Regulatory PathRegulatory requirements compared

Active substance

Vincristine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
VINCRISTIN SULPH. 1MG-ML VIAL1 mg/mlSolution for injection · Intravenous use5 VialSAR 159.80Generic · PrescriptionHOSPIRA UK LIMITEDValid
VINCRISTIN SULPH. 1MG-ML VIAL1 mg/mlSolution for injection · Intravenous use5 VialSAR 244.45Generic · PrescriptionHOSPIRA UK LIMITEDValid
VINBLASTINE SULPHATE 10MG-10ML VIAL1 mg/mlSolution for injection · Intravenous use5 VialSAR 223.75Generic · PrescriptionHOSPIRA AUSTRALIAWithdrawn by MAH · Not Marketed
VINCRISTIN SULPH. 1MG-ML VIAL1 mg/mlSolution · Intravenous use5 VialSAR 244.45Generic · PrescriptionHOSPIRA AUSTRALIAWithdrawn by MAH · Not Marketed
VINCRISTIN SULPH. 1MG-ML VIAL1 mg/mlSolution · Intravenous use5 VialSAR 159.80Generic · PrescriptionHOSPIRA AUSTRALIAWithdrawn by MAH · Not Marketed
VINCRISTINE ROGER BELLON 1MG-VIAL1 mgSolution · Intravenous use1 VialSAR 39.70Generic · PrescriptionSANOFI WINTHROP INDUSTRIEWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); BONE SARCOMAS; BRAIN CANCERS; BURKITT`S LYMPHOMA; CASTLEMAN DISEASE; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HODGKIN'S LYMPHOMA; IMMUNE THROMBOCYPTOPENIC PUPURA; LYMPHOPLASMACYTIC LYMPHOMA; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; Neuroblastoma; Neurofibromatosis Type 1 - Optic Pathway Glioma; PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL); PEDIATRIC B-CELL LYMPHOMA; RETINOBLASTOMA; SMALL CELL LUNG CANCER (SCLC); SOFT TISSUE SARCOMA - RHABDOMYOSARCOMA; T-CELL LYMPHOMA; THROMBOTIC THROMBOCYTOPENIC PURPURA; WILMS TUMOR

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

ProductStrengthForm · routeApplicantStatusFirst approved
VINCRISTINE SULFATE PFS1MG/MLinjectable · injectionHOSPIRAPrescription19 Apr 1988
ONCOVIN1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionLILLYDiscontinued10 Jul 1963
VINCASAR PFS1MG/MLinjectable · injectionTEVA PARENTERALDiscontinued17 Jul 1987
VINCREX5MG/VIALinjectable · injectionBRISTOL MYERS SQUIBBDiscontinued12 Jul 1988
VINCRISTINE SULFATE PFS1MG/MLinjectable · injectionTEVA PHARMS USADiscontinued1 Sep 1999
VINCRISTINE SULFATE1MG/MLinjectable · injectionFRESENIUS KABI USADiscontinued20 Dec 2002
VINCRISTINE SULFATE1MG/MLinjectable · injectionFRESENIUS KABI USADiscontinued28 Oct 2003
MARQIBO KIT5MG/5ML (1MG/ML)injectable, liposomal · intravenousACROTECHDiscontinued9 Aug 2012
VINCRISTINE SULFATE1MG/MLinjectable · injectionABRAXIS PHARMDiscontinued
VINCRISTINE SULFATE1MG/MLinjectable · injectionQUAD PHARMSDiscontinued
VINCRISTINE SULFATE1MG/MLinjectable · injectionQUAD PHARMSDiscontinued
VINCRISTINE SULFATE1MG/MLinjectable · injectionABICDiscontinued
VINCRISTINE SULFATE1MG/VIALinjectable · injectionQUAD PHARMSDiscontinued
VINCRISTINE SULFATE2MG/VIALinjectable · injectionQUAD PHARMSDiscontinued
VINCRISTINE SULFATE1MG/VIALinjectable · injectionHOSPIRADiscontinued
VINCRISTINE SULFATE2MG/VIALinjectable · injectionHOSPIRADiscontinued
VINCRISTINE SULFATE5MG/VIALinjectable · injectionHOSPIRADiscontinued
VINCRISTINE SULFATE5MG/VIALinjectable · injectionQUAD PHARMSDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
VINCRISTINE SULFATE INJECTION021433051 MG / MLSOLUTION · INTRAVENOUSTEVA CANADA LIMITED
VINCRISTINE SULFATE INJECTION USP021830131 MG / MLSOLUTION · INTRAVENOUSPFIZER CANADA ULC

WHO WHO Model List of Essential Medicines (2025)

  • 8.2.1. Cytotoxic medicines · complementary
    Other specified gliomas of brain; Diffuse large B-cell lymphoma, not otherwise specified; Burkitt lymphoma including Burkitt leukaemia; Lymphoid leukaemia, not elsewhere classified; Langerhans cell histiocytosis; Kaposi sarcoma of unspecified primary site; Rhabdomyosarcoma primary site; Hodgkin lymphoma; Malignant trophoblastic neoplasms of placenta; Follicular lymphoma; Ewing sarcoma of bone or articular cartilage of unspecified sites; Retinoblastoma; Malignant neoplasms of kidney, except renal pelvis
    Parenteral > General injections > IV: 1 mg in vial (vincristine sulfate); 5 mg in vial (vincristine sulfate); 1 mg per mL in vial (vincristine sulfate); 2 mg per 2 mL in vial (vincristine sulfate)

Safety signals and safety-related labeling changes

  • US FDA 8 Jun 2020 MARQIBO KIT — 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 vincristine →

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.