Cancellation of state registration. Helex®

October 27, 2016
Active substances:
Trade names:
ICD-10:
V.F30-F39.F32    Depressive episode
V.F30-F39.F33    Recurrent depressive disorder
V.F40-F48.F40    Phobic anxiety disorders
V.F40-F48.F41.0    Panic disorder [episodic paroxysmal anxiety]
V.F40-F48.F41.2    Mixed anxiety and depressive disorder
V.F40-F48.F43    Reaction to severe stress and adaptation disorders
V.F40-F48.F48.0    Neurasthenia
V.F50-F59.F51.2    Sleep and wakefulness disorder inorganic etiology
Helex, Alprazolam, Depression, Depression Treatment, Neurasthenia, Sleep Disorders

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 P N013561 / 01 from 07.08.2007 issued to Krka, dd, Novo mesto, Slovenia):

Helex® (trade name of the medicinal product)

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

tablets, 0.25 mg, 0.5 mg, 1 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 the application by the authorized legal entity of JSC "Krka" to cancel the state registration of the medicinal product.