Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: ObsEva Ireland Ltd., Penthouse Floor, 5 Lapps Quay, Cork, T12 RW7D, Ireland
Yselty 100 mg film-coated tablets.
Yselty 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
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 | Description | |
|---|---|---|
| Linzagolix |
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 |
|---|
|
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) per cardboard box.
ObsEva Ireland Ltd., Penthouse Floor, 5 Lapps Quay, Cork, T12 RW7D, Ireland
EU/1/21/1606/001
EU/1/21/1606/002
Date of first authorisation: 14 June 2022
| Drug | Countries | |
|---|---|---|
| YSELTY | Austria, France, Croatia, Italy, Lithuania |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
