CHMP recommends approval for Ulipristal Acetate Gedeon Richter for the pre-operative treatment of uterine fibroids. Gedeon Richter.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ulipristal Acetate Gedeon Richter, intended for the pre- operative treatment of uterine fibroids. The application for Ulipristal Acetate Gedeon Richter was an informed consent application. In an informed consent application, reference is made to an authorised medicine where the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application procedure. The reference product for Ulipristal Acetate Gedeon Richter is Esmya.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.