Kabazitaksel EVER Pharma 10 mg/ml koncentrat za otopinu za infuziju
| Name | Kabazitaksel EVER Pharma 10 mg/ml koncentrat za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-237716434 |
| Active Substance | kabazitaksel hidrat |
| Composition | jedan ml koncentrata za otopinu za infuziju sadrži bezvodni ili kabazitaksel hidrat što odgovara 10 mg kabazitaksela |
| Pharmaceutical Form | koncentrat za otopinu za infuziju |
| Packaging [MA Number for Packaging] | 1 bočica s 4,5 ml koncentrata za otopinu za infuziju, u kutiji [HR-H-237716434-01] 1 bočica s 5 ml koncentrata za otopinu za infuziju, u kutiji [HR-H-237716434-02] 1 bočica s 6 ml koncentrata za otopinu za infuziju, u kutiji [HR-H-237716434-03] |
| Manufacturer | Ever Pharma Jena GmbH, Jena, Njemačka Ever Pharma Jena GmbH, Jena, Njemačka |
| Marketing Authorisation Holder | EVER Valinject GmbH, Oberburgau 3, Unterach am Attersee, Austrija |
| Marketing Authorisation Date | 22.10.2020 |
| MA Period of Validity | 22.10.2025 |
| Classification Number | UP/I-530-09/19-01/122 |
| Registration Number | 381-12-01/30-20-05 |
| 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 |
