COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 13 August 2015, a delegate of the Secretary of the Department of Health, on the application of Atnahs Pharma Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of:
- naproxen (NAPROSYN SR 1000) sustained release 1000 mg tablets [AUST R 10173]
- naproxen (NAPROSYN SR 750) sustained release 750 mg tablets [AUST R 10174]
- naproxen (NAPROSYN 500) 500 mg tablets blister pack [ AUST R 65246]
- naproxen (NAPROSYN) 250 mg tablets blister pack [AUST R 65247]
- naproxen sodium (ANAPROX 550) 550 mg tablets blister pack [AUST R 66544]
- naproxen sodium (CRYSANAL) 550 mg tablets blister pack [AUST R 67927]
that do not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that labels bear the former supplier and/or sponsor name, logo and contact details.
The consent is effective from 13 August 2015 until 30 April 2016.
The consent is subject to the following conditions:
- The labels to which this consent applies are those currently approved for the former sponsor Roche Products Pty Ltd;
- Arrangements are in place in place for all queries to be directed to Atnahs Pharma Australia Pty Ltd [the current sponsor]; and
- No other changes have been made to the products.