Fareston

RSS

toremifene

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

Overview

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

This EPAR was last updated on 21/08/2018

Authorisation details

Product details
Name
Fareston
Agency product number
EMEA/H/C/000091
Active substance
toremifene
International non-proprietary name (INN) or common name
toremifene
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L02BA02
Publication details
Marketing-authorisation holder
Orion Corporation
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
14/02/1996
Contact address
Orionintie 1
FI-02200 Espoo
Finland

Product information

26/07/2018 Fareston - EMEA/H/C/000091 - PSUSA/00002999/201709

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

ENDOCRINE THERAPY

Therapeutic indication

First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.
Fareston is not recommended for patients with estrogen receptor negative tumours.

Assessment history

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