Yselty

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linzagolix choline

Authorised
This medicine is authorised for use in the European Union.

Overview

Yselty is a medicine for treating moderate to severe symptoms of uterine fibroids in adult women of childbearing age. Uterine fibroids are non-cancerous (benign) tumours of the womb (uterus).

Yselty contains the active substance linzagolix choline.

This EPAR was last updated on 19/08/2022

Authorisation details

Product details
Name
Yselty
Agency product number
EMEA/H/C/005442
Active substance
linzagolix choline
International non-proprietary name (INN) or common name
linzagolix choline
Therapeutic area (MeSH)
Leiomyoma
Anatomical therapeutic chemical (ATC) code
H01CC04
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
ObsEva Ireland Ltd
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
14/06/2022
Contact address

Penthouse Floor 5
Lapps Quay Cork
T12 RW7 Ireland

Product information

17/08/2022 Yselty - EMEA/H/C/005442 - IB/0002/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Pituitary and hypothalamic hormones and analogues

Therapeutic indication

Yselty is indicated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

Assessment history

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