COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 19 August 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) 0.5 mg tablet bottle [AUST R 69608]
that do not conform with the requirements of paragraph 3(2)(l) of Therapeutic Goods Order No. 69 General standard for labels for medicines, in that the product labels do not include the current sponsor name and address.
The consent is effective from 19 August 2015 for batches T0124 and T0125.
The consent is subject to the following conditions:
- The labels to which this consent applies are those 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, the current sponsor.