Ciklofosfamid Accord 200 mg/ml koncentrat za otopinu za injekciju/infuziju
| Name | Ciklofosfamid Accord 200 mg/ml koncentrat za otopinu za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-872342996 |
| Active Substance | ciklofosfamid hidrat |
| Composition | 1 ml koncentrata sadrži 200 mg ciklofosfamida u obliku ciklofosfamid hidrata |
| Pharmaceutical Form | Koncentrat za otopinu za injekciju / infuziju |
| Manufacturer | Laboratori Fundacio Dau, Barcelona, Španjolska Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska Accord Healthcare Single Member S.A., Lamia, Grčka |
| Marketing Authorisation Holder | Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
| Marketing Authorisation Date | 09.05.2024 |
| MA Period of Validity | 09.05.2029 |
| Classification Number | UP/I-530-09/23-01/14 |
| Registration Number | 381-12-01/171-24-09 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L01AA01 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
