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PRODUCT DETAIL

Dabigatran etexilate Accord 150 mg tvrdé kapsuly

Code 3861E
MA number EU/1/22/1665/022
Product Form: cps dur 30x1x150 mg (blis.OPA/Al/DES PE-PET/Al/PE - jednotl.d.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Accord Healthcare S.L.U, Spain
Therapeutic Class: 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B01 ANTITHROMBOTIC AGENTS
B01A ANTITHROMBOTIC AGENTS
B01AE DIRECT THROMBIN INHIBITORS
B01AE07 Dabigatran etexilate
Shelf life: 36
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 26.05.2023
Validity: 26.05.2028
SmPC + PL: European Medicines Agency's database
Dokument: dabigatran etexilát_Príručka pre predpisujúceho lekára VTE.pdf  
Dokument: dabigatran etexilát_Príručka pre predpisujúceho lekára CMP.pdf  
Dokument: dabigatran etexilát_Príručka pre predpisujúceho lekára - pediatria.pdf  
Safety feature Yes
Data update: 27.06.2023
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