/001 BAYER UAB LT
Aspirin Cardio, 100 mg gastroresistentsed tabletid
not available 680710 BAYER UAB EE
Aspirin Cardio, 100 mg gastroresistentsed tabletid
not available 680710 BAYER UAB EE
ASPIRIN CARDIO, 100 mg, tabletki powlekane
not available R/6841 BAYER SP.Z.O.O PL
List of nationally authorised medicinal products EMA/382341/2015 Page 20/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRIN CARDIO, 100 mg, tabletki powlekane
not available R/6841 BAYER SP.Z.O.O PL
ASPIRIN direkt 500 mg žvečljive tablete
not available H/92/00220/003 BAYER D.O.O SI
ASPIRIN direkt 500 mg žvečljive tablete
not available H/92/00220/003 BAYER D.O.O SI
Aspirin Effect 500 mg szájban diszpergálódó granulátum
not available OGYI-T-1505/09 BAYER HUNGARIA KFT HU
Aspirin Effect 500 mg szájban diszpergálódó granulátum
not available OGYI-T-1505/08 BAYER HUNGARIA KFT HU
Aspirin Effect 500 mg szájban diszpergálódó granulátum
not available OGYI-T-1505/09 BAYER HUNGARIA KFT HU
Aspirin Effect 500 mg szájban diszpergálódó granulátum
not available OGYI-T-1505/08 BAYER HUNGARIA KFT HU
ASPIRIN EFFECT, 500 mg, granulat
not available 17668 BAYER SP.Z.O.O PL
ASPIRIN EFFECT, 500 mg, granulat
not available 17668 BAYER SP.Z.O.O PL
List of nationally authorised medicinal products EMA/382341/2015 Page 21/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin Express 500 mg obalené tablety
not available 07/0067/18-S BAYER SPOL SRO SK
Aspirin Express 500 mg obalené tablety
not available 07/0067/18-S BAYER SPOL SRO SK
Aspirin Forte 1000 mg überzogene Tabletten
DE/H/5404/001 94582.00.00 BAYER VITAL GMBH DE
ASPIRIN MAX 1000 mg drajeuri
DE/H/5404/001 9056/2016/06 BAYER SRL RO
ASPIRIN MAX 1000 mg drajeuri
DE/H/5404/001 9056/2016/08 BAYER SRL RO
ASPIRIN MAX 1000 mg drajeuri
DE/H/5404/001 9056/2016/04 BAYER SRL RO
ASPIRIN MAX 1000 mg drajeuri
DE/H/5404/001 9056/2016/01 BAYER SRL RO
ASPIRIN MAX 1000 mg drajeuri
DE/H/5404/001 9056/2016/02 BAYER SRL RO
ASPIRIN MAX 1000 mg drajeuri
DE/H/5404/001 9056/2016/03 BAYER SRL RO
List of nationally authorised medicinal products EMA/382341/2015 Page 22/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRIN MAX 1000 mg drajeuri
DE/H/5404/001 9056/2016/05 BAYER SRL RO
ASPIRIN MAX 1000 mg drajeuri
DE/H/5404/001 9056/2016/07 BAYER SRL RO
Aspirin migran 500 mg šumeče tablete
not available H/92/00220/004 BAYER D.O.O SI
Aspirin migran 500 mg šumeče tablete
not available H/92/00220/004 BAYER D.O.O SI
ASPIRIN MIGRÄNE 500 mg Brausetablette Acetylsalicylsäure
not available 50352.00.00 BAYER VITAL GMBH DE
ASPIRIN MIGRÄNE 500 mg Brausetablette Acetylsalicylsäure
not available 50352.00.00 BAYER VITAL GMBH DE
ASPIRIN musująca, 500 mg, tabletki musujące
not available R/7312 BAYER SP.Z.O.O PL
ASPIRIN musująca, 500 mg, tabletki musujące
not available R/7312 BAYER SP.Z.O.O PL
ASPIRIN PRO FORTE, 1000 mg, tabletki drażowane
PT/H/1384/001(OTC) 23417 BAYER SP.Z.O.O PL
List of nationally authorised medicinal products EMA/382341/2015 Page 23/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRIN PRO, 500 mg, tabletki powlekane
FR/H/0482/001 21625 BAYER SP.Z.O.O PL
Aspirin Protect 100 mg Filmtabletten
not available 1-25792 BAYER AUSTRIA GMBH AT
Aspirin Protect 100 mg Filmtabletten
not available 1-25792 BAYER AUSTRIA GMBH AT
Aspirin protect 100 mg gastrorezistentne tablete
not available H/92/00220/006 BAYER D.O.O SI
Aspirin protect 100 mg gastrorezistentne tablete
not available H/92/00220/005 BAYER D.O.O SI
Aspirin protect 100 mg gastrorezistentne tablete
not available H/92/00220/006 BAYER D.O.O SI
Aspirin protect 100 mg gastrorezistentne tablete
not available H/92/00220/005 BAYER D.O.O SI
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/06 BAYER AG HU
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/08 BAYER AG HU
List of nationally authorised medicinal products EMA/382341/2015 Page 24/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/07 BAYER AG HU
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/02 BAYER AG HU
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/01 BAYER AG HU
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/05 BAYER AG HU
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/09 BAYER AG HU
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/06 BAYER AG HU
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/08 BAYER AG HU
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/07 BAYER AG HU
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/02 BAYER AG HU
List of nationally authorised medicinal products EMA/382341/2015 Page 25/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/01 BAYER AG HU
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/05 BAYER AG HU
Aspirin Protect 100 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/09 BAYER AG HU
