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PRODUCT DETAIL

Sislaf 5 mg

Code 1084F
MA number 16/0307/25-S
Product Form: tbl flm 56x1x5 mg (blis.PVC/PVDC/Al) - jednotk.bal.
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
MAH, country: Glenmark Pharmaceuticals s.r.o., Czechia
Therapeutic Class: 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B01 ANTITHROMBOTIC AGENTS
B01A ANTITHROMBOTIC AGENTS
B01AF Direct factor Xa inhibitors
B01AF02 Apixaban
Shelf life: 36
Container: blister PVC/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 12.09.2025
Validity: 12.09.2030
PIL: PIL_Sislaf 5 mg_tbl flm_09.2025.pdf  
SPC: SPC_Sislaf 5 mg_tbl flm_10.2025.pdf  
Safety feature Yes
Data update: 01.10.2025
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