Yselty (linzagolix choline)
- Region
- 🇪🇺 EU
- Active substance
- linzagolix choline
- Company
- Theramex Ireland Limited
- Status
- Authorised
- Therapeutic area
- Leiomyoma
- CHMP opinion
- Thu 16 Dec 2021
- EU approval
- Tue 14 Jun 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005442
- ATC
- H01CC04
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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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.