AMGEVITA^® AUTHORISED
INDICATIONS IN EUROPE¹

AMGEVITA^® in combination with methotrexate, is indicated for:

AMGEVITA^® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

AMGEVITA^® reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate (refer to the Summary of Product Characteristics).

AMGEVITA^® in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). AMGEVITA^® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1 of the Summary of Product Characteristics).

Adalimumab has not been studied in patients aged less than 2 years.

AMGEVITA^® is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1 of the Summary of Product Characteristics).

AMGEVITA^® is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

AMGEVITA^® is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.

AMGEVITA^® 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. AMGEVITA^® reduces the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1 of the Summary of Product Characteristics) and improves physical function.

AMGEVITA^® is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

AMGEVITA^® is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.

AMGEVITA^® is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2 of the Summary of Product Characteristics).

AMGEVITA^® is indicated for 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.

AMGEVITA^® is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.

AMGEVITA^® is indicated for the treatment of moderately to severely ulcerative colitis in adult patients who have had an inadequate response to conventional therapy corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

AMGEVITA^® is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

AMGEVITA^® is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.