Supply of betamethasone (as valerate) (CELESTONE-M) 0.2mg/g cream tube by Merck Sharp & Dohme Australia Pty Ltd

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 product betamethasone (as valerate) (CELESTONE-M) 0.2 mg/g cream tube [Aust R 18778] by Merck Sharp & Dohme Australia Pty Ltd, North Ryde NSW (“the Company”):

That does 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 tube 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 to batches 2028, 2030 and 2031 of the product betamethasone (as valerate) (CELESTONE-M) 0.2 mg/g cream tube [Aust R 18778].
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 product betamethasone (as valerate) (CELESTONE-M) 0.2 mg/g cream tube [Aust R 18778].
4. Arrangements are in place to ensure complaints or queries concerning these products will be dealt with promptly.