| Code | 9670D | ||||||||||
| MA number | 19/0036/22-S | ||||||||||
| Product Form: | tbl flm 300x1x360 mg (blis.Al/PVC/PE/PVDC-multibal.-jednotliv.dáv.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister Al/PVC/PE/PVDC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 26.02.2022 |
| Validity: | 26.02.2027 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Deferasirox STADA 180 mg, 360 mg tbl flm_02 2022.pdf
|
| SPC: |
SPC_Deferasirox STADA 180 mg, 360 mg tbl flm_02 2022.pdf
|
| Dokument: |
Deferasirox_Prirucka pre pacienta.pdf
|
| Dokument: |
Deferasirox_Prirucka pre lekarov.pdf
|
| Dokument: |
Deferasirox_Kontrolny zoznam.pdf
|
| Safety feature | Yes |
| Data update: | 11.03.2022 |
