gadodiamide List of nationally authorised medicinal products - … · List of nationally authorised...

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© European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged.

14 January 2021 EMA/21095/2021 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: gadodiamide Procedure no.: PSUSA/00001503/202004

List of nationally authorised medicinal products EMA/21095/2021 Page 2/23

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

Omniscan 0,5 mmol/ml-parenterale Kontrastmittellösung

not available 1-20968 GE HEALTHCARE HANDELS GMBH

AT

Omniscan 0,5 mmol/ml-parenterale Kontrastmittellösung

not available 1-20968 GE HEALTHCARE HANDELS GMBH

AT

Omniscan 0,5 mmol/ml Injektionslösung

not available BE167307 GE HEALTHCARE BVBA BE







Omniscan 0,5 mmol/ml solution injectable








Omniscan 0,5 mmol/ml oplossing voor injectie





































Омнискен 0,5 mmol/ml инжекционен разтвор

not available II-16150/15.12.2011 GE HEALTHCARE AS BG

Омнискен 0,5 mmol/ml инжекционен разтвор

not available II-16150/15.12.2011 GE HEALTHCARE AS BG

OMNISCAN® Ενέσιμο διάλυμα 0,5 mmol(287mg)/ ml

not available 17961 PHADISCO LTD CY

OMNISCAN® Ενέσιμο διάλυμα 0,5 mmol(287mg)/ ml

not available 17961 PHADISCO LTD CY

Omniscan 0,5 mmol/ml Injekční roztok

not available 48/142/95-A/C GE HEALTHCARE AS CZ

Omniscan 0,5 mmol/ml Injekční roztok v

not available 48/142/95-B/C GE HEALTHCARE AS CZ






předplněné injekční stříkačce Omniscan 0,5 mmol/ml Injekční roztok

not available 48/142/95-A/C GE HEALTHCARE AS CZ

Omniscan 0,5 mmol/ml Injekční roztok v předplněné injekční stříkačce

not available 48/142/95-B/C GE HEALTHCARE AS CZ

OMNISCAN™ 0,5 mmol/ml Injektionslösung

SE/H/0428/001 65460.00.00 GE HEALTHCARE BUCHLER GMBH & CO. KG

DE

OMNISCAN™ 0,5 mmol/ml Injektionslösung in Fertigspritzen


DE

OMNISCAN™ 0,5 mmol/ml Injektionslösung


DE

OMNISCAN™ 0,5 mmol/ml Injektionslösung in Fertigspritzen


DE

OMNISCAN 0,5 mmol/ml süstelahus

not available 069394 GE HEALTHCARE AS EE

OMNISCAN 0,5 mmol/ml süstelahus

not available 069394 GE HEALTHCARE AS EE

OMNISCAN 0,5 mmol/ml solución inyectable en jeringa precargada

not available 60.331 GE HEALTHCARE BIO-SCIENCES, S.A.U.

ES

OMNISCAN 0,5 mmol/ml solución inyectable


ES

OMNISCAN 0,5 mmol/ml solución inyectable en jeringa precargada


ES






OMNISCAN 0,5 mmol/ml solución inyectable


ES

OMNISCAN 0,5 mmol/mL, solution injectable

not available 34009 342 427 8 6 GE HEALTHCARE SAS FR



















OMNISCAN 0,5 mmol/mL, solution







injectable OMNISCAN 0,5 mmol/mL, solution injectable














OMNISCAN 0,5 mmol/mL, solution injectable en seringue pré-remplie



























OMNISCAN 0,5 mmol/mL, solution







injectable en seringue pré-remplie OMNISCAN 0,5 mmol/mL, solution injectable en seringue pré-remplie




OMNISCAN® ¿¿¿s¿µ¿ d¿¿¿¿µa 0,5 mmol(287mg)/ ml|

not available 70059/3-8-2017 GE HEALTHCARE AE GR

OMNISCAN® ¿¿¿s¿µ¿ d¿¿¿¿µa 0,5 mmol(287mg)/ ml|

not available 70059/3-8-2017 GE HEALTHCARE AE GR

Omniscan 287 mg/ml otopina za injekciju (napunjene štrcaljke)

not available HR-H-717692685 GE HEALTHCARE AS HR

OMNISCAN 287 mg/ml otopina za injekciju


Omniscan 287 mg/ml otopina za injekciju (napunjene štrcaljke)


OMNISCAN 287 mg/ml otopina za injekciju


Omniscan 0,5 mmol/ml oldatos injekció

not available OGYI-T-5675/01 GE HEALTHCARE AS HU

























































Omniscan 0.5 mmol/ml Solution for injection, glass vials/bottles

SE/H/0428/001 PA 0735/008/006 GE HEALTHCARE AS IE

Omniscan 0.5 mmol/ml Solution for Injection, polypropylene bottles


Omniscan 0.5 mmol/ml Solution for Injection, pre-filled syringe


Omniscan 0.5 mmol/ml Solution for injection, glass vials/bottles


Omniscan 0.5 mmol/ml Solution for Injection, polypropylene bottles


Omniscan 0.5 mmol/ml Solution for Injection, pre-filled syringe


Omniscan 0,5 mmól/ml stungulyf, lausn

not available 940178 GE HEALTHCARE AS IS

Omniscan 0,5 mmól/ml stungulyf, lausn, áfyllt sprauta


Omniscan 0,5 mmól/ml stungulyf, lausn


Omniscan 0,5 mmól/ml stungulyf, lausn, áfyllt sprauta







OMNISCAN 0,5 mmol/ml soluzione iniettabile per uso endovenoso

not available 028993044 GE HEALTHCARE S.R.L. IT





















OMNISCAN 0,5 mmol/ml not available 028993119 GE HEALTHCARE S.R.L. IT






soluzione iniettabile per uso endovenoso OMNISCAN 0,5 mmol/ml soluzione iniettabile per uso endovenoso




















