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PRODUCT DETAIL

Modylan 5 mg filmom obalené tablety

Code 8293E
MA number 16/0335/24-S
Product Form: tbl flm 100x1x5 mg (blis.Al-PVC/PVDC - jednotk.bal.)
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
B01AF02 Apixaban
Shelf life: 24
Container: blister Al/PVC/PVDC
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 28.12.2024
Validity: 28.12.2029
PIL: PIL_Xapa 5 mg filmom obalené tablety_12_2024.pdf  
SPC: SPC_Xapa 5 mg filmom obalené tablety_12_2024.pdf  
Safety feature Yes
Data update: 07.02.2025
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