List of nationally authorised medicinal products · IU, effervescent granules for oral solution in...

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© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.

11 June 2020 EMA/322204/2020 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: calcium salts / colecalciferol

Procedure no.: PSUSA/00010386/201910

List of nationally authorised medicinal products EMA/382258/2015 Page 2/32

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

Adcal-D3® Lemon Chewable tablets

not available PL 16508/0028 KYOWA KIRIN LTD UK

CACIT 1000 mg/880 UI, granulado efervescente para solução oral em saquetas

FR/H/0103/002 5865985 THERAMEX IRELAND LIMITED

PT

CACIT 500 mg/440 UI, granulado efervescente para solução oral em saquetas


PT

CACIT D3 500 mg/440 IU, effervescent granules for oral solution in sachet

FR/H/0103/001 PL 49876/0014 THERAMEX IRELAND LIMITED

UK

CACIT VITAMINA D3 1000 mg/880 U.I., granulato effervescente per soluzione orale in bustine.


IT



IT




IT



IT

Cacit Vitamine D3 1000 mg /880 IE, Brausegranulat für Trinklösung

FR/H/0103/002 BE179891 THERAMEX IRELAND LIMITED

BE

Cacit Vitamine D3 1000 mg /880 IE, Brausegranulat für Trinklösung Calcium/Cholecalciferol-Konzentrat


LU

Cacit Vitamine D3 1000 mg /880 IE, bruisgranulaat voor drank


BE


Cacit Vitamine D3 1000 mg /880 UI, granulés effervescents pour solution buvable


BE



LU

CACIT VITAMINE D3 1000 mg/880 UI, granulés effervescents pour solution buvable en sachet

FR/H/0103/002 34009 338 787 3 3 THERAMEX IRELAND LIMITED

FR



FR



FR

Cacit Vitamine D3 500 mg /440 IE bruisgranulaat voor drank


BE


Cacit Vitamine D3 500 mg /440 IE, Brausegranulat für Trinklösung


BE

Cacit Vitamine D3 500 mg /440 IE, Brausegranulat für Trinklösung Calcium/Cholecalciferol-Konzentra


LU



BE



LU

CACIT VITAMINE D3 500 mg/1000 U.I., comprimé à sucer ou à croquer

DE/H/5016/001 34009 301 528 6 7 THERAMEX IRELAND LIMITED

FR

CACIT VITAMINE D3 500 mg/1000 U.I., comprimé à sucer ou à croquer

DE/H/5016/001 34009 301 528 7 4 THERAMEX IRELAND LIMITED

FR




FR



FR



FR

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

Calcial D 600 mg/400 UI 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 B.V. NL


