Fylrevy (estetrol)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- estetrol
- Company
- Gedeon Richter Plc.
- Status
- Authorised
- Therapeutic area
- Menopause
- CHMP opinion
- Thu 29 Jan 2026
- EU approval
- Thu 26 Mar 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006213
- ATC
- G03CA10
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
Thu 26 Mar 2026🇪🇺 EU approval (EC decision)
Fylrevy (estetrol) approved in the EU
Marketing authorisation to Gedeon Richter Plc.; Additional monitoring · source
Thu 29 Jan 2026🇪🇺 CHMP positive opinion
Fylrevy (estetrol): CHMP positive opinion
Gedeon Richter Plc.; Additional monitoring · source
Same substance in other markets
- 🇪🇺 Lydisilka Authorised · Estetra SPRL
- 🇪🇺 Drovelis Authorised · Gedeon Richter Plc.
Follow Fylrevy
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.