Supply of products by Baxter Healthcare Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On June 13, 2013 the delegate of the Secretary of the Department of Health and Ageing 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 products

• thrombin – human and calcium chloride (TISSELL VH S/D) 400-625 IU/ mL and 36-44 micromole /mL frozen fibrin sealant syringe [Aust R 147141]
• thrombin and calcium chloride (ARTISS FIBRIN SEALANT VH S/D 4 IU) 3.2-5 IU/mL and 36-44 micromole / mL frozen solution for sealant syringe [Aust R 163515]

 by Baxter Healthcare Pty Ltd, Toongabbie, NSW (“the Company”);

That does not conform with paragraphs 3(2)(m) of Therapeutic Goods Order (TGO) 69, which stipulates that “ a statement of the purpose or purposes for which the good is intended to be used” has to be included on the label.

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. The consent expires on the June 13, 2018.
2. No other changes have been made to the products;

• thrombin – human and calcium chloride (TISSELL VH S/D) 400-625 IU/ mL and 36-44 micromole /mL frozen fibrin sealant syringe [Aust R 147141]
• thrombin and calcium chloride (ARTISS FIBRIN SEALANT VH S/D 4 IU) 3.2-5 IU/mL and 36-44 micromole / mL frozen solution for sealant syringe [Aust R 163515]