Supply of noradrenline (as titrate)(LEVOPHED 1:1000) 2 mg/mL injection ampoule by Hospira Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On February 28 2013 the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:

(a)   the supply of the product noradrenline (as tartrate)(LEVOPHED 1:1000) 2 mg/mL injection ampoule [Aust R 12584] by Hospira Pty Ltd Melbourne, VIC, (“the Company”);

That does not conform with paragraph 3(2)(1) of Therapeutic Goods Order (TGO) 69, in that the previous address of the Company is listed on the carton labels, rather than the current address.

Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:

1. The consent applies until 30 September 2013.
2. No other changes have been made to the product noradrenline (as tartrate)(LEVOPHED 1:1000) 2 mg/mL injection ampoule [Aust R 12584].
3. The label to be used is identical to that provided with the letter of application from the Company dated February 1, 2013
4. Arrangements are in place to redirect all mail sent to the old address to the current address until all stock bearing the old address has expired.