| Code | 1534C | ||||||||||
| MA number | 46/0463/16-S | ||||||||||
| Product Form: | sol inj 4x2 ml/20 mg (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 46 - DERMATOLOGICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 30 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 27.10.2016 |
| Validity: | 26.06.2026 |
| Pediatric posology: | Yes |
| PIL: |
PIL_BELKYRA 10 mg-ml_08.2023.pdf
|
| SPC: |
SPC_BELKYRA 10 mg-ml_08.2023.pdf
|
| Dokument: |
Belkyra Návod na používanie a kontrolný zoznam pre výber pacienta pre lekárov.pdf
|
| Safety feature | Yes |
| Data update: | 15.12.2021 |
