COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 25 February 2015, 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”), on the application of AstraZeneca Pty Ltd, gave consent to the importation and supply of
- dapagliflozin (as propanediol monohydrate) (FORXIGA) 10 mg film coated tablets blister pack [AUST R 180147]
that does not conform with the requirements of paragraph 3(2)(l), of the Therapeutic Goods Order 69 – General requirements for labels for medicines in that the carton label states the previous sponsor contact details.
The consent is effective from the 25 February 2015 until batch number is 4C86509 (sample Pack) is exhausted or is expired.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels are those currently supplied which state the previous sponsor details as well as the current sponsor (as the distributor);
- Arrangements are in place to redirect all correspondence to the current sponsor (AstraZeneca); and
- No other changes have been made to the product.