Calci-Chew D3 500 mg/1000 I.E. citroen kauwtabletten


Calci-Chew D3 500 mg/400 I.E. kauwtabletten


Calci-Chew D3 500 mg/800 I.E., kauwtabletten


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


Calci-Chew D3 FLEX 500 mg/400 I.E. filmomhulde tabletten


Calcichew D3 Forte mansikka-meloni 500 mg/10 mikrog -purutabletti


Calcichew D3 Forte mansikka-meloni 500 mg/10 mikrog-tuggtablett



Calcichew D3 Forte sitruuna 500 mg/10 mikrog -purutabletti


Calcichew D3 Jahoda 500 mg/400 IU žvýkací tablety

SE/H/0126/006 39/414/15-C TAKEDA AS CZ

CALCICHEW D3 Lemon 1000 mg/800 IU žvýkací tablety

SE/H/0126/002 39/550/12-C TAKEDA AS CZ

CALCICHEW D3 Lemon 500 mg/400 IU žvýkací tablety

SE/H/0126/001 39/549/12-C TAKEDA AS CZ

Calcichew D3 Opti mansikka-meloni 500 mg/25 mikrog -purutabletti


Calcichew D3 Opti mansikka-meloni 500 mg/25 mikrog-tuggtablett


Calcichew® D3 Extra appelsiini 500 mg/20 mikrog-tuggtabletter


Calcichew® D3 Extra sitruuna 500 mg/20 mikrog-tuggtabletter



Calcichew® D3 Forte minttu 500 mg/10 mikrog-tuggtabletter


Calcichew® D3 Forte sitruuna 500 mg/10 mikrog-filmdragerade tabletter


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


not available OGYI-T-8573/01 TAKEDA AS HU

Calcichew-D3 500 mg/400 IU Caplets

SE/H/0126/003 PL 16189/0027 TAKEDA UK LTD UK


SE/H/0126/001 OGYI-T-22251/01 TAKEDA PHARMA KFT. HU

Calcichew-D3 Apelsin 500 mg/800 IE tuggtabletter

SE/H/0126/005 42960 TAKEDA AS SE


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

Calcichew-D3 Citron 1000 mg/800 IE tuggtablett


Calcichew-D3 Citron 500 mg/400 IE tuggtabletter


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 500 mg/800 IE tuggtabletter


Calcichew-D3 Citron, 500 mg/1000 IE tuggtablett


Calcichew-D3 Forte 500 mg/400 IU Chewable Tablets

not available PA 2229/005/002 TAKEDA PRODUCTS IRELAND LTD.

IE

Calcichew-D3 Forte 500 mg/400 IU Chewable Tablets

not available PL 16189/0026 TAKEDA UK LTD UK

Calcichew-D3 Forte Double Strength 1000 mg/ 800 IU Chewable Tablets

SE/H/0126/002 PA 2229/005/004 TAKEDA PRODUCTS IRELAND LTD.

IE


CalcichewD3 Forte sitruuna 500 mg/10 mikrog -tabletti, kalvopäällysteinen


Calcichew-D3 Forte, tyggetabletter

SE/H/0126/001 18189 TAKEDA PHARMA A/S DK

Calcichew-D3 Melon 500 mg/1000 IE tuggtablett


Calcichew-D3 Melon 500 mg/400 IE tuggtablett


Calcichew-D3 Mite Citron 500 mg/200 IE tuggtabletter


Calcichew-D3 Spearmint 500 mg/400 IE tuggtabletter


Calciflex-D3 Citron 500 mg/400 IE filmdragerade tabletter


CALCIGAUROL VITAMINE D3 500mg/400 UI, comprimé à croquer ou à sucer

not available NL 22529-3400934880254 LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE

FR

CALCIGEN D forte 1000 mg/880 I.E. Brausetabletten

not available 48562.00.00 MEDA PHARMA GMBH & CO. KG

DE


Calcigran 500 mg/200 TV kramtomosios tabletės

not available LT/1/98/1332/002 TAKEDA AS LT

Calcigran 500 mg/200 TV kramtomosios tabletės


Calcigran Forte 1000 mg/800 IE tyggetabletter

SE/H/0126/002 07-5272 TAKEDA AS NO

Calcigran Forte 1000 mg/800 TV kramtomosios tabletės

SE/H/0126/002 LT/1/05/0177/009 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/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 Lemon 500 mg/800 TV kramtomosios tabletės


Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletės


Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės


Calcigran Forte Orange 500 mg/800 TV kramtomosios tabletės



Calcigran Forte Red 500 mg/1000 RÜ närimistabletid

SE/H/0126/008 878015 TAKEDA PHARMA AS EE

Calcimagon® Extra D3, 500 mg / 800 I.E., Kautabletten

SE/H/0126/004 79553.00.00 TAKEDA GMBH DE

Calcimagon®-D3 UNO, 1.000 mg/800 I.E., Kautabletten

SE/H/0126/002 78240.00.00 TAKEDA GMBH DE

Calcimagon®-D3, 500 mg / 400 I.E, Kautabletten

DE/H/0843/001 40923.00.00 TAKEDA GMBH DE

Calcimagon-D3 - Kautabletten

not available 1-25486 TAKEDA PHARMA GES.M.B.H.

AT

Calcio D Isdin 600 mg/400 UI 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) μασώμενο δισκίο

SE/H/0126/001 38746/05-04-2019 TAKEDA HELLAS S.A. GR

CALCIPRAT VITAMINE D3 1000 mg/800 UI, comprimé à sucer

not available 34009 360 124 3 1 ALFASIGMA FRANCE FR






CALCIUM D SANDOZ 1500 mg + 400 U.I. Comprimido efervescente

DE/H/0198/001 3211588 SANDOZ FARMACÊUTICA LDA.

