list of nationally authorised medicinal products · mansikka-meloni 500 mg/25 mikrog-tuggtablett...
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
6 July 2017 EMA/434947/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: calcium salts / colecalciferol
Procedure no.: PSUSA/00010386/201610
List of nationally authorised medicinal products EMA/434947/2017 Page 2/50
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
BONESIL D FLAS 1500 mg/400 UI comprimidos bucodispersables
not available 68.620 ITALFARMACO S.A. ES
BONESIL D FLAS 1500 mg/400 UI comprimidos bucodispersables
not available 68.620 ITALFARMACO S.A. ES
Cacit D3 effervescent granules, 500 mg/440 IU
FR/H/0103/001/MR PL 10947/0017 WARNER CHILCOTT UK LIMITED
UK
Cacit VITAMINA D3 1000 mg / 880 U.I., granulato effervescent per soluzione orale in bustine
FR/H/103/001 032033058 WARNER CHILCOTT ITALY S.R.L.
IT
CACIT VITAMINA D3 1000 mg / 880 U.I., granulato effervescente per soluzione orale in bustine
FR/H/103/001 032033019 WARNER CHILCOTT ITALY S.R.L.
IT
CACIT VITAMINA D3 500 mg / 440 U.I., granulato effervescente per soluzione orale in bustine
FR/H/103/002 032033033 WARNER CHILCOTT ITALY S.R.L.
IT
Cacit VITAMINA D3 500 mg/440 U.I., granulato effervescente per soluzione orale in bustine
FR/H/103/002 032033060 WARNER CHILCOTT ITALY S.R.L.
IT
CACIT VITAMINE D3 1000 mg/880 UI, granules effervescents pour solution buvable en
FR/H/103/001 372 410-6 WARNER CHILCOTT FRANCE FR
List of nationally authorised medicinal products EMA/434947/2017 Page 3/50
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
sachet
Cacit Vitamine D3 1000/880, Brausegranulat für Trinklösung
FR/H/103/002/MR 0643/01/06/6398 WARNER CHILCOTT PHARMACEUTICALS BVBA
LU
Cacit Vitamine D3 1000/880, bruisgranulaat voor drank
FR/H/0103/002 BE179891 WARNER CHILCOTT PHARMACEUTICALS BVBA
BE
Cacit Vitamine D3 1000/880, granulé effervescent pour boisson
FR/H/0103/002 0643/01/06/6398 WARNER CHILCOTT PHARMACEUTICALS BVBA
LU
CACIT VITAMINE D3 500 mg/440 UI, granules effervescents pour solution buvable en sachet
FR/H/103/002 19044 WARNER CHILCOTT FRANCE FR
Cacit Vitamine D3 500/440, Brausegranulat für Trinklösung
FR/H/0103/001 BE179882 WARNER CHILCOTT PHARMACEUTICALS BVBA
BE
Cacit Vitamine D3 500/440, Brausegranulat für Trinklösung
FR/H/103/001/MR 0643/01/06/6397 WARNER CHILCOTT PHARMACEUTICALS BVBA
LU
CACIT VITAMINE D3 500/440, comprime a sucer ou a croquer
not available 364 409-2 WARNER CHILCOTT FRANCE FR
List of nationally authorised medicinal products EMA/434947/2017 Page 4/50
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
Cacit Vitamine D3 500/440, granulé effervescent pour boisson
FR/H/0103/001 0643/01/06/6397 WARNER CHILCOTT PHARMACEUTICALS BVBA
LU
CALCEOS 500mg/400IU Chewable Tablets
not available PL 19152/0001 LABORATOIRE INNOTECH INTERNATIONAL
UK
CALCEOS 500mg/400IU Chewable Tablets
not available PL 19152/0001 LABORATOIRE INNOTECH INTERNATIONAL
UK
Calchichew-D3 Forte, tyggetabletter
SE/H/0126/001 18189 TAKEDA PHARMA A/S DK
CALCIAL D comprimidos masticables
not available 66.064 ESPECIALIDADES FARMACEUTICAS CENTRUM, S.A
ES
Calci-Chew D3 1000 mg/800 I.E. kauwtabletten
SE/H/0126/002 RVG 101127 TAKEDA NEDERLAND BV NL
CALCICHEW D3 200 IU žvýkací tablety
not available 39/546/00-C TAKEDA AUSTRIA GMBH CZ
Calci-Chew D3 500 mg/400 I.E. kauwtabletten
SE/H/0126/001 RVG 25692 TAKEDA NEDERLAND BV NL
Calci-Chew D3 500 mg/800 I.E., kauwtabletten
SE/H/0126/004 RVG 105832 TAKEDA NEDERLAND BV NL
List of nationally authorised medicinal products EMA/434947/2017 Page 5/50
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
Calcichew D3 Extra appelsiini 500 mg/20 mikrog -purutabletti
SE/H/0126/005 27854 TAKEDA OY FI
Calcichew D3 Extra sitruuna 500 mg/20 mikrog -purutabletti
SE/H/0126/004 27855 TAKEDA OY FI
Calci-Chew D3 FLEX 500 mg/400 I.E. filmomhulde tabletten
SE/H/0126/003 RVG 104844 TAKEDA NEDERLAND BV NL
Calcichew D3 Forte mansikka-meloni 500 mg/10 mikrog -purutabletti
SE/H/0126/006 32239 TAKEDA OY FI
Calcichew D3 Forte mansikka-meloni 500 mg/10 mikrog-tuggtablett
SE/H/0126/006 32239 TAKEDA OY FI
Calcichew D3 Forte minttu 500 mg/10 mikrog -purutabletti
SE/H/0412/001 20058 TAKEDA OY FI
Calcichew D3 Forte sitruuna 500 mg/10 mikrog -purutabletti
SE/H/0126/001 15953 TAKEDA OY FI
Calcichew D3 Forte sitruuna 500 mg/10 mikrog -tabletti, kalvopäällysteinen
SE/H/0126/003 24110 TAKEDA OY FI
List of nationally authorised medicinal products EMA/434947/2017 Page 6/50
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
Calcichew D3 Jahoda 500 mg/1000 IU žvýkací tablety
SE/H/0126/008 39/415/15-C TAKEDA BELGIUM SCA/CVA CZ
Calcichew D3 Jahoda 500 mg/400 IU žvýkací tablety
SE/H/0126/006 39/414/15-C TAKEDA NYCOMED AS CZ
CALCICHEW D3 Lemon 400 IU žvýkací tablety
SE/H/0126/001 39/549/12-C TAKEDA NYCOMED AS CZ
Calcichew D3 Lemon 500 mg/1000 IU žvýkací tablety
SE/H/0126/007 39/413/15-C TAKEDA NYCOMED AS CZ
CALCICHEW D3 Lemon 800 IU žvýkací tablety
SE/H/0126/002 39/550/12-C TAKEDA NYCOMED AS CZ
Calcichew D3 Opti mansikka-meloni 500 mg/25 mikrog -purutabletti
SE/H/0126/008 32240 TAKEDA OY FI
Calcichew D3 Opti mansikka-meloni 500 mg/25 mikrog-tuggtablett
SE/H/0126/008 32240 TAKEDA OY FI
Calcichew® D3 Extra appelsiini 500 mg/20 mikrog-tuggtabletter
SE/H/0126/005 27854 TAKEDA OY FI
Calcichew® D3 Extra sitruuna 500 mg/20 mikrog-tuggtabletter
SE/H/0126/004 27855 TAKEDA OY FI
List of nationally authorised medicinal products EMA/434947/2017 Page 7/50
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
Calcichew® D3 Forte minttu 500 mg/10 mikrog-tuggtabletter
SE/H/0412/001 20058 TAKEDA OY FI
Calcichew® D3 Forte sitruuna 500 mg/10 mikrog-filmdragerade tabletter
SE/H/0126/003 24110 TAKEDA OY FI
Calcichew® D3 Forte sitruuna 500 mg/10 mikrog-tuggtabletter
SE/H/0126/001 15953 TAKEDA OY FI
Calcichew®-D3 - Kautabletten
not available 1-25487 TAKEDA PHARMA GES.M.B.H. AT
Calcichew-D3 1000 mg/800 IU Once Daily Chewable tablets
SE/H/0126/002 PL 16189/0028 TAKEDA UK LTD UK
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/20 TAKEDA PHARMA KFT. HU
