Linzagolix (1) – Yselty®
Uterine fibroid
Characteristics
| Start date | 15.09.2024 – Marketing authorisation: 14.06.2022 |
|---|---|
| Resolution | 06.03.2025 |
| INN | Linzagolix |
| Brand name | Yselty® |
| Pharm. company | Theramex Ireland Limited |
| G-BA Procedure ID | D-1098 |
| ATC code | H01CC04 Anti-gonadotropin-releasing hormones (H01CC) |
| Therapeutic area | Genitourinary system diseases |
| Reason for procedure | Initial assessment |
| Specialty | ACT change |
Studies and Results
Adult women of childbearing age with moderate to severe symptoms of uterine fibroids
- For adult women of childbearing age with moderate to severe symptoms of uterine fibroids, the additional benefit is not proven.
- In summary, additional benefit is not proven for adult women of childbearing age with moderate to severe symptoms of uterine fibroids compared with the appropriate comparator therapy.
- Overall assessment
- On balance, therefore, the additional benefit of linzagolix over the appropriate comparator therapy is not proven for adult women of childbearing age with moderate to severe symptoms of uterine fibroids.
Courtesy translation only, please refer to the German original.
Associated procedures
| Linzagolix (2) | Yselty® | Theramex Ireland Limited | Endometriosis | 8,100–13,900 | 100% additional benefit not proven | |
| Linzagolix (1) | Yselty® | Theramex Ireland Limited | Uterine fibroid | 20,160–100,800 | 100% additional benefit not proven |
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