Votrient

RSS

pazopanib

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 28/05/2018

Authorisation details

Product details
Name
Votrient
Agency product number
EMEA/H/C/001141
Active substance
pazopanib
International non-proprietary name (INN) or common name
pazopanib
Therapeutic area (MeSH)
Carcinoma, Renal Cell
Anatomical therapeutic chemical (ATC) code
L01XE11
Publication details
Marketing-authorisation holder
Novartis Europharm Limited 
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
13/06/2010
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

07/05/2018 Votrient - EMEA/H/C/001141 - T/0046

Contents

  • 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.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

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