THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On March 18 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 product linezolid (ZYVOX) 600 mg tablets blister pack [AUST R 79694], by Pfizer Australia Pty Ltd , West Ryde, NSW (“the Company”);
That do not conform with paragraph 3(2)(a) of Therapeutic Goods Order (TGO) 69, in that the product name on the foil labels is given as “Zyvoxid” instead of the registered name “Zyvox”.
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 to supply applies to 1000 packs of batch C121170 only.
- The foil labels to which this consent applies are identical to those supplied with the application on March 14 2013, being those for product manufactured in South Africa and having the product name given as “Zyvoxid” instead of the registered name “Zyvox”.
- The appearance of the tablets supplied under this consent differs from that registered, in that the inked marking reads “Zyvoxid 600 mg” instead of “Zyvox 600 mg”.
- The blisters are packaged in the approved Australian cartons, which include an insert which states: ‘Please note – The tablets contained in this pack are marked “ZYVOXID
600 mg”. These are ZYVOX 600 mg tablets. Important – Keep the tablet blister pack within the outer carton at all times until the pack has been finished’.
5. No other changes have been made to the product linezolid (ZYVOX) 600 mg tablets blister pack [AUST R 79694].