| Code | 0212F | ||||||||||
| MA number | 44/0212/25-S | ||||||||||
| Product Form: | tbl flm 30x1x100 mg (blis.PVC/PE/PVDC/Al) - jednotk. bal. | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| 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: | 18.06.2025 |
| Validity: | 18.06.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Imatinib STADA Arzneimittel 100 mg, 400 mg filmom obalené tablety_tbl flm_06/2025_REG.pdf
|
| PIL: |
PIL_Imatinib STADA Arzneimittel 100 mg filmom obalené tablety_06.2025.pdf
|
| Safety feature | Yes |
| Data update: | 20.06.2025 |
