COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 20 July 2015, a delegate of the Secretary of the Department of Health, on the application of CSL Behring (Australia) Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- human prothrombin complex (BERIPLEX P/N) 500 IU powder for injection vial
[AUST R 156459]
- human prothrombin complex (BERIPLEX P/N) 1000 IU powder for injection vial
[AUST R 228338]
that do not conform with the requirements of paragraphs 3(5)(b) and 3(2)(l) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines, in that the name and address of the sponsor on the container vial label and the name and quantity of each excipient in the goods on both the carton and container labels could not be included without sacrificing legibility.
The consent is effective from the 20 July 2015 until further notice.