Is Cilastatin + Imipenem 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 Cilastatin + Imipenem, including IMIPENEM-CILASTATIN LABATEC 500/500 VIAL (500,500 mg,mg, Powder for solution for infusion, SAR 313.35); IVNEM (500,500 mg,mg, Powder for solution for infusion, SAR 313.35); Imesta 500 mg/500 mg Powder For IV Infusion (10S) (500,500 mg,mg, Powder for solution for infusion, SAR 348.15); Imesta 500 mg/500 mg Powder For IV Infusion (1Vial) (500,500 mg,mg, Powder for solution for infusion, SAR 34.80); LASTINEM 500 mg powder for solution for infusion (500,500 mg,mg, Powder for solution for infusion, SAR 213.50).

Is Cilastatin + Imipenem approved by the US FDA?

Drugs@FDA lists 8 application product lines for Cilastatin + Imipenem, including PRIMAXIN (Prescription); IMIPENEM AND CILASTATIN (Prescription); IMIPENEM AND CILASTATIN (Prescription); PRIMAXIN (Discontinued); PRIMAXIN (Discontinued).

Is Cilastatin + Imipenem on the WHO Model List of Essential Medicines?

Yes — 6.2.2. Watch group antibiotics (complementary list): Second choice: Therapeutic equivalent to meropenem for Peritoneal abscess (severe); Second choice: Therapeutic equivalent to meropenem for Neutropaenia (high-risk); Second choice: Therapeutic equivalent to meropenem for Peritonitis (severe).

Active substances

Cilastatin + Imipenem

SFDA 7
US FDA 8
Health Canada 2
WHO EML 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
IMIPENEM-CILASTATIN LABATEC 500/500 VIAL	500,500 mg,mg	Powder for solution for infusion · Intravenous use	10 Vial	SAR 313.35	Generic · Prescription	Labatec- Pharma S.A	Valid
IVNEM	500,500 mg,mg	Powder for solution for infusion · Intravenous use	10 Vial	SAR 313.35	Generic · Prescription	Hikma FARMACEUTICA Portugal SA	Valid
Imesta 500 mg/500 mg Powder For IV Infusion (10S)	500,500 mg,mg	Powder for solution for infusion · Intravenous use	10 Vial	SAR 348.15	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Imesta 500 mg/500 mg Powder For IV Infusion (1Vial)	500,500 mg,mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 34.80	Generic · Prescription	SPIMACO ADDWAEIH	Valid
LASTINEM 500 mg powder for solution for infusion	500,500 mg,mg	Powder for solution for infusion · Intravenous use	5 Vial	SAR 213.50	Generic · Prescription	VENUS REMEDIES LIMITED	Valid
TIENAM 500 MG VIAL I.V.	500,500 mg,mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 56.30	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
ZAYNAM powder for solution for infusion	500,500 mg,mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 47.85	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE BACTERIAL PROSTATITIS; ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); ACUTE PANCREATITIS; ACUTE PYELONEPHRITIS; BACTERIAL SKIN INFECTIONS - CELLULITIS; BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL SKIN INFECTIONS - GAS GANGRENE; BACTERIAL SKIN INFECTIONS - NECROTIZING FASCIITIS; BACTERIAL SKIN INFECTIONS - SURGICAL SITE INFECTIONS; COMMUNITY ACQUIRED PNEUMONEA; ENDOCARDITIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; INTRA-ABDOMINAL INFECTIONS; OSTEOMYELITIS; PERITONITIS; Pyogenic Arthritis; Septic Shock; TRAVEL RELATED INFECTIONS-TREATMENT; TUBERCULOSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	powder · intravenous	MERCK	Prescription	26 Nov 1985
IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL; EQ 500MG BASE/VIAL;500MG/VIAL	powder · intravenous	ACS DOBFAR	Prescription	21 Dec 2011
IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	powder · intravenous	HQ SPCLT PHARMA	Prescription	12 Dec 2019
PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	powder · intravenous	MERCK	Discontinued	26 Nov 1985
PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL; EQ 500MG BASE/VIAL;500MG/VIAL	injectable · injection	MERCK	Discontinued	8 Jan 1987
PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL; EQ 750MG BASE/VIAL;750MG/VIAL	powder · intramuscular	MERCK	Discontinued	14 Dec 1990
IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL; EQ 500MG BASE/VIAL;500MG/VIAL	powder · intravenous	HOSPIRA INC	Discontinued	16 Nov 2011
IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	powder · intravenous	HOSPIRA INC	Discontinued	16 Nov 2011

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
IMIPENEM AND CILASTATIN FOR INJECTION USP	02358344	500 MG / VIAL; 500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
TARO-IMIPENEM-CILASTATIN	02351706	500 MG / VIAL; 500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	SUN PHARMA CANADA INC

WHO WHO Model List of Essential Medicines (2025)

6.2.2. Watch group antibiotics · complementary
Second choice: Therapeutic equivalent to meropenem for Peritoneal abscess (severe); Second choice: Therapeutic equivalent to meropenem for Neutropaenia (high-risk); Second choice: Therapeutic equivalent to meropenem for Peritonitis (severe)
6.2.5. Antituberculosis medicines · core
Therapeutic equivalent to meropenem for Multi-drug resistant Mycobacterium tuberculosis

Components

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.