Is Insulin glargine + Lixisenatide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Insulin glargine + Lixisenatide, including SOLIQUA SOLOSTAR (33 mcg/ml) /100 U Solution for Injection (100,0.33 IU/ml,µ/ml, Solution for injection in pre-filled syringe, SAR 748.75); SOLIQUA SOLOSTAR 50 mcg/ml) /100 U Solution for Injection (100,0.5 IU/ml,µ/ml, Solution for injection in pre-filled syringe, SAR 898.40).

Is Insulin glargine + Lixisenatide approved by the US FDA?

Drugs@FDA lists 1 application product line for Insulin glargine + Lixisenatide, including SOLIQUA 100/33 (Prescription).

Is Insulin glargine + Lixisenatide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Insulin glargine + Lixisenatide: Suliqua.

Active substances

Insulin glargine + Lixisenatide

SFDA 4
US FDA 1
EMA 1
Health Canada 1
US price lines 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
SOLIQUA SOLOSTAR (33 mcg/ml) /100 U Solution for Injection	100,0.33 IU/ml,µ/ml	Solution for injection in pre-filled syringe · Subcutaneous use	5 Pre-filled pen	SAR 748.75	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
SOLIQUA SOLOSTAR (33 mcg/ml) /100 U Solution for Injection	100,0.33 IU/ml,µ/ml	Solution for injection in pre-filled syringe · Subcutaneous use	3 Pre-filled pen	SAR 449.25	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
SOLIQUA SOLOSTAR 50 mcg/ml) /100 U Solution for Injection	100,0.5 IU/ml,µ/ml	Solution for injection in pre-filled syringe · Subcutaneous use	5 Pre-filled pen	SAR 898.40	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
SOLIQUA SOLOSTAR 50 mcg/ml) /100 U Solution for Injection	100,0.5 IU/ml,µ/ml	Solution for injection in pre-filled syringe · Subcutaneous use	3 Pre-filled pen	SAR 539.05	Biological · Prescription	SANOFI WINTHROP INDUSTRIE	Valid

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

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

Product	Strength	Form · route	Applicant	Status	First approved
SOLIQUA 100/33	300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML)	solution · subcutaneous	SANOFI-AVENTIS US	Prescription	21 Nov 2016

EMA European Union — centrally authorised medicines

Suliqua Sanofi Winthrop Industrie · Authorised · authorised 11 Jan 2017 · ATC A10AE54

Therapeutic indication (EMA)

Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SOLIQUA	02478293	33 MCG / ML; 100 UNIT / ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	SOLIQUA 100 UNIT-33 MCG/ML PEN	$57.06155	per ML	23 Sep 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.

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.