| Code | 0161E | ||||||||||
| MA number | 44/0080/22-S | ||||||||||
| Product Form: | tbl flm 60x400 mg (blis.Al/PVC/PE/PVDC) | ||||||||||
| 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 |