Cancellation of state registration. Mirzaten®

April 19, 2018
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
Mirzaten, mertazapine, depression, Depressive states, insomnia, suicidal thoughts, antidepressant, treatment of depression

The Ministry of Health of the Russian Federation in accordance with Article 32 of the Federal Law No. 61-FZ of 12.04.2010 "On circulation of medicines"a decision on the abolition of state registration and exclusion from the state register of medicinal products for medical use of the medicinal product (registration certificate LS-000347 dated 05.05.2010 issued to Krka, dd, Novo mesto, Slovenia):

Mirzaten® (trade name of the medicinal product)

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

film-coated tablets, 30 mg, 45 mg (dosage form, dosage)

KRKA, dd, Novo mesto, Slovenia Smarjeska cesta 6, 8501 Novo mesto, Slovenia (name and address of the location of the manufacturer of the medicinal product)

on the basis of filing by the authorized legal entity LLC KRKA-RUS, an application for the cancellation of the state registration of the medicinal product.