Blackmores - Kaloba

Therapeutic Goods Act 1989

I, Dr Jane Cook, Office Head, Office of Product Review, Therapeutic Goods Administration, and delegate of the Secretary to the Department of Health and Ageing, on receipt of an application by Blackmores Ltd, have approved under section 42DF (1) of the Therapeutic Goods Act 1989 (the Act) the restricted representation described in paragraph (a) below for use in advertisements directed to consumers, for the products identified in paragraph (b) provided the condition in paragraph (c) is met:

1. Representations to the effect that advertisements to consumers for the medicine described in paragraph (b) may refer to "acute bronchitis" and "acute sinusitis"
2. Kaloba Oral Liquid (ARTG 193170)
3. The restricted representations described in paragraph (a) must be used solely in the context of one or more of the following statements used in any combination:
   1. Kaloba relieves the symptoms of acute bronchitis
   2. Kaloba reduces the severity of symptoms of acute bronchitis
   3. Kaloba shortens the duration of acute bronchitis
   4. Kaloba improves the recovery time of acute bronchitis
   5. Kaloba relieves the symptoms of acute sinusitis
   6. Kaloba reduces the severity of symptoms of acute sinusitis
   7. Kaloba shortens the duration of acute sinusitis
   8. Kaloba improves the recovery time of acute sinusitis

Dated this 14 day of March 2013

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