| Code | 9327D | ||||||||||
| MA number | 16/0308/21-S | ||||||||||
| Product Form: | tbl flm 100x1x5 mg (blis.PVC/PVDC/Al-jednotliv.dáv.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Viatris Limited, Ireland | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 22.12.2021 |
| Validity: | 22.12.2026 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Apixaban Viatris 5 mg_04.2024.pdf
|
| Dokument: |
Karta pacienta.pdf
|
| PIL: |
PIL_Apixaban Viatris 5 mg_05.2025.pdf
|
| Dokument: |
Apixaban_Príručka pre lekára.pdf
|
| Safety feature | Yes |
| Data update: | 10.07.2024 |
