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Autorisation de mise sur le marché sans désignation orpheline - Europe

  • Nom commercial: HALIMATOZ
  • Code ATC : L04AB04
  • Identifiant UE: EU/1/18/1288
  • Date d'AMM : 25/07/2018
  • Détenteur de l'AMM: SANDOZ GMBH
  • Rapport d'évaluation

Therapeutic indication

In combination with methotrexate 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). HALIMATOZ can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Adalimumab has not been studied in patients aged less than 2 years.
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.
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.
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.

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