Enzalutamid Accord 40 mg meke kapsule
| Name | Enzalutamid Accord 40 mg meke kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-421153417 |
| Active Substance | enzalutamid |
| Composition | jedna meka kapsula sadrži 40 mg enzalutamida |
| Pharmaceutical Form | Kapsula, meka |
| Manufacturer | Pharmadox Healthcare Limited, Paola, Malta Accord Healthcare B.V., Utrecht, Nizozemska 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 | 19.04.2024 |
| MA Period of Validity | 19.04.2029 |
| Classification Number | UP/I-530-09/21-01/152 |
| Registration Number | 381-12-01/70-24-08 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L02BB04 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
