Apotex - Apohealth Cardio Aspirin

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Apotex Pty Ltd

I, Jane Cook, Head, Post-market Surveillance Branch, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health, on receipt of an application from Apotex Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in advertisements directed to consumers, for the product identified in paragraph (b), provided the conditions identified in paragraph (c) are met:

1. "cardiovascular or cerebrovascular disease", "myocardial infarction", "unstable angina", "transient ischemic attack" and "cerebrovascular accident (stroke)".
2. Apohealth Cardio Aspirin 100mg enteric coated tablets (AUST R 229733)
3. The advertisement must include
   1. A warning for the patient to "consult a medical practitioner prior to commencing use of Apohealth Cardio Aspirin" or words to that effect;
   2. A statement that: "The use of low dose aspirin may be only one component of your medical practitioner's management plan to prevent you having a further heart attack or stroke. You should discuss this plan with your medical practitioner" or words to that effect;
   3. A warning: "Do not substitute other medicines containing aspirin for this medicine, without first consulting your pharmacist or medical practitioner" or words to that effect; and
   4. Conditions (a) - (c) above must be given the same prominence in any advertising as is required for mandatory statements by section 6 of the Therapeutic Goods Advertising Code 2007.

Dated this 18 day of February 2015

Jane Cook
Delegate of the Secretary to the Department of Health; and
Head
Post-market Surveillance Branch