Regulatory PathRegulatory requirements compared

Active substance

Nalmefene

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
NALMEFENE HYDROCHLORIDEEQ 2MG BASE/2ML (EQ 1MG BASE/ML)solution · intramuscular, intravenous, subcutaneousKNOA PHARMAPrescription8 Feb 2022
OPVEEEQ 2.7MG BASE/SPRAYspray · nasalINDIVIORPrescription22 May 2023
NALMEFENE HYDROCHLORIDEEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML); EQ 2MG BASE/2ML (EQ 1MG BASE/ML); 2MG BASE/2ML (EQ 1MGBASE/ML)solution · intramuscular, intravenous, subcutaneousCHENGDU SHUODEPrescription15 Nov 2023
ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)solution · intramuscular, subcutaneousKNOA PHARMAPrescription7 Aug 2024
REVEXEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · intramuscular, intravenous, subcutaneousHIKMA PHARMSDiscontinued17 Apr 1995

EMA European Union — centrally authorised medicines

Selincro H. Lundbeck A/S · Authorised · authorised 24 Feb 2013 · ATC N07BB05

Therapeutic indication (EMA)

Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification. Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACOPVEE 2.7 MG NASAL SPRAY$46.78808per EA23 Sep 2026
NHS Drug TariffNalmefene 18mg tablets£84.8428 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

All safety entries for nalmefene →

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.