Trabektedin EVER Pharma 0,25 mg prašak za koncentrat za otopinu za infuziju
Name | Trabektedin EVER Pharma 0,25 mg prašak za koncentrat za otopinu za infuziju |
---|---|
Marketing Authorisation Number | HR-H-659215652 |
Active Substance | trabektedin |
Composition | Jedna bočica s praškom sadrži 0,25 mg trabektedina. Jedan ml rekonstituirane otopine sadrži 0,05 mg trabektedina. |
Pharmaceutical Form | Prašak za 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 | 24.03.2023 |
MA Period of Validity | 24.03.2028 |
Classification Number | UP/I-530-09/21-01/331 |
Registration Number | 381-12-01/171-23-08 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01CX01 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |