This is a summary of the European public assessment report (EPAR) for Votrient. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Votrient.
Votrient : EPAR - Summary for the public (PDF/87.91 KB)
First published: 08/07/2010
Last updated: 05/07/2013
Votrient : EPAR - Risk management plan summary (PDF/62.56 KB) (new)
First published: 28/07/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Carcinoma, Renal Cell
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
17/12/2020 Votrient - EMEA/H/C/001141 - II/0059
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Renal-cell carcinoma (RCC)
Votrient is indicated in adults for the first-line treatment of advanced renal-cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.
Soft-tissue sarcoma (STS)
Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy.
Efficacy and safety have only been established in certain STS histological tumour subtypes.