Aspen Pharmacare Australia - Maltofer tablets and Maltofer syrup

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Aspen Pharmacare Australia Pty Ltd

I, Simon Waters, Delegate of the Secretary to the Department of Health, on receipt of an application from Aspen Pharmacare Australia Pty Ltd, 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 advertisements directed to consumers, for the product identified in paragraph (b):

1.  
   1. Maltofer is for the treatment of iron deficiency in adults and adolescents where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate;
   2. For the prevention of iron deficiency in adults and adolescents determined by a medical practitioner to be at high-risk, where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate.; and
   3. If you have iron deficiency, your doctor will advise you whether an oral iron treatment is required.
2. Maltofer Tablets and Maltofer Syrup (ARTG Nos 229647 and 230643 respectively)

Dated this 17th day of August 2017

Simon Waters
Delegate of the Secretary to the Department of Health
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch