Cancellation of state registration. Insivo

November 17, 2016
Active substances:
Trade names:
ICD-10:
I.B15-B19.B18.2    Chronic viral hepatitis C
Insivo, telaprevir, hepatitis C, hepatitis C treatment

The Ministry of Health of the Russian Federation, in accordance with Article 32 of Federal Law No. 61-FZ of 12.04.2010 "On circulation of medicines", decided to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate LI-001931 dated 14.12.2012 issued by Johnson & Johnson, Russia):

Insivo (trade name of the medicinal product)

Telaprevir (international non-proprietary, or grouping, or chemical name medicinal product)

film-coated tablets, 375 mg (dosage form, dosage)

Janssen-Szilag SpL, Italy Via FROM. Janssen, loc. Borgo S.Michele, 04010 Latina (LT), Italy; OAO Pharmstandard-UfaVITA, Russia 450077, Republic of Bashkortostan, inUfa, Khudayberdin, 28 (name and address of the location of the manufacturer of the medicinal product)

on the basis of the filing of an authorized LLC Johnson & Johnson, Russia drug registration application.