Varuby

Withdrawn

This medicine's authorisation has been withdrawn

rolapitant

Overview

The marketing authorisation for Varuby has been withdrawn at the request of the marketing-authorisation holder.

Varuby : EPAR - Summary for the public

Reference Number: EMA/141777/2017

Product information

Varuby : EPAR - Product Information

Latest procedure affecting product information: T/0015

11/03/2019

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Varuby : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Varuby
• Active substance:
  rolapitant
• International non-proprietary name (INN) or common name:
  rolapitant
• Therapeutic area (MeSH):
  • Vomiting
  • Nausea
  • Cancer
• Anatomical therapeutic chemical (ATC) code:
  A04AD

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.

Authorisation details

• EMA product number:
  EMEA/H/C/004196
• Marketing authorisation holder:
  TESARO Bio Netherlands B.V.

  Joop Geesinkweg 901; 1114 AB Amsterdam-Duivendrecht; The Netherlands

• Opinion adopted:
  22/02/2017
• Marketing authorisation issued:
  19/04/2017
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Varuby : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Varuby : EPAR - Public assessment report

Reference Number: EMA/239011/2017

CHMP summary of positive opinion for Varuby

Reference Number: EMA/CHMP/97358/2017