Code | 7224D | ||||||||||
MA number | 16/0092/21-S | ||||||||||
Product Form: | tbl flm 5x1x10 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: |
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Shelf life: | 24 | ||||||||||
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 |
SPC: | SPC_Rivaroxabán Teva 10 mg_tbl flm_12.2023.pdf |
Dokument: | Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf |
PIL: | PIL_Rivaroxabán Teva 10 mg_tbl flm_07.2024.pdf |
Safety feature | Yes |
Data update: | 16.04.2021 |