Cancellation of state registration. Orokamag®

August 30, 2017
Trade names:
ICD-10:
IX.I20-I25.I20    Angina pectoris [angina pectoris]
IX.I20-I25.I25.9    Chronic ischemic heart disease, unspecified
IX.I30-I52.I49.1    Premature depolarization of the atria
Orokamag, potassium and magnesium preparations, treatment of ischemic heart disease, IHD, supraventricular extrasystole

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 the circulation of medicines" decided to cancelstate registration and exclusion from the state register of medicinal products for medical use of the medicinal product (registration certificate LP-001581 dated March 15, 2012, issued by PIK-PHARMA LLC, Russia)

Orokamag® (trade name of the medicinal product)

Potassium orotate + Magnesium orotate (international non-proprietary, or grouping, or chemical name medicinal product)

tablets, 250 mg + 250 mg (dosage form, dosage)

Limited Liability Company "PIK-PHARMA PRO" (LLC "PIK-PHARMA PRO"), Russia 188663, Leningrad Region, Vsevolozhsky District, Kuzmolovsky Town, Building of Shop No. 92 (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 quality of the medicinal product and the examination of the relationship of the expected benefit to the possible risk of drug use.