en

PRODUCT DETAIL

Xiltess 2,5 mg

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:
B BLOOD AND BLOOD FORMING ORGANS
B01 ANTITHROMBOTIC AGENTS
B01A ANTITHROMBOTIC AGENTS
B01AF Direct factor Xa inhibitors
B01AF01 Rivaroxaban
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
eu-flag.png sk-flag.png