THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On May 31, 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 products:
- darifenacin (as hydrobromide) (ENABLEX) 7.5 mg modified release tablet blister pack [Aust R 99418]
- darifenacin (as hydrobromide) (ENABLEX) 15 mg modified release tablet blister pack [Aust R 99439]
by Aspen Pharmacare Australia Pty Ltd, St Leonards, NSW (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the sponsor name and address details on the labels are those of the previous sponsor Novartis Pharmaceuticals Australia Pty Ltd, instead of the new sponsor, Aspen Pharmacare Australia Pty Ltd.
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:
- The consent to supply applies until March 31, 2014.
- The labels to which this consent applies are those previously approved for the old sponsor, having the name and address details of Novartis Pharmaceuticals Australia Pty Ltd
- No other changes have been made to the products:
- darifenacin (as hydrobromide) (ENABLEX) 7.5 mg modified release tablet blister pack [Aust R 99418]
- darifenacin (as hydrobromide) (ENABLEX) 15 mg modified release tablet blister pack [Aust R 99439]
4. Arrangements are in place with the previous sponsor Novartis Pharmaceuticals Australia Pty Ltd for the prompt referral of any queries or complaints concerning the products to the new sponsor Aspen Pharmacare Australia Pty Ltd.