Regulatory PathRegulatory requirements compared

Active substance

Carboplatin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CARBOPLATIN "EBEWE" 50MG-5ML10 mg/mlConcentrate for solution for infusion · Parenteral use1 VialSAR 141.40Generic · PrescriptionEBEWE PHARMAValid
CARBOPLATIN "EBEWE" 50MG-5ML10 mg/mlConcentrate for solution for infusion · Parenteral use1 VialSAR 281.35Generic · PrescriptionEBEWE PHARMAValid
CARBOPLATIN 10MG-ML VIAL10 mg/mlSolution · Parenteral use1 VialSAR 141.40NCE · PrescriptionHOSPIRA UK LIMITEDValid
CARBOPLATIN 10MG-ML VIAL10 mg/mlSolution · Parenteral use1 VialSAR 336.65NCE · PrescriptionHOSPIRA UK LIMITEDValid
CARTINUM 10 MG/ML VIAL10 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 242.20Generic · PrescriptionAccord Healthcare LimitedValid
CARTINUM 150 MG/15 ML10 mg/mlConcentrate for solution for infusion · Intravenous use1 VialSAR 127.25Generic · PrescriptionAccord Healthcare LimitedValid
CARBOPLATIN "EBEWE" 50MG-5ML10 mg/mlConcentrate for solution for infusion · Parenteral use1 VialSAR 51.40Generic · PrescriptionEBEWE PHARMAWithdrawn by MAH · Not Marketed
CARBOPLATIN 10MG-ML VIAL10 mg/mlSolution · Parenteral use1 VialSAR 446.55NCE · PrescriptionHOSPIRA AUSTRALIAWithdrawn by MAH · Not Marketed
CARBOPLATIN 10MG-ML VIAL10 mg/mlSolution · Parenteral use1 VialSAR 194.50NCE · PrescriptionHOSPIRA AUSTRALIAWithdrawn by MAH · Not Marketed
CARBOTINOL 10MG/ML INJECTION10 mg/mlInjection · Intravenous use1 VialSAR 293.30Generic · PrescriptionEMIC UNITED PHARMACEUTICALSWithdrawn by MAH · Not Marketed
KARBOTEEN 10 mg/ml Solution For IV Infusion10 mg/mlSolution · Intravenous use1 VialSAR 102.85Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Withdrawn by MAH · Not Marketed
KARBOTEEN 10 mg/ml Solution For IV Infusion10 mg/mlSolution · Intravenous use1 VialSAR 257.10Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Withdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ANAL CANCER; BLADDER CANCER; BONE SARCOMAS; BRAIN CANCERS; BREAST CANCER EARLY HER-2 -VE; BREAST CANCER HER-2 +VE; BREAST CANCER MET.HER-2 +VE; BREAST CANCER MET.HER-2 -VE; BURKITT`S LYMPHOMA; Cervical Cancer; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); ENDOMETRIAL CANCER; ESOPHAGEAL CANCER; FOLLICULAR LYMPHOMA; GASTRIC CANCER; HEAD AND NECK CANCER; HODGKIN'S LYMPHOMA; MANTLE CELL LYMPHOMA; MESOTHELIOMA; Neuroblastoma; NEUROENDOCRINE TUMORS; Neurofibromatosis Type 1 - Optic Pathway Glioma; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); OVARIAN CANCER; PEDIATRIC B-CELL LYMPHOMA; PROSTATE CANCER; RENAL CELL CARCINOMA (RCC)-COLLECTING DUCT, MEDULLARY NON-CC RCC; RETINOBLASTOMA; SMALL CELL LUNG CANCER (SCLC); SOFT TISSUE SARCOMA - RHABDOMYOSARCOMA; T-CELL LYMPHOMA; TESTICULAR CANCER; THYROID CANCER-ANAPLASTIC CARCINOMA; VAGINAL AND VULVAR CANCERS; WILMS TUMOR