Aspirin Protect 300 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/04 BAYER AG HU
Aspirin Protect 300 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/03 BAYER AG HU
Aspirin Protect 300 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/04 BAYER AG HU
Aspirin Protect 300 mg gyomornedv-ellenálló bevont tabletta
not available OGYI-T-5950/03 BAYER AG HU
Aspirin Tablets BP 300 mg
not available PL 20395/0100 RELON CHEM LIMITED UK
Aspirin Ultra 500 mg bevont tabletta
FR/H/0482/001 OGYI-T-01505/10 BAYER HUNGARIA KFT HU
List of nationally authorised medicinal products EMA/382341/2015 Page 26/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin Ultra 500 mg bevont tabletta
FR/H/0482/001 OGYI-T-01505/12 BAYER HUNGARIA KFT HU
Aspirin Ultra 500 mg bevont tabletta
FR/H/0482/001 OGYI-T-01505/11 BAYER HUNGARIA KFT HU
Aspirin Ultra 500 mg bevont tabletta
FR/H/0482/001 OGYI-T-01505/13 BAYER HUNGARIA KFT HU
Aspirin Ultra Forte 1000 mg bevont tabletta
DE/H/5404/001 OGYI-T-01505/14 BAYER HUNGARIA KFT HU
Aspirin Ultra Forte 1000 mg bevont tabletta
DE/H/5404/001 OGYI-T-01505/16 BAYER HUNGARIA KFT HU
Aspirin Ultra Forte 1000 mg bevont tabletta
DE/H/5404/001 OGYI-T-01505/18 BAYER HUNGARIA KFT HU
Aspirin Ultra Forte 1000 mg bevont tabletta
DE/H/5404/001 OGYI-T-01505/19 BAYER HUNGARIA KFT HU
Aspirin Ultra Forte 1000 mg bevont tabletta
DE/H/5404/001 OGYI-T-01505/17 BAYER HUNGARIA KFT HU
Aspirin Ultra Forte 1000 mg bevont tabletta
DE/H/5404/001 OGYI-T-01505/21 BAYER HUNGARIA KFT HU
List of nationally authorised medicinal products EMA/382341/2015 Page 27/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin Ultra Forte 1000 mg bevont tabletta
DE/H/5404/001 OGYI-T-01505/20 BAYER HUNGARIA KFT HU
Aspirin Ultra Forte 1000 mg bevont tabletta
DE/H/5404/001 OGYI-T-01505/15 BAYER HUNGARIA KFT HU
Aspirin, 500 mg tabletid not available 019193 BAYER UAB EE
Aspirin, 500 mg tabletid not available 019193 BAYER UAB EE
ASPIRIN, 500 mg, tabletki
not available R/1926 BAYER SP.Z.O.O PL
ASPIRIN, 500 mg, tabletki
not available R/1926 BAYER SP.Z.O.O PL
ASPIRIN® not available 19677 BAYER HELLAS SA CY
ASPIRIN® not available 19677 BAYER HELLAS SA CY
ASPIRIN® not available 20714/1-4-2008 BAYER HELLAS SA GR
List of nationally authorised medicinal products EMA/382341/2015 Page 28/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRIN® not available 20718/1-4-2008 BAYER HELLAS SA GR
ASPIRIN® not available 20720/1-4-2008 BAYER HELLAS SA GR
ASPIRIN® not available 20713/1-4-2008 BAYER HELLAS SA GR
ASPIRIN® not available 20715/1-4-2008 BAYER HELLAS SA GR
ASPIRIN® not available 20714/1-4-2008 BAYER HELLAS SA GR
ASPIRIN® not available 20718/1-4-2008 BAYER HELLAS SA GR
ASPIRIN® not available 20720/1-4-2008 BAYER HELLAS SA GR
ASPIRIN® not available 20713/1-4-2008 BAYER HELLAS SA GR
ASPIRIN® not available 20715/1-4-2008 BAYER HELLAS SA GR
List of nationally authorised medicinal products EMA/382341/2015 Page 29/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin® 500 mg Kautabletten
not available 1-20680 BAYER AUSTRIA GMBH AT
Aspirin® 500 mg Kautabletten
not available 1-20680 BAYER AUSTRIA GMBH AT
Aspirin® 500 mg Tabletten
not available 3155 BAYER AUSTRIA GMBH AT
Aspirin® 500 mg Tabletten
not available 3155 BAYER AUSTRIA GMBH AT
ASPIRIN® 500 mg tabletter
not available 138 BAYER OY FI
ASPIRIN® 500 mg tabletter
not available 138 BAYER OY FI
ASPIRIN® 500 mg tabletti
not available 138 BAYER OY FI
ASPIRIN® 500 mg tabletti
not available 138 BAYER OY FI
Aspirin® Direkt 500 mg Granulat
not available 1-31667 BAYER AUSTRIA GMBH AT
List of nationally authorised medicinal products EMA/382341/2015 Page 30/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin® Direkt 500 mg Granulat
not available 1-31667 BAYER AUSTRIA GMBH AT
Aspirin® Direkt 500 mg Kautablette Acetylsalicylsäure
not available 38117.00.00 BAYER VITAL GMBH DE
Aspirin® Direkt 500 mg Kautablette Acetylsalicylsäure
not available 51094.00.00 BAYER VITAL GMBH DE
ASPIRIN® EC not available 20717/1-4-2008 BAYER HELLAS SA GR
ASPIRIN® EC not available 20716/1-4-2008 BAYER HELLAS SA GR
ASPIRIN® EC not available 20717/1-4-2008 BAYER HELLAS SA GR
ASPIRIN® EC not available 20716/1-4-2008 BAYER HELLAS SA GR
Aspirin® Effect 500 mg Granulat Acetylsalicylsäure
not available 38118.00.00 BAYER VITAL GMBH DE
Aspirin® Effect 500 mg Granulat Acetylsalicylsäure
not available 52012.00.00 BAYER VITAL GMBH DE
List of nationally authorised medicinal products EMA/382341/2015 Page 31/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin® Effect 500 mg Granulat Acetylsalicylsäure
not available 2018110305 BAYER SA NV LU
Aspirin® Effect 500 mg Granulat Acetylsalicylsäure
not available 2018110305 BAYER SA NV LU
Aspirin® Express 500 mg überzogene Tablette
FR/H/0482/001 135296 BAYER AUSTRIA GMBH AT
Aspirin® N 100 mg Tablette Acetylsalicylsäure (Ph.Eur.)
