Medicinal Products

Esmya

Name Esmya
Active Substance ulipristal acetate
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
ATC Code G03XB02
Medicinal product marketed in the Croatia Privremeni prekid opskrbe
Educational materials
for healthcare professionals
Vodič za liječnike za pravilno propisivanje i sigurnu primjenu lijeka, verzija 2
Vodič za patologe, verzija 2
Educational materials
for patients / caregivers
Kartica za pacijentice kolovoz 2018

Note

The medicinal product has been authorised via centralised procedure in all Member States of the European Union based on the European Medicines Agency's expert opinion. Additional information on the medicinal product can be found under the following link:https://www.ema.europa.eu/en/medicines/human/EPAR/esmya

The marketing authorisation has been granted by the European Commission. All marketing authorisations of the European Commission can be found under the following link: http://ec.europa.eu/health/documents/community-register/html/index_en.htm

Direct Healthcare Professional Communication

Name Date Download
Pismo zdravstvenim radnicima o restrikciji indikacije za lijek Esmya (ulipristalacetat) za liječenje fibroida maternice zbog rizika od teškog oštećenja jetre 27.01.2021 Gedeon Richter Plc.
Pismo zdravstvenim radnicima o ograničenju primjene ulipristalacetata jačine 5 mg za liječenje simptoma fibroida maternice tijekom postupka ocjene rizika od oštećenja funkcije jetre 24.03.2020 Gedeon Richter Plc.
Pismo zdravstvenim radnicima o restrikciji indikacije, uvođenju nove kontraindikacije i potrebi praćenja jetrene funkcije za lijek Esmya (ulipristalacetat) 06.08.2018 Gedeon Richter Plc.
Pismo zdravstvenim radnicima o ograničenju uporabe lijeka Esmya (ulipristalacetat) 22.02.2018 Gedeon Richter Plc.
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