Cancellation of state registration. Bicalutamide Sandoz®

February 15, 2017
Active substances:
ICD-10:
II.C60-C63.C61    Malignant neoplasm of prostate
Bicalutamide, prostate cancer, antiandrogen, prostate cancer treatment

Russian Ministry of Health in accordance with Article 32 of the Federal Law of 12.04.2010 number 61-FZ "On Circulation of Medicines" decided to cancel state registration and exclusion from the state register of medicines for medicalapplication of the medicinal product (registration certificate LP-002032 dated March 22, 2013 issued by Sandoz dd, Slovenia):

Bicalutamide Sandoz® (trade name of the medicinal product)

Bicalutamide (international non-proprietary or grouping or chemical name)

film-coated tablets, 50 mg, 150 mg (dosage form, dosage)

Lekd, Slovenia Verovskova 57, Ljubljana, 1526, Slovenia (name and address of the location of the manufacturer of the medicinal product)

on the basis of filing an application by an authorized legal entity of ZAO Sandoz to cancel the state registration of the medicinal product.