Azacitidin Sandoz 25 mg/ml prašak za suspenziju za injekciju
| Name | Azacitidin Sandoz 25 mg/ml prašak za suspenziju za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-152619540 |
| Active Substance | azacitidin |
| Composition | svaka bočica s praškom sadrži 100 mg azacitidina, nakon rekonstitucije jedan ml suspenzije sadrži 25 mg azacitidina |
| Pharmaceutical Form | prašak za suspenziju za injekciju |
| Manufacturer | Pharmadox Healthcare Limited, Paola PLA, Malta Lek Pharmaceuticals d.d., Ljubljana, Slovenija Salutas Pharma GmbH, Barleben, Njemačka |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 02.06.2020 |
| MA Period of Validity | 02.06.2025 |
| Classification Number | UP/I-530-09/19-01/04 |
| Registration Number | 381-12-01/70-20-04 |
| 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 |
