| Code | 1765F | ||||||||||
| MA number | 16/0363/25-S | ||||||||||
| Product Form: | tbl flm 196x2,5 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | AUXpharma s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PE/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 18.11.2025 |
| Validity: | 18.11.2030 |
| PIL: |
PIL_Rivaroxaban AUXpharma 2,5 mg filmom obalené tablety_10.2025.pdf
|
| SPC: |
SPC_Rivaroxaban AUXpharma 2,5 mg filmom obalené tablety_10.2025.pdf
|
| Safety feature | Yes |
| Data update: | 21.11.2025 |
