EU CHMP recommends approval of Nordimet (methotrexate) for rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriatic arthritis- Nordic Group
The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nordimet (methotrexate), from Nordic Group, intended for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriatic arthritis.
Approval is based on studies which show the benefits with Nordimet are its ability to reduce the symptoms of rheumatoid arthritis, psoriasis and psoriatic arthritis. The most common side effects are abnormal liver function tests, stomatitis, dyspepsia, nausea, abdominal pain and loss of appetite.
Comment: Nordimet is a hybrid of Lantarel FS (25 mg solution for injection), a medicine containing the same active substance that has been authorised in Germany since 1992.
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