Supply of paracetamol (PARACETAMOL IV PFIZER) 10 mg/mL solution for infusion 100mL PVC Bag by Pfizer Australia

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On March 1 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 paracetamol (PARACETAMOL IV PFIZER) 10 mg/ mL solution for infusion 100mL PVC bag [Aust R 1932132], by Pfizer Australia, West Ryde, NSW (“the Company”);

That do not conform with paragraphs 3(5)(b)(i) of Therapeutic Goods Order (TGO) 69, in that the units for the quantity of excipients are expressed incorrectly.

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 batches P121001, P121002, P121003, P 121004, P121005, P 131001, P131002, P131003, P131004, P131005, P131006 and P131007 of the product paracetamol (PARACETAMOL IV PFIZER) 10 mg/ mL solution for infusion 100mL PVC bag [Aust R 1932132].
2. The labels for use are identical to those submitted with the Company’s application.
3. No other changes have been made to the product, paracetamol (PARACETAMOL IV PFIZER) 10 mg/ mL solution for infusion 100mL PVC bag [Aust R 1932132].