Supply of dexmedetomidine hydrochloride (PRECEDEX) 200 micrograms/2 mL injection vial by Hospira Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On February 5 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 his consent to:

(a)   the supply of the product dexmedetomidine hydrochloride (PRECEDEX) 200 micrograms/2 mL injection vial [Aust R 81323] by Hospira Pty Ltd, Melbourne VIC (“the Company”):

That does not conform with the requirements of paragraph 3(2)(l) of Therapeutic Goods Order 69, in that the previous address of the Company are listed on the carton and vial labels, rather than the current address.

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. This consent applies to batches 19133DK06 and 19133DK02 (totalling 47 745 vials) of the product dexmedetomidine hydrochloride (PRECEDEX) 200 micrograms in 2 mL injection vial [Aust R 81323].
2. No other changes have been made to the product dexmedetomidine hydrochloride (PRECEDEX) 200 micrograms in 2 mL injection vial [Aust R 81323].

3.       The labels to be used are identical to those provided by the Company in correspondence dated January 18 2013.