COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On May 7, 2014, 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 palifermin (rbe) KEPIVANCE 6.25 mg powder for injection vial
[Aust R 107304], by A Menarini Australia, CHATSWOOD, NSW;
That does not conform with the Therapeutic Goods Order No. 69—General requirements for labels for medicines (TGO 69), in that the product has United Kingdom (UK) packaging.
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:
- Supply is restricted to the product in UK packaging as provided to the TGA in the application on February 27, 2014.
- A sticker containing Australian sponsor details and ARTG number will be placed on the packaging.
- An Australian PI will be supplied with each box
- The sponsor must inform the TGA in writing at least once every 12 months of the numbers of patients treated with KEPIVANCE in the previous 12 month period. This information should be submitted to biological.medicines@tga.gov.au unless you have reached agreement with the TGA for an alternative.
- The consent is granted until there is an increase in patient numbers above 35 per calendar year (as stated in the electronic mail dated April 09, 2014), or if the medicine is listed on the PBS or if the medicine is approved for an extension of indication. The sponsor must inform the TGA in writing as soon as possible if any of these changes occurs.