| Code | 9571E | ||||||||||
| MA number | 16/0096/25-S | ||||||||||
| Product Form: | cps dur 180 (3x60x1)x150 mg (blis. Al/OPA/Al/PVC) - jednotk.bal.-multibal. | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| 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: | 24.04.2025 |
| Validity: | 24.04.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Dabigatran etexilate Polpharma 150 mg tvrdé kapsuly_09.2025.pdf
|
| PIL: |
PIL_Dabigatran etexilate Polpharma 150 mg tvrdé kapsuly_09.2025.pdf
|
| Safety feature | Yes |
| Data update: | 17.09.2025 |