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/21 TAKEDA PHARMA KFT. HU
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/22 TAKEDA PHARMA KFT. HU
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/23 TAKEDA PHARMA KFT. HU
List of nationally authorised medicinal products EMA/434947/2017 Page 8/50
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
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/24 TAKEDA PHARMA KFT. HU
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/25 TAKEDA PHARMA KFT. HU
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/26 TAKEDA PHARMA KFT. HU
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/27 TAKEDA PHARMA KFT. HU
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/28 TAKEDA PHARMA KFT. HU
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/29 TAKEDA PHARMA KFT. HU
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/30 TAKEDA PHARMA KFT. HU
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/31 TAKEDA PHARMA KFT. HU
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/32 TAKEDA PHARMA KFT. HU
List of nationally authorised medicinal products EMA/434947/2017 Page 9/50
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
Calcichew-D3 1000 mg/800 NE rágótabletta
SE/H/0126/002 OGYI-T-22251/33 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/1000 NE rágótabletta
SE/H/0126/007 OGYI-T-22251/34 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/1000 NE rágótabletta
SE/H/0126/007 OGYI-T-22251/35 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/1000 NE rágótabletta
SE/H/0126/007 OGYI-T-22251/36 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/1000 NE rágótabletta
SE/H/0126/007 OGYI-T-22251/37 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/1000 NE rágótabletta
SE/H/0126/007 OGYI-T-22251/38 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 IU Caplets
SE/H/0126/003 PL 16189/0027 TAKEDA UK LTD UK
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/02 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/04 TAKEDA PHARMA KFT. HU
List of nationally authorised medicinal products EMA/434947/2017 Page 10/50
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
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/07 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/09 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/11 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/13 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/15 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/19 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/01 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/03 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/05 TAKEDA PHARMA KFT. HU
List of nationally authorised medicinal products EMA/434947/2017 Page 11/50
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
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/06 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/08 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/10 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/12 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/14 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/16 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/18 TAKEDA PHARMA KFT. HU
Calcichew-D3 500 mg/400 NE rágótabletta
SE/H/0126/001 OGYI-T-22251/17 TAKEDA PHARMA KFT. HU
Calcichew-D3 Citron 1 000 mg/800 IU žuvacie tablety
SE/H/0126/002 39/0322/12-S TAKEDA PHARMACEUTICALS SLOVAKIA S.R.O.
SK
List of nationally authorised medicinal products EMA/434947/2017 Page 12/50
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
Calcichew-D3 Citron 1000 mg/800 IE tuggtablett
SE/H/0126/002 26065 TAKEDA AS SE
Calcichew-D3 Citron 500 mg/400 IE tuggtabletter
SE/H/0126/001 12634 TAKEDA AS SE
Calcichew-D3 Citron 500 mg/400 IU žuvacie tablety
SE/H/0126/001 39/0321/12-S TAKEDA PHARMACEUTICALS SLOVAKIA S.R.O.
SK
Calcichew-D3 Citron, 500mg/1000IE tuggtablett
SE/H/0126/007 51115 TAKEDA NYCOMED AS SE
Calcichew-D3 Extra 500 mg/1000 IU chewable tablets
SE/H/0126/007 PA 1547/7/5 TAKEDA UK LTD IE
Calcichew-D3 Forte 500 mg / 400 IU Film-coated Tablets
SE/H/0126/003 PA1547/007/003 TAKEDA UK LTD IE
Calcichew-D3 Forte 500 mg/400 IU Chewable Tablets
not available PL 16189/0026 TAKEDA UK LTD UK
Calcichew-D3 Forte Apelsin 500 mg/800 IE tuggtabletter
SE/H/0126/005 42960 TAKEDA AS SE
Calcichew-D3 Forte Chewable Tablets, calcium carbonate/colecalciferol equivalent to 500mg
not available PA 1547/007/002 TAKEDA UK LTD IE
List of nationally authorised medicinal products EMA/434947/2017 Page 13/50
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
Calcium / 400IU colecalciferol
Calcichew-D3 Forte Citron 500 mg/800 IE tuggtabletter
SE/H/0126/004 42959 TAKEDA AS SE
Calcichew-D3 Forte Double Strength 1000 mg / 800 IU Chewable Tablets
SE/H/0126/002 PA 1547/007/004 TAKEDA UK LTD IE
Calcichew-D3 Forte Strawberry and Watermelon 500 mg/400 IU chewable tablets
SE/H/0126/006 PL 16189/0029 TAKEDA UK LTD UK
Calcichew-D3 Melon, 500mg/1000IE tuggtablett
SE/H/0126/008 51116 TAKEDA NYCOMED AS SE
Calcichew-D3 Melon, 500mg/400IE tuggtablett
SE/H/0126/006 51114 TAKEDA NYCOMED AS SE
Calcichew-D3 Mite Citron 500 mg/200 IE tuggtabletter
SE/H/0411/001 16506 TAKEDA AS SE
Calcichew-D3 Spearmint 500 mg/400 IE tuggtabletter
SE/H/0412/001 16924 TAKEDA AS SE
Calciflex-D3 Citron 500 mg/400 IE filmdragerade tabletter
SE/H/0126/003 26066 TAKEDA AS SE
List of nationally authorised medicinal products EMA/434947/2017 Page 14/50
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
CALCIGAUROL VITAMINE D3 500mg/400 UI, comprimé à croquer ou à sucer
not available NL 22529-3400934880254 LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
CALCIGAUROL VITAMINE D3 500mg/400 UI, comprimé à croquer ou à sucer
not available NL 22529-3400934880254 LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
Calcigran 500 mg/200 TV kramtomosios tabletės
not available LT/1/98/1332/002 TAKEDA AS LT
