Code | 8160B | ||||||||||
MA number | 44/0089/16-S | ||||||||||
Product Form: | tbl flm 1x30x400 mg (fľ.HDPE s PP/PE uzáver.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
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: | 15.02.2016 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Imatinib STADA 400 mg filmom obalené tablety_03.2023.pdf |
SPC: | SPC_Imatinib STADA 400 mg filmom obalené tablety_06.2024.pdf |
Safety feature | Yes |
Data update: | 19.06.2024 |