Orgovyx Accord Healthcare S.L.U. · Authorised · authorised 29 Apr 2022 · ATC L02BX
Therapeutic indication (EMA)
Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.
Active substance
Relugolix
- US FDA 2
- EMA 1
- Health Canada 1
- NHS prices 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ORGOVYX | 02542137 | 120 MG | TABLET · ORAL | KNIGHT THERAPEUTICS INC. |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| NHS Drug Tariff | Relugolix 120mg tablets | £87.45 | 30 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 8 Oct 2025 ORGOVYX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Combinations containing Relugolix
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.