THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On July 16, 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
- abatacept (ORENCIA) 250 mg powder for IV infusion vial
[Aust R 130100]
- abatacept (ORENCIA) 125 mg single dose syringe subcutaneous injection flange extender [Aust R 177176]
by Bristol- Myers Squibb Australia Pty Ltd, MT MAVERLEY, VIC (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the products are supplied with labels containing the previous sponsor address and not the current sponsor address.
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 expires on December 31, 2013.
- The Company will retain for the period of the exemption a mail redirection service from the address contained on the label to the current sponsor address.
- No other changes have been made to the products
- abatacept (ORENCIA) 250 mg powder for IV infusion vial
[Aust R 130100]
- abatacept (ORENCIA) 125 mg single dose syringe subcutaneous injection flange extender [Aust R 177176]