Calcigran 500 mg/200 TV kramtomosios tabletės
not available LT/1/98/1332/003 TAKEDA AS LT
Calcigran Forte 1000 mg/800 IE tyggetabletter
SE/H/0126/002 07-5272 TAKEDA AS NO
Calcigran Forte 1000 mg/800 TV kramtomosios tabletes
SE/H/0126/002 LT/1/05/0177/016 TAKEDA AS LT
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/009 TAKEDA AS LT
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/010 TAKEDA AS LT
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/011 TAKEDA AS LT
List of nationally authorised medicinal products EMA/434947/2017 Page 15/50
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
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/012 TAKEDA AS LT
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/013 TAKEDA AS LT
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/014 TAKEDA AS LT
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/015 TAKEDA AS LT
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/017 TAKEDA AS LT
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/018 TAKEDA AS LT
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/019 TAKEDA AS LT
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/020 TAKEDA AS LT
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/021 TAKEDA AS LT
List of nationally authorised medicinal products EMA/434947/2017 Page 16/50
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
Calcigran Forte 1000 mg/800 TV kramtomosios tabletės
SE/H/0126/002 LT/1/05/0177/022 TAKEDA AS LT
Calcigran Forte 500 mg/1000 TV kramtomosios tabletės
SE/H/0126/008 LT/1/05/3786/001 TAKEDA AS LT
Calcigran Forte 500 mg/1000 TV kramtomosios tabletės
SE/H/0126/008 LT/1/05/3786/002 TAKEDA AS LT
Calcigran Forte 500 mg/1000 TV kramtomosios tabletės
SE/H/0126/008 LT/1/05/3786/003 TAKEDA AS LT
Calcigran Forte 500 mg/1000 TV kramtomosios tabletės
SE/H/0126/008 LT/1/05/3786/004 TAKEDA AS LT
Calcigran Forte 500 mg/1000 TV kramtomosios tabletės
SE/H/0126/008 LT/1/05/3786/005 TAKEDA AS LT
Calcigran Forte 500 mg/400 IE tabletter, filmdrasjerte
SE/H/0126/003 07-5268 TAKEDA AS NO
Calcigran Forte 500 mg/400 IE tyggetabletter
SE/H/0126/001 97-1657 TAKEDA AS NO
Calcigran Forte 500 mg/400 TV kramtomosios tabletės
not available LT/1/2000/1332/001 TAKEDA AS LT
List of nationally authorised medicinal products EMA/434947/2017 Page 17/50
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
Calcigran Forte 500 mg/800 IE tyggetabletter med appelsinsmak
SE/H/0126/005 09-6986 TAKEDA AS NO
Calcigran Forte 500 mg/800 IE tyggetabletter med sitronsmak
SE/H/0126/004 09-6985 TAKEDA AS NO
Calcigran Forte D Lemon, 500 mg/800 RÜ närimistabletid
SE/H/0126/004 700010 TAKEDA PHARMA AS EE
Calcigran Forte Extra D 500 mg/800 SV košļājamās tabletes
SE/H/0126/005 10-0340 TAKEDA AS LV
Calcigran Forte Flex 500 mg/400 SV apvalkotas tabletes
SE/H/0126/003 10-0061 TAKEDA AS LV
Calcigran Forte Flex 500 mg/400 TV plevele dengtos tabletes
SE/H/0126/003 LT/1/05/1837/006 TAKEDA AS LT
Calcigran Forte Flex 500 mg/400 TV plevele dengtos tabletes
SE/H/0126/003 LT/1/05/1837/009 TAKEDA AS LT
Calcigran Forte Flex 500 mg/400 TV plėvele dengtos tabletės
SE/H/0126/003 LT/1/05/1837/001 TAKEDA AS LT
Calcigran Forte Flex 500 mg/400 TV plėvele dengtos tabletės
SE/H/0126/003 LT/1/05/1837/002 TAKEDA AS LT
List of nationally authorised medicinal products EMA/434947/2017 Page 18/50
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
Calcigran Forte Flex 500 mg/400 TV plėvele dengtos tabletės
SE/H/0126/003 LT/1/05/1837/003 TAKEDA AS LT
Calcigran Forte Flex 500 mg/400 TV plėvele dengtos tabletės
SE/H/0126/003 LT/1/05/1837/004 TAKEDA AS LT
Calcigran Forte Flex 500 mg/400 TV plėvele dengtos tabletės
SE/H/0126/003 LT/1/05/1837/005 TAKEDA AS LT
Calcigran Forte Flex 500 mg/400 TV plėvele dengtos tabletės
SE/H/0126/003 LT/1/05/1837/007 TAKEDA AS LT
Calcigran Forte Flex 500 mg/400 TV plėvele dengtos tabletės
SE/H/0126/003 LT/1/05/1837/008 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/040 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/023 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/024 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/025 TAKEDA AS LT
List of nationally authorised medicinal products EMA/434947/2017 Page 19/50
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
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/026 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/027 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/028 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/029 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/030 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/031 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/032 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/033 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/034 TAKEDA AS LT
List of nationally authorised medicinal products EMA/434947/2017 Page 20/50
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
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/035 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/036 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/037 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/038 TAKEDA AS LT
Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės
SE/H/0126/004 LT/1/05/0177/039 TAKEDA AS LT
Calcigran Forte Mint 500 mg/400 TV kramtomosios tabletės
SE/H/0412/001 LT/1/05/0177/001 TAKEDA AS LT
Calcigran Forte Mint 500 mg/400 TV kramtomosios tabletės
SE/H/0412/001 LT/1/05/0177/002 TAKEDA AS LT
Calcigran Forte Mint 500 mg/400 TV kramtomosios tabletės
SE/H/0412/001 LT/1/05/0177/003 TAKEDA AS LT
Calcigran Forte Mint 500 mg/400 TV kramtomosios tabletės
SE/H/0412/001 LT/1/05/0177/004 TAKEDA AS LT
List of nationally authorised medicinal products EMA/434947/2017 Page 21/50
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
Calcigran Forte Mint 500 mg/400 TV kramtomosios tabletės
SE/H/0412/001 LT/1/05/0177/005 TAKEDA AS LT
Calcigran Forte Mint 500 mg/400 TV kramtomosios tabletės
SE/H/0412/001 LT/1/05/0177/006 TAKEDA AS LT
