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Assessment report Abilify International non-proprietary name: aripiprazole

The applicant submitted a type II variation application to propose changes in SmPC sections 4.1 and 4.2 regarding the treatment of schizophrenia in adolescents from “aged 15 years and older” to “aged 13 years and older”, and the corresponding changes in SmPC section 4.2 from “below 15 years” to “below 13 years” and the package leaflet as a new therapeutic indication (extension of target population for the same disease, based on a different age range).


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