Code | 5099D | ||||||||||
MA number | 59/0164/20-S | ||||||||||
Product Form: | sol ira 3x1 ml (striek.inj.napl.v pere) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | 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: | 20.07.2020 |
Validity: | 20.07.2025 |
SPC: | SPC_COPAXONE PEN 40 mg_05.2024.pdf |
PIL: | PIL_COPAXONE PEN 40 mg_05.2024.pdf |
Safety feature | Yes |
Data update: | 06.04.2022 |