Basic Information
Nordimet
Regulatory Information
EMEA/H/C/003983
August 18, 2016
June 23, 2016
24
September 5, 2024
Company Information
the netherlands
Siriusdreef 41 NL-2132 WT Hoofddorp
Nordic Group BV
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Nordimet is indicated for the treatment of: - active rheumatoid arthritis in adult patients, - polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate, - moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, - induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.
Overview Summary
Nordimet is a medicine used to treat the following inflammatory conditions: - active rheumatoid arthritis, a disease causing inflammation in joints; - severe juvenile idiopathic arthritis (JIA), a joint disease in children, when medicines known as NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough; - plaque psoriasis (a disease causing red, scaly patches on the skin) in adults with moderate to severe disease who can be treated with a medicine given by mouth or injection; - severe psoriatic arthritis, inflammation of the joints that occurs in patients with psoriasis; - Crohn's disease (a disease causing inflammation of the gut) in adults. It can be used in combination with corticosteroids or on its own to induce or maintain remission (a period without disease symptoms after treatment). Nordimet contains the active substance methotrexate. Nordimet is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Nordimet is available in more strengths. The reference medicine for Nordimet is Lantarel FS.