en

PRODUCT DETAIL

Dabigatran Etexilate Viatris 110 mg tvrdé kapsuly

Code 5628E
MA number 16/0015/24-S
Product Form: cps dur 30x110 mg (blis.Al/OPA/Al/PVC)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
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: 24
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 29.02.2024
Validity: 01.03.2029
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric contraindication: Yes
Pediatric warnings: Yes
SPC: SPC_Dabigatran Etexilate Viatris 110 mg tvrdé kapsuly_02_2024.pdf  
PIL: PIL_Dabigatran Etexilate Viatris 110 mg tvrdé kapsuly_02_2024.pdf  
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: 07.03.2024
eu-flag.png sk-flag.png