| Code | 5100D | ||||||||||
| MA number | 59/0164/20-S | ||||||||||
| Product Form: | sol ira 12x1 ml (striek.inj.napl.v pere) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| 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_04.2022.pdf
|
| PIL: |
PIL_COPAXONE PEN 40 mg_09.2023.pdf
|
| Safety feature | Yes |
| Data update: | 06.04.2022 |
