Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by Evolution Health Pty Ltd
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 Evolution Health Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a)(i) - (iii) below for use in advertisements directed to consumers, for the product identified in paragraph (b), provided the conditions identified in paragraphs (c), (d) and (e) are met:
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- Contains Lactobacillus fermentum CECT 5716 which may help to relieve or reduce breast pain and discomfort associated with mastitis; and
- Contains Lactobacillus fermentum CECT 5716 which may reduce the recurrence of mastitis. Use at the first signs of mastitis; and
- Lactobacillus fermentum CECT 5716 may be used in conjunction with conventional treatment - under direction of your health care professional
- Probiotic for Pregnancy & Breastfeeding (AUST L 277491)
- The use of the approved representations on a label for the Medicine must be accompanied by a warning, prominently displayed or communicated, i.e. standing out so as to be easily read from a normal viewing distance, which advises consumers to seek medical advice if symptoms persist;
- The use of the approved representations in consumer advertising of the Medicine (including on the label) must be accompanied by a warning, prominently displayed or communicated, i.e. standing out so as to be easily read from a normal viewing distance, which advises consumers to seek prompt medical advice if the breast is red, hot and tender and/or if flu‐like symptoms with a fever are present; and
- The recommended daily dose (RDD) of the Medicine must deliver a minimum of 3 billion CFU of Lactobacillus fermentum CECT 5716.
Dated this 9th day of February 2017
Leanne McCauley
Delegate of the Secretary to the Department of Health; and
Director
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch