Trudexa
Withdrawn
This medicine's authorisation has been withdrawn
adalimumab
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 1 September 2003 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Trudexa, 40 mg solution for injection, intended for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The marketing authorisation holder (MAH) responsible for Trudexa is Abbott Laboratories.
On 20 June 2007, the European Commission was notified by the MAH of its decision to voluntarily withdraw the marketing authorisation for Trudexa for commercial reasons. Trudexa was never placed onto the market in any member state of the European Economic Area. Therapeutic alternatives are available throughout the European Union, including an identical product, Humira, and other tumour necrosis factor (TNF) blockers. On 9 July 2007 the European Commission issued a decision to withdraw the marketing authorisation for Trudexa.
Pursuant to this decision the European Public Assessment Report for Trudexa is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
II/0037
29/06/2007
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).
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
ImmunosuppressantsTherapeutic 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).
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