Simponi - withdrawal of application for variation to marketing authorisation

Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn

golimumab

Overview

On 12 May 2014, Janssen Biologics B.V. officially notified the European Medicines Agency that it wished to withdraw its application to make Simponi (golimumab) also available as a concentrate (12.5 mg/ml) for solution for infusion into a vein. Simponi is available as a solution for injection under the skin at 50 and 100 mg, in pre-filled pens and syringes.Further information can be found in the assessment report under the tab 'All documents'.

Key facts

• Name of medicine:
  Simponi
• EMA product number:
  EMEA/H/C/000992
• Active substance:
  Golimumab
• International non-proprietary name (INN) or common name:
  golimumab
• Therapeutic area (MeSH):
  • Arthritis, Psoriatic
  • Spondylitis, Ankylosing
  • Colitis, Ulcerative
  • Arthritis, Rheumatoid
• Anatomical therapeutical chemical (ATC) code:
  L04AB06
• Marketing authorisation holder:
  Janssen Biologics B.V.
• Date of issue of marketing authorisation valid throughout the European Union:
  01/10/2009
• Date of withdrawal:
  12/05/2014

Documents

Withdrawal assessment report for Simponi

Adopted Reference Number: EMA/416184/2014

Withdrawal letter: Simponi