Varuby

Withdrawn

This medicine's authorisation has been withdrawn

rolapitant

Overview

On 23 January 2020 the European Commission withdrew the marketing authorisation for Varuby (rolapitant) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Tesaro Bio Netherlands B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Varuby was granted marketing authorisation in the EU on 20 April 2017 for the prevention of nausea and vomiting. The marketing authorisation was initially valid for a 5-year period. 

The European Public Assessment Report (EPAR) for Varuby is updated to indicate that the marketing authorisation is no longer valid.

Varuby : EPAR - Summary for the public

Reference Number: EMA/141777/2017

Product information

Varuby : EPAR - Product Information

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