Supply of carmustine (BiCNU) 100 mg powder for injection vial with diluent vial by Watson Pharma Pty Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

SECTION14 AND 14A NOTICE

On November 29, 2013 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”) gave his consent to:

(a)   the supply of the product carmustine (BiCNU) 100 mg powder for injection vial with diluent vial [Aust R 19243]

by Watson Pharma Pty Ltd, The Rocks Sydney, NSW; (“the Company”).

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 applies only to 245 units of batch CDDA310 of the product.
2. The US labels to be used for affected batch of the product are those provided in the application.
3. The carton label is over-labelled with the over-sticker provided in the electronic mail of November 29, 2013.
4. The Dear Doctor letter submitted with the electronic mail of November 29, 2013 along with the Australian product information (PI) for BiCNU is provided to users with each order of the product.