Fotivda
tivozanib hydrochloride monohydrate
Table of contents
Overview
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.
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List item
Fotivda : EPAR - Summary for the public (PDF/73.45 KB)
First published: 22/11/2017
Last updated: 22/11/2017
EMA/427397/2017 -
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List item
Fotivda : EPAR - Risk management plan summary (PDF/362.57 KB)
First published: 27/10/2021
Authorisation details
Product details | |
---|---|
Name |
Fotivda
|
Agency product number |
EMEA/H/C/004131
|
Active substance |
tivozanib
|
International non-proprietary name (INN) or common name |
tivozanib hydrochloride monohydrate
|
Therapeutic area (MeSH) |
Carcinoma, Renal Cell
|
Anatomical therapeutic chemical (ATC) code |
L01EK03
|
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 | |
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Marketing-authorisation holder |
EUSA Pharma (Netherlands) BV
|
Revision |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
24/08/2017
|
Contact address |
Beechavenue 54 |
Product information
15/07/2022 Fotivda - EMEA/H/C/004131 - R/0021
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.