Code | 4674D | ||||||||||
MA number | 16/0128/20-S | ||||||||||
Product Form: | tbl flm 20x2,5 mg (blis.PVC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Zentiva k.s., Czechia | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | blister PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 04.06.2020 |
SPC: | SPC_Xanirva 2,5 mg_ tbl flm_03_2024.pdf |
PIL: | PIL_Xanirva 2,5 mg_ tbl flm_03_2024.pdf |
Dokument: | Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf |
Safety feature | Yes |
Data update: | 26.08.2024 |