Cancellation of state registration. Cyclosporine Sandoz®

May 04, 2018
Active substances:
ICD-10:
VII.H30-H36.H30    Chorioretinal inflammation
XII.L20-L30.L20.8    Other atopic dermatitis
XII.L40-L45.L40    Psoriasis
XIII.M05-M14.M05    Seropositive rheumatoid arthritis
XIII.M30-M36.M35.2    Behcet's disease
XIV.N00-N08.N04    Nephrotic syndrome
XXI.Z80-Z99.Z94    Presence of transplanted organs and tissues
Cyclosporin Sandoz, cyclosporine, andmmunodepressant, prophylaxis of rejection after transplantation, nephrotic syndrome, endogenous uveitis,prevention of graft rejection after bone marrow transplantation, kidney transplantation, liver transplantation, heart transplantation, graft versus host reaction

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 exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate P N014330 / 01 from 20.11.2008 issued by Sandoz dd, Slovenia, registration certificate P N014330 / 02 dated 31.10.2008 issued by Sandoz dd, Slovenia):

Cyclosporine Sandoz® (trade name of the medicinal product)

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

capsules, 25 mg, 50 mg, 100 mg, oral solution, 100 mg / ml (dosage form, dosage)

Salutas Pharma GmbH, Germany Otto-von-Guericke-AIlee 1, 39179 Barleben, Germany (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.