Is 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 Rosiglitazone.

Is Rosiglitazone approved by the US FDA?

Drugs@FDA lists 2 application product lines for Rosiglitazone, including AVANDIA (Discontinued); ROSIGLITAZONE MALEATE (Discontinued).

Is Rosiglitazone authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Rosiglitazone.

Are there safety signals or safety updates for Rosiglitazone?

US FDA: 2 entries; MHRA: 1 entry (latest 2019-02-05).

Active substance

Rosiglitazone

SFDA 2
US FDA 2
EMA 3
Health Canada 3
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AVANDIA 4MG TABLETS	4 mg	Film-coated tablet · Oral use	28 Blister	SAR 107.95	NCE · Prescription	GLAXO SAUDI ARABIA	Withdrawn by regulatory authority · Not Marketed
AVANDIA 4MG TABLETS	4 mg	Film-coated tablet · Oral use	14 Blister	SAR 60.45	NCE · Prescription	GLAXO SAUDI ARABIA	Withdrawn by regulatory authority · Not Marketed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
AVANDIA	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	WOODWARD	Discontinued	25 May 1999
ROSIGLITAZONE MALEATE	EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	ANI PHARMS	Discontinued	25 Jan 2013

EMA European Union — centrally authorised medicines

Avandia SmithKline Beecham Plc · Expired · authorised 11 Jul 2000 · ATC A10BG02

Therapeutic indication (EMA)

Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus: as monotherapy-in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with-metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin-a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylurea as triple oral therapy in combination with-metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).

Nyracta SmithKline Beecham Plc · Withdrawn · authorised 11 Jul 2000 · ATC A10BG02

Therapeutic indication (EMA)

Rosiglitazone is indicated as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Rosiglitazone is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or a sulphonylurea:- in combination with metformin particularly in overweight patients.- in combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated.

Venvia SmithKline Beecham Plc · Withdrawn · authorised 11 Jul 2000 · ATC A10BG02

Therapeutic indication (EMA)

Rosiglitazone is indicated as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Rosiglitazone is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or a sulphonylurea: in combination with metformin particularly in overweight patients. in combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ROSIGLITAZONE	02403366	2 MG	TABLET · ORAL	AA PHARMA INC
ROSIGLITAZONE	02403374	4 MG	TABLET · ORAL	AA PHARMA INC
ROSIGLITAZONE	02403382	8 MG	TABLET · ORAL	AA PHARMA INC

Safety signals and safety-related labeling changes

US FDA 5 Feb 2019 AVANDIA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Apr 2017 AVANDAMET — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 11 Dec 2014 Rosiglitazone: recommended withdrawal from clinical use
Suspension of the marketing authorisations of rosiglitazone (Avandia, Avandamet) recommended across the European Union.

All safety entries for rosiglitazone →

Combinations containing Rosiglitazone

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.