Cancellation of state registration. Esprital®

November 16, 2017
Active substances:
Trade names:
ICD-10:
V.F30-F39.F31    Bipolar affective disorder
V.F30-F39.F32    Depressive episode
V.F30-F39.F33    Recurrent depressive disorder
V.F40-F48.F41.2    Mixed anxiety and depressive disorder
Mirtazapine, Esprital, depression, depression treatment, insomnia, suicidal thoughts, depressive state

The Ministry of Health of the Russian Federation in accordance with Article 32 of the Federal Law of 12.04.2010 No. 61-FZ "On the circulation of medicines" decided to cancelstate registration and exclusion from the state register of medicinal products for the medical use of the medicinal product (registration certificate LS-000697 dated 20.03.2012 issued to Zentiva, Czech Republic):

Esprital® (trade name of the drug)

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

film-coated tablets, 30 mg (dosage form, dosage)

Zentiva, Czech Republic Ukabelovny 130, 102 37 Prague 10, Dolni Mecholupy, Czech Republic (name and address of the location of the manufacturer of the medicinal product)

on the basis of an application by the authorized legal entity of the Sanofi-aventis Group JSC to cancel the state registration of the medicinal product.