European CHMP issues a positive opinion for a label update of Abilify Maintena® (aripiprazole for prolonged-release suspension for injection) to describe new clinical data for the treatment of acutely relapsed adults with schizophrenia
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Europe Ltd. (Otsuka) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for a type-II variation related to the update of the European summary of the product characteristics (SmPC) for Abilify Maintena.The update of the SmPC includes new Abilify Maintena data related to its effect and safety on acutely relapsed adults with schizophrenia. The application was submitted to the European Medicines Agency (EMA) and the assessment started end November