Supply of mometasone furoate products 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 following products by Merck Sharp & Dohme Australia Pty Ltd, North Ryde NSW (“the Company”):

• mometasone furoate (ELOCON) 1 mg/g cream tube [Aust R 43342]
• mometasone furoate (ELOCON) 1 mg/g ointment tube [Aust R 43344]
• mometasone furoate (ELOCON) 1 mg/g lotion bottle [Aust R 53472]

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 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 2UHKA32001, 2UHKA05001 and 2UHKA35002 of the product mometasone furoate (ELOCON) 1 mg/g ointment tube [Aust R 43344].
2. This consent applies to batches 2NGFA08001 and 2NGFA69001 of the product mometasone furoate (ELOCON) 1 mg/g cream tube [Aust R 43342].
3. This consent applies to batches 110262, 120045, 120109 and 120125a of the product mometasone furoate (ELOCON) 1 mg/g lotion bottle [Aust R 53472].
4. The labels to which this consent applies are those currently used, having the previous sponsor details.
5. No other changes have been made to the products:

• mometasone furoate (ELOCON) 1 mg/g cream tube [Aust R 43342]

• mometasone furoate (ELOCON) 1 mg/g ointment tube [Aust R 43344]
  • mometasone  furoate (ELOCON) 1 mg/g lotion bottle [Aust R 53472].

1. Arrangements are in place to ensure complaints or queries concerning these products will be dealt with promptly.