Code | 5587D | ||||||||||
MA number | 16/0211/20-S | ||||||||||
Product Form: | cps dur 14x20 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Zentiva, k.s., Czechia | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
|
||||||||||
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: | 28.09.2020 |
Validity: | 28.09.2025 |
MA renewed: | Renewal application submitted |
SPC: | SPC_Xanirva 20 mg_cps dur_03_2024.pdf |
PIL: | PIL_Xanirva 15 mg_20 mg_cps dur_03_2024.pdf |
Dokument: | Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf |
Safety feature | Yes |
Data update: | 06.10.2020 |