COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On February 7, 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”) gave his consent to:
(a) the supply of the product:
- dasatinib (SPRYCEL) 20 mg tablet bottle [AUST R 125557]
by Bristol-Myers Squib Pty Ltd, MT WAVERLY, VIC;
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69 (General requirements for labels for medicines), in that the old sponsor address is used on the product label.
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:
- The consent to supply applies until the end of September 2014.
- The labels to which this consent applies are those currently used for the product, bearing the previous address details, 556 Princes Highway Noble Park Victoria 3174 instead of the new address, 4 Nexus Court, Mulgrave Victoria 3170.
- No other changes have been made to the product.
4. Arrangements are in place so that consumer queries or complaints are promptly forwarded to the new address.