THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On February 14 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”):

• clopidogrel (as hydrogen sulphate) (ISCOVER) 75 mg tablet blister pack [Aust R 79021]
• clopidogrel (as hydrogen sulphate)/aspirin (DUOCOVER) 75 mg/100 mg tablet blister pack [Aust R 151075]

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:

1. This consent applies until February 14 2014.
2. 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.
3. No other changes have been made to the products:

• clopidogrel (as hydrogen sulphate) (ISCOVER) 75 mg tablet blister pack [Aust R 79021]
• clopidogrel (as hydrogen sulphate)/aspirin (DUOCOVER) 75 mg/100 mg tablet blister pack [Aust R 151075]

4.       Arrangements are in place for the prompt referral of all enquiries or complaints regarding the products to the Company.