COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On November 4, 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 quetiapine (as fumarate)(seroquel XR) modified release tablet 50 mg in blister pack [Aust R 138917] by AstraZeneca, NORTH RYDE, NSW (“the Company”);
That do not conform with paragraphs 3(2)(n) of Therapeutic Goods Order (TGO) 69, in that the label for the product contains the incorrect registration number of the product.
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 of supply is restricted to batch 60009807 (3150 packs), batch 60010214 (5074 packs) and batch 60010402 (7810 packs).
- The carton label for use with the above packs are currently in use, i.e. with the Aust R number 153883.
- The non-compliance with TGO 69 is in relation to sub-clause 3(2)(n) only, all other aspects of the label must comply with the said Order.