FARESTON Tablet Ref.[9651] Active ingredients: Toremifene

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Orion Corporation, Orionintie 1, FI-02200, Espoo, Finland

Product name and form

Fareston 60 mg tablets.

Pharmaceutical Form

Tablet.

White, round, flat, bevelled edge tablet with TO 60 on one side.

Qualitative and quantitative composition

Each tablet contains 60 mg toremifene (as citrate).

Excipient with known effect: One tablet contains 28.5 mg of lactose. For the full list of excipients, see section 6.1.

Active Ingredient Description
Toremifene

Toremifene is a nonsteroidal triphenylethylene derivative that binds to estrogen receptors and may produce estrogenic, anti-estrogenic or both effects, depending upon the duration of treatment, animal species, gender, target organ and variable selected. Toremifene is indicated in first line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.

List of Excipients

Maize starch
Lactose monohydrate
Povidone
Sodium starch glycolate
Magnesium stearate
Cellulose, microcrystalline
Silica, colloidal anhydrous

Pack sizes and marketing

Green PVC foil and aluminium foil blister in a cardboard box.

Package sizes: 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation, Orionintie 1, FI-02200, Espoo, Finland

Marketing authorization dates and numbers

EU/1/96/004/001
EU/1/96/004/002

Date of first authorisation: 14 February 1996
Date of latest renewal: 2 February 2006

Drugs

Drug Countries
FARESTON Austria, Australia, Estonia, Finland, France, Croatia, Ireland, Japan, Lithuania, Poland, Romania, United Kingdom, United States, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.