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EMA Product

Yselty

Product approved by European Medicines Agency (EU)

Basic Information

Yselty

Regulatory Information

EMEA/H/C/005442

Authorised

June 14, 2022

December 16, 2021

5

March 12, 2025

Company Information

Ireland

3rd Floor, Kilmore House Park Lane, Spencer Dock Dublin 1, D01 YE64

Theramex Ireland Ltd.

Drug Classification

Additional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic 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).

Overview Summary

Yselty is a medicine used in adult women of childbearing age to treat: - moderate to severe symptoms of uterine fibroids, which are non-cancerous (benign) tumours of the womb (uterus); - symptoms of endometriosis, a condition where tissue similar to the endometrium (the lining of the womb) grows outside the womb. It is used in women who have already had treatment for this condition. Yselty contains the active substance linzagolix choline.

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