Consent given pursuant to Sections 14 and 14A for the supply and importation of the therapeutic goods specified - between 28 October 2014 and 10 March 2015

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On October 28 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 AbbVie Pty Ltd gave consent to the importation and supply of:

Lopinavir (KALETRA) 100 mg and ritonavir 25 mg tablets bottle [AUST R 140509] 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 old sponsor’s name (Abbott) is used instead of the new sponsor’s name (AbbVie) on the labels.

The consent is effective from October 28 2014 until March 10 2015.

The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. The labels for use are those previously approved bearing the details of the previous sponsor of the products.
2. Details of the process are in place to ensure continuous customer contact with the company as the sponsor are as described in the Company letter; and
3. No other changes have been made to the product.