Calcigran Forte Mint 500 mg/400 TV kramtomosios tabletės
SE/H/0412/001 LT/1/05/0177/007 TAKEDA AS LT
Calcigran Forte Mint 500 mg/400 TV kramtomosios tabletės
SE/H/0412/001 LT/1/05/0177/008 TAKEDA AS LT
Calcigran Forte Mint, 500 mg/400 RÜ närimistabletid
SE/H/0412/001 464805 TAKEDA PHARMA AS EE
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/042 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/041 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/043 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/044 TAKEDA AS LT
List of nationally authorised medicinal products EMA/434947/2017 Page 22/50
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
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/045 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/046 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/047 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/048 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/049 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/050 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/051 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/052 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/053 TAKEDA AS LT
List of nationally authorised medicinal products EMA/434947/2017 Page 23/50
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
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/054 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/055 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/056 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/057 TAKEDA AS LT
Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės
SE/H/0126/005 LT/1/05/0177/058 TAKEDA AS LT
Calcigran Forte Red 500 mg/1000 RÜ närimistabletid
SE/H/0126/008 878015 TAKEDA PHARMA AS EE
Calcigran Forte spearmint 500 mg/400 IE tyggetabletter
SE/H/0412/001 04-2980 TAKEDA AS NO
Calcimagon® Extra D3, 500 mg / 800 I.E., Kautabletten
SE/H/0126/004 79553.00.00 TAKEDA GMBH (KONSTANZ) DE
Calcimagon®-D3 - Kautabletten
not available 1-25486 TAKEDA PHARMA GES.M.B.H. AT
List of nationally authorised medicinal products EMA/434947/2017 Page 24/50
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
Calcimagon®-D3 UNO, 1.000 mg/800 I.E., Kautabletten
SE/H/0126/002 78240.00.00 TAKEDA GMBH (KONSTANZ) DE
Calcimagon®-D3, 500 mg / 400 I.E, Kautabletten
DE/H/0843/001 40923.00.00 TAKEDA GMBH (KONSTANZ) DE
Calcio D Isdin Comprimidos masticables
not available 66.063 ISDIN, S.A. ES
Calcioral D3® 1000 mg + 20 μg (800 IU) μασώμενο δισκίο
SE/H/0126/002 18468/29-2-2016 TAKEDA HELLAS S.A. GR
Calcioral D3® 500 mg + 10 μg (400 IU) επικαλυμμένο με λεπτό υμένιο δισκίο
SE/H/0126/003 24147/15/24-05-2016 TAKEDA HELLAS S.A. GR
Calcioral D3® 500 mg + 10 μg (400 IU) μασώμενο δισκίο
SE/H/0126/001 34250 TAKEDA HELLAS S.A. GR
Calcioral D3® 500 mg + 10 μg (400 IU) μασώμενο δισκίο
SE/H/0126/001 37742/13-05-2016 TAKEDA HELLAS S.A. GR
Calcioral D3® Forte 500 mg + 20 μg (800 IU) μασώμενο δισκίο
SE/H/0126/004 37743/13-05-2016 TAKEDA HELLAS S.A. GR
CALCIPRAT VITAMINE D3 1000 mg/800 UI, comprimé à sucer
not available 3400936012431 ALFA WASSERMANN PHARMA FR
List of nationally authorised medicinal products EMA/434947/2017 Page 25/50
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
CALCIPRAT VITAMINE D3 1000 mg/800 UI, comprimé à sucer
not available 3400937389532 ALFA WASSERMANN PHARMA FR
CALCIPRAT VITAMINE D3 500 mg/400 UI, comprimé à sucer
not available 3400934115608 ALFA WASSERMANN PHARMA FR
Calcium Vit.D3 "Meda" 500mg/400 I.E.-Kautabletten
not available 1-25573 MEDA PHARMA GMBH AT
CALCIUM VITAMINE D3 BIOGARAN® 500 mg/400 UI, comprimé à sucer
not available 3400935646026 BIOGARAN FR
CALCIUM VITAMINE D3 RATIOPHARM 500 mg/400 UI, comprimé à sucer ou à croquer
not available NL26675 TEVA SANTÉ FR
CALCIUM VITAMINE D3 TEVA 500 mg/400 UI, comprimé à sucer ou à croquer
not available NL25498 TEVA SANTÉ FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 034 4 0 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 031 5 0 ZYDUS FRANCE FR
List of nationally authorised medicinal products EMA/434947/2017 Page 26/50
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
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 032 1 1 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 033 8 9 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 035 0 1 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 036 7 9 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 037 3 0 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 039 6 9 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 040 4 1 ZYDUS FRANCE FR
List of nationally authorised medicinal products EMA/434947/2017 Page 27/50
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
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 041 0 2 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 042 7 0 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 043 3 1 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 045 6 0 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 046 2 1 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 047 9 9 ZYDUS FRANCE FR
CALCIUM VITAMINE D3 ZYDUS 500 mg/400 U.I., comprimé à sucer ou à croquer
not available 34009 416 048 5 0 ZYDUS FRANCE FR
List of nationally authorised medicinal products EMA/434947/2017 Page 28/50
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
Calcium Wyeth® comprimido revestido
not available 8712836 PFIZER BIOFARMACEUTICA, SOCIEDADE UNIPESSOAL LDA
PT
Calcium Wyeth® comprimido revestido
not available 8712828 PFIZER BIOFARMACEUTICA, SOCIEDADE UNIPESSOAL LDA
PT
Calcium-DSandoz 600mg + 400IU, comprimidos efervescentes
DE/H/0198/001 3211588 SANDOZ FARMACÊUTICA LDA.
PT
Calcium-DSandoz 600mg + 400IU, comprimidos efervescentes
DE/H/0198/001 3211687 SANDOZ FARMACÊUTICA LDA.
PT
Calcium-DSandoz 600mg + 400IU, comprimidos efervescentes
DE/H/0198/001 3211885 SANDOZ FARMACÊUTICA LDA.
PT
Calcium-DSandoz 600mg + 400IU, comprimidos efervescentes
DE/H/0198/001 3211786 SANDOZ FARMACÊUTICA LDA.
