COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On August 12 2014, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), by application of Aspen Pharmacare Australia Pty Ltd, gave consent to the importation and supply, of
fondaparinux sodium (ARIXTRA) 2.5 mg/0.5 mL solution for injection syringe [AUST R 80279] that does not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the carton labels do not include the current sponsor’s name and address details; instead, the details of the previous sponsor GlaxoSmithKline are present.
The consent is effective from August 12, 2014 until May 31, 2015.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those used by the previous sponsor, GlaxoSmithKline, and arrangements are in place with the previous sponsor to ensure that all customer enquiries or complaints and adverse event reports are promptly forwarded to the new sponsor, Aspen Pharmacare Australia Pty Ltd.