| Code | 3849E | ||||||||||
| MA number | EU/1/22/1665/011 | ||||||||||
| Product Form: | cps dur 180x110 mg (blis.OPA/Al/DES PE-PET/Al/PE) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Accord Healthcare S.L.U, Spain | ||||||||||
| 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: | 26.05.2023 |
| Validity: | 26.05.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| 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: | 27.06.2023 |
