| Code | 7522D | ||||||||||
| MA number | 19/0136/21-S | ||||||||||
| Product Form: | tbl flm 100x360 mg (blis.PA/Al/PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 02.06.2021 |
| Validity: | 02.06.2026 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Deferasirox Sandoz 360 mg_05_2021.pdf
|
| PIL: |
PIL_Deferasirox Sandoz_tbl flm_10_2022.pdf
|
| Dokument: |
Deferasirox_Prirucka pre pacienta.pdf
|
| Dokument: |
Deferasirox_Prirucka pre lekarov.pdf
|
| Dokument: |
Deferasirox_Kontrolny zoznam.pdf
|
| Safety feature | Yes |
| Data update: | 07.06.2021 |
