Supply of Benzathine Benzylpenicillin 0.9 g/2 mL injection syringe with needle by Pfizer Australia Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On January 7 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 benzathine benzylpenicillin (BICILLIN LA) 0.9 g/2 mL injection syringe with needle [Aust R 147169] by Pfizer Australia Pty Ltd, West Ryde NSW (“the Company”)

That does not conform with paragraphs 3(2)(b), 3(2)(c), 3(2)(f), 3(2)(j) and 3(5)(b) of Therapeutic Goods Order 69 (TGO 69), in that the syringe and carton labels are different to that of the approved versions.

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 for 2000 packs of batch 66446.
2. The Company will pay the normal fee that applies for an application to make this change.
3. The United States (US) product information submitted by the Company in correspondence dated January 3 2012 will be supplied with the product packaged in the US syringe and carton labels with the carton overstickered as described in an electronic mail from the Company of 11.14 am on January 4 2013. The carton label will include the correct batch number and expiry date.
4. The Dear Healthcare Professional letter included in correspondence from the Company dated January 3 2013 will be distributed to those health professionals involved in the supply and/or use of the product.
5. No other changes have been made to the product benzathine benzylpenicillin (BICILLIN LA) 0.9 g/2 mL injection syringe with needle [Aust R 147169].