PT



PT



PT



PT

Calcium Vit.D3 "Meda" 500mg/400 I.E.-Kautabletten

not available 1-25573 MEDA PHARMA GMBH AT

CALCIUM VITAMINE D3 ARROW 500 mg/400 UI, comprimé à sucer ou à croquer

not available NL25498 ARROW GENERIQUES FR


CALCIUM VITAMINE D3 BIOGARAN 500 mg / 400 UI, comprimé à sucer

not available 3400935646026 BIOGARAN FR

CALCIUM VITAMINE D3 BIOGARAN 500 mg / 400 UI, comprimé à sucer

not available 3400937919012 BIOGARAN FR

CALCIUMOSTEO D 500mg/400 UI comprimidos efervescentes

not available 42.013 GLAXOSMITHKLINE CONSUMER HEALTHCARE, S.A.

ES

CALDEVITA, comprimé effervescent

not available 34009 344 137 7 3 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


Cal-D-or 500 mg/400 I.E. - Kautabletten



Cal-D-or Lemon 500 mg/800 I.E. - Kautabletten


Cal-D-or Orange 500 mg/800 I.E. - Kautabletten


CAL-D-VITA 600 mg /400 UI comprimate masticabile

not available 11626/2019/02 BAYER SRL RO

CAL-D-VITA 600 mg /400 UI comprimate masticabile


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


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

CALPEROS D3, comprimé à sucer

not available 3400934629884 BOUCHARA RECORDATI FR










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 BGP PRODUCTS UNIPESSOAL, LDA.

PT

D-vital 500 mg/ 880 IE, Brausegranulat (Kalzium/Vitamin D3)

not available BE464391 WILL-PHARMA S.A. BE


D-vital 500 mg/ 880 IE, Brausegranulat (Kalzium/Vitamin D3)

not available 2016040037 WILL-PHARMA LUXEMBOURG

LU

D-vital 500 mg/ 880 UI, Granulés effervescents Calcium / Vitamine D3


D-vital 500 mg/ 880 UI, Granulés effervescents Calcium / Vitamine D3


LU

D-vital 500 mg/880 IE, Bruisgranulaat Calcium / Vitamine D3


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 IE, bruisgranulaat


D-vital forte citron 1000 mg/880 UI, granulés effervescents


D-vital forte citron 1000 mg/880 UI, granulés effervescents


LU


D-vital forte orange 1000 mg/880 IE, bruisgranulaat


D-vital forte orange 1000 mg/880 UI, granulés effervescents


D-vital orange 500 mg/440 IE, bruisgranulaat


D-vital orange 500 mg/440 UI, granulés effervescents


D-vital orange 500 mg/440 UI, granulés effervescents

not available 0489/03077784 WILL-PHARMA LUXEMBOURG

LU

D-vital® forte citron 1000 mg/880 IE, Brausegranulat


D-vital® forte citron 1000 mg/880 IE, Brausegranulat


LU

D-vital® forte orange 1000 mg/880 IE, Brausegranulat



D-vital® orange 500 mg/440 IE, Brausegranulat


EUROCAL D3 1000 mg/880 U.I., granulato effervescente

not available 032840011 AMDIPHARM LIMITED IT

EUROCAL D3 1000 mg/880 U.I., granulato effervescente


EUROCAL D3 500 mg / 440 U.I., granulato effervescente.


EUROCAL D3 500 mg / 440 U.I., granulato effervescente.


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 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 NE rágótabletta

