EPAR summary for the public
This document 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).
What is Fareston?
Fareston is a medicine that contains the active substance toremifene. It is available as white, round tablets (60 mg).
What is Fareston used for?
Fareston is used to treat
The medicine can only be obtained with a prescription.
How is Fareston used?
The recommended dose of Fareston is one tablet once a day. It should be used with caution in patients who have problems with their liver.
How does Fareston work?
Most types of breast cancer grow in response to the hormone oestrogen. The active substance in Fareston, toremifene, is an
How has Fareston been studied?
The effects of Fareston were first tested in experimental models before being studied in humans. Fareston has been studied in 1,869 postmenopausal women with metastatic breast cancer in four main studies. The effects of Fareston were compared with those of tamoxifen (another
What benefit has Fareston shown during the studies?
The effectiveness of Fareston and tamoxifen were equivalent. Looking at the results of the three largest main studies taken together, patients taking Fareston had similar response rates, times to
progression and survival rates as the patients taking tamoxifen. This was confirmed in the fourth study.
What is the risk associated with Fareston?
The most common side effects with Fareston (seen in more than 1 patient in 10) are hot flushes and sweating. For the full list of all side effects reported with Fareston, see the Package Leaflet.
Fareston should not be used in people who may be hypersensitive (allergic) to toremifene or any of the other ingredients. It must not be used on a
Why has Fareston been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits and risks of Fareston were comparable to those of tamoxifen in women with
Other information about Fareston:
The European Commission granted a marketing authorisation valid throughout the European Union for Fareston on 14 February 1996. The marketing authorisation was renewed on 14 February 2001 and on 14 February 2006. The marketing authorisation holder is Orion Corporation.
The full EPAR for Fareston can be found here.
This summary was last updated in