COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On September 16, 2013, the delegate of the Secretary of the Department of Health 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 product exemestane (AROMASIN) 25 mg tablet blister pack [Aust R 76369], by Pfizer Australia Pty Ltd, West Ryde, NSW (“the Company”);
That do not conform with paragraphs 3(2)(h) and (i) of Therapeutic Goods Order (TGO) 69, in that blister foil labels do not include the relevant pre-fixes for batch number and expiry date.
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:
- The consent applies to batches U955A and V220B only.
- The carton and blister foil labels for the affected batches are those provided in the
Company’s electronic mail of September 6, 2013.
3. Each supply of the affected batches must be accompanied by the Dear Health Care Professional/Pharmacist letter of September 16, 2013.