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Ritiro dell’autorizzazione alla commercializzazione - Europa
- denominazione commerciale: CYLTEZO
- Codice ATC : L04AB04
- Numero EU: EU/1/17/1240
- AIC data : 10/11/2017
- Titolare dell'AIC: BOEHRINGER INGELHEIM PHARMA GMBH
- Relazione di Valutazione Pubblica Europea (EPAR)
In combination with methotrexate is 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). Adalimumab 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.