not available 16854.01.00 BAYER VITAL GMBH DE
Aspirin® N 100 mg Tablette Acetylsalicylsäure (Ph.Eur.)
not available 16854.01.00 BAYER VITAL GMBH DE
Aspirin® N 300 mg Tablette Acetylsalicylsäure (Ph.Eur.)
not available 16854.00.00 BAYER VITAL GMBH DE
Aspirin® N 300 mg Tablette Acetylsalicylsäure (Ph.Eur.)
not available 30828.00.00 BAYER VITAL GMBH DE
Aspirin® N 300 mg Tablette Acetylsalicylsäure (Ph.Eur.)
not available 16854.00.00 BAYER VITAL GMBH DE
Aspirin® N 300 mg Tablette Acetylsalicylsäure (Ph.Eur.)
not available 30828.00.00 BAYER VITAL GMBH DE
List of nationally authorised medicinal products EMA/382341/2015 Page 32/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin® protect 100 mg Magensaftresistente Tablette Acetylsalicylsäure
not available 16854.01.01 BAYER VITAL GMBH DE
Aspirin® protect 100 mg Magensaftresistente Tablette Acetylsalicylsäure
not available 33171.00.00 BAYER VITAL GMBH DE
Aspirin® protect 100 mg Magensaftresistente Tablette Acetylsalicylsäure
not available 30828.01.01 BAYER VITAL GMBH DE
Aspirin® protect 100 mg Magensaftresistente Tablette Acetylsalicylsäure
not available 16854.01.01 BAYER VITAL GMBH DE
Aspirin® protect 100 mg Magensaftresistente Tablette Acetylsalicylsäure
not available 33171.00.00 BAYER VITAL GMBH DE
Aspirin® protect 100 mg Magensaftresistente Tablette Acetylsalicylsäure
not available 30828.01.01 BAYER VITAL GMBH DE
Aspirin® protect 300 mg Magensaftresistente Tablette Acetylsalicylsäure
not available 30828.00.01 BAYER VITAL GMBH DE
Aspirin® protect 300 mg Magensaftresistente Tablette Acetylsalicylsäure
not available 16854.00.01 BAYER VITAL GMBH DE
Aspirin® protect 300 mg Magensaftresistente Tablette Acetylsalicylsäure
not available 33171.01.00 BAYER VITAL GMBH DE
List of nationally authorised medicinal products EMA/382341/2015 Page 33/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirin® protect 300 mg Magensaftresistente Tablette Acetylsalicylsäure
not available 30828.00.01 BAYER VITAL GMBH DE
Aspirin® protect 300 mg Magensaftresistente Tablette Acetylsalicylsäure
not available 16854.00.01 BAYER VITAL GMBH DE
Aspirin® protect 300 mg Magensaftresistente Tablette Acetylsalicylsäure
not available 33171.01.00 BAYER VITAL GMBH DE
Aspirin® Tablette mit 500 mg Acetylsalicylsäure
not available 25144.00.00 BAYER VITAL GMBH DE
Aspirin® Tablette mit 500 mg Acetylsalicylsäure
not available 25144.00.00 BAYER VITAL GMBH DE
ASPIRIN® ZIPP 500 mg granulat
not available 16587 BAYER OY FI
ASPIRIN® ZIPP 500 mg granulat
not available 16587 BAYER OY FI
ASPIRIN® ZIPP 500 mg rakeet
not available 16587 BAYER OY FI
ASPIRIN® ZIPP 500 mg rakeet
not available 16587 BAYER OY FI
List of nationally authorised medicinal products EMA/382341/2015 Page 34/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRINA 325 mg compresse
not available 004763241 BAYER SPA IT
ASPIRINA 325 mg compresse
not available 004763254 BAYER SPA IT
ASPIRINA 325 mg compresse
not available 004763266 BAYER SPA IT
ASPIRINA 500 mg compresse
not available 004763049 BAYER SPA IT
ASPIRINA 500 mg compresse
not available 004763025 BAYER SPA IT
ASPIRINA 500 mg compresse
not available 004763037 BAYER SPA IT
ASPIRINA 500 mg compresse
not available 004763367 BAYER SPA IT
ASPIRINA 500 mg compresse
not available 004763049 BAYER SPA IT
ASPIRINA 500 mg compresse
not available 004763025 BAYER SPA IT
List of nationally authorised medicinal products EMA/382341/2015 Page 35/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRINA 500 mg compresse
not available 004763037 BAYER SPA IT
ASPIRINA 500 mg compresse
not available 004763367 BAYER SPA IT
ASPIRINA 500 mg comprimidos
not available 2.011 BAYER HISPANIA SL ES
ASPIRINA 500 mg comprimidos
not available 2.011 BAYER HISPANIA SL ES
ASPIRINA 500 mg comprimidos
not available 2002194 BAYER PORTUGAL LDA PT
ASPIRINA 500 mg comprimidos
not available 3209384 BAYER PORTUGAL LDA PT
ASPIRINA 500 mg comprimidos
not available 2002194 BAYER PORTUGAL LDA PT
ASPIRINA 500 mg comprimidos
not available 3209384 BAYER PORTUGAL LDA PT
ASPIRINA 500 mg Granulado
not available 67.875 BAYER HISPANIA SL ES
List of nationally authorised medicinal products EMA/382341/2015 Page 36/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRINA 500 mg Granulado
not available 67.875 BAYER HISPANIA SL ES
ASPIRINA 500 mg Granulado
not available 5273289 BAYER PORTUGAL LDA PT
ASPIRINA 500 mg Granulado