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

ProductStrengthForm · routeApplicantStatusFirst approved
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML)injectable · intravenousHOSPIRAPrescription14 Oct 2004
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML); 600MG/60ML (10MG/ML)injectable · intravenousPHARMACHEMIE BVPrescription14 Oct 2004
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML); 600MG/60ML (10MG/ML)injectable · intravenousHIKMA PHARMSPrescription15 Oct 2004
CARBOPLATIN600MG/60ML (10MG/ML)injectable · intravenousHOSPIRAPrescription23 Nov 2004
CARBOPLATIN450MG/45ML (10MG/ML); 600MG/60ML (10MG/ML)injectable · intravenousFRESENIUS KABI USAPrescription15 Feb 2006
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML); 600MG/60ML (10MG/ML)injectable · intravenousTEYRO LABSPrescription18 Jan 2007
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML)injectable · intravenousSANDOZPrescription8 May 2008
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML)injectable · intravenousSUN PHARMPrescription19 Sep 2008
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML)injectable · intravenousEPIC PHARMA LLCPrescription29 Jul 2009
CARBOPLATIN600MG/60ML (10MG/ML)injectable · intravenousEPIC PHARMA LLCPrescription28 Jul 2010
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML); 600MG/60ML (10MG/ML)injectable · intravenousEUGIA PHARMAPrescription28 Mar 2016
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML); 600MG/60ML (10MG/ML); 1GM/100ML (10MG/ML)injectable · intravenousACCORD HLTHCAREPrescription9 Feb 2017
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML); 600MG/60ML (10MG/ML)injectable · intravenousGLANDPrescription15 Feb 2017
KYXATA80MG/8ML (10MG/ML); 500MG/50ML (10MG/ML)solution · intravenousAVYXA HOLDINGSPrescription8 Aug 2025
PARAPLATIN50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionCORDEN PHARMADiscontinued3 Mar 1989
PARAPLATIN50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 150MG/15ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 450MG/45ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 600MG/60ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · intravenousCORDENPHARMADiscontinued14 Jul 2003
CARBOPLATIN50MG/VIAL; 150MG/VIAL; 450MG/VIALinjectable · injectionHIKMA PHARMSDiscontinued14 Oct 2004
CARBOPLATIN50MG/VIAL; 150MG/VIAL; 450MG/VIALinjectable · injectionWATSON LABS TEVADiscontinued14 Oct 2004
CARBOPLATIN50MG/VIAL; 150MG/VIAL; 450MG/VIALinjectable · injectionFRESENIUS KABI USADiscontinued14 Oct 2004
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML)injectable · intravenousFRESENIUS KABI USADiscontinued21 Oct 2004
CARBOPLATIN50MG/VIAL; 150MG/VIAL; 450MG/VIALinjectable · injectionHOSPIRADiscontinued27 Oct 2004
CARBOPLATIN50MG/VIAL; 150MG/VIAL; 450MG/VIALinjectable · injectionPLIVADiscontinued16 Nov 2004
CARBOPLATIN50MG/VIAL; 150MG/VIAL; 450MG/VIALinjectable · injectionSANDOZDiscontinued18 Mar 2005
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML); 600MG/60ML (10MG/ML)injectable · intravenousMEITHEALDiscontinued14 Jun 2005
CARBOPLATIN50MG/5ML (10MG/ML); 150MG/15ML (10MG/ML); 450MG/45ML (10MG/ML); 600MG/60ML (10MG/ML)injectable · intravenousTEVA PHARMS USADiscontinued21 Sep 2005

14 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CARBOPLATIN INJECTION0212543910 MG / MLSOLUTION · INTRAVENOUSTEVA CANADA LIMITED
CARBOPLATIN INJECTION BP0212668010 MG / MLSOLUTION · INTRAVENOUSPFIZER CANADA ULC
CARBOPLATIN INJECTION BP0232037110 MG / MLSOLUTION · INTRAVENOUSACCORD HEALTHCARE INC

WHO WHO Model List of Essential Medicines (2025)

  • 8.2.1. Cytotoxic medicines · complementary
    Other specified gliomas of brain; Malignant neoplasms of other or ill-defined sites in the lip, oral cavity or pharynx; Malignant neoplasms of cervix uteri; Malignant neoplasms of hypopharynx; Malignant neoplasms of nasopharynx; Malignant neoplasms of oropharynx; Osteosarcoma of bone or articular cartilage of unspecified sites; Other specified malignant neoplasms of the ovary; Germ cell tumour of testis; Other specified carcinomas of ovary; Other specified malignant neoplasms of bronchus or lung; Malignant neoplasms of breast; Retinoblastoma; Malignant neoplasms of kidney, except renal pelvis
    Parenteral > General injections > IV: 50 mg per 5 mL; 150 mg per 15 mL; 450 mg per 45 mL; 600 mg per 60 mL

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.