| Code | 0163E | ||||||||||
| MA number | 44/0080/22-S | ||||||||||
| Product Form: | tbl flm 30x1x400 mg (blis.Al/PVC/PE/PVDC-jednotliv.dáv.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Zentiva k.s., Czechia | ||||||||||
| 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: | 31.03.2022 |
| Validity: | 31.03.2027 |
| Pediatric warnings: | Yes |
| PIL: |
|
| SPC: |
|
| Safety feature | Yes |
| Data update: | 23.03.2023 |