Code | 9662D | ||||||||||
MA number | 19/0035/22-S | ||||||||||
Product Form: | tbl flm 30x1x180 mg (blis.Al/PVC/PE/PVDC-jednotliv.dáv.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
ATC: |
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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 |
Safety feature | Yes |
Data update: | 11.03.2022 |