Novo Nordisk Pharmaceutical - Sterile hypodermic needles

Therapeutic Goods Act 1989

Approval under section 42DF for use of a restricted representation by Novo Nordisk Pharmaceuticals Pty.

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 Novo Nordisk Pharmaceutical Pty, 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 identified in paragraph (c) is met:

1. Representation to the effect that advertisements to consumers for the for the goods described in paragraph (b) may refer to
   • "Diabetes";
2. Sterile hypodermic needles (including tradename 'NovoFine') for use with drug pen injectors, with the Australian Register of Therapeutic Goods entry number 196775;
3. The advertisements in which the representation is made must advise consumers to seek advice from their medical practitioner/health care professional.

Dated this 30th day of July 2012

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