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Autorisation de mise sur le marché sans désignation orpheline - Europe

  • Nom commercial: HUMIRA
  • Code ATC : L04AB04
  • Identifiant UE: EU/1/03/256
  • Date d'AMM : 08/09/2003
  • Détenteur de l'AMM: ABBVIE LTD.
  • Rapport d'évaluation

Therapeutic indication

* In combination with methotrexate Humira is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged 2 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy). Humira has not been studied in children 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 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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