COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 5 May 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of Merck Sharp & Dohme Australia Pty Ltd , gave consent to the importation and supply of
- rizatriptan (as benzoate) (RIZATRIPTAN WAFERS ) 10 mg wafer blister pack [AUST R 225969]
that does not conform with the requirements of the paragraph 3(12)(a) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the blister foil label does not include either the name or the registered trade-mark of the sponsor and the product name of the medicine.
The consent is effective from the 5 May 2015 until 30 May 2016.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions.
- The blister foil label for use with the product is that provided with the application.