Sigma Pharmaceuticals (Australia) - Guardian aspirin

Therapeutic Goods Act 1989

I, MICHAEL DODSON, Director, Non-Prescription Medicines Branch, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing 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 ofthe 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 "For inhibition of platelet aggregation to help prevent heart attack and stroke in patients with known cardiovascular or cerebrovascular disease".
2. GUARDIAN ASPIRIN 100 aspirin 100mg tablet blister pack
3. supplied as an over-the-counter drug by Sigma Pharmaceuticals (Australia) Pty Limited.

Dated this 24th day of May 2010.

MICHAEL DODSON
Delegate of the Secretary to the Department of Health and Ageing