COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On September 5 2014, 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”), by application of Ikaria Australia Pty Ltd, gave consent to the importation and supply of :
- terlipressin (LUCASSIN) 0.85 mg powder for injection vial [AUST R 176845] (Lot 300953FR only) that does not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the carton label includes the old sponsor address.
The consent is effective from September 5, 2014 until the expiry date of Lot 300953FR of the product, viz June 2016.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- All hospitals and/or healthcare facilities using this batch of the product have been informed of the change in sponsor address and updated contact details.
2. The labels, inclusive of the package insert, to which this consent applies are those provided with your letter of application and appropriate arrangements are in place for the prompt referral of any mail, queries or complaints concerning the product to the sponsor at the new address.