Pfizer Australia - Caltrate Bone

Therapeutic Goods Act 1989

Approval under section 42DF (1) for use of a restricted representation by Pfizer Australia Pty Limited

I, Dr Jane Cook, Head, Office of Product Review, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health, on receipt of an application by Pfizer Australia Pty Limited, have approved under section 42DF (1) of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in consumer advertisements for the products identified in paragraph (b), provided the conditions in paragraph (c) are met:

1. Representations to the effect that consumer advertisements for the medicines described in paragraph (b) may refer to "low testosterone levels", "Coeliac disease" and "Crohn's disease" in the following questions as part of a nine point questionnaire - the "One Minute Risk Test":
   1. "5. For men: have you ever suffered from symptoms related to low testosterone levels?" and
   2. "9. Do you suffer from intestinal problems such as Coeliac disease or Crohn's disease?
2. Caltrate Bone Health (AUST L 214748) and Caltrate Bone and Muscle Health (AUST L 214783) sponsored by Pfizer Australia Pty Ltd.
3. Subject to the conditions that:
   1. the questionnaire (presented as the "One Minute Risk Test" at Attachment 1 of Pfizer's application of 18 September 2012) must be used in its entirety; and
   2. the final advisory paragraph of the "One Minute Risk Test" questionnaire must be included and read:
      1. "If you answered 'yes' to any of these questions, you may be at risk of developing osteoporosis. Osteoporosis is a serious condition which needs close management by your doctor. Do not attempt to self-treat osteoporosis, consult your doctor and discuss the matter. The good news is that osteoporosis can be relatively easily diagnosed and treated under medical supervision."

Dated this 3 day of January 2014

Dr Jane Cook
Delegate of the Secretary to the Department of Health; and
Head
Office of Product Review