Supply of VOLTAREN EMULGEL 12 HOURLY 2.32% diclofenac diethylammonium gel tube by Novartis Consumer Health Australasia Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

I, Gaelene Pyke, Delegate of the Secretary to the Department of Health and Ageing for the purposes of sections 14, 14A and 15 of the Therapeutic Goods Act 1989 (‘the Act’) hereby give my consent, pursuant to sections 14 and 14A of the Act, for Novartis Consumer Health Australasia Pty Ltd to supply VOLTAREN EMULGEL 12 HOURLY 2.32% diclofenac diethylammonium gel tube (AUST R 208848) whose label does not comply with the Therapeutic Goods Order No. 69 General requirements for labels for medicines in that it does not include the Required Advisory Statements for Medicine Labels (RASML) statement numbers 126 and 160.  

Pursuant to section 15(1) of the Act, my consent is subject to the following condition:

1. In place of RASML statement 160, the label includes the statements “Do not use for more than 2 weeks except on medical advice” and “Do not exceed the recommended dose.  Excessive use can be harmful”.
2. The product complies with all other aspects of Therapeutic Goods Order No. 69.

(Signed by)

Gaelene Pyke

Delegate of the Secretary

Office of Medicines Authorisation

2 May 2013