Aurobindo Pharma Australia - Aspirin

Therapeutic Goods Act 1989

I, Peter Bird, Head, Office of Medicines Authorisation, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health for the purposes of section 42 DK (1) of the Therapeutic Goods Act, give notice that the restricted representations described in paragraph (a) below, being representations that are necessary for the appropriate use of the therapeutic goods described in paragraph (b) below, may be included either on the label of the package of those goods or in information included in the package in which those goods are contained:

1. Representations to the effect that the goods described in paragraph (b) below may be used 'For the treatment of patients with known cardiovascular or cerebrovascular disease as an antiplatelet agent for prophylaxis against acute myocardial infarction, unstable angina, transient ischaemic attack and cerebrovascular accident (stroke)' and 'Reduces the risk of heart attack and stroke in patients with known cardiovascular or cerebrovascular disease, by helping to prevent blood clotting'.
2. AUROBINDO PHARMA ASPIRIN enteric coated tablet 100mg blister pack (AUST R  217823)
3. Supplied as an over-the-counter medicines by Aurobindo Pharma Australia Pty Ltd.

Dated this 29 day of November 2013.

Dr Peter Bird
Delegate of the Secretary to the Department of Health