Enbrel

RSS

etanercept

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Enbrel. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Enbrel.

This EPAR was last updated on 07/12/2018

Authorisation details

Product details
Name
Enbrel
Agency product number
EMEA/H/C/000262
Active substance
etanercept
International non-proprietary name (INN) or common name
etanercept
Therapeutic area (MeSH)
  • Spondylitis, Ankylosing
  • Arthritis, Juvenile Rheumatoid
  • Arthritis, Psoriatic
  • Psoriasis
  • Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AB01
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
57
Date of issue of marketing authorisation valid throughout the European Union
02/02/2000
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

30/07/2018 Enbrel - EMEA/H/C/000262 - T/0222

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis

Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.

Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.

Juvenile idiopathic arthritis

Treatment of polyarthritis (rheumatoid-factor-positive or -negative) and extended oligoarthritis in children and adolescents from the age of two years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.

Enbrel has not been studied in children aged less than two years.

Psoriatic arthritis

Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.

Axial spondyloarthritis

Ankylosing spondylitis (AS)

Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Non-radiographic axial spondyloarthritis

Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).

Plaque psoriasis

Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).

Paediatric plaque psoriasis

Treatment of chronic severe plaque psoriasis in children and adolescents from the age of six years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating