Fludarabin Accord 25 mg/ml koncentrat za otopinu za injekciju ili infuziju
| Name | Fludarabin Accord 25 mg/ml koncentrat za otopinu za injekciju ili infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-663938715 |
| Active Substance | fludarabinfosfat |
| Composition | svaki ml sadrži 25 mg fludarabinfosfata |
| Pharmaceutical Form | koncentrat za otopinu za injekciju/infuziju |
| Manufacturer | Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska Accord Healthcare B.V., Utrecht, Nizozemska |
| Marketing Authorisation Holder | Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
| Marketing Authorisation Date | 14.06.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/18-02/308 |
| Registration Number | 381-12-01/70-23-06 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01BB05 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
