THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On September 3 2012, 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 Ascent Pharma Pty Ltd, South Melbourne, VIC (“the Company”):

• Ranitidine (as hydrochloride) (Ranoxyl) 150 mg tablet blister pack [Aust R 199391]
• Ranitidine (as hydrochloride) (Ranoxyl) 300 mg tablet blister pack [Aust R 199392]

That do not conform with paragraph 3(2)(c) of Therapeutic Goods Order 69, in that the quantity of the active ingredient is expressed differently to the approved versions on the labels on the cartons.

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. The consent applies only to batches B732 (150 mg tablet) and B734 (300 mg tablet) of the above products.
2. No other changes have been made to the products:

• Ranitidine (as hydrochloride) (Ranoxyl) 150 mg tablet blister pack [Aust R 199391]
• Ranitidine (as hydrochloride) (Ranoxyl) 300 mg tablet blister pack [Aust R 199392]

3.       The carton labels to be used for the above batches are identical to those provided by the Company in correspondence dated August 23 2012. It includes the over-sticker as specified by the TGA.