THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On February 13 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 following products by Sanofi-Aventis Australia Pty Ltd, North Ryde Business Centre NSW (“the Company”):
- irbesartan (AVAPRO) 75 mg tablet blister pack [Aust R 101730]
- irbesartan (AVAPRO) 150 mg tablet blister pack [Aust R 101734]
- irbesartan (AVAPRO) 300 mg tablet blister pack [Aust R 101736]
- irbesartan and hydrochlorothiazide (AVAPRO HCT 150/12.5) 50 mg/12.5 mg tablet blister pack [Aust R 102017]
- irbesartan and hydrochlorothiazide (AVAPRO HCT 300/12.5) 300 mg/12.5 mg tablet blister pack [Aust R 102086]
- irbesartan and hydrochlorothiazide (AVAPRO HCT 300/25) 300 mg/25 mg tablet blister pack [Aust R 129436]
That do not conform with the requirements of paragraph 3(l) of Therapeutic Goods Order 69, in that the details of the previous sponsor (Bristol-Myers Squibb Australia Pty Ltd) are listed on the carton and blister foil labels, rather than that of the Company.
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:
- This consent applies until February 13 2014.
- The labels subject to this consent to supply are identical to those approved for the previous sponsor, having the logo and address details of Bristol-Myers Squibb Australia Pty Ltd.
- No other changes have been made to the products listed above.
- Arrangements are in place for the prompt referral of all enquiries or complaints regarding the products to the Company.