Sigma Company - Blooms The Chemist enteric coated aspirin 100 mg

Therapeutic Goods Act 1989

I, Lyndall Soper, 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:

1. 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, by helping to prevent blood clotting'
2. BLOOMS THE CHEMIST ENTERIC COATED ASPIRIN 100 mg enteric coated tablet blister pack (AUST R 258433)
3. supplied as an over-the-counter medicine by the sponsor Sigma Company Limited.

Dated this 26 day of May 2016

Lyndall Soper
Delegate of the Secretary to the Department of Health; and
Head, Complementary & OTC Medicines Branch
Medicines Regulation Division