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Autorizzazione all’immissione in commercio senza designazione orfana - Europa
- denominazione commerciale: IDACIO
- Codice ATC : L04AB04
- Numero EU: EU/1/19/1356
- AIC data : 02/04/2019
- Titolare dell'AIC: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
- Relazione di Valutazione Pubblica Europea (EPAR)
* In combination with methotrexate indicated 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). IDACIO 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.