Cancellation of state registration. Holetar®

December 9, 2016
Active substances:
Trade names:
ICD-10:
IV.E70-E90.E78.0    Pure hypercholesterolemia
IV.E70-E90.E78.2    Mixed hyperlipidemia
Lovastatin, choletar, hypercholesterolemia, hyperlipidemia, treatment of atherosclerosis

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 N014638 / 01 from 29.08.2008 issued by Krka, dd, Novo mesto, Slovenia):

Holetar® (trade name of the medicinal product)

Lovastatin (international nonproprietary, or grouping, or chemical name medicinal product)

tablets, 20 mg, 40 mg (dosage form, dosage)

KRKA, dd, Novo mesto, Slovenia Smarjeska cesta 6, 8501 Novo mesto, Slovenia; ZAO VECTOR-MEDICA, Russia 630559, Р1овосибирская обл., Новосибирский район, р.п. Koltsovo, building. 13, 15 (name and address of the location of the manufacturer of the medicinal product)

on the basis of a representative of JSC "Krka, dd, Novo mesto." Russia applications for the abolition of state registration of a medicinal product.