Cancellation of state registration. Lothor

September 13, 2017
Active substances:
Trade names:
ICD-10:
IX.I10-I15.I10    Essential [primary] hypertension
IX.I30-I52.I50.0    Congestive heart failure
Lotor, losartan, treatment of hypertension, chronic heart failure

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 medicinal products" decided to abolish state registration and exclude from the state register of medicinal products for medical usemedicinal product (registration certificate LP-001755 dated 02.07.2012, issued by Hemofarm AD, Serbia):

Lothor (trade name of the medicinal product)

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

film-coated tablets, 50 mg, 100 mg (dosage form, dosage)

Hemofarm AD, Serbia 26300, Vrsac, Beogradski put, bb, Serbia OOO "Hemofarm", Russia 249030, Kaluga Region, Obninsk, Kievskoye Highway 62 (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.