Fylrevy

Opinion

EMA has issued an opinion on this medicine

estetrol

Overview

On 29 January 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Fylrevy, intended as hormone replacement therapy (HRT) to treat women who have been through the menopause and experience symptoms associated with oestrogen deficiency.

The applicant for this medicinal product is Gedeon Richter Plc.

Fylrevy will be available as 14.2 mg and 18.9 mg film-coated tablets. The active substance of Fylrevy is estetrol, a sex hormone and modulator of the genital system (ATC code: G03CA10). Estetrol substitutes for the loss of oestrogen production in women who have gone through the menopause and alleviates symptoms associated with the menopause, including vasomotor symptoms (VMS).

The benefit of Fylrevy is a statistically significant reduction in the frequency and severity of moderate to severe VMS in women who have gone through the menopause, compared with placebo, as shown in two randomised double-blind, placebo-controlled multicentre clinical trials.

The most common side effects in women who have been through the menopause, have not undergone hysterectomy, had not had menses for at least 12 months, and were treated with Fylrevy in combination with progesterone, include endometrial thickening, vaginal haemorrhage and disordered proliferative endometrium. The other most common side effects with Fylrevy regardless of whether women had undergone hysterectomy, include breast tenderness and breast pain.

The full indication is:

Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in hysterectomised postmenopausal women.

Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in non-hysterectomised postmenopausal women with at least 12 months since last menses.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Fylrevy

Adopted Reference Number: EMA/CHMP/24373/2026

Product details

• Name of medicine:
  Fylrevy
• Active substance:
  estetrol monohydrate
• International non-proprietary name (INN) or common name:
  estetrol
• Therapeutic area (MeSH):
  Menopause
• Anatomical therapeutic chemical (ATC) code:
  G03CA
• EMA product number:
  EMEA/H/C/006213
• Marketing authorisation applicant:
  Gedeon Richter Plc.
• Opinion adopted:
  29/01/2026
• Opinion status:
  Positive