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PRODUCT DETAIL

Xerdoxo 2,5 mg filmom obalené tablety

Code 4381D
MA number 16/0098/20-S
Product Form: tbl flm 100x2,5 mg (blis.PVC/PVDC/PVC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: KRKA, d.d., Novo mesto, Slovenia
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: 36
Container: blister PVC/PVDC/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 06.05.2020
Validity: 06.05.2025
MA renewed: Renewal application submitted
Dokument: Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf  
SPC: SPC_Xerdoxo 2,5 mg_tbl flm_05_2024.pdf  
PIL: PIL_Xerdoxo 2,5 mg_tbl flm_05_2024.pdf  
Safety feature Yes
Data update: 24.11.2023
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