Ministry of Health of the Russian Federation in accordance with Articles 29 and 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 LP- 001684 dated 02.05.2012, issued by OAO Nizhpharm, Russia):
Topiramate (trade name of the medicinal product)
Topiramate (international non-proprietary, or grouping, or chemical name medicinal product)
film coated tablets, 25 mg, 100 mg (dosage form, dosage)
OOO "MAKIZ-PHARMA", Russia 109029, Moscow, Automobile travel, house 6, page 4, 6, 8; OOO "Hemofarm", Russia 249030, Kaluga Oblast, Obninsk, Kievskoye Shosse, 62 (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 quality of the medicinal product and the examination of the relationship of the expected benefit to the possible risk of drug use.