EMA — authorised 14 June 2022
- Marketing authorisation holder: OBSEVA IRELAND LTD
- Status: approved
🇪🇺 Yselty in European Union
EMA authorised Yselty on 14 June 2022
Marketing authorisations
EMA — authorised 14 June 2022
- Application: EMEA/H/C/005442
- Marketing authorisation holder: Theramex Ireland Limited
- Local brand name: Yselty
- Indication: Yselty is indicated in adult women of reproductive age for: - treatment of moderate to severe symptoms of uterine fibroids,- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis (see section 5.1).
- Status: approved
Yselty 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 Yselty approved in European Union?
Yes. EMA authorised it on 14 June 2022; EMA authorised it on 14 June 2022.
Who is the marketing authorisation holder for Yselty in European Union?
OBSEVA IRELAND LTD holds the EU marketing authorisation.