| Code | 3567E | ||||||||||
| MA number | 16/0112/23-S | ||||||||||
| Product Form: | cps dur 3x10x110 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 110 mg tvrdé kapsuly_10.2023.pdf
|
| SPC: |
SPC_Dabahib 110 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 |