PT
Calcivit D® forte Brausetabletten, 1000 mg/880 I.E.|Wirkstoffe: Calciumcarbonat und Colecalciferol
not available 46565.00.00 HEXAL AG DE
CALDEFIX 1000 mg/880UI, comprimate efervescente
not available 1880/2009/01 RECORDATI ROMANIA SRL RO
List of nationally authorised medicinal products EMA/434947/2017 Page 29/50
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
CALDEVITA, comprimé effervescent
not available 34009 344 137 7 3 BAYER HEALTHCARE FR
CALDEVITA, comprimé effervescent
not available 34009 344 138 3 4 BAYER HEALTHCARE FR
CALDEVITA, comprimé effervescent
not available 34009 344 140 8 4 BAYER HEALTHCARE FR
CALDEVITA, comprimé effervescent
not available 34009 344 136 0 5 BAYER HEALTHCARE FR
Cal-D-or 1000 mg/800 I.E. - Kautabletten
SE/H/0126/002 1-29825 TAKEDA AUSTRIA GMBH AT
Cal-D-or 500 mg/400 I.E. - Filmtabletten
SE/H/0126/003 1-29826 TAKEDA AUSTRIA GMBH AT
Cal-D-or 500 mg/400 I.E. - Kautabletten
SE/H/0126/001 1-22817 TAKEDA AUSTRIA GMBH AT
Cal-D-or Lemon 500 mg/800 I.E. - Kautabletten
SE/H/0126/004 1-29720 TAKEDA AUSTRIA GMBH AT
Cal-D-or Orange 500 mg/800 I.E. - Kautabletten
SE/H/0126/005 1-29721 TAKEDA AUSTRIA GMBH AT
List of nationally authorised medicinal products EMA/434947/2017 Page 30/50
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
CAL-D-VITA 600 MG /400 UI, comprimate masticabile
not available 6143/2006/01 BAYER SRL RO
CAL-D-VITA 600 MG /400 UI, comprimate masticabile
not available 6143/2006/02 BAYER SRL RO
Cal-D-Vita 600 mg/400 IE tuggtablett
SE/H/0134/002 13384 BAYER AB SE
CAL-D-VITA 600 mg/400 UI, comprimate efervescente
not available 5200/2005/01 BAYER SRL RO
CAL-D-VITA 600 mg/400 UI, comprimate efervescente
not available 5200/2005/02 BAYER SRL RO
Cal-D-Vita 600mg/400 IE, brustablett
SE/H/0134/001 13383 BAYER AB SE
CAL-D-VITA® - Kautabletten
SE/H/0134/002 1-22440 BAYER AUSTRIA GMBH AT
Calisvit not available 023651058 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
Calperos D3 1250 mg/ 400 TV tabletės
not available LT/1/99/0526/001 BOUCHARA RECORDATI LT
List of nationally authorised medicinal products EMA/434947/2017 Page 31/50
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
CALPEROS D3, comprimé à sucer
not available 346 298-8 BOUCHARA RECORDATI FR
CALPEROS D3, comprimé à sucer
not available 34009 346 297 1 6 BOUCHARA RECORDATI FR
CALPEROS D3, comprimé à sucer
not available 34009 366 749 5 0 BOUCHARA RECORDATI FR
CALPEROS D3, comprimé à sucer
not available 34009 341 157 7 6 BOUCHARA RECORDATI FR
CALPEROS D3, comprimé à sucer
not available 34009 372 234 3 0 BOUCHARA RECORDATI FR
CALPEROS D3, comprimé à sucer
not available 0241648 BOUCHARA RECORDATI LU
CITROKALCIUMD 300 mg/300 NE tabletta
not available OGYI-T-22788/01 PHARMA PATENT KFT. HU
CitrokalciumD 300 mg/300 NE tabletta
not available OGYI-T-22788/02 PHARMA PATENT KFT. HU
DAGRAVIT D-CALCIUM 250 mg + 250 mg + 100 U.I., Comprimido para mastigar
not available 9937136 MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
List of nationally authorised medicinal products EMA/434947/2017 Page 32/50
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
DISNAL comprimidos masticables
not available 62871 ITALFARMACO S.A. ES
D-vital 500/440 Calcium / Vitamine D3 Granulés effervescents
not available BE184877 WILL-PHARMA S.A. BE
D-vital 500/440 Calcium / Vitamine D3 granulés effervescents
not available 0489/03077784 WILL-PHARMA LUXEMBOURG LU
D-vital Forte 1000/880 Calcium / Vitamine D3 Bruisgranulaat
not available BE184861 WILL-PHARMA S.A. BE
D-vital Forte 1000/880 Calcium / Vitamine D3 granulés effervescents
not available 0489/03077785 WILL-PHARMA LUXEMBOURG LU
D-vital forte citron 1000 mg/880 UI, granulés effervescents
not available BE474924 WILL-PHARMA S.A. BE
EUROCAL D3 1000 mg/880 U.I, granulato effervescente
not available 32840011 AMDIPHARM LIMITED IT
EUROCAL D3 1000 mg/880 U.I, granulato effervescente
not available 32840023 AMDIPHARM LIMITED IT
EUROCAL D3 500 mg / 440 U.I., granulato effervescente
not available 032840047 AMDIPHARM LIMITED IT
List of nationally authorised medicinal products EMA/434947/2017 Page 33/50
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
EUROCAL D3 500 mg / 440 U.I., granulato effervescente
not available 032840050 AMDIPHARM LIMITED IT
FIXICAL VITAMINE D3 1000 mg/800 UI, comprimé à sucer
not available 34009 364 247 2 2 LABORATOIRES EXPANSCIENCE
FR
FIXICAL VITAMINE D3 1000 mg/800 UI, comprimé à sucer
not available 34009 376 287 4 7 LABORATOIRES EXPANSCIENCE
FR
Ideos not available 39/0263/03-S LABORATOIRE INNOTECH INTERNATIONAL
SK
Ideos not available 39/0263/03-S LABORATOIRE INNOTECH INTERNATIONAL
SK
Ideos 500 mg / 400 IE Kautabletten
not available 34358.00.00 LABORATOIRE INNOTECH INTERNATIONAL
DE
Ideos 500 mg / 400 IE Kautabletten
not available 34358.00.00 LABORATOIRE INNOTECH INTERNATIONAL
DE
Ideos 500 mg/400 NE rágótabletta
not available OGYI-T- 8315/01 LABORATOIRE INNOTECH INTERNATIONAL
HU
Ideos 500 mg/400 NE rágótabletta
not available OGYI-T- 8315/02 LABORATOIRE INNOTECH INTERNATIONAL
HU
List of nationally authorised medicinal products EMA/434947/2017 Page 34/50
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
Ideos 500 mg/400 NE rágótabletta
not available OGYI-T- 8315/01 LABORATOIRE INNOTECH INTERNATIONAL
HU
Ideos 500 mg/400 NE rágótabletta
not available OGYI-T- 8315/02 LABORATOIRE INNOTECH INTERNATIONAL
HU
IDEOS 500 mg/400 RÜ närimistabletid
not available 458404 LABORATOIRE INNOTECH INTERNATIONAL
EE
IDEOS 500 mg/400 RÜ närimistabletid
not available 458404 LABORATOIRE INNOTECH INTERNATIONAL
