Regulatory PathRegulatory requirements compared

Active substance

Rocuronium

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ESMERON 10MG\ML VIAL10 mg/mlSolution for injection · Intravenous use10 VialSAR 215.05NCE · PrescriptionMerck Sharp & Dohme B.VValid
LAXIRA10 mg/mlSolution for injection · Intravenous use10 AmpouleSAR 182.80Generic · PrescriptionSPIMACO ADDWAEIHValid
RUCORON 50MG\5ML SOLUTION FOR IV BOLUS OR INFUSION10 mg/mlSolution for injection · Intravenous use10 VialSAR 182.80Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Rocuronium Bromide BOS10 mg/mlSolution for injection · Intravenous use10 VialSAR 127.95Generic · PrescriptionBoston Oncology ArabiaValid
Indications — CHI Daman Drug Formulary

ANESTHESIA

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

ProductStrengthForm · routeApplicantStatusFirst approved
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionHOSPIRAPrescription26 Nov 2008
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionMYLAN INSTITUTIONALPrescription26 Nov 2008
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionSANDOZPrescription5 Dec 2008
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionFRESENIUS KABI USAPrescription29 Dec 2008
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionSAGENT PHARMS INCPrescription28 Jul 2010
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionTAMARANGPrescription27 Aug 2012
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionWEST WARD PHARM CORPPrescription28 Feb 2017
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionEUGIA PHARMAPrescription12 Apr 2017
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionGLANDPrescription4 Apr 2018
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionPIRAMAL CRITICALPrescription13 Aug 2019
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionPRINSTON INCPrescription26 May 2022
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionCAPLINPrescription2 Mar 2023
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionMEITHEALPrescription8 May 2023
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionSHANDONGPrescription12 Jul 2024
ROCURONIUM BROMIDE50MG/5ML (10MG/ML)injectable · injectionSTERISCIENCEPrescription22 Jul 2024
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionMANKIND PHARMAPrescription29 May 2025
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)solution · intravenousFRESENIUS KABI USAPrescription9 Jun 2025
ROCURONIUM BROMIDE50MG/5ML (10MG/ML)solution · intravenousB BRAUN MEDICALPrescription24 Oct 2025
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionASPIROPrescription4 Mar 2026
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionBAXTER HLTHCARE CORPPrescription18 Sep 2026
ZEMURON50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionORGANON USA INCDiscontinued17 Mar 1994
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionTEVA PHARMSDiscontinued26 Nov 2008
ROCURONIUM BROMIDE50MG/5ML (10MG/ML)injectable · injectionHIKMADiscontinued24 May 2023
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionRISINGDiscontinued12 Jul 2024
ROCURONIUM BROMIDE50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML)injectable · injectionKNACKDiscontinued6 Jan 2026

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
EUGIA-ROCURONIUM BROMIDE INJECTION0249882010 MG / MLSOLUTION · INTRAVENOUSEUGIA PHARMA INC.
ROCURONIUM BROMIDE INJECTION0231841510 MG / MLSOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
ROCURONIUM BROMIDE INJECTION0246977410 MG / MLSOLUTION · INTRAVENOUSJUNO PHARMA CANADA INC.
ROCURONIUM BROMIDE INJECTION0251774410 MG / MLSOLUTION · INTRAVENOUSHIKMA CANADA LIMITED
ROCURONIUM BROMIDE INJECTION0252865710 MG / MLSOLUTION · INTRAVENOUSEUGIA PHARMA INC.
ROCURONIUM BROMIDE INJECTION0252983110 MG / MLSOLUTION · INTRAVENOUSJAMP PHARMA CORPORATION

Safety signals and safety-related labeling changes

All safety entries for rocuronium →

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.