Code | 1687D | ||||||||||
MA number | 16/0175/19-S | ||||||||||
Product Form: | tbl flm 28x20 mg (blis.Al/PVC) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Belupo lijekovi i kozmetika d.d., Croatia | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | blister Al/PVC | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 11.06.2019 |
SPC: | SPC_RIBAS 15 mg_20 mg_11.2023.pdf |
Dokument: | Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf |
PIL: | PIL_RIBAS 15 mg_20 mg_09.2024.pdf |
Safety feature | Yes |
Data update: | 29.11.2023 |