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Trudexa (adalimumab)

Region
🇪🇺 EU
Active substance
adalimumab
Company
Abbott Laboratories Ltd.
Status
Withdrawn
Therapeutic area
Spondylitis, Ankylosing; Arthritis, Rheumatoid; Arthritis, Psoriatic; Crohn Disease
EU approval
Mon 01 Sep 2003
Application
EMEA/H/C/000482
ATC
L04AA17
Official record
www.ema.europa.eu

Indication

Rheumatoid arthritisTrudexa 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 arthritisTrudexa 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 spondylitisTrudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Crohn's diseaseTrudexa 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).

Regulatory milestones

No milestones recorded in the last year.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.