Humira

RSS

adalimumab

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

Overview

Humira is a medicine that acts on the immune system and is used to treat the following conditions:

  • plaque psoriasis, a disease causing red, scaly patches on the skin

  • psoriatic arthritis (red, scaly patches on the skin with inflammation of the joints)

  • rheumatoid arthritis (a disease causing inflammation of the joints)

  • axial spondyloarthritis (inflammation of spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation

  • Crohn’s disease (a disease causing inflammation of the gut)

  • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut)

  • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints)

  • hidradenitis suppurativa (acne inversa), a chronic skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin

  • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).

    Humira is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments. For detailed information on the use of Humira in all conditions, including when it can be used in children, see package leaflet or contact your doctor or pharmacist.

    Humira contains the active substance adalimumab.

This EPAR was last updated on 14/03/2019

Authorisation details

Product details
Name
Humira
Agency product number
EMEA/H/C/000481
Active substance
adalimumab
International non-proprietary name (INN) or common name
adalimumab
Therapeutic area (MeSH)
  • Spondylitis, Ankylosing
  • Arthritis, Juvenile Rheumatoid
  • Uveitis
  • Colitis, Ulcerative
  • Psoriasis
  • Arthritis, Psoriatic
  • Crohn Disease
  • Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AB04
Publication details
Marketing-authorisation holder
AbbVie Deutschland GmbH Co. KG
Revision
73
Date of issue of marketing authorisation valid throughout the European Union
08/09/2003
Contact address
Knollstrasse
67061 Ludwigshafen
Germany

Product information

31/10/2018 Humira - EMEA/H/C/000481 - II/0182

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

Please refer to the product information document.

Assessment history

Changes since initial authorisation of medicine

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