| 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 | ||||||||||
| MAH, country: | TEVA GmbH, Germany | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
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| 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 |
| Dokument: |
DHPC_Glatirameracetát_14.08.2024.pdf
|
| SPC: |
SPC_Copaxone 20 mg_ml_01.2025.pdf
|
| PIL: |
PIL_Copaxone 20 mg_ml_01.2025.pdf
|
| Safety feature | Yes |
| Data update: | 11.09.2019 |
