Regulatory PathRegulatory requirements compared

Active substance

Fosaprepitant dimeglumine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Fosaprepitant SPC150 mgpowder for solution for injection · Intravenous use1 VialSAR 183.45NCE · PrescriptionSUDAIR PHARMA COMPANYValid
Envona150 mgPowder for solution for infusion · Intravenous use10 VialSAR 286.20NCE · PrescriptionBoston Oncology ArabiaWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

NAUSEA AND VOMITING IN CANCER

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

ProductStrengthForm · routeApplicantStatusFirst approved
EMENDEQ 150MG BASE/VIALpowder · intravenousMERCK AND CO INCPrescription25 Jan 2008
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousFRESENIUS KABI USAPrescription9 Jun 2016
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousMYLAN LABS LTDPrescription5 Sep 2019
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousMSNPrescription5 Sep 2019
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousBE PHARMSPrescription5 Sep 2019
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousTEVA PHARMS USAPrescription5 Sep 2019
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousQILU PHARM HAINANPrescription8 Sep 2020
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousDR REDDYSPrescription9 Dec 2020
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousEUGIA PHARMAPrescription12 Jan 2021
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousCHIA TAI TIANQINGPrescription3 Mar 2021
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousASPIROPrescription29 Jul 2021
FOCINVEZEQ 150MG BASE/50ML (EQ 3MG BASE/ML)solution · intravenousSTERISCIENCEPrescription22 Aug 2023
NAVITRUXEQ 150MG BASE/VIALpowder · intravenousAVYXA HOLDINGSPrescription24 Jun 2026
EMENDEQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**powder · intravenousMERCK AND CO INCDiscontinued25 Jan 2008
FOSAPREPITANT DIMEGLUMINEEQ 115MG BASE/VIALpowder · intravenousMYLAN LABS LTDDiscontinued5 Sep 2019
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousAPOTEXDiscontinued5 Sep 2019
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousLUPINDiscontinued5 Sep 2019
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousQUAGENDiscontinued5 Sep 2019
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousBAXTER HLTHCARE CORPDiscontinued5 Sep 2019
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousCHARTWELL RXDiscontinued20 Aug 2020
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousACCORD HLTHCAREDiscontinued26 Aug 2020
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousCAPLINDiscontinued8 Dec 2020
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousQUAGENDiscontinued4 Oct 2021
FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALpowder · intravenousPIRAMAL CRITICALDiscontinued16 May 2023

Safety signals and safety-related labeling changes

  • US FDA 2 May 2022 EMEND — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for fosaprepitant dimeglumine →

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.