| Code | 7247D | ||||||||||
| MA number | 16/0094/21-S | ||||||||||
| Product Form: | tbl flm 28x1x20 mg (blis.PVC/PVDC/Al-jednotliv.dáv.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | TEVA GmbH, Germany | ||||||||||
| 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: | 07.04.2021 |
| Validity: | 07.04.2026 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Rivaroxabán Teva 15 mg_20 mg_tbl flm_07.2024.pdf
|
| SPC: |
SPC_Rivaroxabán Teva 20 mg filmom obalené tablety_01.2025.pdf
|
| Dokument: |
Rivaroxabán_Príručka pre predpisujúceho lekára.pdf
|
| Safety feature | Yes |
| Data update: | 22.01.2025 |
