Cancellation of state registration. Risperidone Zentiva

November 29, 2017
Active substances:
ICD-10:
V.F20-F29.F20    Schizophrenia
V.F20-F29.F21    Chrysotile disorder
V.F20-F29.F22    Chronic delusional disorders
V.F20-F29.F23    Acute and transient psychotic disorders
V.F20-F29.F25    Schizoaffective disorder
V.F20-F29.F29    Inorganic psychosis, unspecified
V.F30-F39.F30    Manic episode
V.F30-F39.F31    Bipolar affective disorder
Risperidone, schizophrenia, mental disorders, treatment of schizophrenia, psychosis, manic episode

The Ministry of Health of the Russian Federation, in accordance with Article 32 of Federal Law No. 61-FZ of 12.04.2010 "On the circulation of medicinal products", decided to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate LSR-002126 / 08 of 27.03.2008 issued by ZENTIVA, Czech Republic):

Risperidone Zentiva (trade name of the medicinal product)

Risperidone (international non-proprietary or grouping or chemical name)

coated tablets, 1 mg, 2 mg, 3 mg, 4 mg (dosage form, dosage)

ZENTIVA, Czech Republic U kabelovny 130, 102 37 Prague 10, Dolni Mecholup, Czech Republic (name and address of the location of the manufacturer of the medicinal product)

on the basis of a filing by an authorized legal entity of the Representative Office of Sanofi-aventis Group (France) on the abolition of state registration of medicinal preparation.