Richter’s hormone replacement therapy product receives positive opinion from the European Medicines Agency

According to the announcement, the proposed indication is for the treatment of estrogen deficiency symptoms in postmenopausal women who have not undergone a hysterectomy and who have had at least 12 months since their last menstrual period. The CHMP also supports the use of FYLREVY in postmenopausal women who have undergone a hysterectomy for the treatment of estrogen deficiency symptoms.

It was added that the European Commission will make the final decision on the application for marketing authorization after reviewing the CHMP recommendation. The decision will apply to all member states of the European Economic Area.

The announcement quoted Péter Turek, head of Richter’s gynecology business, as saying: following the approval of the European Commission, FYLREVY could be the first innovative hormonal therapy product for the treatment of menopausal symptoms on the European market in recent decades. He added that the registration of an original product would be an outstanding achievement for Richter.

FYLREVY® and DONESTA® are registered trademarks of Estetra SRL, a subsidiary of Richter Gedeon Nyrt. DROVELIS® is a registered trademark of Richter Gedeon Plc. – it was noted in the announcement.

Richter, founded in 1901, headquartered in Hungary, with a market capitalization of 4.7 billion euros in 2024, operates the largest R&D center in Central Europe. The company conducts groundbreaking research in the fields of neuropsychiatry and gynecology – it was announced.

The shares of Richter Gedeon Plc. are listed in the premium category of the BSE, and the stock price strengthened by 1.23 percent on Friday afternoon, to 10,740 forints, in a turnover of 1.2 billion forints. The highest share price in the past year was 11,150 forints, and the lowest was 9,380 forints.