ARIMIDEX Film-coated tablets

Active ingredients: Anastrozole

Product name and form

Arimidex 1 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, round, biconvex film-coated tablets of about 6.1 mm marked with ‘A’ on one side and ‘Adx1’ on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 1 mg anastrozole.

Excipients with known effect: Each film-coated tablet contains 93 mg of lactose monohydrate (see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Anastrozole is a potent and highly selective non-steroidal aromatase inhibitor. It inhibits the enzyme aromatase, which is responsible for converting androgens to estrogens. Anastrozole is a drug indicated in the treatment of breast cancer in post-menopausal women.

List of Excipients

Lactose monohydrate
Povidone
Sodium starch glycollate
Magnesium stearate
Hypromellose
Macrogol 300
Titanium dioxide

Pack sizes and marketing

PVC blister/aluminium foil packs of 20, 28, 30, 84, 98, 100 and 300 tablets contained in a carton. Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK

Marketing authorization dates and numbers

PL 17901/0002

Date of first authorisation: 18 June 2000
Date of latest renewal: 14 December 2013

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Cyprus, Germany, Spain, Finland, France, Hong Kong, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, United States, South Africa