Medicinal Products

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
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
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.
Back