Details
Product Name in the RMS: Copaxone 40 mg/ml Injektionslösung in einer Fertigspritze
MR Number: DE/H/5283/004
Date of outcome: 04.12.2014
Type of application | |
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Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Full Dossier Chemical Substance Prescription Only |
Active Substances |
glatiramer acetate 40 mg/ml |
Form | |
MA Holder in the RMS |
TEVA GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany |
RMS | Germany |
Date of last change | 20.01.2021 |
ATC-Code |
L03AX13 Glatiramer acetate |
CMS Country | Domestic Product Name |
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Austria | Copaxone 40 mg/ml Injektionslösung in einer Fertigspritze |
Belgium | Copaxone 40mg/ml Solution injectable en seringue préremplie |
Croatia | Copaxone 40 mg/ml otopina za injekciju u napunjenoj štrcaljki |
Cyprus | COPAXONE SOL FOR INJECTION IN PFS |
Czech Republic | Copaxone 40 mg/ml, injekční roztok v předplněné injekční stříkačce |
Denmark | |
Estonia | COPAXONE |
Finland | |
France | |
Greece | |
Hungary | COPAXONE 40 mg/ml oldatos injekció előretöltött fecskendőben |
Iceland | Copaxone 40 mg/ml Innrennslislyf, lausn í áfylltri sprautu |
Ireland | |
Italy | |
Latvia | Copaxone 40 mg/ml šķīdums injekcijām pilnšļircē |
Lithuania | COPAXONE 40 mg/ml injekcinis tirpalas užpildytame švirkšte |
Luxembourg | Copaxone 40 mg / 1 mL Solution injectable en seringue préremplie |
Netherlands | |
Norway | Copaxone |
Poland | |
Portugal | |
Romania | COPAXONE 40 mg/ml soluţie injectabilă în seringă preumplută |
Slovak Republic | Copaxone 40 mg/ml |
Slovenia | |
Spain | |
Sweden | |
United Kingdom | Copaxone 40 mg/ml solution for injection, pre-filled syringe |
Documents | |
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PAR: | DE_H_5283_004_PAR.pdf (07.12.2017) |
FinalSPC: | DE_H_5283_004_FinalSPC_1of2.pdf (16.10.2019) |
FinalSPC: | DE_H_5283_004_FinalSPC_2of2.pdf (16.10.2019) |
FinalLabelling: | DE_H_5283_004_FinalLabelling_1of2.pdf (16.10.2019) |
FinalLabelling: | DE_H_5283_004_FinalLabelling_2of2.pdf (16.10.2019) |
Finalised Product Information: | DE_H_5283_004_FinalPI_1of2.pdf (10.01.2019) |
Finalised Product Information: | DE_H_5283_004_FinalPI_2of2.pdf (10.01.2019) |