Yselty
linzagolix choline
Table of contents
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.
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Yselty - EPAR - Medicine overview (PDF/120.45 KB)
First published: 01/07/2022
EMEA/H/C/005442 -
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Yselty : EPAR - Risk management plan summary (PDF/350.18 KB)
First published: 01/07/2022
Authorisation details
Product details | |
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Name |
Yselty
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Agency product number |
EMEA/H/C/005442
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Active substance |
linzagolix choline
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International non-proprietary name (INN) or common name |
linzagolix choline
|
Therapeutic area (MeSH) |
Leiomyoma
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Anatomical therapeutic chemical (ATC) code |
H01CC04
|
Additional 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 | |
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Marketing-authorisation holder |
Theramex Ireland Limited
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Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
14/06/2022
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Contact address |
3rd Floor, Kilmore House |
Product information
28/04/2023 Yselty - EMEA/H/C/005442 - IB/0006/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.