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
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	29.09.2021
ATC-Code	L03AX13 Glatiramer acetate

CMS Country	Domestic Product Name
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
XI	Copaxone 40 mg/ml solution for injection, pre-filled syringe

Documents
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)