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PRODUCT DETAIL

Dabigatran-etexilát STADA Arzneimittel 150 mg tvrdé kapsuly

Code 5900E
MA number 16/0070/24-S
Product Form: cps dur 100 (2x50x1) x150 mg (blis.Al/OPA/Al/PVC - jednotk.bal. - multibal.)
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
Container: blister Al/OPA/Al/PVC
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 02.04.2024
Validity: 02.04.2029
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric contraindication: Yes
Pediatric warnings: Yes
PIL: PIL_Dabigatran_etexilát STADA Arzneimittel 150 mg REG.pdf  
SPC: SPC_Dabigatran_etexilát STADA Arzneimittel 150 mg REG.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: 04.04.2024
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