COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 30 July 2015, a delegate of the Secretary of the Department of Health, on the application of AFT Pharma Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- Levetiracetam (LEVETIRACETAM-AFT) oral solution 100 mg/mL in bottle [AUST R 218279]
that do not conform with the requirements of paragraph 3(2)(d)(iii) of the Therapeutic Goods Order No. 69 –General requirements for labels for medicines, in that the carton label does not declare the presence and content of the ingredient, maltitol, in the product.
The consent is effective from the 30 July 2015 and applies only to Batch 150073 of the product.
The consent is subject to the following conditions:
- The labels for use with the above batch are those currently approved for the product.