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REMSIMA (infliximab) (maladie de Crohn)

Opinions on drugs - Posted on Aug 26 2021

Reason for request

Reevaluation

Key points

Favourable opinion for maintenance of reimbursement in:

  • the treatment of moderately to severely active Crohn's disease, in adult 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,
  • the treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).

Clinical Benefit

Substantial

The Committee considers that the clinical benefit of REMSIMA (infliximab) remains substantial in the treatment of Crohn’s disease in adults.


Clinical Added Value

Comments without ASMR value

The Committee considers that the data from the studies submitted is not of a nature to modify its assessment of the clinical benefit formulated in its previous opinion of 21 January 2015.


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