EMA — authorised 19 May 2021
- Marketing authorisation holder: Gedeon Richter Plc; Estetra SPRL
- Status: approved
🇪🇺 Nextstellis in European Union
EMA authorised Nextstellis on 19 May 2021
Marketing authorisations
EMA — authorised 19 May 2021
- Application: EMEA/H/C/005336
- Marketing authorisation holder: Gedeon Richter Plc.
- Local brand name: Drovelis
- Indication: oral contraceptive
- Status: approved
EMA — authorised 19 May 2021
- Application: EMEA/H/C/005382
- Marketing authorisation holder: Estetra SPRL
- Local brand name: Lydisilka
- Indication: Oral contraception. The decision to prescribe Lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lydisilka compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
- Status: approved
EMA — authorised 26 March 2026
- Application: EMEA/H/C/006213
- Marketing authorisation holder: Gedeon Richter Plc.
- Local brand name: Fylrevy
- 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.
- Status: approved
On 26 March 2026, the European Medicines Agency (EMA) granted marketing authorisation to Gedeon Richter Plc.'s Fylrevy (Nextstellis) for the treatment of hormone replacement therapy (HRT) in postmenopausal women. Fylrevy is indicated for the relief of oestrogen deficiency symptoms in hysterectomised postmenopausal women and in non-hysterectomised postmenopausal women with at least 12 months since their last menstrual period. This approval was granted under the standard expedited pathway.
Nextstellis in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in European Union
Frequently asked questions
Is Nextstellis approved in European Union?
Yes. EMA authorised it on 19 May 2021; EMA authorised it on 19 May 2021; EMA authorised it on 19 May 2021.
Who is the marketing authorisation holder for Nextstellis in European Union?
Gedeon Richter Plc; Estetra SPRL holds the EU marketing authorisation.