THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On March 14 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
- leuprorelin acetate (ELIGARD) 7.5 mg modified release injections in pre-filled syringe [Aust R 97449]
- leuprorelin acetate (ELIGARD) 30 mg modified release injections in pre-filled syringe [Aust R 97451]
by Hospria Pty Ltd Melbourne, VIC (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the previous address of the Company is listed on the carton labels, rather than the current 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 applies to 477 units of batch 6102D1 of ELIGARD 7.5 mg and 450 units of batch 6106B1 of ELIGARD 30 mg.
2. The labels for use are those submitted with the application, viz labels bearing the previous address details of the Company.
3. The products are supplied with the Product Information provided in the letter from the Company dated February 18 2013.
4 No other changes have been made to the products
- leuprorelin acetate (ELIGARD) 7.5 mg modified release injections in pre-filled syringe [Aust R 97449]
- leuprorelin acetate (ELIGARD) 30 mg modified release injections in pre-filled syringe [Aust R 97451]
5 Details of the process in place to ensure continuous customer contact with the Company are as described in the letter dated February18 2013.