EU CHMP recommends extension of indication for Emend (fosaprepitant dimeglumine) in treating nausea- Merck

The EU's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending changes to the terms of the marketing authorisation for Emend (fosaprepitant dimeglumine), from Merck, in treating nausea. The recommended approval of a new pharmaceutical form (125 mg powder for oral suspension) with a new indication is for the 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.

In addition the CHMP adopted an extension to the existing indication for the 80 mg and 125 mg hard capsules for prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12.