| Code | 6757D | ||||||||||
| MA number | 16/0053/21-S | ||||||||||
| Product Form: | tbl flm 28x20 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Glenmark Pharmaceuticals s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| 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: | 26.02.2021 |
| Validity: | 26.02.2026 |
| Dokument: |
Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf
|
| SPC: |
SPC_Rivaxa 10 mg filmom obalené tablety_06_2024.pdf
|
| SPC: |
SPC_Rivaxa 15 mg filmom obalené tablety_06_2024.pdf
|
| SPC: |
SPC_Rivaxa 20 mg filmom obalené tablety_06_2024.pdf
|
| SPC: |
SPC_Rivaxa 15 mg_20 mg_Balenie na úvodnú liečbu_06_2024.pdf
|
| PIL: |
PIL_Rivaxa 10 mg filmom obalené tablety_06_2024.pdf
|
| PIL: |
PIL_Rivaxa 15 mg_20 mg_Balenie na úvodnú liečbu_06_2024.pdf
|
| PIL: |
PIL_Rivaxa 15 mg_20 mg filmom obalené tablety_06_2024.pdf
|
| Safety feature | Yes |
| Data update: | 27.06.2024 |
