COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 17 August 2015, a delegate of the Secretary of the Department of Health, on the application of Teva Pharma Australia Pty Ltd consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- filgrastim (TEVAGRASTIM) 300 microgram/0.5 mL injection [AUST R 163675]
- filgrastim (TEVAGRASTIM) 480 microgram/0.8 mL injection [AUST R 163677]
that do not conform with the requirements of paragraph 3(2)(l) to the Therapeutic Goods Order No.69 General requirements for labels for medicines, in that the product labels will bear Aspen Pharmacare Australia Pty Ltd livery until revised packaging material is available despite transfer of sponsorship to Teva Pharma Australia Pty Ltd on 1 July 2015.
The consent is effective from 17 August 2015 until 30 November 2015.
The consent is subject to the following conditions:
- The labels to which this consent applies are for products indicated in the letter and in the letter of application dated 24 July 2015. The PI/CMI provided as a package insert will also bear the Aspen name until the revised packaging material is available.
- A confirmation that enquiries received by Aspen relating to Tevagrastim will be directed to Teva Pharma Australia Pty Limited.
- A confirmation that adverse event reports received by Aspen will be forwarded to Teva Pharma Australia Pty Limited.