not available OGYI-T- 8315/01 LABORATOIRE INNOTECH INTERNATIONAL

HU



HU



HU



HU

IDEOS 500 mg/400 RÜ närimistabletid

not available 458404 LABORATOIRE INNOTECH INTERNATIONAL

EE

IDEOS 500 mg/400 RÜ närimistabletid


EE

Ideos 500 mg/400 UI comprimidos masticables

not available 61.159 THERAMEX IRELAND LIMITED

ES

IDEOS 500 mg/400 UI, Comprimate masticabile

not available 7138/2014/01 LABORATOIRE INNOTECH INTERNATIONAL

RO

IDEOS 500 mg/400 UI, Comprimate masticabile

not available 7138/2014/02 LABORATOIRE INNOTECH INTERNATIONAL

RO


IDEOS 500 mg/400 UI, comprimé à sucer ou à croquer

FR/H/0114/001 34009 360 752 4 5 LABORATOIRE INNOTECH INTERNATIONAL

FR


FR/H/0114/001 342 533-2 LABORATOIRE INNOTECH INTERNATIONAL

FR



FR



FR



FR



FR



FR



FR



FR/H/0114/001 342 533-2 LABORATOIRE INNOTECH INTERNATIONAL

FR



FR



FR



FR



FR



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 Forte 500 mg/1.000 UI comprimidos masticables

DE/H/5016/001/DC 83.477 THERAMEX IRELAND LIMITED

ES


IDEOS UNIDIA 1000 mg/880 UI granulado efervescente

FR/H/0103/002 68.006 THERAMEX IRELAND LIMITED

ES

IDEOS, 500 mg /400 UI Comprimido para mastigar

FR/H/0114/001 2711380 LABORATOIRE INNOTECH INTERNATIONAL

PT



PT



PT



PT



PT



PT



PT




PT



PT



PT



PT



PT



PT



PT

IDEOS, 500 mg/400 UI Compresse masticabili


IT



IT




IT



IT



IT



IT



IT



IT



IT



IT



IT



IT

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 granule pro perorální roztok v sáčku

not available 39/252/00-C MYLAN IRE HEALTHCARE LIMITED

CZ

Kombi-Kalz 500mg/400 I.E.Vit. D3 - Kautabletten


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/400 U.I comprimidos masticables sabor fresa


ES

Mastical D 500 mg/400 UI comprimidos masticables sabor naranja

not available 65.097 TAKEDA FARMACÉUTICA ESPAÑA S.A

ES

Mastical D 500 mg/800 UI comprimidos masticables


ES

Mastical D sabor limón 500 mg/400 UI comprimidos masticables


ES

Mastical D Unidia 1000 mg/800 UI comprimidos masticables


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


Nycoplus Calcigran 500 mg/200 IE tyggetabletter

SE/H/0411/001 7420 TAKEDA AS NO

Nycoplus Calcigran Forte 500 mg/400 IE tyggetabletter med spearmintsmak

SE/H/0412/001 04-2980 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/1000 UI, comprimé à croquer

SE/H/0126/007 NL 44530 ARROW GENERIQUES FR

OROCAL VITAMINE D3 500 mg/200 UI, comprimé à sucer

SE/H/0554/001 NL31018 ARROW GENERIQUES FR

OROCAL VITAMINE D3 500 mg/400 U.I., comprimé à sucer

not available NL20442 ARROW GENERIQUES FR

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

OSTINE Comprimidos masticables.

not available 62.321 ANGELINI FARMACEUTICA, S.A.

ES

OSTINE Comprimidos masticables.

not available 62.321 ANGELINI FARMACEUTICA, S.A.

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 U.I. comprimés pelliculés

SE/H/0126/003 2010060035 TAKEDA BELGIUM SCA/CVA LU

Steovit D3 citroen 500 mg/400 I.E. kauwtabletten


Steovit D3 citroen 500 mg/400 I.E. kauwtabletten



Steovit D3 citron 500 mg/400 U.I. comprimés à croquer


Steovit D3 orange 500 mg/800 U.I. comprimés à croquer


Steovit D3 sinaasappel 500 mg/800 I.E. kauwtabletten


Steovit D3 sinaasappel 500 mg/800 I.E. kauwtabletten


Steovit Forte citroen 1000 mg/800 I.E. kauwtabletten


Steovit Forte citroen 1000 mg/800 I.E. kauwtabletten


Steovit Forte citron 1000 mg/800 U.I. comprimés à croquer


Tacal D3 500 mg/400 I.E. Munt, kauwtabletten


Tacal D3 500 mg/800 I.E. sinaasappel, kauwtabletten



ИДЕОС 500 mg/ 400 IU таблетки за дъвчене


BG



BG



BG

List of nationally authorised medicinal products · IU, effervescent granules for oral solution in...

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