Cancellation of state registration. Piklodorm®

November 22, 2016
Active substances:
Trade names:
ICD-10:
V.F50-F59.F51.2    Sleep and wakefulness disorder inorganic etiology
X.J40-J47.J45    Asthma
Piklodorm, zopiclone, sleeping pill, treatment of sleep disorders

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 the medicinal product (registration certificate LP- 000132 dated January 11, 2011, issued by Binnopharm, Russia)

Piklodorm® (trade name of the medicinal product)

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

film-coated tablets, 7.5 mg (dosage form, dosage)

Binnopharm, Russia 124460, Moscow, Zelenograd, ul. Designer Guskova, 3, building 1 (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.