Varuby

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rolapitant

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

Overview

This is a summary of the European public assessment report (EPAR) for Varuby. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Varuby.

For practical information about using Varuby, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 06/11/2017

Authorisation details

Product details
Name
Varuby
Agency product number
EMEA/H/C/004196
Active substance
rolapitant
International non-proprietary name (INN) or common name
rolapitant
Therapeutic area (MeSH)
  • Vomiting
  • Nausea
  • Cancer
Anatomical therapeutic chemical (ATC) code
A04AD
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Tesaro UK Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
20/04/2017
Contact address
55 Baker Street
London
W1U 7EU
United Kingdom

Product information

02/10/2017 Varuby - EMEA/H/C/004196 - N/0002

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

ANTIEMETICS AND ANTINAUSEANTS

Therapeutic indication

Prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.
Varuby is given as part of combination therapy.

Assessment history

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