| Code | 2326D | ||||||||||
| MA number | 19/0264/19-S | ||||||||||
| Product Form: | tbl flm 30x180 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Vivanta Generics s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| 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: | 26.08.2019 |
| Validity: | 26.08.2024 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
SPC_Deferasirox MSN _tbl flm_01_2023.pdf
|
| PIL: |
PIL_Deferasirox MSN_tbl flm_01_2023.pdf
|
| Dokument: |
Deferasirox_Prirucka pre pacienta.pdf
|
| Dokument: |
Deferasirox_Prirucka pre lekarov.pdf
|
| Dokument: |
Deferasirox_Kontrolny zoznam.pdf
|
| Safety feature | Yes |
| Data update: | 03.09.2019 |
