COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 22 October 2015, a delegate of the Secretary of the Department of Health, on the application of AFT Pharmaceuticals Pty Ltd , consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- Pizotifen (as malate)(SANDOMIGRAN) tablet 0.5 mg bottle [AUST R 69608]
that do 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 product label does not include the sponsor details of the current sponsor.
The consent is effective from 22 October 2015 until the 31 October 2016.
The consent is subject to the following conditions:
- The labels to which this consent applies is that previously approved for the former sponsor, Novartis Pharmaceuticals Australia Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the product to AFT Pharmaceuticals Pty Ltd