Is Insulin glulisine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Insulin glulisine, including APIDRA SOLOSTAR 100 U- ML DISPOSABLE PEN (100 U/ml, Solution for injection, SAR 169.10).

Is Insulin glulisine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Insulin glulisine: Apidra.

Is Insulin glulisine 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 glulisine?

EMA PRAC: 5 entries (latest 2020-04-17).

Active substance

Insulin glulisine

SFDA 2
EMA 1
Health Canada 3
NHS prices 3
WHO EML 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
APIDRA SOLOSTAR 100 U- ML DISPOSABLE PEN	100 U/ml	Solution for injection · Subcutaneous use	5 Bottle	SAR 169.10	Biological · Prescription	sanofi-aventis	Valid
APIDRA 100 U- ML Injection*	100 U/ml	Solution · Subcutaneous use	5 Vial	SAR 146.45	Biological · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

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

EMA European Union — centrally authorised medicines

Apidra sanofi-aventis Deutschland GmbH · Authorised · authorised 27 Sep 2004 · ATC A10AB06

Therapeutic indication (EMA)

Treatment of adults, adolescents and children, six years or older with diabetes mellitus, where treatment with insulin is required.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APIDRA	02279460	100 UNIT / ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC
APIDRA	02279479	100 UNIT / ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC
APIDRA	02294346	100 UNIT / ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Insulin glulisine 100units/ml solution for injection 10ml vials	£16.00	1 vial	1 Oct 2026
NHS Drug Tariff	Insulin glulisine 100units/ml solution for injection 3ml cartridges	£28.30	5 cartridge	1 Oct 2026
NHS Drug Tariff	Insulin glulisine 100units/ml solution for injection 3ml pre-filled disposable devices	£28.30	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

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
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 glulisine →

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.