Sigma Company - Amcal aspirin EC 100

Therapeutic Goods Act 1989

I, Peter Bird, Head, Medicines Authorisation 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 'Reduce the risk of heart attack and stroke in patients with known cardiovascular or cerebrovascular disease, by helping to prevent blood clotting'
2. AMCAL ASPIRIN EC 100 aspirin 100 mg enteric coated tablet blister pack (new formulation) (AUST R 236225)
3. supplied as an over-the-counter medicine by the sponsor Sigma Company Limited.

Dated this 19th day of May 2015

Dr Peter Bird
Delegate of the Secretary to the Department of Health; and
Head, Medicines Authorisation Branch