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PRODUCT DETAIL

XABOPLAX 15 mg + 20 mg filmom obalené tablety

Code 5444E
MA number 16/0021/24-S
Product Form: tbl flm 49(42x15 mg+7x20 mg) (blis.PVC/PE/PVdC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
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 Al/PVC/PE/PVDC
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 15.02.2024
Validity: 15.02.2029
SPC: SPC_XABOPLAX 15 mg + 20 mg filmom obalené tablety_02_2024.pdf  
PIL: PIL_XABOPLAX 15 mg +20 mg filmom obalené tablety_02_2024.pdf  
Dokument: Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf  
Safety feature Yes
Data update: 21.02.2024
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