Trudexa

Withdrawn

This medicine's authorisation has been withdrawn

adalimumab

Overview

The marketing authorisation for Trudexa has been withdrawn at the request of the marketing authorisation holder.

Trudexa : EPAR - Summary for the public

Product information

Trudexa : EPAR - Product Information

Latest procedure affecting product information: II/0037

29/06/2007

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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).

Trudexa : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Trudexa
• 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

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).

Authorisation details

• EMA product number:
  EMEA/H/C/000482
• Marketing authorisation holder:
  Abbott Laboratories Ltd.

  Queenborough; Kent ME11 5EL; United Kingdom

• Marketing authorisation issued:
  01/09/2003
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

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

Trudexa-H-C-482-II-33 : EPAR - Scientific Discussion - Variation

Adopted

Trudexa-H-C-482-II-06 : EPAR - Scientific Discussion - Variation

Adopted

Trudexa-H-C-482-II-21 : EPAR - Scientific Discussion - Variation

Adopted

Trudexa-H-C-482-II-22 : EPAR - Scientific Discussion - Variation

Adopted

Trudexa-H-C-482-II-26 : EPAR - Scientific Discussion - Variation

Adopted

Initial marketing authorisation documents

Trudexa : EPAR - Procedural steps taken before authorisation

Trudexa : EPAR - Scientific Discussion