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ARIMIDEX Film-coated tablets (2017)

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.

Chemical substance
Description
Anastrozole

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