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Labelling/packaging exemption: Medix low dose aspirin

20 April 2007

THERAPEUTIC GOODS ACT 1989

I, PIO CESARIN, Director, Non-Prescription Medicines Branch, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing for the purposes of section 42 DK (1) of the Therapeutic Goods Act, give notice that the restricted representation described in paragraph (a) below, being a representation that is 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. a representation 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 agent for prophylaxis against acute myocardial infarction, unstable angina, transient ischaemic attack and cerebrovascular accident (stroke)".
  2. MEDIX LOW DOSE ASPIRIN 100mg enteric coated tablet blister pack;
    supplied as an over-the-counter drug by Nova Pharmaceuticals Australasia Pty Ltd.

Dated this 20th day of April 2007.

PIO CESARIN
Delegate of the Secretary to the Department of Health and Ageing