Code | 6761D | ||||||||||
MA number | 16/0054/21-S | ||||||||||
Product Form: | tbl flm 49(42x15 mg +7x20 mg) (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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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: | 26.02.2021 |
Validity: | 26.02.2026 |
PIL: | PIL_Rivaxa 15 mg_20 mg_Balenie na úvodnú liečbu_05.2022.pdf |
SPC: | SPC_Rivaxa 15 mg_20 mg_Balenie na úvodnú liečbu_06.2023.pdf |
Dokument: | Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf |
Safety feature | Yes |
Data update: | 05.03.2021 |