Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 3047026
Name of medicinal product: YSELTY
Active substances:
Linzagolix
Estonian, English, Latin
ATC code: H01CC04
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 200mg
Amount in package: 84TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Yselty is indicated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Theramex Ireland Limited 
Marketing authorization number: EU/1/21/1606 
Marketing authorization issued on: June 14, 2022 
Marketing authorization expires on: June 17, 2027 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: October 30, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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