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On 14 September 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Nordimet. The marketing authorisation holder for this medicinal product is Nordic Group B.V.

The CHMP adopted a new indication to include treatment of moderate psoriasis in adults who are candidates for systemic therapy. For information, the full indications for Nordimet will be as follows1:

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 severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, 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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

1New text in bold, removed text as strikethrough

Key facts

Agency product number
International non-proprietary name (INN) or common name
  • methotrexate
Active substance
  • Methotrexate
Therapeutic area
Arthritis, Psoriatic
Arthritis, Juvenile Rheumatoid
Arthritis, Rheumatoid
Date opinion adopted
Company name
Nordic Group B.V.
Application type

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