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 |
Marketing Authorisation Holder | Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, Hrvatska |
Marketing Authorisation Date | 18.06.2020 |
MA Period of Validity | 18.06.2025 |
Classification Number | UP/I-530-09/19-01/121 |
Registration Number | 381-12-01/38-20-16 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01XX05 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |