Kabazitaksel EVER Pharma 10 mg/ml koncentrat za otopinu za infuziju
Name | Kabazitaksel EVER Pharma 10 mg/ml koncentrat za otopinu za infuziju |
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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 |
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 | Medicinal product subject to medical prescription |
Type of prescription | ograničeni recept |
Distribution | Supply through pharmacies (community) |
Advertising to general public | not allowed |
ATC Code | L01CD04 |
Marketing status | stavljeno u promet |
Shortage status | nema nestašice |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |