Supply of the product Saxagliptin (as hydrochloride) by AstraZeneca Pty Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On May 6, 2014, 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

• 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]

by AstraZeneca Pty Ltd, NORTH RYDE, NSW;

That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order No. 69—General requirements for labels for medicines (TGO 69), in that the carton label states the previous sponsor contact details.

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. This consent applies for 12 months from the date of this letter.
2. The labels are those currently supplied which state the previous sponsor details as well as the current sponsor (as the distributor).
3. Arrangements are in place to redirect all correspondence to the current sponsor (AstraZeneca).
4. No other changes have been made to the product.