Regulatory PathRegulatory requirements compared

Active substance

Oxaliplatin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
BATIPAN 100 mg per 50 ml - VIAL2 mg/mlPowder for solution for infusion · Intravenous use1 VialSAR 237.25Generic · PrescriptionBoston Oncology ArabiaValid
BATIPAN 50MG INJECTION5 mgPowder for solution for infusion · Intravenous use1 VialSAR 118.60Generic · PrescriptionBoston Oncology ArabiaValid
ELOXATIN 100MG VIAL100 mgConcentrate for solution for infusion · Intravenous use1 VialSAR 1835.65NCE · PrescriptionSANOFI AVENTIS DEUTSCHLAND GMBHValid
ELOXATIN 50MG VIAL50 mgConcentrate for solution for infusion · Intravenous use1 VialSAR 966.10NCE · PrescriptionSANOFI AVENTIS DEUTSCHLAND GMBHValid
OXALIPLATIN 5MG/ML (20ml)5 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 444.35Generic · PrescriptionAccord Healthcare LimitedValid
OXALIPLATIN MEDAC 100MG POWDER100 mgPowder for solution for infusion · Intravenous use1 VialSAR 773.50Generic · PrescriptionMEDACValid
OXALIPLATIN MEDAC 150MG POWDER150 mgPowder for solution for infusion · Intravenous use1 VialSAR 1160.25Generic · PrescriptionMEDACValid
OXALIPLATIN MEDAC 50MG POWDER50 mgPowder for solution for infusion · Intravenous use1 VialSAR 396.80Generic · PrescriptionMEDACValid
Oxaliplatin AqVida 100 mg per 20 ml5 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 234.75Generic · PrescriptionAqVida GmbHValid
Oxaliplatin AqVida 200 mg per 40 ml5 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 449.30Generic · PrescriptionAqVida GmbHValid
Oxaliplatin AqVida 50 mg per 10 ml5 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 114.90Generic · PrescriptionAqVida GmbHValid
PLAXOTRIN 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION (10ml)5 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 118.60Generic · PrescriptionGENEPHARM S.AValid
PLAXOTRIN 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION (20 ml)5 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 237.25Generic · PrescriptionGENEPHARM S.AValid
XALTIN 5MG/ML CONC. FOR SOLUTION FOR INFUSION (10ml)5 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 222.15Generic · PrescriptionAccord Healthcare LimitedValid
Xaliptine5 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 234.75Generic · PrescriptionHEXAL AGValid
Xaliptine5 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 114.90Generic · PrescriptionHEXAL AGValid
ELOXATIN 100MG VIAL100 mgConcentrate for solution for infusion · Intravenous use1 VialSAR 2402.40NCE · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
ELOXATIN 50MG VIAL50 mgConcentrate for solution for infusion · Intravenous use1 VialSAR 1396.75NCE · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
OXALIPLATIN 5 MG-ML VIAL5 mg/mlSolution for infusion · Intravenous use1 VialSAR 1458.10Generic · PrescriptionEBEWE PHARMAWithdrawn by MAH · Not Marketed
OXALIPLATIN 5 MG-ML VIAL5 mg/mlSolution for infusion · Intravenous use1 VialSAR 1968.45Generic · PrescriptionEBEWE PHARMAWithdrawn by MAH · Not Marketed
OXALIPLATIN 5 MG-ML VIAL5 mg/mlSolution for infusion · Intravenous use1 VialSAR 767.45Generic · PrescriptionEBEWE PHARMAWithdrawn by MAH · Not Marketed
OXALIPLATIN ACTAVIS 100 mg lyophilisate for solution for infusion100 mgSolution for infusion · Intravenous use1 VialSAR 444.35Generic · PrescriptionACTAVISWithdrawn by MAH · Not Marketed
OXALIPLATIN ACTAVIS 50 mg lyophilisate for solution for infusion50 mgSolution for infusion · Intravenous use1 VialSAR 222.15Generic · PrescriptionACTAVISWithdrawn by MAH · Not Marketed
OXALIPLATIN HOSPIRA 5MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION5 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 619.90Generic · PrescriptionHOSPIRA UK LIMITEDWithdrawn by MAH · Not Marketed
OXALIPLATIN HOSPIRA 5MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION5 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 309.95Generic · PrescriptionHOSPIRA UK LIMITEDWithdrawn by MAH · Not Marketed

