Is Metformin + 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 Metformin + Rosiglitazone.

Is Metformin + Rosiglitazone approved by the US FDA?

Drugs@FDA lists 2 application product lines for Metformin + Rosiglitazone, including AVANDAMET (Discontinued); ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE (Discontinued).

Is Metformin + Rosiglitazone authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Metformin + Rosiglitazone.

Active substances

Metformin + Rosiglitazone

SFDA 1
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
AVANDAMET 2MG-500MG TABLETS	2, 500 mg	Film-coated tablet · Oral use	56 Blister	SAR 120.15	NCE · Prescription	GLAXO SAUDI ARABIA	Withdrawn by regulatory authority · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
AVANDAMET	500MG;EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 500MG;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 500MG;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 1GM;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 1GM;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	SB PHARMCO	Discontinued	10 Oct 2002
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE; 500MG;EQ 4MG BASE; 1GM;EQ 2MG BASE; 1GM;EQ 4MG BASE; 500MG;EQ 1MG BASE	tablet · oral	TEVA	Discontinued	7 May 2014

EMA European Union — centrally authorised medicines

Avandamet SmithKline Beecham Plc · Expired · authorised 20 Oct 2003 · ATC A10BD03

Therapeutic indication (EMA)

AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients: who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea (see section 4.4).

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.