Regulatory PathRegulatory requirements compared

Active substance

Clofarabine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Allbloc1 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 4011.70NCE · PrescriptionBoston Oncology ArabiaValid
Clofarabine Ratiopharm1 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 1737.10Generic · PrescriptionRatiopharm GmbHValid
Evoltra1 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 4011.70NCE · PrescriptionGENZYME EUROPE B.V.Valid
Retebin1 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 3811.10Generic · PrescriptionPharma Pharmaceutical Industries (PPI)Valid

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

ProductStrengthForm · routeApplicantStatusFirst approved
CLOFARABINE20MG/20ML (1MG/ML)solution · intravenousDR REDDYSPrescription6 Nov 2017
CLOFARABINE20MG/20ML (1MG/ML)solution · intravenousAMNEALPrescription6 Nov 2017
CLOFARABINE20MG/20ML (1MG/ML)solution · intravenousMSNPrescription6 Dec 2017
CLOFARABINE20MG/20ML (1MG/ML)solution · intravenousGLANDPrescription31 Oct 2018
CLOFARABINE20MG/20ML (1MG/ML)solution · intravenousACCORD HLTHCAREPrescription22 Feb 2019
CLOFARABINE20MG/20ML (1MG/ML)solution · intravenousMEITHEALPrescription23 Oct 2020
CLOFARABINE20MG/20ML (1MG/ML)solution · intravenousSCINOPHARM TAIWANPrescription3 Jan 2025
CLOLAR20MG/20ML (1MG/ML)solution · intravenousGENZYMEDiscontinued28 Dec 2004
CLOFARABINE20MG/20ML (1MG/ML)solution · intravenousMLVDiscontinued9 May 2017
CLOFARABINE20MG/20ML (1MG/ML)solution · intravenousPHARMOBEDIENTDiscontinued6 Nov 2017
CLOFARABINE20MG/20ML (1MG/ML)solution · intravenousINGENUS PHARMS LLCDiscontinued14 Sep 2018
CLOFARABINE20MG/20ML (1MG/ML)solution · intravenousHOSPIRADiscontinued27 Dec 2018
CLOFARABINE20MG/20ML (1MG/ML)solution · intravenousEUGIA PHARMADiscontinued3 Oct 2022

EMA European Union — centrally authorised medicines

Evoltra Sanofi B.V. · Authorised · authorised 29 May 2006 · ATC L01BB06

Therapeutic indication (EMA)

Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis.

Ivozall ORPHELIA Pharma · Withdrawn · authorised 14 Nov 2019 · ATC L01BB06

Therapeutic indication (EMA)

Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CLOLAR023304071 MG / MLSOLUTION · INTRAVENOUSSANOFI-AVENTIS CANADA INC

Safety signals and safety-related labeling changes

  • US FDA 20 Dec 2019 CLOLAR — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for clofarabine →

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.