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
Authorization Dates

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

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

Marketing authorization number:

PL 17901/0002

Drugs

Drug
Countries
Austria, Australia, Canada, Cyprus, Spain, France, Hong Kong, Lithuania, Netherlands, Singapore, United Kingdom, United States