Regulatory PathRegulatory requirements compared

Active substance

Flumazenil

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ANEXATE 0.5MG AMP 5ML0.1 mg/mlSolution for injection · Intravenous use5 AmpouleSAR 270.65NCE · PrescriptionCHEPLAPHARM Arzneimittel GmbHValid
EXITINE0.1 mg/mlSolution for infusion · Intravenous use5 VialSAR 219.90Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
Flumazenil PSI0.1 mg/mlSolution for injection/infusion · Intravenous use5 VialSAR 208.90Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
Indications — CHI Daman Drug Formulary

ANESTHESIA

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

ProductStrengthForm · routeApplicantStatusFirst approved
FLUMAZENIL1MG/10ML (0.1MG/ML); 0.5MG/5ML (0.1MG/ML)injectable · injectionHIKMA PHARMSPrescription12 Oct 2004
FLUMAZENIL1MG/10ML (0.1MG/ML); 0.5MG/5ML (0.1MG/ML)injectable · injectionBAXTER HLTHCARE CORPPrescription12 Oct 2004
FLUMAZENIL1MG/10ML (0.1MG/ML); 0.5MG/5ML (0.1MG/ML)injectable · injectionFRESENIUS KABI USAPrescription12 Oct 2004
FLUMAZENIL0.5MG/5ML (0.1MG/ML); 1MG/10ML (0.1MG/ML)injectable · injectionSANDOZPrescription3 May 2005
FLUMAZENIL0.5MG/5ML (0.1MG/ML)injectable · injectionRISINGPrescription13 May 2008
FLUMAZENIL0.5MG/5ML (0.1MG/ML); 1MG/10ML (0.1MG/ML)injectable · injectionHIKMA FARMACEUTICAPrescription23 Mar 2009
FLUMAZENIL0.5MG/5ML (0.1MG/ML); 1MG/10ML (0.1MG/ML)injectable · injectionSAGENT PHARMSPrescription28 Aug 2012
ROMAZICON1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionHOFFMANN LA ROCHEDiscontinued20 Dec 1991
FLUMAZENIL1MG/10ML (0.1MG/ML); 0.5MG/5ML (0.1MG/ML)injectable · injectionDR REDDYSDiscontinued12 Oct 2004
FLUMAZENIL1MG/10ML (0.1MG/ML); 0.5MG/5ML (0.1MG/ML)injectable · injectionHIKMA PHARMSDiscontinued12 Oct 2004
FLUMAZENIL1MG/10ML (0.1MG/ML)injectable · injectionRISINGDiscontinued13 May 2008

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
FLUMAZENIL INJECTION022495610.1 MG / MLSOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
FLUMAZENIL INJECTION, USP022663420.1 MG / MLSOLUTION · INTRAVENOUSFRESENIUS KABI CANADA LTD

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFLUMAZENIL 0.5 MG/5 ML VIAL$1.17913per ML19 Aug 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.