tivozanib hydrochloride monohydrate

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Fotivda. 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 Fotivda.

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

This EPAR was last updated on 14/04/2021

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
tivozanib hydrochloride monohydrate
Therapeutic area (MeSH)
Carcinoma, Renal Cell
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional 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
EUSA Pharma (Netherlands) BV
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Beechavenue 54
1119PW Schiphol-Rijk
The Netherlands

Product information

26/01/2021 Fotivda - EMEA/H/C/004131 - IAIN/0015


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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.

Treatment of advanced renal cell carcinoma.

Assessment history

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