Supply of Coloxyl with Senna Film Coated Tablets by Aspen Pharma Pty Ltd

SECTion 14 AND 14A NOTICE

I, MAYADA KAYALI, 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 Aspen Pharma Pty Ltd, 34–36 Chandos Street, St Leonards NSW 2065 to supply COLOXYL WITH SENNA FILM COATED TABLETS bottle (AUST R 59118), AMCAL SENNA-COL film coated tablets bottle (AUST R 81753), and GUARDIAN SENNA-COL film coated tablets bottle (AUST R 139220) that do not comply with the requirements of Therapeutic Goods Order No. 78 in respect of the limits for content of sennosides and for content of docusate sodium in the finished product specifications.

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

1. The limits for content of sennosides in the finished product specifications will be 90.0–110.0% at release and 90.0–110.0% at expiry.
2. The limits for content of docusate sodium in the finished product specifications will be 90.0–110.0% at expiry.
3. Other than the above exempted limits for content of sennosides and for content of docusate sodium, the products will comply with all requirements of Therapeutic Goods Order No. 78.

(Signed by)

Mayada Kayali

Delegate of the Secretary

Office of Medicines Authorisation

 11 December 2012