not available 5273289 BAYER PORTUGAL LDA PT
ASPIRINA 500 mg Granulato
not available 004763393 BAYER SPA IT
ASPIRINA 500 mg Granulato
not available 004763544 BAYER SPA IT
ASPIRINA 500 mg Granulato
not available 004763405 BAYER SPA IT
ASPIRINA 500 mg Granulato
not available 004763595 BAYER SPA IT
ASPIRINA 500 mg Granulato
not available 004763393 BAYER SPA IT
ASPIRINA 500 mg Granulato
not available 004763544 BAYER SPA IT
List of nationally authorised medicinal products EMA/382341/2015 Page 37/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRINA 500 mg Granulato
not available 004763405 BAYER SPA IT
ASPIRINA 500 mg Granulato
not available 004763595 BAYER SPA IT
Aspirina Dolore e Infiammazione 500 mg compresse rivestite
IT/H/0548/001 041962010 BAYER SPA IT
Aspirina Dolore e Infiammazione 500 mg compresse rivestite
IT/H/0548/001 041962022 BAYER SPA IT
Aspirina Dolore e Infiammazione 500 mg compresse rivestite
IT/H/0548/001 041962034 BAYER SPA IT
Aspirina Dolore e Infiammazione 500 mg compresse rivestite
IT/H/0548/001 041962046 BAYER SPA IT
Aspirina GR 100 mg Comprimidos Gastrorresistentes 100 mg comprimidos gastrorresistentes
not available 5481379 BAYER PORTUGAL LDA PT
Aspirina GR 100 mg Comprimidos Gastrorresistentes 100 mg comprimidos gastrorresistentes
not available 3045580 BAYER PORTUGAL LDA PT
Aspirina GR 100 mg Comprimidos Gastrorresistentes 100 mg comprimidos
not available 5481379 BAYER PORTUGAL LDA PT
List of nationally authorised medicinal products EMA/382341/2015 Page 38/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
gastrorresistentes
Aspirina GR 100 mg Comprimidos Gastrorresistentes 100 mg comprimidos gastrorresistentes
not available 3045580 BAYER PORTUGAL LDA PT
Aspirina Microactive 500 mg comprimidos revestidos
FR/H/0482/001 5588165 BAYER PORTUGAL LDA PT
Aspirina Microactive 500 mg comprimidos revestidos
FR/H/0482/001 5588207 BAYER PORTUGAL LDA PT
Aspirina Microactive 500 mg comprimidos revestidos
FR/H/0482/001 5588173 BAYER PORTUGAL LDA PT
Aspirina Microactive 500 mg comprimidos revestidos
FR/H/0482/001 5588215 BAYER PORTUGAL LDA PT
ASPIRINA rapida 500 mg compresse masticabili
not available 004763379 BAYER SPA IT
ASPIRINA rapida 500 mg compresse masticabili
not available 004763417 BAYER SPA IT
ASPIRINA rapida 500 mg compresse masticabili
not available 004763379 BAYER SPA IT
List of nationally authorised medicinal products EMA/382341/2015 Page 39/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRINA rapida 500 mg compresse masticabili
not available 004763417 BAYER SPA IT
Aspirina Xpress 1000 mg comprimidos revestidos
PT/H/1384/001 5687819 BAYER PORTUGAL LDA PT
Aspirina Xpress 1000 mg comprimidos revestidos
PT/H/1384/001 5687801 BAYER PORTUGAL LDA PT
Aspirina Xpress 1000 mg comprimidos revestidos
PT/H/1384/001 5687777 BAYER PORTUGAL LDA PT
Aspirinaact dolore e infiammazione 1000 mg compresse rivestite
PT/H/1384/001 044095014 BAYER SPA IT
Aspirinaact dolore e infiammazione 1000 mg compresse rivestite
PT/H/1384/001 044095077 BAYER SPA IT
Aspirinaact dolore e infiammazione 1000 mg compresse rivestite
PT/H/1384/001 044095053 BAYER SPA IT
Aspirinaact dolore e infiammazione 1000 mg compresse rivestite
PT/H/1384/001 044095026 BAYER SPA IT
Aspirinaact dolore e infiammazione 1000 mg compresse rivestite
PT/H/1384/001 044095065 BAYER SPA IT
List of nationally authorised medicinal products EMA/382341/2015 Page 40/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirinaact dolore e infiammazione 1000 mg compresse rivestite
PT/H/1384/001 044095038 BAYER SPA IT
Aspirinaact dolore e infiammazione 1000 mg compresse rivestite
PT/H/1384/001 044095040 BAYER SPA IT
Aspirinaact dolore e infiammazione 1000 mg compresse rivestite
PT/H/1384/001 044095089 BAYER SPA IT
ASPIRINE 100, 100 mg comprimés
not available BE163581 BAYER SA NV BE
ASPIRINE 100, 100 mg comprimés
not available BE163581 BAYER SA NV BE
ASPIRINE 100, 100 mg comprimés
not available 1999065236 BAYER SA NV LU
ASPIRINE 100, 100 mg comprimés
not available 1999065236 BAYER SA NV LU
Aspirine 100, 100 mg Tabletten
not available BE163581 BAYER SA NV BE
Aspirine 100, 100 mg tabletten
not available BE163581 BAYER SA NV BE
List of nationally authorised medicinal products EMA/382341/2015 Page 41/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirine 100, 100 mg Tabletten
not available BE163581 BAYER SA NV BE
