Is Linzagolix choline authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Linzagolix choline: Yselty.

Is Linzagolix choline authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 2 products containing Linzagolix choline, including YSELTY 100 MG FILM-COATED TABLETS; YSELTY 200 MG FILM-COATED TABLETS.

Active substance

Linzagolix choline

EMA 1
UK MHRA 2

Open in the medicines table

EMA European Union — centrally authorised medicines

Yselty Theramex Ireland Limited · Authorised · authorised 14 Jun 2022 · ATC H01CC04

Therapeutic indication (EMA)

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).

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
YSELTY 100 MG FILM-COATED TABLETS	PLGB 49876/0023	THERAMEX IRELAND LIMITED	POM
YSELTY 200 MG FILM-COATED TABLETS	PLGB 49876/0024	THERAMEX IRELAND LIMITED	POM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.