Abilify (aripiprazole) tablets, orodispersible tablets and oral solution - Otsuka and Bristol-Myers Squibb - revised SPC

Source: eMC (electronic Medicines Compendium) Area: Other Library Updates > SPC Changes As a result of the new paediatric indication, section 1 has been updated to include an inverted black triangle with an asterisk (*) which signifies that:   * Intensive monitoring is requested only when used for the recently-licensed indication extension to paediatric patients.   Section 4.1 Therapeutic indications now includes additional/new indications for use as below:   ABILIFY is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar 1 Disorder in adolescents aged 13 years and older.   Section 4.2  Posology and method of administration has been updated to include additional information for the new indication as written in the text below:   ABILIFY is not recommended for use in patients with schizophrenia below 15 years of age due to insufficient data on safety and efficacy.   Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose ...
Source: NeLM - Mental Health - Category: Psychiatry Source Type: news