Is Insulin lispro registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Insulin lispro, including HUMALOG 100 I.U VIALS (100 IU/ml, Solution for injection, SAR 89.80); HUMALOG KWIK-PEN 100IU/ML (100 IU/ml, Solution for injection, SAR 161.30).

Is Insulin lispro approved by the US FDA?

Drugs@FDA lists 3 application product lines for Insulin lispro, including ADMELOG (Prescription); ADMELOG SOLOSTAR (Prescription); LYUMJEV (Prescription).

Is Insulin lispro authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Insulin lispro: Humalog, Liprolog, Insulin lispro Sanofi, Lyumjev (previously Liumjev), Bysumlog.

Is Insulin lispro on the WHO Model List of Essential Medicines?

Yes — 18.5.1. Insulins (core list): Therapeutic equivalent to insulin (analogue, rapid-acting) for Type 1 diabetes mellitus; Therapeutic equivalent to insulin (analogue, rapid-acting) for Type 2 diabetes mellitus.

Are there safety signals or safety updates for Insulin lispro?

EMA PRAC: 5 entries; US FDA: 3 entries (latest 2023-08-31).

Active substance

Insulin lispro

SFDA 9
US FDA 3
EMA 6
Health Canada 8
US price lines 8
NHS prices 4
WHO EML 1
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
HUMALOG 100 I.U VIALS	100 IU/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 89.80	Biological · Prescription	Eli Lilly and Company	Valid
HUMALOG KWIK-PEN 100IU/ML	100 IU/ml	Solution for injection · Subcutaneous use	5 Pre-filled pen	SAR 161.30	Biological · Prescription	ELI LILLY NEDERLAND B.V.	Valid
HUMALOG CARTIDGE 100IU/ml	100 IU/ml	Solution for infusion in cartridge · Subcutaneous use	5 Cartridge	SAR 168.60	Generic · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed
HUMALOG KWIK-PEN 100IU/ML	100 IU/ml	Suspension for injection · Subcutaneous use	5 Pre-filled pen	SAR 167.95	Biological · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed
Humalog Tempo Pen	100 IU/ml	Solution for injection in pre-filled pen · Subcutaneous use	5 Pre-filled pen	SAR 167.95	Biological · Prescription	ELI LILLY NEDERLAND B.V.	Withdrawn by MAH · Not Marketed
LYUMJEV	100 IU/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 93.75	Biological · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed
LYUMJEV Junior Kwikpen	100 IU/ml	Solution for injection · Subcutaneous use	5 Pre-filled pen	SAR 167.95	Biological · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed
LYUMJEV Kwikpen	100 IU/ml	Solution for injection · Subcutaneous use	5 Pre-filled pen	SAR 167.85	Biological · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed
Lyumjev KwikPen	200 IU/ml	Solution for injection · Subcutaneous use	5 Pre-filled pen	SAR 297.20	Biological · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 1; DIABETES MELLITUS TYPE 2; DIABETIC KETOACIDOSIS; GESTATIONAL DIABETES

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

Product	Strength	Form · route	Applicant	Status	First approved
ADMELOG	1000 UNITS/10ML (100 UNITS/ML); 300 UNITS/3ML (100 UNITS/ML)	solution · intravenous, subcutaneous	SANOFI-AVENTIS US	Prescription	11 Dec 2017
ADMELOG SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	solution · subcutaneous	SANOFI-AVENTIS US	Prescription	11 Dec 2017
LYUMJEV	100UNITS/ML(U-100); 200UNITS/ML(U-200)	injectable · injection	ELI LILLY AND CO	Prescription	15 Jun 2020

EMA European Union — centrally authorised medicines

Humalog Eli Lilly Nederland B.V. · Authorised · authorised 30 Apr 1996 · ATC A10AB04;A10AD04

Therapeutic indication (EMA)

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.

Liprolog Eli Lilly Nederland B.V. · Authorised · authorised 1 Aug 2001 · ATC A10AB04;A10AD04

Therapeutic indication (EMA)

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilisation of diabetes mellitus.

Insulin lispro Sanofi Sanofi Winthrop Industrie · Authorised · authorised 19 Jul 2017 · ATC A10AB04

Therapeutic indication (EMA)

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of diabetes mellitus.

