Cancellation of state registration. Mycophenolate Sandoz®

April 3rd, 2018
Active substances:
ICD-10:
XXI.Z80-Z99.Z94    Presence of transplanted organs and tissues
Mycophenolate Sandoz, mycophenolate mofetil, immunosuppressive drug, transplantation, organ transplantation, immunosuppression, prevention of acute organ rejection, kidney transplantation, heart transplantation, liver transplantation

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"a decision was made to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate LP-001816 dated August 29, issued by Sandoz dd, Slovenia):

Mycophenolate Sandoz® (trade name of the medicinal product)

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

film coated tablets, 500 mg (dosage form, dosage)

Sandoz Private Limited, India Plot. No 8-A / 2 & 8-B, TTS Industrial Area, Kalwe Block, Village Dighe, Navi Mumbai, 400 708 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 quality of the medicinal product and the examination of the relationship of the expected benefit to the possible risk of drug use.