Supply of the product Brentuximab Vedotin (rch) (Adcetris) by Nycomed Pty Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

SECTION 14 and 14A NOTICE

On December 19, 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:

• brentuximab vedotin (rch) (ADCETRIS) 50 mg powder for injection vial [Aust R 203372]

 by Nycomed Pty Ltd North Ryde, NSW;

That does not conform with all requirements of Therapeutic Goods Order (TGO) 69.

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 approved Australian Product Information accompanies each carton that is supplied.
2. The consent expires on December 19, 2014.
3. No other changes have been made to the product.