Consent given pursuant to sections 14 and 14A for the importation and supply of the therapeutic goods specified - AstraZeneca Pty Ltd

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:

• saxagliptin (as hydrochloride)(KOMBIGLYZE XR) 2.5/1000 tablets 2.5 mg immediate release and 1000 mg metformin hydrochloride modified release [AUST R 202207]

• saxagliptin (as hydrochloride)(KOMBIGLYZE XR) 5/1000 tablets 5 mg immediate release and 1000 mg metformin hydrochloride modified release [AUST R 202208]

• saxagliptin (as hydrochloride)(KOMBIGLYZE XR) 5/500 tablets 5 mg immediate release and 500 mg metformin hydrochloride modified release [AUST R 202209]

that do 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.

                                                                *Sample pack

The consent is effective from 25 February 2015 until batch numbers per the above are exhausted or have expired.

The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. The labels are those currently supplied which state the previous sponsor details as well as the current sponsor (as the distributor);
2. Arrangements are in place to redirect all correspondence to the current sponsor (AstraZeneca); and
3. No other changes have been made to the product.