| Code | 0001F | ||||||||||
| MA number | 16/0186/25-S | ||||||||||
| Product Form: | tbl flm 56x20 mg (blis.PVC/PVDC-Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | MSN LABS EUROPE Limited, Malta | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 12.06.2025 |
| Validity: | 12.06.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Rivaroxaban MSN 15 mg a 20 mg filmom obalené tablety_05_2025.pdf
|
| SPC: |
SPC_Rivaroxaban MSN 20 mg filmom obalené tablety_05_2025.pdf
|
| Safety feature | Yes |
| Data update: | 13.06.2025 |