EE
IDEOS 500 mg/400 UI, Comprimate masticabile
not available 8017/2006/01 LABORATOIRE INNOTECH INTERNATIONAL
RO
IDEOS 500 mg/400 UI, Comprimate masticabile
not available 8017/2006/02 LABORATOIRE INNOTECH INTERNATIONAL
RO
IDEOS 500 mg/400 UI, Comprimate masticabile
not available 8017/2006/01 LABORATOIRE INNOTECH INTERNATIONAL
RO
IDEOS 500 mg/400 UI, Comprimate masticabile
not available 8017/2006/02 LABORATOIRE INNOTECH INTERNATIONAL
RO
IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer
FR/H/0114/001 360 752-4 LABORATOIRE INNOTECH INTERNATIONAL
FR
List of nationally authorised medicinal products EMA/434947/2017 Page 35/50
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
IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer
FR/H/0114/001 342 533-2 LABORATOIRE INNOTECH INTERNATIONAL
FR
IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer
FR/H/0114/001 342 534-9 LABORATOIRE INNOTECH INTERNATIONAL
FR
IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer
FR/H/0114/001 338 097-7 LABORATOIRE INNOTECH INTERNATIONAL
FR
IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer
FR/H/0114/001 347 338-3 LABORATOIRE INNOTECH INTERNATIONAL
FR
IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer
FR/H/0114/001 563 749-8 LABORATOIRE INNOTECH INTERNATIONAL
FR
IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer
FR/H/0114/001 360 752-4 LABORATOIRE INNOTECH INTERNATIONAL
FR
IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer
FR/H/0114/001 342 533-2 LABORATOIRE INNOTECH INTERNATIONAL
FR
IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer
FR/H/0114/001 342 534-9 LABORATOIRE INNOTECH INTERNATIONAL
FR
IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer
FR/H/0114/001 338 097-7 LABORATOIRE INNOTECH INTERNATIONAL
FR
List of nationally authorised medicinal products EMA/434947/2017 Page 36/50
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
IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer
FR/H/0114/001 347 338-3 LABORATOIRE INNOTECH INTERNATIONAL
FR
IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer
FR/H/0114/001 563 749-8 LABORATOIRE INNOTECH INTERNATIONAL
FR
IDEOS 500mg/400 IU Chewable Tablets
not available PA1033/001/001 LABORATOIRE INNOTECH INTERNATIONAL
IE
IDEOS 500mg/400 IU Chewable Tablets
not available PA1033/001/001 LABORATOIRE INNOTECH INTERNATIONAL
IE
Ideos Kramtomosios tabletės
not available 97/4704/7 LABORATOIRE INNOTECH INTERNATIONAL
LT
Ideos Kramtomosios tabletės
not available 97/4704/7 LABORATOIRE INNOTECH INTERNATIONAL
LT
IDÉOS TYGGETABLETTER not available 97-2598 LABORATOIRE INNOTECH INTERNATIONAL
NO
IDÉOS TYGGETABLETTER not available 97-2598 LABORATOIRE INNOTECH INTERNATIONAL
NO
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 2711380 LABORATOIRE INNOTECH INTERNATIONAL
PT
List of nationally authorised medicinal products EMA/434947/2017 Page 37/50
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
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 2585784 LABORATOIRE INNOTECH INTERNATIONAL
PT
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 2585883 LABORATOIRE INNOTECH INTERNATIONAL
PT
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 2585982 LABORATOIRE INNOTECH INTERNATIONAL
PT
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 2711489 LABORATOIRE INNOTECH INTERNATIONAL
PT
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 2586089 LABORATOIRE INNOTECH INTERNATIONAL
PT
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 4162384 LABORATOIRE INNOTECH INTERNATIONAL
PT
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 2711380 LABORATOIRE INNOTECH INTERNATIONAL
PT
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 2585784 LABORATOIRE INNOTECH INTERNATIONAL
PT
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 2585883 LABORATOIRE INNOTECH INTERNATIONAL
PT
List of nationally authorised medicinal products EMA/434947/2017 Page 38/50
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
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 2585982 LABORATOIRE INNOTECH INTERNATIONAL
PT
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 2711489 LABORATOIRE INNOTECH INTERNATIONAL
PT
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 2586089 LABORATOIRE INNOTECH INTERNATIONAL
PT
IDEOS, 500 mg /400 UI Comprimido para mastigar
FR/H/0114/001 4162384 LABORATOIRE INNOTECH INTERNATIONAL
PT
IDEOS, 500 mg/400 IU Μασώμενα Δισκία
FR/H/0114/001 75221/1-11-2011 VIANEX S.A. GR
IDEOS, 500 mg/400 IU Μασώμενα Δισκία
FR/H/0114/001 75221/1-11-2011 VIANEX S.A. GR
IDEOS, 500 mg/400 UI Compresse masticabili
FR/H/0114/001 034213013 MEDA PHARMA S.P.A. IT
IDEOS, 500 mg/400 UI Compresse masticabili
FR/H/0114/001 034213025 MEDA PHARMA S.P.A. IT
IDEOS, 500 mg/400 UI Compresse masticabili
FR/H/0114/001 034213037 MEDA PHARMA S.P.A. IT
List of nationally authorised medicinal products EMA/434947/2017 Page 39/50
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
IDEOS, 500 mg/400 UI Compresse masticabili
FR/H/0114/001 034213049 MEDA PHARMA S.P.A. IT
IDEOS, 500 mg/400 UI Compresse masticabili
FR/H/0114/001 034213052 MEDA PHARMA S.P.A. IT
IDEOS, 500 mg/400 UI Compresse masticabili
FR/H/0114/001 034213064 MEDA PHARMA S.P.A. IT
IDEOS, 500 mg/400 UI Compresse masticabili
FR/H/0114/001 034213013 MEDA PHARMA S.P.A. IT
IDEOS, 500 mg/400 UI Compresse masticabili
FR/H/0114/001 034213025 MEDA PHARMA S.P.A. IT
IDEOS, 500 mg/400 UI Compresse masticabili
FR/H/0114/001 034213037 MEDA PHARMA S.P.A. IT
IDEOS, 500 mg/400 UI Compresse masticabili
