Afinitor

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everolimus

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

Overview

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

This EPAR was last updated on 18/10/2018

Authorisation details

Product details
Name
Afinitor
Agency product number
EMEA/H/C/001038
Active substance
everolimus
International non-proprietary name (INN) or common name
everolimus
Therapeutic area (MeSH)
  • Carcinoma, Renal Cell
  • Breast Neoplasms
  • Pancreatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XE10
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
03/08/2009
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

20/09/2018 Afinitor - EMEA/H/C/001038 - II/0058

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

Hormone-receptor-positive advanced breast cancer

Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

Neuroendocrine tumours of pancreatic origin

Afinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.

Neuroendocrine tumours of gastrointestinal or lung origin

Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.

Renal-cell carcinoma

Afinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.

Assessment history

Changes since initial authorisation of medicine

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