Is Cisplatin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Cisplatin, including CIPALIN 0.5 mg/ml Vial (10 mg, Concentrate for solution for infusion, SAR 21.00); CISPLATIN 0.5MG-ML INJ. (0.5 mg/ml, Concentrate for dispersion for injection, SAR 86.50); CISPLATIN 1MG-1ML VIAL (1 mg/ml, concentrate for solution for injection, SAR 72.10); Cisplatin 1 mg/ml VIAL (1 mg/ml, Solution for infusion, SAR 60.00).

Is Cisplatin approved by the US FDA?

Drugs@FDA lists 12 application product lines for Cisplatin, including CISPLATIN (Prescription); CISPLATIN (Prescription); CISPLATIN (Prescription); CISPLATIN (Prescription); CISPLATIN (Prescription).

Is Cisplatin on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (complementary list): 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 oropharynx; Malignant neoplasms of nasopharynx; Germ cell tumour of testis; Osteosarcoma of bone or articular cartilage of unspecified sites; Other specified malignant neoplasms of the ovary; Other specified malignant neoplasms of bronchus or lung.

Are there safety signals or safety updates for Cisplatin?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2019-02-22).

Active substance

Cisplatin

SFDA 13
US FDA 12
Health Canada 4
WHO EML 2
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CIPALIN 0.5 mg/ml Vial	10 mg	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 21.00	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
CIPALIN 0.5 mg/ml Vial	10 mg	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 43.25	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
CIPALIN 0.5 mg/ml Vial	10 mg	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 60.00	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
CISPLATIN 0.5MG-ML INJ.	0.5 mg/ml	Concentrate for dispersion for injection · Parenteral use	1 Vial	SAR 86.50	Generic · Prescription	EBEWE PHARMA	Valid
CISPLATIN 0.5MG-ML INJ.	0.5 mg/ml	Concentrate for dispersion for injection · Parenteral use	1 Vial	SAR 24.40	Generic · Prescription	EBEWE PHARMA	Valid
CISPLATIN 1MG-1ML VIAL	1 mg/ml	concentrate for solution for injection · Parenteral use	1 Vial	SAR 72.10	Generic · Prescription	HOSPIRA UK LIMITED	Valid
Cisplatin 1 mg/ml VIAL	1 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 60.00	Generic · Prescription	Accord Healthcare Limited	Valid
CISPLATIN 1MG-1ML VIAL	1 mg/ml	concentrate for solution for injection · Parenteral use	1 Vial	SAR 54.60	Generic · Prescription	HOSPIRA AUSTRALIA	Withdrawn by MAH · Not Marketed
CISPLATIN 1MG-1ML VIAL	1 mg/ml	concentrate for solution for injection · Parenteral use	1 Vial	SAR 106.80	Generic · Prescription	HOSPIRA AUSTRALIA	Withdrawn by MAH · Not Marketed
CISPLATYL 10MG VIAL	10 mg	Solution · Intramuscular use	1 Vial	SAR 28.35	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
CISPLATYL 25MG VIAL	25 mg	Solution · Intramuscular use	1 Vial	SAR 57.70	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
CISPLATYL 50MG VIAL	50 mg	Solution · Intramuscular use	1 Vial	SAR 66.70	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
Cisplatin 1 mg/ml VIAL	1 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 21.00	Generic · Prescription	Accord Healthcare Limited	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANAL CANCER; BILIARY TRACT CANCER; BLADDER CANCER; BONE SARCOMAS; BRAIN CANCERS; BREAST CANCER - TRIPLE NEGATIVE; 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; MALIGNANT NEOPLASM OF THE PANCREAS; MANTLE CELL LYMPHOMA; MESOTHELIOMA; MULTIPLE MYELOMA; Neuroblastoma; NEUROENDOCRINE TUMORS; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); OVARIAN CANCER; RENAL CELL CARCINOMA (RCC)-COLLECTING DUCT, MEDULLARY NON-CC RCC; SMALL CELL LUNG CANCER (SCLC); T-CELL LYMPHOMA; TESTICULAR CANCER; THYROID CANCER-ANAPLASTIC CARCINOMA; VAGINAL AND VULVAR CANCERS

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

Product	Strength	Form · route	Applicant	Status	First approved
CISPLATIN	50MG/VIAL; 1MG/ML	injectable · injection	HQ SPCLT PHARMA	Prescription	19 Dec 1978
CISPLATIN	1MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	16 Jul 1999
CISPLATIN	1MG/ML	injectable · injection	PHARMACHEMIE BV	Prescription	16 May 2000
CISPLATIN	1MG/ML	injectable · injection	HIKMA PHARMS	Prescription	7 Nov 2000
CISPLATIN	1MG/ML	injectable · injection	ACCORD HLTHCARE	Prescription	18 Aug 2015
CISPLATIN	1MG/ML	injectable · injection	GLAND	Prescription	17 Mar 2017
CISPLATIN	1MG/ML	injectable · injection	QILU	Prescription	10 May 2024
PLATINOL	10MG/VIAL	injectable · injection	HQ SPCLT PHARMA	Discontinued	19 Dec 1978
PLATINOL-AQ	0.5MG/ML	injectable · injection	HQ SPCLT PHARMA	Discontinued	19 Dec 1978
CISPLATIN	1MG/ML	injectable · injection	TEVA PHARMS USA	Discontinued	16 May 2000
CISPLATIN	10MG/VIAL; 50MG/VIAL	injectable · injection	BEDFORD	Discontinued	14 Nov 2000
CISPLATIN	1MG/ML	injectable · injection	PHARMOBEDIENT	Discontinued	18 Apr 2012

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CISPLATIN INJECTION	02403188	1.0 MG / ML	SOLUTION · INTRAVENOUS	TEVA CANADA LIMITED
CISPLATIN INJECTION BP	02126613	1 MG / ML	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
CISPLATIN INJECTION BP	02536285	1 MG / ML	SOLUTION · INTRAVENOUS	HIKMA CANADA LIMITED
CISPLATIN INJECTION, BP	02355183	1 MG / ML	SOLUTION · INTRAVENOUS	ACCORD 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 oropharynx; Malignant neoplasms of nasopharynx; Germ cell tumour of testis; Osteosarcoma of bone or articular cartilage of unspecified sites; Other specified malignant neoplasms of the ovary; Other specified malignant neoplasms of bronchus or lung
Parenteral > General injections > IV: 10 mg per 10 mL; 20 mg per 20 mL; 50 mg per 50 mL; 100 mg per 100 mL
8.2.1. Cytotoxic medicines · core
Malignant neoplasms of nasopharynx
Parenteral > General injections > IV: 50 mg per 50 mL; 100 mg per 100 mL; 10 mg per 10 mL; 20 mg per 20 mL

Safety signals and safety-related labeling changes

US FDA 22 Feb 2019 CISPLATIN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 9 Jun 2016 PRAC signal: Peripheral arterial thromboembolic events (ATEs) and arterial occlusion
Action for MAH: update of the product information: No
EMA PRAC 14 Jan 2016 PRAC signal: Peripheral arterial thromboembolic events (ATEs) and arterial occlusion
Action for MAH: update of the product information: No

All safety entries for cisplatin →

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.