4 more — full table

Indications — CHI Daman Drug Formulary

ANAL CANCER; BILIARY TRACT CANCER; COLORECTAL CANCER-EARLY & ADVANCED; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); ESOPHAGEAL CANCER; FOLLICULAR LYMPHOMA; GASTRIC CANCER; HODGKIN'S LYMPHOMA; MALIGNANT NEOPLASM OF THE PANCREAS; MANTLE CELL LYMPHOMA; NEUROENDOCRINE TUMORS; OVARIAN CANCER; T-CELL LYMPHOMA; TESTICULAR CANCER

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

ProductStrengthForm · routeApplicantStatusFirst approved
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML)injectable · intravenousHOSPIRA WORLDWIDEPrescription7 Aug 2009
OXALIPLATIN50MG/VIAL; 100MG/VIALinjectable · intravenousFRESENIUS KABI USAPrescription2 Jun 2010
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML)injectable · intravenousFRESENIUS KABI USAPrescription10 Jun 2010
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML)injectable · intravenousSANDOZPrescription24 Jan 2011
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML)injectable · intravenousMYLAN LABS LTDPrescription7 Aug 2012
OXALIPLATIN50MG/VIAL; 100MG/VIALinjectable · intravenousQILU PHARM HAINANPrescription11 May 2016
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML); 200MG/40ML (5MG/ML)injectable · intravenousQILU PHARM HAINANPrescription7 Jun 2016
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML)injectable · intravenousGLANDPrescription10 Feb 2017
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML)injectable · intravenousACCORD HLTHCAREPrescription21 Mar 2017
OXALIPLATIN50MG/VIAL; 100MG/VIALinjectable · intravenousGLANDPrescription23 May 2017
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML)injectable · intravenousMEITHEALPrescription11 Jan 2024
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML)injectable · intravenousHETERO LABS LTD VIPrescription27 Jan 2025
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML)injectable · intravenousSHANDONGPrescription15 Jan 2026
ELOXATIN50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · intravenousSANOFI AVENTIS USDiscontinued9 Aug 2002
ELOXATIN50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · intravenousSANOFI AVENTIS USDiscontinued31 Jan 2005
OXALIPLATIN50MG/VIAL; 100MG/VIALinjectable · intravenousFRESENIUS KABI ONCOLDiscontinued7 Aug 2009
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML)injectable · intravenousSANDOZDiscontinued7 Aug 2009
OXALIPLATIN50MG/VIAL; 100MG/VIALinjectable · intravenousSUN PHARMDiscontinued7 Aug 2009
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML)injectable · intravenousTEVA PHARMSDiscontinued7 Aug 2009
OXALIPLATIN50MG/VIAL; 100MG/VIALinjectable · intravenousHOSPIRA INCDiscontinued30 Sep 2009
OXALIPLATIN50MG/VIAL; 100MG/VIALinjectable · intravenousSANDOZDiscontinued28 Apr 2011
OXALIPLATIN200MG/40ML (5MG/ML)injectable · intravenousMYLAN LABS LTDDiscontinued7 Aug 2012
OXALIPLATIN50MG/VIAL; 100MG/VIALinjectable · intravenousACTAVIS TOTOWADiscontinued8 Aug 2012
OXALIPLATIN50MG/VIAL; 100MG/VIALinjectable · intravenousPHARMOBEDIENTDiscontinued8 Aug 2012
OXALIPLATIN50MG/10ML (5MG/ML); 100MG/20ML (5MG/ML); 200MG/40ML (5MG/ML)injectable · intravenousSUN PHARMDiscontinued8 Apr 2014

9 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
OXALIPLATIN024447635 MG / MLSOLUTION · INTRAVENOUSPFIZER CANADA ULC
OXALIPLATIN INJECTION024350715 MG / MLSOLUTION · INTRAVENOUSTEVA CANADA LIMITED
OXALIPLATIN INJECTION024369575 MG / MLSOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
OXALIPLATIN INJECTION, USP024574235 MG / MLSOLUTION · INTRAVENOUSFRESENIUS KABI CANADA LTD
OXALIPLATIN INJECTION, USP024584035 MG / MLSOLUTION · INTRAVENOUSDR REDDY'S LABORATORIES LTD

WHO WHO Model List of Essential Medicines (2025)

  • 8.2.1. Cytotoxic medicines · complementary
    Malignant neoplasm metastasis in large intestine; Malignant neoplasms of colon
    Parenteral > General injections > IV: 50 mg in vial powder for injection; 100 mg in vial powder for injection; 50 mg per 10 mL in 10 mL vial; 100 mg per 20 mL in 20 mL vial; 200 mg per 40 mL in 40 mL vial

Safety signals and safety-related labeling changes

  • US FDA 31 Oct 2024 OXALIPLATIN — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 23 Jun 2023 ELOXATIN — safety-related labeling change
    Labeling sections changed: Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for oxaliplatin →

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.