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 the goods or in information included in the package in which those goods are contained:
- Representations to the effect that the goods described in paragraph (b) below may be used 'For inhibition of platelet aggregation to help prevent heart attack and stroke in patients with known cardiovascular and cerebrovascular disease.'
- AMCAL ASPIRIN 100 aspirin 100 mg tablet blister pack (AUST R 231440)
- supplied as an over-the-counter medicine by the sponsor Sigma Company Limited.
Dated this 11th day of December 2014.
Dr Peter Bird
Delegate of the Secretary to the
Department of Health