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EMA recommends approval of six medicines, expands indications for nine

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EMA’s human medicines committee (CHMP) published the outcomes of their meeting on Friday (30 January). EMA recommended six medicines for approval at its meeting and extended the therapeutic indications of nine medicines.

Here are some highlights:

Menopause: The committee recommended marketing authorisation for Fylrevy (estetrol),  a hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women who have had a hysterectomy, made by Hungarian company Gedeon Richter Plc.

GR’s Head of Women’s Healthcare (WHC), Dr Péter Turek, Business Unit, said that it was an important milestone, saying it may be the first innovative hormonal therapy for menopause in the European market in decades. 

“Bringing an original product to the market – our second, based on the unique, proprietary Estetrol platform – would be a major achievement for Richter. It reflects our unwavering commitment to improving the quality of life of women globally, validates our strategy to invest in original research, and further strengthens our leading position in Europe.”

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