Aspirine 100, 100 mg tabletten
not available BE163581 BAYER SA NV BE
Aspirine 100, 100 mg Tabletten
not available 1999065236 BAYER SA NV LU
Aspirine 100, 100 mg Tabletten
not available 1999065236 BAYER SA NV LU
ASPIRINE 100, tabletten 100 mg
not available RVG 01414 BAYER BV NL
ASPIRINE 100, tabletten 100 mg
not available RVG 01414 BAYER BV NL
Aspirine 500 Brause, 500 mg, Brausetabletten
not available BE108866 BAYER SA NV BE
Aspirine 500 Brause, 500 mg, Brausetabletten
not available BE108866 BAYER SA NV BE
Aspirine 500 Brause, 500 mg, Brausetabletten
not available 1970120093 BAYER SA NV LU
List of nationally authorised medicinal products EMA/382341/2015 Page 42/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirine 500 Brause, 500 mg, Brausetabletten
not available 1970120093 BAYER SA NV LU
Aspirine 500 Bruis, 500 mg bruistabletten
not available BE108866 BAYER SA NV BE
Aspirine 500 Bruis, 500 mg bruistabletten
not available BE108866 BAYER SA NV BE
Aspirine 500 Effervescent, 500 mg comprimés effervescents
not available BE108866 BAYER SA NV BE
Aspirine 500 Effervescent, 500 mg comprimés effervescents
not available BE108866 BAYER SA NV BE
Aspirine 500 Effervescent, 500 mg comprimés effervescents
not available 1970120093 BAYER SA NV LU
Aspirine 500 Effervescent, 500 mg comprimés effervescents
not available 1970120093 BAYER SA NV LU
ASPIRINE 500 mg, tabletten 500 mg
not available RVG 00613 BAYER BV NL
ASPIRINE 500 mg, tabletten 500 mg
not available RVG 00613 BAYER BV NL
List of nationally authorised medicinal products EMA/382341/2015 Page 43/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRINE DU RHÔNE 500 mg, comprimé
not available 34009 351 467 9 3 BAYER HEALTHCARE FR
ASPIRINE DU RHÔNE 500 mg, comprimé
not available 34009 351 469 1 5 BAYER HEALTHCARE FR
ASPIRINE DU RHÔNE 500 mg, comprimé
not available 34009 559 144 8 8 BAYER HEALTHCARE FR
ASPIRINE DU RHÔNE 500 mg, comprimé
not available 34009 341 561 2 0 BAYER HEALTHCARE FR
ASPIRINE DU RHÔNE 500 mg, comprimé
not available 34009 351 468 5 4 BAYER HEALTHCARE FR
ASPIRINE DU RHÔNE 500 mg, comprimé
not available 34009 351 467 9 3 BAYER HEALTHCARE FR
ASPIRINE DU RHÔNE 500 mg, comprimé
not available 34009 351 469 1 5 BAYER HEALTHCARE FR
ASPIRINE DU RHÔNE 500 mg, comprimé
not available 34009 559 144 8 8 BAYER HEALTHCARE FR
ASPIRINE DU RHÔNE 500 mg, comprimé
not available 34009 341 561 2 0 BAYER HEALTHCARE FR
List of nationally authorised medicinal products EMA/382341/2015 Page 44/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRINE DU RHÔNE 500 mg, comprimé
not available 34009 351 468 5 4 BAYER HEALTHCARE FR
ASPIRINE DU RHONE 500 mg, comprimé à croquer
not available 34009 334 247 4 9 BAYER HEALTHCARE FR
ASPIRINE DU RHONE 500 mg, comprimé à croquer
not available 34009 363 986 6 5 BAYER HEALTHCARE FR
ASPIRINE DU RHONE 500 mg, comprimé à croquer
not available 34009 363 984 3 6 BAYER HEALTHCARE FR
ASPIRINE DU RHONE 500 mg, comprimé à croquer
not available 34009 334 248 0 0 BAYER HEALTHCARE FR
ASPIRINE DU RHONE 500 mg, comprimé à croquer
not available 34009 334 247 4 9 BAYER HEALTHCARE FR
ASPIRINE DU RHONE 500 mg, comprimé à croquer
not available 34009 363 986 6 5 BAYER HEALTHCARE FR
ASPIRINE DU RHONE 500 mg, comprimé à croquer
not available 34009 363 984 3 6 BAYER HEALTHCARE FR
ASPIRINE DU RHONE 500 mg, comprimé à croquer
not available 34009 334 248 0 0 BAYER HEALTHCARE FR
List of nationally authorised medicinal products EMA/382341/2015 Page 45/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Aspirine EC Protect 100, maagsapresistente tabletten 100 mg
not available RVG 20952 BAYER BV NL
Aspirine EC Protect 100, maagsapresistente tabletten 100 mg
not available RVG 20952 BAYER BV NL
ASPIRINE FASTTABS 500 mg comprimés enrobés
FR/H/0482/001 BE445112 BAYER SA NV BE
ASPIRINE FASTTABS 500 mg comprimés enrobés
FR/H/0482/001 2014040012 BAYER SA NV LU
ASPIRINE FASTTABS 500 mg omhulde tabletten
FR/H/0482/001 BE445112 BAYER SA NV BE
ASPIRINE FASTTABS 500 mg überzogene Tabletten
FR/H/0482/001 BE445112 BAYER SA NV BE
ASPIRINE FASTTABS 500 mg überzogene Tabletten
FR/H/0482/001 2014040012 BAYER SA NV LU
ASPIRINE kauwtablet, kauwtabletten 500 mg
not available RVG 16362 BAYER BV NL
ASPIRINE kauwtablet, kauwtabletten 500 mg
not available RVG 16362 BAYER BV NL
List of nationally authorised medicinal products EMA/382341/2015 Page 46/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRINE pH8 500 mg, comprimé gastro-résistant
