EMA Adopts a Positive Opinion Recommending Changes to the Terms of the Marketing Authorisation for Aprepitant
Changes concern approval of a new pharmaceutical form and an extension to the existing indication
On 22 October 2015, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending changes to the terms of the marketing authorisation for the medicinal product aprepitant (EMEND).
The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme Limited.
The CHMP recommended approval of a new pharmaceutical form (125 mg powder for oral suspension) with a new indication as follows:
Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years.
EMEND powder for oral suspension is given as part of combination therapy.
Furthermore the CHMP adopted an extension to the existing indication for the 80mg and 125mg hard capsules as follows:
Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12.
EMEND 80/125 mg is given as part of combination therapy.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.