FR/H/0114/001 034213049 MEDA PHARMA S.P.A. IT
IDEOS, 500 mg/400 UI Compresse masticabili
FR/H/0114/001 034213052 MEDA PHARMA S.P.A. IT
IDEOS, 500 mg/400 UI Compresse masticabili
FR/H/0114/001 034213064 MEDA PHARMA S.P.A. IT
List of nationally authorised medicinal products EMA/434947/2017 Page 40/50
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
IDEOS, Chewable tablets not available MA093/00201 LABORATOIRE INNOTECH INTERNATIONAL
MT
IDEOS, Chewable tablets not available MA093/00201 LABORATOIRE INNOTECH INTERNATIONAL
MT
KOMBI-KALZ 1000/880 not available 39/252/00-C MEDA PHARMA S.R.O. CZ
Kombi-Kalz 1000/880 not available 39/0172/00-S MEDA PHARMA GMBH SK
Kombi-Kalz 500mg/400 I.E.Vit. D3 - Kautabletten
not available 1-25151 MEDA PHARMA GMBH AT
Mastical D 500 mg/1000 U.I comprimidos masticables sabor fresa
SE/H/0126/008 79937 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
Mastical D 500 mg/1000 U.I comprimidos masticables sabor limón
SE/H/0126/007 79939 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
Mastical D 500 mg/400 U.I comprimidos masticables sabor fresa
SE/H/0126/006 79938 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
Mastical D 500 mg/400 UI comprimidos masticables sabor naranja
not available 65.097 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
List of nationally authorised medicinal products EMA/434947/2017 Page 41/50
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
Mastical D 500 mg/800 UI comprimidos masticables
SE/H/0126/004 72.582 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
Mastical D sabor limón 500 mg/400 UI comprimidos masticables
SE/H/0126/001 67.800 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
Mastical D Unidia 1000 mg/800 UI comprimidos masticables
SE/H/0126/002 71639 TAKEDA FARMACÉUTICA ESPAÑA S.A
ES
Maxi-Kalz Vit. D3 1000 mg/880 I.E. - Granulat
FR/H/0103/002 1-21503 MEDA PHARMA GMBH AT
Maxi-Kalz Vit. D3 500 mg/400 I.E.-Kautabletten
not available 1-25150 MEDA PHARMA GMBH AT
Nycoplus Calcigran 500 mg/200 IE tyggetabletter
SE/H/0411/001 00-7420 TAKEDA AS NO
Orocal D3, 500 mg + 10 μg (400 j.m.), tabletki do żucia
SE/H/0412/001 11390 TAKEDA PHARMA SP.Z.O.O. PL
Orocal Vitamine D3 500 mg/200 UI, comprimé à sucer
SE/H/0554/001 NL 31018 TEVA SANTÉ FR
OROCAL VITAMINE D3 500 mg/400 U.I., comprimé à sucer
not available NL 20442 TEVA SANTÉ FR
List of nationally authorised medicinal products EMA/434947/2017 Page 42/50
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
OROTRE 500 mg + 400 UI compresse
not available 033861028 TAKEDA ITALIA S.P.A. IT
OROTRE 500 mg + 400 UI compresse
not available 033861016 TAKEDA ITALIA S.P.A. IT
OSSEANS VITAMINE D3 500 mg/400 UI, comprimé à sucer ou à croquer
not available 24509-3400938751536 LABORATOIRES SCIENCEX FR
OSTEOMERCK 1200 mg / 800 UI polvo para suspensión oral
DE/H/0372/001 62.474 MERCK, S.L. ES
OSTRAM VITAMINE D3 1200 mg/800 U.I., poudre pour suspension buvable en sachet-dose
DE/H/0372/001 348 810-8 MERCK SANTÉ S.A.S. FR
OSTRAM VITAMINE D3 1200 mg/800 U.I., poudre pour suspension buvable en sachet-dose
DE/H/0372/001 348 807-7 MERCK SANTÉ S.A.S. FR
OSTRAM VITAMINE D3 1200 mg/800 U.I., poudre pour suspension buvable en sachet-dose
DE/H/0372/001 351 546-6 MERCK SANTÉ S.A.S. FR
OSTRAM VITAMINE D3 1200 mg/800 U.I., poudre pour suspension buvable en sachet-dose
DE/H/0372/001 348 805-4 MERCK SANTÉ S.A.S. FR
List of nationally authorised medicinal products EMA/434947/2017 Page 43/50
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
OSTRAM VITAMINE D3 1200 mg/800 U.I., poudre pour suspension buvable en sachet-dose
DE/H/0372/001 348 808-3 MERCK SANTÉ S.A.S. FR
OSTRAM VITAMINE D3 1200 mg/800 U.I., poudre pour suspension buvable en sachet-dose
DE/H/0372/001 348 806-0 MERCK SANTÉ S.A.S. FR
Reliveran 600 mg/400 UI comprimidos
not available 68428 FARMASIERRA LABORATORIOS, S.L.
ES
Sandocal®-D 1000 mg/880 I.E. Brausegranulat
not available 38695.01.00 HEXAL AG DE
Sandocal®-D 500 mg/440 I.E. Brausegranulat
not available 38695.00.00 HEXAL AG DE
Steovit D3 500 mg/400 I.E. filmomhulde tabletten
SE/H/0126/003 BE362582 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 500 mg/400 I.E. Filmtabletten
SE/H/0126/003 BE362582 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 500 mg/400 I.E. Filmtabletten
SE/H/0126/003 2010060035 TAKEDA BELGIUM SCA/CVA LU
Steovit D3 500 mg/400 U.I. comprimés pelliculés
SE/H/0126/003 BE362582 TAKEDA BELGIUM SCA/CVA BE
List of nationally authorised medicinal products EMA/434947/2017 Page 44/50
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
Steovit D3 500 mg/400 U.I. comprimés pelliculés
SE/H/0126/003 2010060035 TAKEDA BELGIUM SCA/CVA LU
Steovit D3 aardbei/watermeloen 500 mg/1000 I.E. kauwtabletten
SE/H/0126/008 BE476933 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 aardbei/watermeloen 500 mg/400 I.E. kauwtabletten
SE/H/0126/006 BE476915 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 Apfelsine 500mg/800 I.E. Kautabletten
SE/H/0126/005 BE377535 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 Apfelsine 500mg/800 I.E. Kautabletten
SE/H/0126/005 BE377544 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 Apfelsine 500mg/800 I.E. Kautabletten
SE/H/0126/005 2011040073 TAKEDA BELGIUM SCA/CVA LU
Steovit D3 citroen 500 mg/1000 I.E. kauwtabletten
SE/H/0126/007 BE476924 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 citroen 500 mg/400 I.E. kauwtabletten
SE/H/0126/001 BE324922 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 citroen 500 mg/400 I.E.
