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PRODUCT DETAIL

Copaxone 20 mg/ml

Code 5363A
MA number 59/0463/06-S
Product Form: sol iru 30x1 ml/20 mg (striek.skl.napl.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L03 Immunomodulators/-stimulants
L03A Immunostimulants
L03AX Other immunostimulants
L03AX13 Glatiramer acetate
Shelf life: 36
Container: glass pre-filled syringe
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 01.11.2006
Pediatric posology: Yes
SPC: SPC_Copaxone 20 mg_ml_02.2022.pdf  
PIL: PIL_Copaxone 20 mg_ml_09.2023.pdf  
Safety feature Yes
Data update: 11.09.2019
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