COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 20 October 2015, a delegate of the Secretary of the Department of Health, on the application of Reckitt Benckiser Australia consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of:
- NUROFEN FOR CHILDREN BABY 3+ MONTHS strawberry flavour ibuprofen 40mg/mL oral liquid bottle (new) – AUST R 108772 – batch numbers J05 & J06.
- Nurofen Tablets ibuprofen 200 mg blister pack – AUST R 127272 – batch number BH835
that will not conform to the requirements of paragraph 3(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicine, in that the medicine labels do not include the advisory statement ‘Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting’ that will be required by schedule 2 of the Medicines Advisory Statements Specification 2014, from 12 December 2015.
The consent is effective from 20 October 2015 until 30 June 2016.
The consent is subject to the following condition:
- The labels to which this consent applies are those provided with the application of 9 October 2015.