Cancellation of state registration. Metformin Sandoz®

December 05, 2016
Active substances:
ICD-10:
IV.E10-E14.E11    Non-insulin-dependent diabetes mellitus
Metformin, type 2 diabetes mellitus, non-insulin dependent diabetes mellitus, hypoglycemicemic drug

The Ministry of Health of the Russian Federation in accordance with articles 29 and 32 of the Federal Law of 12.04.2010 No. 61-FZ "On circulation of medicines" decided to abolish state registration and exclusion from the state register of medicinal products for medical use of medicinalpreparation (registration certificate LP-000747 dated September 29, 2011, issued by Sandoz dd, Slovenia):

Metformin Sandoz® (trade name of the medicinal product)

Metformin (international non-proprietary, or grouping, or chemical name medicinal product)

film coated tablets, 500 mg, 850 mg, 1000 mg (dosage form, dosage)

Lek SA, Poland 16, Podlipie Str., 95-010 Strykow, Poland; for a dosage of 850 mg: 50C, Domaniewska Str., 02-672 Warsaw, Poland (name and address of the place of production)

in connection with the non-confirmation of the state registration of the medicinal product for medical use according to the results of the examination of the relationship between the expected benefit and the possible risk of drug use.