Cancellation of state registration. Trilipix®

April 19, 2017
Active substances:
Trade names:
ICD-10:
IV.E70-E90.E78.0    Pure hypercholesterolemia
IV.E70-E90.E78.1    Pure hyperglyceridemia
IV.E70-E90.E78.2    Mixed hyperlipidemia
IV.E70-E90.E78.3    Hyperchilomicronemia
Trilipix, choline fenofibrate, dyslipidemia, hyperlipidemia, hypercholesterolemia

The Ministry of Health of the Russian Federation in accordance with articles 29 and 32 of the Federal Law of 12.04.2010 No. 61-FZ "On circulation of medicines" decided to abolish state registration and exclusion fromthe state register of medicinal products for the medical use of the medicinal product (registration certificate LP-001501 dated February 13, 2012, issued by Abbott Laboratories GmbH, Germany):

Trilipix® (trade name of the medicinal product)

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

modified release capsules, 45 mg, 135 mg (dosage form, dosage)

Mailan Laboratories SAS, France Route de Belleville Lieu-dit Maillard, 01400 Chatillon-sur-Chalaronne, France (name and address of the place of production)

in connection with the non-confirmation of the state registration of the medicinal product for medical use according to the results of the examination of the relationship between the expected benefit and the possible risk of drug use.