Cancellation of state registration. Balutar®

April 13, 2018
Active substances:
Trade names:
ICD-10:
II.C60-C63.C61    Malignant neoplasm of prostate
Balutar, bicalutamide, prostate cancer, prostate cancer

The Ministry of Health of the Russian Federation, in accordance with Article 32 of Federal Law No. 61-FZ dated 12.04.2010 "On circulation of medicines", decided to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificateLP-002117 dated July 2, 2013 issued by TAD Pharma GmbH, Germany):

Balutar® (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)

TAD Pharma GmbH, Germany Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany (name and address of the location of the manufacturer of the medicinal product)

on the basis of an application by the authorized legal entity of the JSC "Krka, dd, Novo mesto" to cancel the state registration of the medicinal product.