Regulatory PathRegulatory requirements compared

Active substance

Estetrol

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EMA European Union — centrally authorised medicines

Fylrevy Gedeon Richter Plc. · Authorised · authorised 26 Mar 2026 · ATC G03CA10

Therapeutic indication (EMA)

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

Safety signals and safety-related labeling changes

All safety entries for estetrol →

Combinations containing Estetrol

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.