Etraga 25 mg/ml prašak za suspenziju za injekciju
| Name | Etraga 25 mg/ml prašak za suspenziju za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-730251649 |
| Active Substance | azacitidin |
| Composition | svaka bočica s praškom sadrži 100 mg ili 150 mg azacitidina nakon rekonstitucije jedan ml suspenzije sadrži 25 mg azacitidina |
| Pharmaceutical Form | prašak za suspenziju za injekciju |
| Manufacturer | STADA Arzneimittel AG, Bad Vilbel, Njemačka
AqVida GmbH, Hamburg, Njemačka |
| Marketing Authorisation Holder | Stada d.o.o., Hercegovačka 14, Zagreb, Hrvatska |
| Marketing Authorisation Date | 09.05.2022 |
| MA Period of Validity | 09.05.2027 |
| Classification Number | UP/I-530-09/20-01/309 |
| Registration Number | 381-12-01/70-22-06 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01BC07 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
