Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: YSELTY
Active substances:
Linzagolix
Estonian, English, Latin
ATC code: H01CC04
Dosage form: film-coated tablet
Strength: 200mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Yselty is indicated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Safety features: Yes
: 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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
3047015  YSELTY  film-coated tablet  200mg 28TK  Prescription           
3047026  YSELTY  film-coated tablet  200mg 84TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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