Cyltezo

Withdrawn

This medicine's authorisation has been withdrawn

adalimumab

Overview

On 15 January 2019, the European Commission withdrew the marketing authorisation for Cyltezo (adalimumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Boehringer Ingelheim International GmbH, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Cyltezo was granted marketing authorisation in the EU on 10 November 2017 for treatment of Rheumatoid arthritis, Juvenile idiopathic arthritis, Axial spondyloarthritis, Psoriatic arthritis, Psoriasis, Paediatric plaque psoriasis, Hidradenitis suppurativa (HS), Crohn’s disease, Paediatric Crohn's disease, Ulcerative colitis, Uveitis, Paediatric Uveitis. The marketing authorisation was initially valid for a 5-year period. The product had never been marketed in the EU. 

Cyltezo is a biosimilar medicine of Humira. There are other biosimilar medicinal products of Humira authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Cyltezo is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Cyltezo : EPAR - Summary for the public

Product information

Cyltezo : EPAR - Product Information

Cyltezo : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Cyltezo
• Active substance:
  adalimumab
• International non-proprietary name (INN) or common name:
  adalimumab
• Therapeutic area (MeSH):
  • Hidradenitis Suppurativa
  • Arthritis, Psoriatic
  • Psoriasis
  • Crohn Disease
  • Arthritis, Juvenile Rheumatoid
  • Uveitis
  • Arthritis, Rheumatoid
  • Colitis, Ulcerative
  • Spondylitis, Ankylosing
• Anatomical therapeutic chemical (ATC) code:
  L04AB04

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Please refer to section 4.1 of the Summary of product characteristics in the product information document.

Authorisation details

• EMA product number:
  EMEA/H/C/004319
• Biosimilar:

  This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

• Marketing authorisation holder:
  Boehringer Ingelheim International GmbH

  Binger Strasse 173 55216; Ingelheim am Rhein; Germany

• Marketing authorisation issued:
  10/11/2017
• Withdrawal of marketing authorisation:
  15/01/2019
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Cyltezo : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Cyltezo : EPAR - Public assessment report

Reference Number: EMA/CHMP/750187/2017

CHMP summary of positive opinion for Cyltezo

Reference Number: EMA/CHMP/532447/2017