🇪🇺 Rolapitant - Oral in European Union

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

EMA authorised Rolapitant - Oral on 19 April 2017

Marketing authorisation

EMA — authorised 19 April 2017

Application: EMEA/H/C/004196
Marketing authorisation holder: TESARO Bio Netherlands B.V.
Local brand name: Varuby
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.
Status: withdrawn

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Frequently asked questions

Is Rolapitant - Oral approved in European Union?

Yes. EMA authorised it on 19 April 2017.

Who is the marketing authorisation holder for Rolapitant - Oral in European Union?

TESARO Bio Netherlands B.V. holds the EU marketing authorisation.