Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland
Yselty 100 mg film-coated tablets.
Yselty 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Yselty 100 mg film-coated tablets: Round, pale yellow, film-coated tablets of 10 mm diameter, debossed “100” on one side and plainfaced on the other side. Yselty 200 mg film-coated tablets: Oblong, pale yellow, film-coated tablets of 19 mm by 9 mm, debossed “200” on one side and plainfaced on the other side. |
Each film-coated tablet contains 100 mg of linzagolix (as choline salt).
Excipient(s) with known effect: Each film-coated tablet contains 119.4 mg lactose.
Each film-coated tablet contains 200 mg of linzagolix (as choline salt).
Excipient(s) with known effect: Each film-coated tablet contains 238.8 mg lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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Linzagolix is a selective, non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signalling by binding competitively to GnRH receptors in the pituitary gland, thereby modulating the hypothalamic-pituitary-gonadal axis. |
| List of Excipients |
|---|
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Tablet core: Lactose monohydrate Film-coating: Macrogol poly(vinyl alcohol) grafted copolymer (E1209) |
PVC-PVDC/aluminium blister containing 14 film-coated tablets per blister.
Pack size of 28 film-coated tablets (two blisters of 14 film-coated tablets) or 84 film-coated tablets (six blisters of 14 film-coated tablets) per cardboard box.
Not all pack sizes may be marketed.
Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland
EU/1/21/1606/001
EU/1/21/1606/002
EU/1/21/1606/003
EU/1/21/1606/004
Date of first authorisation: 14 June 2022
| Drug | Countries | |
|---|---|---|
| YSELTY | Austria, France, Croatia, Italy, Lithuania |
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