Xybaid 500 mg tvrde kapsule
| Name | Xybaid 500 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-183510973 |
| Active Substance | hidroksikarbamid |
| Composition | jedna kapsula sadrži 500 mg hidroksikarbamida |
| Pharmaceutical Form | kapsula, tvrda |
| Manufacturer | Pharmadox Healthcare Limited, Paola, Malta
Makpharm d.o.o., Zagreb, Hrvatska |
| Marketing Authorisation Holder | Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, Hrvatska |
| Marketing Authorisation Date | 09.12.2024 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/24-02/112 |
| Registration Number | 381-12-01/70-24-03 |
| 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 | L01XX05 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
