Lifmior

Lapsed

This medicine's authorisation has lapsed

etanercept

Overview

On 16 February 2020, the marketing authorisation of Lifmior (etanercept) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, Pfizer Europe MA EEIG, had not marketed Lifmior in the EU since its initial marketing authorisation. In accordance with provisions of the sunset clause1, the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation. Pfizer Europe MA EEIG confirmed that the product had not been marketed for commercial reasons. 

Lifmior was granted marketing authorisation in the EU on 13 February 2017 for treatment of rheumatoid arthritis in adults, certain forms of juvenile idiopathic arthritis, plaque psoriasis in adults and children, psoriatic arthritis in adults, ankylosing spondylitis in adults and axial spondyloarthritis in adults. The marketing authorisation was initially valid for a 5-year period. 

Lifmior is an identical product to Enbrel, the reference medicinal product. There are biosimilar medicinal products of Enbrel authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Lifmior is updated to indicate that the marketing authorisation is no longer valid.

Lifmior : EPAR - Summary for the public

Product information

Lifmior : EPAR - Product Information

Lifmior : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Lifmior
• Active substance:
  etanercept
• International non-proprietary name (INN) or common name:
  etanercept
• Therapeutic area (MeSH):
  • Arthritis, Psoriatic
  • Spondylitis, Ankylosing
  • Psoriasis
• Anatomical therapeutic chemical (ATC) code:
  L04AB01

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

• Rheumatoid arthritis;
• Juvenile idiopathic arthritis
• Psoriatic arthritis;
• Axial spondyloarthritis;
• Plaque psoriasis;
• Paediatric plaque psoriasis.

Authorisation details

• EMA product number:
  EMEA/H/C/004167
• Marketing authorisation holder:
  Pfizer Europe MA EEIG

  Boulevard de la Plaine 17; 1050 Bruxelles; Belgium

• Opinion adopted:
  15/12/2016
• Marketing authorisation issued:
  13/02/2017
• Lapse of marketing authorisation:
  16/02/2020
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

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

Lifmior-H-C-4167- WS1362 : EPAR - Assessment Report

Reference Number: EMA/366395/2018

Initial marketing authorisation documents

Lifmior : EPAR - Public assessment report

AdoptedReference Number: EMA/114647/2016

CHMP summary of positive opinion for Lifmior

AdoptedReference Number: EMA/CHMP/764586/2016