Trudexa

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adalimumab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Trudexa has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 14/02/2008

Authorisation details

Product details
Name
Trudexa
Agency product number
EMEA/H/C/000482
Active substance
adalimumab
International non-proprietary name (INN) or common name
adalimumab
Therapeutic area (MeSH)
  • Spondylitis, Ankylosing
  • Arthritis, Rheumatoid
  • Arthritis, Psoriatic
  • Crohn Disease
Anatomical therapeutic chemical (ATC) code
L04AA17
Publication details
Marketing-authorisation holder
Abbott Laboratories Ltd.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
01/09/2003
Contact address
Queenborough
Kent ME11 5EL
United Kingdom

Product information

29/06/2007 Trudexa - EMEA/H/C/000482 - II/0037

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis
Trudexa in combination with methotrexate, is indicated for:

  • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
  • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

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

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

Psoriatic arthritis
Trudexa is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.

Ankylosing spondylitis
Trudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Crohn's disease
Trudexa is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. For induction treatment, Trudexa should be given in combination with cortiocosteroids. Trudexa can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).

Assessment history

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