Cancellation of state registration. Fosinotek H

February 15, 2017
Trade names:
ICD-10:
IX.I10-I15.I10    Essential [primary] hypertension
Fosinotek N, treatment of arterial hypertension, combined antihypertensive drug

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 abolish state registration and exclusion from the state register of medicinal products for medical use of medicinalpreparation (registration certificate LP-000929 dated October 18, 2011, issued by San Pharmaceutical Industries Ltd., India):

Fosinotek H (trade name of the medicinal product)

Hydrochlorothiazide + Fosinopril (international non-proprietary, or grouping, or chemical name medicinal product)

tablets, 12.5 mg + 20 mg (dosage form, dosage)

San Pharmaceutical Industries Ltd., India Industrial Area No. 3, A.V. Road, Dewas - 455001 (MP), India (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.