Kabazitaksel Viatris 20 mg/ml koncentrat za otopinu za infuziju
| Name | Kabazitaksel Viatris 20 mg/ml koncentrat za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-676395661 |
| Active Substance | kabazitaksel |
| Composition | jedan ml koncentrata sadrži 20 mg kabazitaksela jedna bočica s 3 ml koncentrata sadrži 60 mg kabazitaksela |
| Pharmaceutical Form | Koncentrat za otopinu za infuziju |
| Packaging [MA Number for Packaging] | 1 bočica sa 3 ml koncentrata, u kutiji [HR-H-676395661-01] 10 bočica sa 3 ml koncentrata, u kutiji [HR-H-676395661-02] |
| Manufacturer | AqVida GmbH, Hamburg, Njemačka |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 21.04.2022 |
| MA Period of Validity | 21.04.2027 |
| Classification Number | UP/I-530-09/21-01/276 |
| Registration Number | 381-12-01/154-22-05 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01CD04 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
