Therapeutic Goods Act 1989
Approval under section 42DH to vary conditions for use of restricted representations by Reckitt Benckiser (Australia) Pty Ltd
I, Dr Jane Cook, Head, Office of Product Review, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing, on receipt of a request from Reckitt Benckiser (Australia) Pty Ltd, approve the following conditions in the use of the statement 'Reduces blood clotting and reduces the risk of heart attack and stroke in patients with blood vessel disorders. For use under medical supervision only' in consumer advertising of the product 'Cardiprin 100 aspirin 100mg' (ARTG R 15357) to the effect that advertisements in which the representations are made must include:
- A warning for the patient to "Consult a medical practitioner prior to commencing use of CARDIPRIN 100 aspirin 100m" or words to that effect;
- 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 healthcare professional" or words to that effect;
- A warning "Do not substitute other medicines containing aspirin, for this medicine, without first consulting your healthcare professional" or words to that effect; and
- 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.
These conditions are in substitution for the following conditions imposed on 10 October 2007:
- A call for the intervention or advice of a doctor before use must be included;
- An appropriate reference must be included to prevent substitution of the low-dose product with any other aspirin product without the advice of a healthcare professional;
- There must be appropriate advice about lifestyle factors that can reduce the risk of heart attack or stroke;
- There must be a reference to the benefit of an overall program for managing the risk of heart attack or stroke;
- The target audience needs to be appropriate, ie the advertising should target people who would be considered to be at risk of heart attack or stroke; and
- That the considerations outlined above be given appropriate prominence in advertising.
Dated this 10 day of April 2013
Jane Cook
Delegate of the Secretary to the Department of Health and Ageing; and
Head
Office of Product Review