Supply of interferon beta-1B (rbe)(EXTAVIA) 0.25mg (8 million IU) powder for injection vial with diluent syringe by Novartis Pharmaceuticals Australia Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On March 4 2013, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave her consent to the following:

(a)   the supply by Novartis Pharmaceuticals Australia Pty Ltd, North Ryde, NSW (“the Company”) of interferon beta-1B (rbe)(EXTAVIA) 0.25 mg (8 million IU) powder for injection vial with diluent syringe [AUST R 160079].

(b)  for the above goods not to conform with paragraphs 3(10) and 7(1)(a) of Therapeutic Goods Order (TGO) 69- “ General Requirements for Labels for Medicines”, in that the biological source of the active ingredient is not specified, and the relevant warning statements are not included on the syringe labels.

Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:

1. The consent will apply to one batch of a maximum 2000 units only. The details of this batch will be supplied to the TGA when shipped. The outer carton will be the approved Australian specific carton, with only the inner labels being non-compliant.