Cancellation of state registration. Zolsana

May 2, 2017
Active substances:
Trade names:
ICD-10:
V.F50-F59.F51.2    Sleep and wakefulness disorder inorganic etiology
Zolsana, zolpidem, sleep disorder, insomnia, treatment of insomnia

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 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-000553 / 09 of 29.01.2009 issued to Krka, dd, Novo mesto, Slovenia):

Zolsana (trade name of the medicinal product)

Zolpidem (international non-proprietary or chemical name of the drug)

tablets, film-coated, 5 mg, 10 mg (dosage form, dosage)

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

on the basis of filing by the authorized legal entity of the Representative Office of JSC "Krka, dd, Novo mesto", Russia, a statement on the abolition of the state registration of the medicinal product.