Regulatory PathRegulatory requirements compared

Active substance

Elinzanetant

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
LYNKUET60MGcapsule · oralBAYER HLTHCAREPrescription24 Oct 2025

EMA European Union — centrally authorised medicines

Lynkuet Bayer AG · Authorised · authorised 17 Nov 2025 · ATC G02CX07

Therapeutic indication (EMA)

Treatment of moderate to severe vasomotor symptoms (VMS).

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
LYNKUET0255971460 MGCAPSULE · ORALBAYER INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLYNKUET 60 MG CAPSULE$9.97051per EA30 Sep 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.

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.