COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 23 July 2015, a delegate of the Secretary of the Department of Health, on the application of Commercial Eyes Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- Iron (as iron III hydroxide sucrose complex) (VENOFER) 100 mg in 5 mL ampoule
[AUST R 98236]
that do not conform with the requirements of paragraph 3(2)(e) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the dosage form name used is “concentrate for solution for infusion” rather than “concentrated injection”.
The consent is effective from 23 July 2015 until 31 July 2016.
The consent is subject to the following conditions:
- The ampoule label to be used is that provided in the letter of application.