| Code | 9384E | ||||||||||
| MA number | 16/0099/25-S | ||||||||||
| Product Form: | tbl flm 98x1x30 mg (blis.OPA/Al/PVC/Al) - kalend.bal. - jednotk.bal. | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | TAD Pharma GmbH, Germany | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 31.03.2025 |
| Validity: | 31.03.2030 |
| SPC: |
SPC_Edoxaban TAD filmom obalené tablety_03_2025.pdf
|
| PIL: |
PIL_Edoxaban TAD filmom obalené tablety_03_2025.pdf
|
| SPC: |
SPC_Edoxaban TAD filmom obalené tablety_04.2025.pdf
|
| Safety feature | Yes |
| Data update: | 03.04.2025 |