Lyumjev (previously Liumjev) Eli Lilly Nederland B.V. · Authorised · authorised 24 Mar 2020 · ATC A10AB04

Therapeutic indication (EMA)

Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Bysumlog Sandoz GmbH · Authorised · authorised 6 May 2026 · ATC A10AB04

Therapeutic indication (EMA)

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Bysumlog is also indicated for the initial stabilisation of diabetes mellitus.

Liprolog Eli Lilly and Company Limited · Withdrawn · authorised 7 May 1997 · ATC A10AB04

Therapeutic indication (EMA)

For the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilization of diabetes mellitus. Liprolog is a short acting insulin and may be used in conjunction with a longer acting human insulin. Liprolog is indicated for preprandial administration.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ADMELOG	02469898	100 UNIT / ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC
ADMELOG	02469901	100 UNIT / ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC
ADMELOG SOLOSTAR	02469871	100 UNIT / ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC
HUMALOG	02229704	100 UNIT / ML	SOLUTION · SUBCUTANEOUS; INTRAMUSCULAR; INTRAVENOUS	ELI LILLY CANADA INC
HUMALOG	02470152	100 UNIT / ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
HUMALOG (CARTRIDGE)	02229705	100 UNIT / ML	SOLUTION · INTRAMUSCULAR; SUBCUTANEOUS; INTRAVENOUS	ELI LILLY CANADA INC
HUMALOG (KWIKPEN)	02403412	100 UNIT / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS; INTRAMUSCULAR	ELI LILLY CANADA INC
HUMALOG 200 UNITS/ML KWIKPEN	02439611	200 UNIT / ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ADMELOG 100 UNIT/ML VIAL	$9.39379	per ML	23 Sep 2026
US NADAC	ADMELOG 100 UNIT/ML VIAL	$12.56125	per ML	23 Sep 2026
US NADAC	ADMELOG SOLOSTAR 100 UNIT/ML	$12.10918	per ML	23 Sep 2026
US NADAC	INSULIN LISPRO 100 UNIT/ML KWIKPEN	$10.19333	per ML	23 Sep 2026
US NADAC	INSULIN LISPRO 100 UNIT/ML VL	$2.40265	per ML	23 Sep 2026
US NADAC	LYUMJEV 100 UNIT/ML KWIKPEN	$10.15486	per ML	23 Sep 2026
US NADAC	LYUMJEV 100 UNIT/ML VIAL	$7.87326	per ML	23 Sep 2026
US NADAC	LYUMJEV 200 UNIT/ML KWIKPEN	$20.28228	per ML	23 Sep 2026
NHS Drug Tariff	Insulin lispro 100units/ml solution for injection 10ml vials	£16.61	1 vial	1 Oct 2026
NHS Drug Tariff	Insulin lispro 100units/ml solution for injection 3ml cartridges	£28.31	5 cartridge	1 Oct 2026
NHS Drug Tariff	Insulin lispro 100units/ml solution for injection 3ml pre-filled disposable devices	£29.46	5 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Insulin lispro 200units/ml solution for injection 3ml pre-filled disposable devices	£58.92	5 pre-filled disposable injection	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.

WHO WHO Model List of Essential Medicines (2025)

18.5.1. Insulins · core
Therapeutic equivalent to insulin (analogue, rapid-acting) for Type 1 diabetes mellitus; Therapeutic equivalent to insulin (analogue, rapid-acting) for Type 2 diabetes mellitus

Safety signals and safety-related labeling changes

US FDA 31 Aug 2023 ADMELOG — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 Oct 2022 LYUMJEV — 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 17 Apr 2020 PRAC signal: Cutaneous amyloidosis
Action for MAH: update of the product information: Yes
EMA PRAC 28 Nov 2019 PRAC signal: Cutaneous amyloidosis
Action for MAH: update of the product information: No
US FDA 15 Nov 2019 ADMELOG SOLOSTAR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 30 Nov 2017 PRAC signal: Potential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia
Action for MAH: update of the product information: Yes
EMA PRAC 29 Sep 2017 PRAC signal: Potential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia
Action for MAH: update of the product information: No
EMA PRAC 5 May 2017 PRAC signal: Potential increased risk of medication error associated with pre-filled pens and cartridges presentations, leading to inadequate diabetes control
Action for MAH: update of the product information: Yes

All safety entries for insulin lispro →

Combinations containing Insulin lispro

Insulin lispro + insulin protamine

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.