Cancellation of state registration. Rovamycin®

February 27, 2018
Active substances:
Trade names:
Rovamycin, spiramycin, treatment of infectious and inflammatory diseases, pharyngitis, sinusitis, tonsillitis, bronchitis, skin and subcutaneous tissue infections, oral infections, toxoplasmosis, prevention of relapses of rheumatism

The Ministry of Health of the Russian Federation in accordance with Article 32 of the Federal Law of 12.04.2010 No. 61-FZ "On the circulation of medicinal products" decided to abolish state registration and exclusion from the state register of medicinal productsmeans for medical use of the medicinal product (registration certificate P N013418 / 02 from 07.12.2007 issued by the Aventis Laboratory, France):

Rovamycin® (trade name of the medicinal product)

Spiramycin (an international non-proprietary or grouping or chemical name)

lyophilizate for the preparation of a solution for intravenous administration, 1.5 million. ME (dosage form, dosage)

Aventis Intercontinental, France 180, rue Jean Jaures, 94702 Maisons Alford Cedex, France (name and address of the location of the manufacturer of the medicinal product)

on the basis of filing an application by the authorized legal entity of Sanofi-aventis corporation to cancel the state registration of the medicinal product.