Trabektedin EVER Pharma 1 mg prašak za koncentrat za otopinu za infuziju
| Name | Trabektedin EVER Pharma 1 mg prašak za koncentrat za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-470931435 |
| Active Substance | trabektedin |
| Composition | jedna bočica s praškom sadrži 1 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-530-09/21-01/332 |
| Registration Number | 381-12-01/171-23-06 |
| 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 |
