Cancellation of state registration. Avandia

July 22, 2016
Active substances:
Trade names:
ICD-10:
IV.E10-E14.E11    Non-insulin-dependent diabetes mellitus
Rosiglitazone, Avandia, diabetes, insulin dependent diabetes mellitus

Russian Ministry of Health in accordance with Article 32 of the Federal Law of 12.04.2010 number 61-FZ "On Circulation of Medicines" decided to cancel state registration and exclusion from the state register of medicines for medical use of the drug (registration certificate P N013617 / 01ZAO "GlaxoSmithKline Trending", Russia) was issued on 14.07.2008:

Avandia (trade name of the medicinal product). Complete instructions for use on Avandia read here.

Rosiglitazone (international non-proprietary or chemical name of the medicinal product). PFull instruction on the use of the drug Rosiglitazone read here.

Film coated tablets, 4 mg, 8 mg (dosage form, dosage)

Glaxo Wellcome SA, Spain Avda, de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain (name and address of the location of the manufacturer of the medicinal product)

on the basis of filing an application by an authorized legal entity of ZAO GlaxoSmithKline Trading to cancel the state registration of the medicinal product.