OMNISCAN 0,5 mmol/ml soluzione iniettabile per







uso endovenoso OMNISCAN 0,5 mmol/ml soluzione iniettabile per uso endovenoso


OMNISCAN 0,5 mmol/ml injekcinis tirpalas

not available LT/1/96/2661/005 GE HEALTHCARE AS LT



















Omniscan 0,5 mmol/ml (équiv. de 287 mg/ml) solution injectable

not available 196315 GE HEALTHCARE BVBA LU





Omniscan 0,5 mmol/ml not available 301293 GE HEALTHCARE BVBA LU






(équiv. de 287 mg/ml) solution injectable Omniscan 0,5 mmol/ml (équiv. de 287 mg/ml) solution injectable




















Omniscan 0,5 mmol/ml (équiv. de 287 mg/ml)







solution injectable Omniscan 0,5 mmol/ml (équiv. de 287 mg/ml) solution injectable











































OMNISCAN 0,5 mmol/ml šķīdums injekcijām

not available 99-0139 GE HEALTHCARE AS LV

OMNISCAN 0,5 mmol/ml šķīdums injekcijām

not available 99-0139 GE HEALTHCARE AS LV

OMNISCAN™ 0.5 mmol/ml solution for injection

not available MA023/00101 GE HEALTHCARE AS MT

OMNISCAN™ 0.5 mmol/ml solution for injection

not available MA023/00101 GE HEALTHCARE AS MT






Omniscan, oplossing voor injectie 0,5 mmol/ml

not available RVG 16618 GE HEALTHCARE B.V. NL

Omniscan, oplossing voor injectie 0,5 mmol/ml, 10 ml






Omniscan, oplossing voor injectie 0,5 mmol/ml








Omniscan 0,5 mmol/ml injeksjonsvæske, oppløsning

SE/H/0428/001 06-3982 GE HEALTHCARE AS NO

Omniscan 0,5 mmol/ml injeksjonsvæske, oppløsning, ferdigfylt sprøyte


Omniscan 0,5 mmol/ml injeksjonsvæske, oppløsning







Omniscan 0,5 mmol/ml injeksjonsvæske, oppløsning, ferdigfylt sprøyte


Omniscan, 0,5 mmol/ml, roztwór do wstrzykiwan

not available R/3719 GE HEALTHCARE AS PL

Omniscan, 0,5 mmol/ml, roztwór do wstrzykiwan

not available R/3719 GE HEALTHCARE AS PL

Omniscan 287 mg/ml (0,5 mmol/ml) solução injectável

not available 3206083 SATIS-RADIOISÓTOPOS E PROTECÇÕES CONTRA SOBRETENSÕES ELÉCTRICAS UNIPESSOAL, LDA

PT



PT



PT



PT



PT

Omniscan 287 mg/ml not available 3864485 SATIS-RADIOISÓTOPOS E PT






(0,5 mmol/ml) solução injectável

PROTECÇÕES CONTRA SOBRETENSÕES ELÉCTRICAS UNIPESSOAL, LDA



PT



PT



PT



PT



PT



PT








PT



PT



PT



PT



PT



PT


not available 3864683 SATIS-RADIOISÓTOPOS E PROTECÇÕES CONTRA SOBRETENSÕES ELÉCTRICAS UNIPESSOAL,

PT






LDA Omniscan 287 mg/ml (0,5 mmol/ml) solução injectável


PT



PT



PT

Omniscan 0,5 mmoli/ml solutie injectabila

not available 4470/2012/01 GE HEALTHCARE AS RO




































Omniscan 0,5 mmol/ml injektionsvätska, lösning

SE/H/0428/001 11885 GE HEALTHCARE AS SE

Omniscan 0,5 mmol/ml injektionsvätska, lösning, förfylld spruta


Omniscan 0,5 mmol/ml injektionsvätska, lösning


Omniscan 0,5 mmol/ml injektionsvätska, lösning, förfylld spruta


Omniscan 0,5 mmol/ml raztopina za injiciranje

not available H/96/01178/001 GE HEALTHCARE AS SI




















OMNISCAN not available 48/0217/96-S GE HEALTHCARE AS SK OMNISCAN not available 48/0217/96-S GE HEALTHCARE AS SK Omniscan 0.5 mmol/ml Solution for Injection

not available PL 00637/0015 GE HEALTHCARE AS UK

Omniscan 0.5 mmol/ml Solution for Injection






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