Code | 3625E | ||||||||||
MA number | 16/0126/23-S | ||||||||||
Product Form: | tbl flm 56x2,5 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
Container: | blister OPA/Al/PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 21.06.2023 |
Validity: | 21.06.2028 |
SPC: | SPC_Xiltess 2,5 mg_01.2024.pdf |
PIL: | PIL_Xiltess 2,5 mg_01.2024.pdf |
Dokument: | Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf |
Safety feature | Yes |
Data update: | 28.06.2023 |