Cancellation of state registration. Fludara®

June 23, 2017
Active substances:
Trade names:
ICD-10:
II.C81-C96.C82.9    Follicular non-Hodgkin's lymphoma, unspecified
II.C81-C96.C83    Diffuse non-Hodgkin's lymphoma
II.C81-C96.C91.1    Chronic lymphocytic leukemia
Fludara, fludarabine, lymphocytic leukemia, non-Hodgkin's lymphoma, lymphatic leukemia

The Ministry of Health of the Russian Federation, in accordance with Article 32 of Federal Law No. 61-FZ of 12.04.2010 "On circulation of medicines", decided to abolish state registration and exclusion from stateRegister of medicinal products for medical use of medicinal product (registration certificate P N013522 / 02 dated 19.11.2007 issued by Genzyme Europe BV, Netherlands):

Fludara® (trade name of the medicinal product)

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

film coated tablets, 10 mg (dosage form, dosage)

Bayer Schering Pharma AG, Germany D-13342 Berlin, Germany (name and address of the location of the manufacturer of the medicinal product)

on the basis of filing by an authorized person of the Sanofi-aventis Group JSC representative office, Russia a request to cancel the state registration of the medicinal product.