| Code | 5907E | ||||||||||
| MA number | 16/0068/24-S | ||||||||||
| Product Form: | cps dur 30x1x75 mg (blis.Al/OPA/Al/PVC - jednotk.bal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| 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: | 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 75 mg REG.pdf
|
| SPC: |
SPC_Dabigatran_etexilát STADA Arzneimittel 75 mg REG.pdf
|
| Safety feature | Yes |
| Data update: | 04.04.2024 |