not available 300 747-4 MEDA PHARMA SAS FR
ASPIRINE pH8 500 mg, comprimé gastro-résistant
not available 300 746-8 MEDA PHARMA SAS FR
ASPIRINE pH8 500 mg, comprimé gastro-résistant
not available 550 075-3 MEDA PHARMA SAS FR
ASPIRINE PROTECT 100 mg, comprimé gastro-resistant
not available 34009 269 400 1 0 BAYER HEALTHCARE FR
ASPIRINE PROTECT 100 mg, comprimé gastro-resistant
not available 34009 269 399 3 9 BAYER HEALTHCARE FR
ASPIRINE PROTECT 100 mg, comprimé gastro-resistant
not available 34009 269 401 8 8 BAYER HEALTHCARE FR
ASPIRINE PROTECT 100 mg, comprimé gastro-resistant
not available 34009 269 400 1 0 BAYER HEALTHCARE FR
ASPIRINE PROTECT 100 mg, comprimé gastro-resistant
not available 34009 269 399 3 9 BAYER HEALTHCARE FR
ASPIRINE PROTECT 100 mg, comprimé gastro-resistant
not available 34009 269 401 8 8 BAYER HEALTHCARE FR
List of nationally authorised medicinal products EMA/382341/2015 Page 47/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPIRINE PROTECT 300 mg, comprimé gastro-résistant
not available 34009 343 001 4 1 BAYER HEALTHCARE FR
ASPIRINE PROTECT 300 mg, comprimé gastro-résistant
not available 34009 343 000 8 0 BAYER HEALTHCARE FR
ASPIRINE PROTECT 300 mg, comprimé gastro-résistant
not available 34009 343 002 0 2 BAYER HEALTHCARE FR
ASPIRINE PROTECT 300 mg, comprimé gastro-résistant
not available 34009 343 001 4 1 BAYER HEALTHCARE FR
ASPIRINE PROTECT 300 mg, comprimé gastro-résistant
not available 34009 343 000 8 0 BAYER HEALTHCARE FR
ASPIRINE PROTECT 300 mg, comprimé gastro-résistant
not available 34009 343 002 0 2 BAYER HEALTHCARE FR
ASPIRINE UPSA 500 mg, comprimé effervescent
not available 34009 335 151-0 2 UPSA SAS FR
ASPIRINETTA 100 mg Compresse
not available 026721100 BAYER SPA IT
ASPIRINETTA 100 mg Compresse
not available 026721035 BAYER SPA IT
List of nationally authorised medicinal products EMA/382341/2015 Page 48/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPRO 320 mg, comprimé
not available 34009 324 528 0 4 BAYER HEALTHCARE FR
ASPRO 320 mg, comprimé
not available 34009 351 252 2 4 BAYER HEALTHCARE FR
ASPRO 320 mg, comprimé
not available 34009 560 926 6 6 BAYER HEALTHCARE FR
ASPRO 320 mg, comprimé
not available 34009 300 781 8 1 BAYER HEALTHCARE FR
ASPRO 320 mg, comprimé
not available 34009 324 528 0 4 BAYER HEALTHCARE FR
ASPRO 320 mg, comprimé
not available 34009 351 252 2 4 BAYER HEALTHCARE FR
ASPRO 320 mg, comprimé
not available 34009 560 926 6 6 BAYER HEALTHCARE FR
ASPRO 320 mg, comprimé
not available 34009 300 781 8 1 BAYER HEALTHCARE FR
ASPRO 500 Bruis, bruistabletten 500 mg
not available RVG 08186 BAYER BV NL
List of nationally authorised medicinal products EMA/382341/2015 Page 49/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPRO 500 Bruis, bruistabletten 500 mg
not available RVG 08186 BAYER BV NL
ASPRO 500 EFFERVESCENT, comprimé effervescent
not available 34009 320 623 9 3 BAYER HEALTHCARE FR
ASPRO 500 EFFERVESCENT, comprimé effervescent
not available 34009 320 624 5 4 BAYER HEALTHCARE FR
ASPRO 500 EFFERVESCENT, comprimé effervescent
not available 34009 323 955 2 1 BAYER HEALTHCARE FR
ASPRO 500 EFFERVESCENT, comprimé effervescent
not available 34009 320 625 1 5 BAYER HEALTHCARE FR
ASPRO 500 EFFERVESCENT, comprimé effervescent
not available 34009 320 623 9 3 BAYER HEALTHCARE FR
ASPRO 500 EFFERVESCENT, comprimé effervescent
not available 34009 320 624 5 4 BAYER HEALTHCARE FR
ASPRO 500 EFFERVESCENT, comprimé effervescent
not available 34009 323 955 2 1 BAYER HEALTHCARE FR
ASPRO 500 EFFERVESCENT, comprimé effervescent
not available 34009 320 625 1 5 BAYER HEALTHCARE FR
List of nationally authorised medicinal products EMA/382341/2015 Page 50/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPRO 500 mg, comprimé
not available 34009 337 325 6 1 BAYER HEALTHCARE FR
ASPRO 500 mg, comprimé
not available 34009 337 327 9 0 BAYER HEALTHCARE FR
ASPRO 500 mg, comprimé
not available 34009 337 329 1 2 BAYER HEALTHCARE FR
ASPRO 500 mg, comprimé
not available 34009 337 326 2 2 BAYER HEALTHCARE FR
ASPRO 500 mg, comprimé
not available 34009 554 663 7 6 BAYER HEALTHCARE FR
ASPRO 500 mg, comprimé
not available 34009 326 893 8 5 BAYER HEALTHCARE FR
ASPRO 500 mg, comprimé
not available 34009 337 328 5 1 BAYER HEALTHCARE FR
ASPRO 500 mg, comprimé
