Therapeutic Goods Act 1989
I, Mayada Kayali, Acting Head, Complementary & OTC Medicines Branch, 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 to 'Reduces the risk of heart attack and stroke in patients with known cardiovascular or cerebrovascular disease'
- COLES LOW DOSE ASPIRIN 100 mg enteric coated tablet blister pack (AUST R 281316)
- supplied as an over-the-counter medicine by the sponsor Nova Pharmaceuticals Pty Ltd.
14 October 2016
Mayada Kayali
Delegate of the Secretary to the Department of Health; and
A/g Head, Complementary & OTC Medicines Branch
Medicines Regulation Division