| Code | 0438F | ||||||||||
| MA number | 16/0229/25-S | ||||||||||
| Product Form: | tbl flm 50x1x15 mg (blis. PVC/PVDC/Al) - jednotk.bal. | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 18.07.2025 |
| Validity: | 18.07.2030 |
| PIL: |
PIL_Edoxabán STADA 15 mg; 30 mg; 60 mg filmom obalené tablety_06.2025.pdf
|
| SPC: |
SPC_Edoxabán STADA15 mg; 30 mg; 60 mg filmom obalené tablety_06.2025.pdf
|
| Safety feature | Yes |
| Data update: | 24.07.2025 |