not available 34009 337 325 6 1 BAYER HEALTHCARE FR
ASPRO 500 mg, comprimé
not available 34009 337 327 9 0 BAYER HEALTHCARE FR
List of nationally authorised medicinal products EMA/382341/2015 Page 51/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPRO 500 mg, comprimé
not available 34009 337 329 1 2 BAYER HEALTHCARE FR
ASPRO 500 mg, comprimé
not available 34009 337 326 2 2 BAYER HEALTHCARE FR
ASPRO 500 mg, comprimé
not available 34009 554 663 7 6 BAYER HEALTHCARE FR
ASPRO 500 mg, comprimé
not available 34009 326 893 8 5 BAYER HEALTHCARE FR
ASPRO 500 mg, comprimé
not available 34009 337 328 5 1 BAYER HEALTHCARE FR
Aspro Clear not available PL 00010/0309 BAYER PLC UK
Aspro Clear not available PL 00010/0309 BAYER PLC UK
ASPROFLASH 500 mg, comprimé enrobé
FR/H/0482/001 34009 279 071 0 4 BAYER HEALTHCARE FR
ASPROFLASH 500 mg, comprimé enrobé
FR/H/0482/001 34009 279 072 7 2 BAYER HEALTHCARE FR
List of nationally authorised medicinal products EMA/382341/2015 Page 52/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ASPROFLASH 500 mg, comprimé enrobé
FR/H/0482/001 34009 279 069 6 1 BAYER HEALTHCARE FR
ASPROFLASH 500 mg, comprimé enrobé
FR/H/0482/001 34009 279 070 4 3 BAYER HEALTHCARE FR
ASS-ratiopharm® 300 mg Tabletten
not available 6367456.01.00 RATIOPHARM GMBH DE
Bamyl 500 mg brustabletter
not available 8845 MEDA AB SE
Bamyl 500 mg tabletter not available 14792 MEDA AB SE
Bayer-ASPIRIN® Migräne 500 mg Brausetablette
DE/H/0249/001 6245612.00.00 BAYER VITAL GMBH DE
CARDIOASPIRIN 100 mg Compresse gastroresistenti
not available 024840086 BAYER SPA IT
CARDIOASPIRIN 100 mg Compresse gastroresistenti
not available 024840098 BAYER SPA IT
CARDIOASPIRIN 100 mg Compresse gastroresistenti
not available 024840074 BAYER SPA IT
List of nationally authorised medicinal products EMA/382341/2015 Page 53/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
CARDIOASPIRIN 100 mg Compresse gastroresistenti
not available 024840086 BAYER SPA IT
CARDIOASPIRIN 100 mg Compresse gastroresistenti
not available 024840098 BAYER SPA IT
CARDIOASPIRIN 100 mg Compresse gastroresistenti
not available 024840074 BAYER SPA IT
CARDIOASPIRINE 100 mg comprimés gastro-résistants
not available BE186891 BAYER SA NV BE
CARDIOASPIRINE 100 mg comprimés gastro-résistants
not available BE186891 BAYER SA NV BE
CARDIOASPIRINE 100 mg comprimés gastro-résistants
not available 1998020010 BAYER SA NV LU
CARDIOASPIRINE 100 mg comprimés gastro-résistants
not available 1998020010 BAYER SA NV LU
CARDIOASPIRINE 100 mg maagsapresistente tabletten
not available BE186891 BAYER SA NV BE
CARDIOASPIRINE 100 mg maagsapresistente tabletten
not available BE186891 BAYER SA NV BE
List of nationally authorised medicinal products EMA/382341/2015 Page 54/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
CARDIOASPIRINE 100 mg magensaftresistente Tabletten
not available BE186891 BAYER SA NV BE
CARDIOASPIRINE 100 mg magensaftresistente Tabletten
not available BE186891 BAYER SA NV BE
CARDIOASPIRINE 100 mg magensaftresistente Tabletten
not available 1998020010 BAYER SA NV LU
CARDIOASPIRINE 100 mg magensaftresistente Tabletten
not available 1998020010 BAYER SA NV LU
Cartia 100 mg comprimidos gastrorresistentes
not available 9729509 INSTITUTO LUSO-FÁRMACO, LDA
PT
Danamep 75mg Tablets not available 04077 / 0182 M&A PHARMACHEM LTD UK
Dispersible Aspirin 300mg Tablets
not available PL 16028/0019 GALPHARM HEALTHCARE LIMITED
UK
Dispersible Aspirin 75 mg Tablets
not available PL 17907/0155 BRISTOL LABORATORIES LTD (BERKHAMSTED)
UK
Dispersible Aspirin 75 mg Tablets
not available PL 17907/0156 BRISTOL LABORATORIES LTD (BERKHAMSTED)
UK
List of nationally authorised medicinal products EMA/382341/2015 Page 55/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Dispersible Aspirin Tablets 75 mg
not available PL 20416/0230 CRESCENT PHARMA LIMITED
UK
Dispersible Aspirin Tablets 75mg BP
not available 04077 / 0182 M&A PHARMACHEM LTD UK
Dispersible Aspirin Tablets BP 300mg
not available PL 16028/0019 GALPHARM HEALTHCARE LIMITED
UK
Dispersible Aspirin Tablets BP 300mg
not available PL 4077/0175 M&A PHARMACHEM LTD UK
Dispersible Aspirin Tablets BP 75 mg
not available PL 20416/0227 CRESCENT PHARMA LIMITED
UK
DISPERSIBLE ASPIRIN TABLETS BP 75mg
not available PL 0142/0377 ACTAVIS UK LTD. UK
Disprin Original 300mg Dispersible Tablets
not available PA 979/6/1 RECKITT BENCKISER IRELAND LTD.
