COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On December 13, 2013 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 regorafenib (STIVARGA) 40 mg tablet [Aust R 200553]
by Bayer Australia, PYMBLE, NSW (“the Company”);
That do not conform with all requirements of the General requirements for labels for medicines (Therapeutic Goods Order 69).
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 tablets are packed in the carton and bottle labelled according to the Company email dated December 11, 2013 (i.e. USA labelled).
2. The carton is over stickered with information identifying the Australian sponsor and the ARTG number on one panel.
3. This consent expires June 13, 2014.