Is Colistimethate registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Colistimethate, including COLISTIN JPI Powder For Solution For Injection/Infusion (1000000 IU, Powder for solution for injection/infusion, SAR 357.75); Colistimethate SPC (1,000,000 IU, Powder for solution for injection/infusion, SAR 321.95); Colistin JPI (2000000 IU, Powder for nebuliser solution/solution for injection/infusion, SAR 715.50); Olesten (1000000 IU, Powder for solution for injection/infusion, SAR 279.90); Polmycol (1 million IU, Powder for solution for injection/infusion, SAR 305.85).

Is Colistimethate approved by the US FDA?

Drugs@FDA lists 7 application product lines for Colistimethate, including COLISTIMETHATE SODIUM (Prescription); COLISTIMETHATE SODIUM (Prescription); COLISTIMETHATE SODIUM (Prescription); COLISTIMETHATE SODIUM (Prescription); COLY-MYCIN M (Discontinued).

Is Colistimethate authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Colistimethate: Colobreathe.

Are there safety signals or safety updates for Colistimethate?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2025-07-03).

Active substance

Colistimethate

SFDA 6
US FDA 7
EMA 1
Health Canada 1
US price lines 1
NHS prices 3
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
COLISTIN JPI Powder For Solution For Injection/Infusion	1000000 IU	Powder for solution for injection/infusion · Intravenous use	10 Vial	SAR 357.75	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Colistimethate SPC	1,000,000 IU	Powder for solution for injection/infusion · Intravenous use	10 Vial	SAR 321.95	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Colistin JPI	2000000 IU	Powder for nebuliser solution/solution for injection/infusion · Intravenous and Inhalation Use	10 Vial	SAR 715.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Olesten	1000000 IU	Powder for solution for injection/infusion · Intravenous use	10 Vial	SAR 279.90	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Polmycol	1 million IU	Powder for solution for injection/infusion · Intravenous use	10 Vial	SAR 305.85	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
COLIMEX TABLETS 1.5 million UNITS	1500000 IU	Tablet · Oral use	10 Blister	SAR 35.05	NCE · Prescription	ALPHARMA APS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS)-LONG-TERM ORAL ANTIBIOTIC TREATMENT; ACUTE PYELONEPHRITIS; CYSTIC FIBROSIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; INTRA-ABDOMINAL INFECTIONS; OSTEOMYELITIS; PERITONITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	injectable · injection	FRESENIUS KABI USA	Prescription	17 Apr 2008
COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	injectable · injection	AVET LIFESCIENCES	Prescription	28 Sep 2012
COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	injectable · injection	SAGENT PHARMS INC	Prescription	19 Feb 2014
COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	injectable · injection	XELLIA PHARMS APS	Prescription	29 May 2015
COLY-MYCIN M	EQ 150MG BASE/VIAL	injectable · injection	PH HEALTH	Discontinued	4 Jun 1970
COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	injectable · injection	PHARMOBEDIENT	Discontinued	26 Feb 1999
COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	injectable · injection	NEXUS	Discontinued	19 Mar 2004

EMA European Union — centrally authorised medicines

Colobreathe Essential Pharma Limited · Authorised · authorised 13 Feb 2012 · ATC J01XB01

Therapeutic indication (EMA)

Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged six years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
COLISTIMETHATE FOR INJECTION USP	02546639	150 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULAR	MARCAN PHARMACEUTICALS INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	COLISTIMETHATE 150 MG VIAL	$15.48667	per EA	3 Jun 2026
NHS Drug Tariff	Colistimethate 1,662,500unit inhalation powder capsules	£968.80	56 capsule	1 Oct 2026
NHS Drug Tariff	Colistimethate 1million unit powder for solution for injection vials	£33.98	10 vial	1 Oct 2026
NHS Drug Tariff	Colistimethate 2million unit powder for solution for injection vials	£54.96	10 vial	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 3 Jul 2025 COLY-MYCIN M — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
EMA PRAC 9 Feb 2023 PRAC signal: Pseudo-Bartter syndrome
Action for MAH: update of the product information: Yes
EMA PRAC 29 Sep 2022 PRAC signal: Pseudo-Bartter syndrome
Action for MAH: update of the product information: No

All safety entries for colistimethate →

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.