| Name |
Zafrilla 2 mg tablete |
| Marketing Authorisation Number |
HR-H-412022127 |
| Active Substance |
dienogest |
| Composition |
jedna tableta sadrži 2 mg dienogesta |
| Pharmaceutical Form |
tableta |
| Manufacturer |
Gedeon Richter Plc., Budimpešta, Mađarska |
| Marketing Authorisation Holder |
Gedeon Richter Plc., Gyömrői út 19-21, Budimpešta, Mađarska |
| Marketing Authorisation Date |
12.07.2024 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/23-02/20 |
| Registration Number |
381-12-01/70-24-06 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
G03DB08 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
