Code | 2244E | ||||||||||
MA number | 16/0265/22-S | ||||||||||
Product Form: | tbl flm 98x1x10 mg (blis.PVC/PVDC/Al-jednotliv.dáv.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Viatris Limited, Ireland | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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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: | 27.10.2022 |
Validity: | 27.10.2027 |
SPC: | SPC_Vixargio 10 mg_01.2023.pdf |
Dokument: | VHS_SK_H_0260_001-005_DC_Vixargio_PAR.doc |
Dokument: | VHS_SK_H_0260_001-005_DC_Vixargio_summary PAR.doc |
PIL: | PIL_Vixargio 10 mg filmom obalené tablety_11.2023.pdf |
SPC: | SPC_Vixargio 10 mg filmom obalené tablety_12.2023.pdf |
Dokument: | SK_Rivaroxaban_Vixargio_Karta pacienta_NOV_2023_ver 1.3.pdf |
Dokument: | Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf |
Safety feature | Yes |
Data update: | 05.12.2023 |