Regulatory PathRegulatory requirements compared

Active substance

Fezolinetant

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
VEOZAH45MGtablet · oralASTELLASPrescription12 May 2023

EMA European Union — centrally authorised medicines

Veoza Astellas Pharma Europe B.V. · Authorised · authorised 7 Dec 2023 · ATC G02CX06

Therapeutic indication (EMA)

Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
VEOZAH0255360045 MGTABLET · ORALASTELLAS PHARMA CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACVEOZAH 45 MG TABLET$18.58225per EA23 Sep 2026
NHS Drug TariffFezolinetant 45mg tablets£44.8028 tablet1 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

  • MHRA 10 Apr 2025 Fezolinetant▼(Veoza): risk of liver injury; new recommendations to minimise risk
    Fezolinetant treatment is associated with a risk of drug induced liver injury. New recommendations have been introduced to minimise this risk. Liver function should be monitored before and during treatment in all patients taking fezolinetant. Fezolinetant should be avoided in patients with known liver disease or at a higher risk of liver disease.
  • US FDA 16 Dec 2024 VEOZAH — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for fezolinetant →

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.