| Code | 4450D | ||||||||||
| MA number | 16/0105/20-S | ||||||||||
| Product Form: | tbl flm 20x2,5 mg (blis.Al/PVC/PE/PVDC) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 11.05.2020 |
| Validity: | 11.05.2025 |
| MA renewed: | Renewal application submitted |
| PIL: |
PIL_Assubex 2,5 mg_01.2024.pdf
|
| SPC: |
SPC_Assubex 2,5 mg_04.2024.pdf
|
| Dokument: |
Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf
|
| Safety feature | Yes |
| Data update: | 11.04.2024 |
