THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On January 24 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 Merck Sharp & Dohme Australia Pty Ltd, North Ryde NSW (“the Company”):
- eptifibatide (as acetate) (INTEGRILIN) 20 mg/10 mL injection vial [Aust R 71540]
- eptifibatide (as acetate) (INTEGRILIN) 75 mg/100 mL injection vial [Aust R 71541]
That do not conform with the requirements of paragraph 3(2)(l) of Therapeutic Goods Order 69, in that the details of the previous sponsor (Schering-Plough Pty Ltd) are listed on the carton and vial 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 only to:
- batches 1SBHA01008 and 1SBHA010018 for the product eptifibatide (as acetate) (INTEGRILIN) 20 mg/10 mL injection vial [Aust R 71540]
- batches 2FWBA01008, 2FWBA01001 and 2FWBA02006 for the product eptifibatide (as acetate) (INTEGRILIN) 75 mg/100 mL injection vial [Aust R 71541]
2. The labels to which this consent applies are those currently used, having the previous sponsor details.
3. No other changes have been made to the products:
- eptifibatide (as acetate) (INTEGRILIN) 20 mg/10 mL injection vial [Aust R 71540]
- eptifibatide (as acetate) (INTEGRILIN) 75 mg/100 mL injection vial [Aust R 71541]
4. Arrangements are in place to ensure complaints or queries concerning these products will be dealt with promptly.