Infliximab

Rheumatoid arthritis Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: • adult patients with active disease when the response to disease- modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.

• adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. 1). Crohn’s disease Remsima is indicated for: • 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.

• 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).

Indications have been granted on the basis of similarity between Renflexis® and the reference biologic drug Remicade®. RENFLEXIS® (Infliximab for Injection) is indicated for: • use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis.

• the reduction of signs and symptoms and improvement in physical function in patients with active ankylosing spondylitis who have responded inadequately, or are intolerant to, conventional therapies. • reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing and reduction of corticosteroid use in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to a corticosteroid and/or aminosalicylate.

Renflexis® can be used alone or in combination with conventional therapy. • reduction of signs and symptoms and induction and maintenance of clinical remission in pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy (corticosteroid and/or aminosalicylate and/or an immunosuppressant).

Rheumatoid arthritis Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: • adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.

• adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. 1). Adult Crohn’s disease Remsima is indicated for: • 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.

• 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).