Regulatory PathRegulatory requirements compared

Active substance

Propofol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ANESIA10.00 mg/mlEmulsion for injection · Intravenous use5 VialSAR 58.60Generic · PrescriptionBaxterValid
ANESIA10.00 mg/mlEmulsion for injection · Intravenous use10 VialSAR 117.15Generic · PrescriptionBaxterValid
DIPRIVAN VIAL 10MG-ML10 mg/mlEmulsion for injection/infusion · Intravenous use5 VialSAR 110.05NCE · PrescriptionASPEN PHARMA TRADING LIMITED (APTL)Valid
Novfol10 mgEmulsion for infusion · Intravenous use5 VialSAR 85.10Generic · PrescriptionPT. Novell Pharmaceutical LaboratoriesValid
PROPOFOL-LIPURO 0.5% EMULSION FOR Inj./Infusion0.5 %Emulsion for injection/infusion · Intravenous use5 VialSAR 62.25NCE · PrescriptionB. BRAUNValid
PROPOFOL-LIPURO 1%INJ OR INF VIAL1 %Emulsion for injection/infusion · Intravenous use1 BottleSAR 37.70Generic · PrescriptionB. BRAUNValid
PROPOFOL-LIPURO1% INJ OR INF AMPOULE1 %Emulsion for injection/infusion · Intravenous use5 AmpouleSAR 68.95Generic · PrescriptionB. BRAUNValid
PROPOVEN 1% VIAL1 %Emulsion for injection/infusion · Intravenous use10 VialSAR 461.70Generic · PrescriptionFresenius Kabi Deutschland GmbHValid
PROPOVEN 1% VIAL1 %Emulsion for injection/infusion · Intravenous use5 VialSAR 102.90Generic · PrescriptionFresenius Kabi Deutschland GmbHValid
Propofol - Lipuro 1000 mg per 50 ml20 mg/mlEmulsion for injection/infusion · Intravenous use10 VialSAR 629.60Generic · PrescriptionB. BRAUNValid
Propoven20 mg/mlEmulsion for injection/infusion · Intravenous use10 VialSAR 760.45Generic · PrescriptionFresenius Kabi Deutschland GmbHValid
RECOFOL 10MG-ML INJECTION10 mg/mlSolution for injection · Intravenous use1 VialSAR 55.35Generic · PrescriptionBAYER OYValid
RECOFOL 10MG-ML INJECTION10 mg/mlSolution for injection · Intravenous use5 AmpouleSAR 101.40Generic · PrescriptionBAYER OYValid
RECOFOL 10MG-ML INJECTION10 mg/mlSolution for injection · Intravenous use1 VialSAR 101.40Generic · PrescriptionBAYER OYValid
RECOFOL 20MG-ML I.V. EMULSION FOR INFU20 mg/mlEmulsion for infusion · Intravenous use1 VialSAR 80.05Generic · PrescriptionBAYER OYValid
Sedafol10 mg/mlEmulsion for infusion · Intravenous use1 VialSAR 17.00Generic · PrescriptionSaudi AmaroxValid
DIPRIVAN VIAL 10MG-ML10 mg/mlEmulsion for injection/infusion · Intravenous use5 VialSAR 110.05NCE · PrescriptionAstraZenecaWithdrawn by MAH · Not Marketed
DIPRIVAN VIAL 10MG-ML10 mg/mlEmulsion for injection/infusion · Intravenous use1 VialSAR 68.35Generic · PrescriptionAstraZenecaWithdrawn by MAH · Not Marketed
DIPRIVAN VIAL 10MG-ML10 mg/mlEmulsion for injection/infusion · Intravenous use1 VialSAR 68.35Generic · PrescriptionASPEN PHARMA TRADING LIMITED (APTL)Withdrawn by MAH · Not Marketed
PROPOFOL 1% I.V INJ OR INFUSION1 %Emulsion for injection/infusion · Intravenous use5 AmpouleSAR 102.90Generic · PrescriptionFRESENIUS KABIWithdrawn by MAH · Not Marketed
PROPOFOL-LIPURO 1%INJ OR INF VIAL1 %Emulsion for injection/infusion · Intravenous use1 BottleSAR 68.95Generic · PrescriptionB. BRAUNWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ANESTHESIA; BURN MANAGEMENT; STATUS EPILEPTICUS

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

ProductStrengthForm · routeApplicantStatusFirst approved
DIPRIVAN10MG/MLinjectable · injectionFRESENIUS KABI USAPrescription2 Oct 1989
PROPOFOL10MG/MLinjectable · injectionSAGENT PHARMS INCPrescription4 Jan 1999
PROPOFOL10MG/MLinjectable · injectionHIKMA PHARMSPrescription19 Apr 2005
PROPOFOL10MG/MLinjectable · injectionHOSPIRAPrescription17 Mar 2006
PROPOFOL10MG/MLinjectable · injectionDR REDDYSPrescription15 Nov 2018
PROPOFOL10MG/MLinjectable · injectionINNOPHARMAPrescription16 Sep 2020
PROPOFOL10MG/MLinjectable · injectionAVET LIFESCIENCESPrescription12 Oct 2021
PROPOFOL10MG/MLinjectable · injectionASPIROPrescription20 Jun 2024
PROPOFOL10MG/MLinjectable · injectionAMNEALPrescription15 Aug 2024
PROPOFOL10MG/MLinjectable · injectionEMERGE BIOSCIENCEPrescription2 Dec 2025
PROPOFOL10MG/MLinjectable · injectionADAPTISPrescription14 Jul 2026
DIPRIVAN10MG/MLinjectable · injectionFRESENIUS KABI USADiscontinued2 Oct 1989
PROPOFOL10MG/MLinjectable · injectionTEVA PARENTERALDiscontinued19 Sep 2000
PROPOFOL10MG/MLinjectable · injectionWATSON LABS INCDiscontinued22 Dec 2015

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
DIPRIVAN 1%0201895010 MG / MLEMULSION · INTRAVENOUSASPEN PHARMACARE CANADA INC.
PROPOFOL INJECTION0224437910 MG / MLEMULSION · INTRAVENOUSBAXTER CORPORATION
PROPOFOL INJECTION0243764310 MG / MLEMULSION · INTRAVENOUSFRESENIUS KABI CANADA LTD
PROPOFOL INJECTION0252587910 MG / MLEMULSION · INTRAVENOUSMARCAN PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPROPOFOL 200 MG/20 ML VIAL$0.17094per ML2 Sep 2026
US NADACPROPOFOL 500 MG/50 ML VIAL$0.17094per 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.

WHO WHO Model List of Essential Medicines (2025)

  • 1.1.2. General anaesthetics and oxygen > Injectable medicines · core
    Anaesthetics and therapeutic gases
    Parenteral > General injections > IV: 10 mg per mL; 20 mg per mL

Safety signals and safety-related labeling changes

All safety entries for propofol →

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.