Belara 0,03 mg/2 mg filmom obložene tablete
Name | Belara 0,03 mg/2 mg filmom obložene tablete |
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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 |
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 | Medicinal product subject to medical prescription |
Type of prescription | ponovljivi recept |
Distribution | Supply through pharmacies (community) |
Advertising to general public | not allowed |
ATC Code | G03AA15 |
Marketing status | stavljeno u promet |
Shortage status | nema nestašice |
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) |
Packaging
Direct Healthcare Professional Communication
Name | Date | Download |
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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. |