Is Glimepiride + Rosiglitazone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Glimepiride + Rosiglitazone.

Is Glimepiride + Rosiglitazone approved by the US FDA?

Drugs@FDA lists 2 application product lines for Glimepiride + Rosiglitazone, including AVANDARYL (Discontinued); ROSIGLITAZONE MALEATE AND GLIMEPIRIDE (Discontinued).

Is Glimepiride + Rosiglitazone authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Glimepiride + Rosiglitazone.

Active substances

Glimepiride + Rosiglitazone

SFDA 3
US FDA 2
EMA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AVANDARYL 4-1MG F.C. TABLETS	4,1 mg	Film-coated tablet · Oral use	28 Blister	SAR 122.75	NCE · Prescription	SMIITHKLINE BEECHAM	Withdrawn by regulatory authority · Not Marketed
AVANDARYL 4-2MG F.C. TABLETS	4,2 mg	Film-coated tablet · Oral use	28 Blister	SAR 155.50	NCE · Prescription	SMIITHKLINE BEECHAM	Withdrawn by regulatory authority · Not Marketed
AVANDARYL 4-4MG F.C. TABLETS	4,4 mg	Film-coated tablet · Oral use	28 Blister	SAR 147.50	NCE · Prescription	SMIITHKLINE BEECHAM	Withdrawn by regulatory authority · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
AVANDARYL	1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	SB PHARMCO	Discontinued	23 Nov 2005
ROSIGLITAZONE MALEATE AND GLIMEPIRIDE	1MG;4MG; 2MG;4MG; 4MG;4MG; 2MG;8MG; 4MG;8MG	tablet · oral	TEVA PHARMS USA	Discontinued	1 Apr 2016

EMA European Union — centrally authorised medicines

Avaglim SmithKline Beecham Ltd · Withdrawn · authorised 27 Jun 2006 · ATC A10BD04

Therapeutic indication (EMA)

AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.

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.