Aspen Pharma - Spren

Therapeutic Goods Act 1989

Approval under section 42DK for use of a restricted representation by Aspen Pharma Pty Ltd

I, Peter Bird, A/g Head of Office, Office of Medicines Authorisation, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing for the purposes of section 42DK (1) of the Therapeutic Goods Act 1989, 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 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 aggregating agent for prophylaxis against acute myocardial infarction, unstable angina, transient ischaemic attack and cerebrovascular accident (stroke)."
2. SPREN 100 ASPIRIN 100mg tablet bottle
3. supplied as an over-the-counter drug by Aspen Pharma Pty Ltd.

Dated this 12 day of October 2012

Peter Bird
Delegate of the Secretary to the Department of Health and Ageing