SE/H/0126/001 BE221426 TAKEDA BELGIUM SCA/CVA BE
List of nationally authorised medicinal products EMA/434947/2017 Page 45/50
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
kauwtabletten
Steovit D3 citron 500 mg/1000 U.I. comprimés à croquer
SE/H/0126/007 BE476924 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 citron 500 mg/1000 U.I. comprimés à croquer
SE/H/0126/007 2016110329 TAKEDA BELGIUM SCA/CVA LU
Steovit D3 citron 500 mg/400 U.I. comprimés à croquer
SE/H/0126/001 BE221426 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 citron 500 mg/400 U.I. comprimés à croquer
SE/H/0126/001 BE324922 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 citron 500 mg/400 U.I. comprimés à croquer
SE/H/0126/001 2009010134 TAKEDA BELGIUM SCA/CVA LU
Steovit D3 Erdbeere/Wassermelone 500mg/1000 I.E. Kautabletten
SE/H/0126/008 BE476933 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 Erdbeere/Wassermelone 500mg/1000 I.E. Kautabletten
SE/H/0126/008 2016110330 TAKEDA BELGIUM SCA/CVA LU
Steovit D3 Erdbeere/Wassermelone
SE/H/0126/006 BE476915 TAKEDA BELGIUM SCA/CVA BE
List of nationally authorised medicinal products EMA/434947/2017 Page 46/50
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
500mg/400 I.E. Kautabletten
Steovit D3 Erdbeere/Wassermelone 500mg/400 I.E. Kautabletten
SE/H/0126/006 2016110331 TAKEDA BELGIUM SCA/CVA LU
Steovit D3 fraise/pastèque 500 mg/1000 U.I. comprimés à croquer
SE/H/0126/008 BE476933 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 fraise/pastèque 500 mg/1000 U.I. comprimés à croquer
SE/H/0126/008 2016110330 TAKEDA BELGIUM SCA/CVA LU
Steovit D3 fraise/pastèque 500 mg/400 U.I. comprimés à croquer
SE/H/0126/006 BE476915 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 fraise/pastèque 500 mg/400 U.I. comprimés à croquer
SE/H/0126/006 2016110331 TAKEDA BELGIUM SCA/CVA LU
Steovit D3 goût menthe 500 mg/400 U.I. comprimés à croquer
SE/H/0412/001 BE333557 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 goût menthe 500 mg/400 U.I. comprimés à croquer
SE/H/0412/001 2009110047 TAKEDA BELGIUM SCA/CVA LU
List of nationally authorised medicinal products EMA/434947/2017 Page 47/50
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
Steovit D3 Minzgeschmack 500mg/400 I.E. Kautabletten
SE/H/0412/001 BE333557 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 Minzgeschmack 500mg/400 I.E. Kautabletten
SE/H/0412/001 2009110047 TAKEDA BELGIUM SCA/CVA LU
Steovit D3 muntsmaak 500 mg/400 I.E. kauwtabletten
SE/H/0412/001 BE333557 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 orange 500 mg/800 U.I. comprimés à croquer
SE/H/0126/005 BE377535 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 orange 500 mg/800 U.I. comprimés à croquer
SE/H/0126/005 BE377544 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 orange 500 mg/800 U.I. comprimés à croquer
SE/H/0126/005 2011040073 TAKEDA BELGIUM SCA/CVA LU
Steovit D3 sinaasappel 500 mg/800 I.E. kauwtabletten
SE/H/0126/005 BE377535 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 sinaasappel 500 mg/800 I.E. kauwtabletten
SE/H/0126/005 BE377544 TAKEDA BELGIUM SCA/CVA BE
List of nationally authorised medicinal products EMA/434947/2017 Page 48/50
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
Steovit D3 Zitrone 500mg/1000 I.E. Kautabletten
SE/H/0126/007 BE476924 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 Zitrone 500mg/1000 I.E. Kautabletten
SE/H/0126/007 2016110329 TAKEDA BELGIUM SCA/CVA LU
Steovit D3 Zitrone 500mg/400 I.E. Kautabletten
SE/H/0126/001 BE324922 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 Zitrone 500mg/400 I.E. Kautabletten
SE/H/0126/001 BE221426 TAKEDA BELGIUM SCA/CVA BE
Steovit D3 Zitrone 500mg/400 I.E. Kautabletten
SE/H/0126/001 2009010134 TAKEDA BELGIUM SCA/CVA LU
Steovit Forte citroen 1000 mg/800 I.E. kauwtabletten
SE/H/0126/002 BE325044 TAKEDA BELGIUM SCA/CVA BE
Steovit Forte citroen 1000 mg/800 I.E. kauwtabletten
SE/H/0126/002 BE324931 TAKEDA BELGIUM SCA/CVA BE
Steovit Forte citron 1000 mg/800 U.I. comprimés à croquer
SE/H/0126/002 BE325044 TAKEDA BELGIUM SCA/CVA BE
Steovit Forte citron 1000 mg/800 U.I. comprimés à croquer
SE/H/0126/002 BE324931 TAKEDA BELGIUM SCA/CVA BE
List of nationally authorised medicinal products EMA/434947/2017 Page 49/50
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
Steovit Forte citron 1000 mg/800 U.I. comprimés à croquer
SE/H/0126/002 2009020026 TAKEDA BELGIUM SCA/CVA LU
Steovit Forte Zitrone 1000 mg/800 I.E. Kautabletten
SE/H/0126/002 BE324931 TAKEDA BELGIUM SCA/CVA BE
Steovit Forte Zitrone 1000 mg/800 I.E. Kautabletten
SE/H/0126/002 BE325044 TAKEDA BELGIUM SCA/CVA BE
Steovit Forte Zitrone 1000 mg/800 I.E. Kautabletten
SE/H/0126/002 2009020026 TAKEDA BELGIUM SCA/CVA LU
Tacal D3 500 mg/400 I.E. Munt, kauwtabletten
SE/H/0412/001 RVG 31801 TAKEDA NEDERLAND BV NL
Tacal D3 500 mg/800 I.E. sinaasappel, kauwtabletten
SE/H/0126/005 RVG 105833 TAKEDA NEDERLAND BV NL
TEPOX-CAL D polvo para suspensión oral
not available 64.998 LABORATORIO STADA, S.L. ES
VERISCAL D not available 62442 LABORATORIOS FARMACÉUTICOS VALOMED S.A.
ES
VERISCAL D not available 62442 LABORATORIOS FARMACÉUTICOS VALOMED S.A.
ES
List of nationally authorised medicinal products EMA/434947/2017 Page 50/50
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
VERISCAL D FLAS 1500 mg/400 UI comprimidos bucodispersables
not available 68402 LABORATORIOS FARMACÉUTICOS VALOMED S.A.
ES
VERISCAL D FLAS 1500 mg/400 UI comprimidos bucodispersables
not available 68402 LABORATORIOS FARMACÉUTICOS VALOMED S.A.
ES
ИДЕОС 500 mg/ 400 IU таблетки за дъвчене
not available 20030664 LABORATOIRE INNOTECH INTERNATIONAL
BG
ИДЕОС 500 mg/ 400 IU таблетки за дъвчене
not available 20030664 LABORATOIRE INNOTECH INTERNATIONAL
BG