Nova Pharmaceuticals - Coles Low Dose Aspirin

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Nova Pharmaceuticals Australasia

I, Leanne McCauley, Director, Advertising Compliance Unit, Regulatory Practice, Education and Compliance Branch and Delegate of the Secretary to the Department of Health, on receipt of an application from Medical Developments International Limited, 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. Helps prevent blood clotting and reduces the risk of heart attack and stroke in patients with known cardiovascular or cerebrovascular disease.
2. COLES LOW DOSE ASPIRIN 100 mg enteric coated tablet blister pack (AUST R 281316)
3. the advertisement must include:
   1. A warning for the patient to "consult a medical practitioner prior to commencing use of Coles Low Dose 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 patient 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 2015.

Dated this 13th day of December 2016

Leanne McCauley
Delegate of the Secretary to the Department of Health; and
Director
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch