The Ministry of Health of the Russian Federation in accordance with articles 29 and 32 of the Federal Law No. 61-FZ of 12.04.2010 "On circulation of medicines" decided to abolish state registration and exclude from the state register of medicines formedical application of the medicinal product (registration certificate LP-000968 dated October 18, 2011, issued by OOO "Vayet", Russia):
Benefiks® (trade name of the medicinal product)
Nonacog Alpha (international non-proprietary, or grouping, or chemical name medicinal product)
lyophilizate for the preparation of a solution for intravenous administration, 250 ME, 500 ME, 1000 ME, 2000 ME (dosage form, dosage)
Wyeth Pharma SA, Spain Autovia del Norte Al, km 23, desvio Algete, km. 1, San Sebastian de los Reyes 28700, Madrid, Spain (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.