| Code | 9214E | ||||||||||
| MA number | 16/0071/25-S | ||||||||||
| Product Form: | cps dur 180x75 mg (blis.OPA/Al/PE//PE/Al/LDPE) | ||||||||||
| 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 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 19.03.2025 |
| Validity: | 19.03.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Dabigatran-etexilát G.L. Pharma 75 mg tvrdé kapsuly_03.2025.pdf
|
| SPC: |
SPC_Dabigatran-etexilát G.L. Pharma 75 mg tvrdé kapsuly_03.2025.pdf
|
| Safety feature | Yes |
| Data update: | 21.03.2025 |
