Consent given pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified by Bayer Australia Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Sections 14 and 14A Notice

On 7 October 2015, a delegate of the Secretary of the Department of Health, on the application of Bayer Australia Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of

• radium (223Ra) dichloride (XOFIGO) 6.0 MBq per 6 mL solution for injection vial

[AUST R 208905]

that do not conform with the requirements of the subsections 3(2)(b) and 4(7)(c) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines, in that the vial label:

• Uses the US Approved Name 'radium Ra 223 dichloride' instead of the Australian Approved Name ‘radium (223Ra) dichloride’ and
• Includes a statement of activity per millilitre (kBq/mL) in addition to a statement of activity per vial (MBq/vial).

The consent is effective from the date of United States National Institute of Standards and Technology (NIST) reference standard revision and label implementation, stated as 04 April 2015, until further notice.

The consent is subject to the following conditions:

1. The labels to which this consent applies are those provided with the letter of application date 31 August 2015.