| Code | 8450E | ||||||||||
| MA number | EU/1/19/1412/013 | ||||||||||
| Product Form: | tbl flm 300x1x360 mg (blis.PVC/PE/PVDC/Al - jednotk.bal.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Accord Healthcare S.L.U, Spain | ||||||||||
| Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PE/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 09.01.2020 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Deferasirox_Prirucka pre pacienta.pdf
|
| Dokument: |
Deferasirox_Prirucka pre lekarov.pdf
|
| Dokument: |
Deferasirox_Kontrolny zoznam.pdf
|
| Safety feature | Yes |
| Data update: | 02.01.2025 |
