Cancellation of state registration. Moditen® Depot

January 13, 2017
Active substances:
Trade names:
ICD-10:
V.F20-F29.F20    Schizophrenia
V.F20-F29.F21    Chrysotile disorder
V.F20-F29.F22    Chronic delusional disorders
V.F20-F29.F25    Schizoaffective disorder
V.F20-F29.F29    Inorganic psychosis, unspecified
V.F20-F29.F23    Acute and transient psychotic disorders
Moditene depot, fluphenazine, schizophrenia, schizotypic disorder, schizoaffective disorder, psychosis, psychotic disorders

The Ministry of Health of the Russian Federation in accordance with Article 32Federal 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 No. N015939 / 01 dated 18.09.2009 issued by Bristol-Myers Squibb Company, USA):

Moditen® Depot (trade name of the medicinal product)

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

solution for intramuscular administration oily, 25 mg / ml (dosage form, dosage)

Bristol-Myers Squibb Sr.L., Italy Localita Fontana del Ceraso, 03012 Anagni (FR), Italy (name and address of the location of the manufacturer of the medicinal product)

on the basis of filing an application by the authorized legal entity LLC Bristol-Myers Squibb to cancel the state registration of the medicinal product.