Labelling/packaging exemption: Nyal low dose aspirin

15 May 2006

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 to "reduce the risk of heart attack and stroke in patients with blood vessel disorders by helping to prevent blood clotting".
2. NYAL LOW DOSE ASPIRIN 100mg enteric coated tablet blister pack;
   supplied as an over-the-counter drug by Valeant Pharmaceuticals Australasia Pty Ltd.

Dated this 15th day of May 2006.

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