Code | 3569E | ||||||||||
MA number | 16/0113/23-S | ||||||||||
Product Form: | cps dur 3x10x150 mg (blis.Al/OPA/Al/PVC-perfor.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | G.L. Pharma GmbH, Austria | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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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: | 28.04.2023 |
Validity: | 28.04.2028 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Dabahib 150 mg tvrdé kapsuly_10.2023.pdf |
SPC: | SPC_Dabahib 150 mg tvrdé kapsuly_05.2024.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: | 02.05.2024 |