IE
Enprin not available PL 16028/0026 GALPHARM HEALTHCARE LIMITED
UK
HerzASS-ratiopharm® 100 mg Tabletten
not available 6043848.00.00 RATIOPHARM GMBH DE
List of nationally authorised medicinal products EMA/382341/2015 Page 56/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
HerzASS-ratiopharm® 100 mg Tabletten
not available 2009020247 RATIOPHARM GMBH LU
Hjertemagnyl, filmovertrukne tabletter 150 mg
not available 34892 TAKEDA PHARMA A/S DK
Hjertemagnyl, filmovertrukne tabletter 75 mg
not available 34891 TAKEDA PHARMA A/S DK
Magnyl Svage ”DAK”, filmovertrukne tabletter
not available 34914 TAKEDA PHARMA A/S DK
Mandaprin 75mg Dispersible Tablets
not available 04077 / 0182 M&A PHARMACHEM LTD UK
Migraspirina 500 mg comprimido efervescente
DE/H/0249/001 3638780 BAYER PORTUGAL LDA PT
Migraspirina 500 mg comprimido efervescente
DE/H/0249/001 3638681 BAYER PORTUGAL LDA PT
Nu-Seals 300 not available PL 16853/0063 ALLIANCE PHARMACEUTICALS LTD
UK
Nu-Seals 75 Aspirin 75mg Enteric coated tablets
not available MA056/00501 PHADISCO LTD MT
List of nationally authorised medicinal products EMA/382341/2015 Page 57/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Nu-Seals 75 Aspirin 75mg δισκία με εντεροδιαλυτή επικάλυψη
not available 16122 PHADISCO LTD CY
Postmi 300mg Gastro-resistant Tablets
not available PL 20046/0033 FOCUS PHARMACEUTICALS LIMITED
UK
SALOSPIR® Eff. gran 325mg/sachet
not available 57973/26.08.2010 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. gran 325mg/sachet
not available 57973/26.08.2010 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. gran. 1000mg/sachet
not available 8570/06.02.2007 (EOF CODE 1925508)
UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. gran. 1000mg/sachet
not available 8570/06.02.2007 (EOF CODE 1925508)
UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. gran. 100mg/sachet
not available 57971/26.08.2010 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. gran. 100mg/sachet
not available 57971/26.08.2010 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. gran. 500mg/sachet
not available 57967/26.08.2010 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
List of nationally authorised medicinal products EMA/382341/2015 Page 58/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
SALOSPIR® Eff. gran. 500mg/sachet
not available 57967/26.08.2010 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. tablets -1000mg/tab
not available 8570 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. tablets -1000mg/tab
not available 8570 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. tablets -100mg/tab
not available 8570 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. tablets -100mg/tab
not available 8570 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. tablets -325mg/tab
not available 57970 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. tablets -325mg/tab
not available 57970 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. tablets -500mg/tab
not available 57968 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Eff. tablets -500mg/tab
not available 57968 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
List of nationally authorised medicinal products EMA/382341/2015 Page 59/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
SALOSPIR® Gr. tablets -100 mg/tab
not available 22011 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Gr. tablets -100 mg/tab
not available 22011 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Gr. tablets -1000 mg/tab
not available 8570 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Gr. tablets -1000 mg/tab
not available 8570 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Gr. tablets -100mg/tab
not available 17903 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
CY
SALOSPIR® Gr. tablets -100mg/tab
not available 17903 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
CY
SALOSPIR® Gr. tablets -160 mg/tab
not available 22014 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Gr. tablets -160 mg/tab
not available 22014 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Gr. tablets -325 mg/tab
not available 69249/11 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
List of nationally authorised medicinal products EMA/382341/2015 Page 60/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
SALOSPIR® Gr. tablets -325 mg/tab
not available 69249/11 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Gr. tablets -325mg/tab
not available S00041 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
CY
SALOSPIR® Gr. tablets -325mg/tab
not available S00041 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
CY
SALOSPIR® Gr. tablets -500 mg/tab
not available 22019 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Gr. tablets -500 mg/tab
not available 22019 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Gr. tablets -650 mg/tab
not available 8570 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Gr. tablets -650 mg/tab
not available 8570 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Gr. tablets -80 mg/tab
not available 22018 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Gr. tablets -80 mg/tab
not available 22018 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
List of nationally authorised medicinal products EMA/382341/2015 Page 61/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
SALOSPIR® Tablets -100 mg/tab
not available 57975 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Tablets -100 mg/tab
not available 57975 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Tablets -325 mg/tab
not available 57969 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Tablets -325 mg/tab
not available 57969 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Tablets -500 mg/tab
not available 22015 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Tablets -500 mg/tab
not available 22015 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Tablets -75 mg/tab
not available 57974 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR® Tablets -75 mg/tab
not available 57974 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
SALOSPIR®Tablets -500 mg/tab
not available S00782 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
CY
List of nationally authorised medicinal products EMA/382341/2015 Page 62/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
SALOSPIR®Tablets -500 mg/tab
not available S00782 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
CY
SEDERGINE 500 mg, Brausetabletten
not available BE184807 BRISTOL-MYERS SQUIBB BELGIUM S.A.
BE
SEDERGINE 500 mg, Brausetabletten
not available 2011031023-0487228 BRISTOL-MYERS SQUIBB BELGIUM S.A.
LU
SEDERGINE 500 mg, Brausetabletten
not available 2011031023-0487228 BRISTOL-MYERS SQUIBB BELGIUM S.A.
LU
SEDERGINE 500 mg bruistabletten
not available BE184807 BRISTOL-MYERS SQUIBB BELGIUM S.A.
BE
SEDERGINE 500 mg, comprimés effervescents
not available BE184807 BRISTOL-MYERS SQUIBB BELGIUM S.A.
BE
SEDERGINE 500 mg, comprimés effervescents
not available 2011031023-0487228 BRISTOL-MYERS SQUIBB BELGIUM S.A.
LU
SEDERGINE 500 mg, comprimés effervescents
not available 2011031023-0487228 BRISTOL-MYERS SQUIBB BELGIUM S.A.
LU
Tromalyt 150 mg not available 3809787 BGP PRODUCTS UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/382341/2015 Page 63/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
TROMALYT 150 mg cápsulas duras de liberación prolongada
not available 59210 MEDA PHARMA S.L. ES
TROMALYT 300 mg cápsulas duras de liberación prolongada
not available 58791 MEDA PHARMA S.L. ES
АЛКА-ЗЕЛЦЕР 324 mg ефервесцентни таблетки
not available 20010171 BAYER BULGARIA EOOD BG
АЛКА-ЗЕЛЦЕР 324 mg ефервесцентни таблетки
not available 20010171 BAYER BULGARIA EOOD BG
АСПИРИН 500 mg таблетки
not available 20030406 BAYER BULGARIA EOOD BG
АСПИРИН 500 mg таблетки
not available 20030406 BAYER BULGARIA EOOD BG
АСПИРИН ПРОТЕКТ 100 mg стомашно-устойчиви таблетки
not available 20010168 BAYER BULGARIA EOOD BG
АСПИРИН ПРОТЕКТ 100 mg стомашно-устойчиви таблетки
not available 20010168 BAYER BULGARIA EOOD BG
АСПИРИН УЛТРА 500 mg обвити таблетки
not available 20160090 BAYER BULGARIA EOOD BG
List of nationally authorised medicinal products EMA/382341/2015 Page 64/64
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
АСПИРИН УЛТРА 500 mg обвити таблетки
not available 20160090 BAYER BULGARIA EOOD BG