| Code | 4434E | ||||||||||
| MA number | 16/0222/23-S | ||||||||||
| Product Form: | cps dur 10x1x75 mg (blis.OPA/Al/vysúšadlo PE-Al/PE-perfor.-jednodáv.) | ||||||||||
| 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: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 02.10.2023 |
| Validity: | 02.10.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Gribero 75 mg tvrdé kapsuly_09.2024.pdf
|
| PIL: |
PIL_Gribero 75 mg tvrdé kapsuly_12.2024.pdf
|
| Dokument: |
dabigatran-etexilát_Príručka pre predpisujúceho lekára_ VTE.pdf
|
| Dokument: |
dabigatran-etexilát_Príručka pre predpisujúceho lekára_CMP.pdf
|
| Dokument: |
dabigatran-etexilát_Priručka pre predpisujúceho lekára_ pediatria.pdf
|
| Safety feature | Yes |
| Data update: | 09.10.2023 |
