Emend

RSS

aprepitant

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Emend. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Emend.

This EPAR was last updated on 12/06/2018

Authorisation details

Product details
Name
Emend
Agency product number
EMEA/H/C/000527
Active substance
Aprepitant
International non-proprietary name (INN) or common name
aprepitant
Therapeutic area (MeSH)
  • Vomiting
  • Postoperative Nausea and Vomiting
  • Cancer
Anatomical therapeutic chemical (ATC) code
A04AD12
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
11/11/2003
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

24/05/2018 Emend - EMEA/H/C/000527 - T/0057

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Anti emetics and antinauseants

Therapeutic indication

Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.

Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate Summary of Product Characteristics).

Emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.

Emend is also available as powder for oral suspension 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.

Emend 80 mg, 125 mg, 165 mg hard capsules and Emend powder for oral suspension are given as part of combination therapy.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating