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COPAXONE
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1346598
Name of medicinal product:
COPAXONE
Active substances:
Glatiramer acetate
Estonian
,
English
,
Latin
ATC code:
L03AX13
Dosage form:
solution for injection in pre-filled syringe
Route of administration:
subcutaneous use
Strengh:
20mg 1ml
Amount in package:
1ml 7TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Copaxone is indicated for the treatment of relapsing forms of multiple sclerosis (MS) (see section 5.1 for important information on the population for which efficacy has been established). Copaxone is not indicated in primary or secondary progressive MS.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated February 21, 2022)
Package information leaflet (PIL):
EST
(last updated November 17, 2023)
Labelling:
(last updated October 1, 2020)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Teva GmbH
Marketing authorization number:
527006
Marketing authorization issued on:
October 20, 2006
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Mutual recognition
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: November 17, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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