Belara 0,03 mg/2 mg filmom obložene tablete
| Name | Belara 0,03 mg/2 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-368848654 |
| Active Substance | etinilestradiol klormadinonacetat |
| Composition | jedna filmom obložena tableta sadrži 0,030 mg etinilestradiola i 2 mg klormadinonacetata |
| Pharmaceutical Form | filmom obložena tableta |
| Packaging [MA Number for Packaging] | 21 tableta u blisteru, kalendarsko pakiranje, u kutiji [HR-H-368848654-01] 63 tablete u blisteru, kalendarsko pakiranje, u kutiji [HR-H-368848654-02] |
| Manufacturer | Gedeon Richter Plc., Budimpešta, Mađarska |
| Marketing Authorisation Holder | Gedeon Richter Plc., Gyömrői út 19-21, Budimpešta, Mađarska |
| Marketing Authorisation Date | 30.09.2017 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/16-02/78 |
| Registration Number | 381-12-01/30-17-07 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | G03AA15 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Educational materials for healthcare professionals |
Lista provjere za liječnike (verzija 1) Popratno pismo za liječnike Popratno pismo za ljekarnike |
| Educational materials for patients / caregivers |
Važne informacije za korisnicu (verzija 1) |
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o mjerama minimizacije rizika od meningeomapovezanog s primjenom lijekova koji sadrže klormadinonacetat i nomegestrolacetat | 09.11.2022 | Gedeon Richter Plc., Theramex Ireland Limited, Zentiva k.s., Mibe Pharmaceuticals d.o.o. |
