COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 15 April 2015, 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”), on the application of Janssen-Cilag Pty Ltd, gave consent to the importation and supply of
- IMBRUVICA 140 mg ibrutinib capsules
that do not conform with the requirements of the paragraph 3(2)(l) and 3(2)(n) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines, in that the labels lack the registration number and the name and address of the Australian sponsor.
The consent is effective from the date of this letter until 31 July 2015.