Esmya
| Name | Esmya |
|---|---|
| Active Substance | ulipristalacetat |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| ATC Code | G03XB02 |
| Medicinal product marketed in the Croatia | Da |
| Educational materials for healthcare professionals |
Vodič za patologe, verzija 3 Vodič za liječnike za pravilno propisivanje i sigurnu primjenu lijeka, verzija 3 |
| 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. |
