| Name |
Azacitidin Pharmascience 25 mg/ml prašak za suspenziju za injekciju |
| Marketing Authorisation Number |
HR-H-961547190 |
| Active Substance |
azacitidin |
| Composition |
Jedna bočica s praškom sadrži 100 mg ili 150 mg azacitidina. Nakon rekonstitucije 1 ml suspenzije sadrži 25 mg azacitidina. |
| Pharmaceutical Form |
prašak za suspenziju za injekciju |
| Manufacturer |
AqVida GmbH, Hamburg, Njemačka |
| Marketing Authorisation Holder |
Pharmascience International Limited, Lampousas, 1, Nicosia, Cipar |
| Marketing Authorisation Date |
07.01.2022 |
| MA Period of Validity |
07.01.2027 |
| Classification Number |
UP/I-530-09/21-01/209 |
| Registration Number |
381-12-01/154-22-04 |
| Prescription |
na recept |
| Type of prescription |
ograničeni recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
L01BC07 |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
