Supply of sodium nitroprusside by Hospira Australia Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On September 28 2012, 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 sodium nitroprusside (DBL Sodium Nitroprusside Concentrated Injection) 25 mg/mL concentrated injection vial [Aust R 177111 ] by Hospira Australia Pty Ltd, Melbourne Vic (“the Company”)

That does not conform with paragraphs 3(2)(a), 3(2)(g) and 3(5)(b), 3(2)(j) and 7, 3(5)(b)(i), 3(11)(c) and 4(7)(a) of the Therapeutic Goods Order 69, in that:

• The product name on the labels on the cartons and vials is expressed differently to that of the approved version, in that the USA product name “Nitropress” appears on the labels instead of the Australian product name “DBL Sodium Nitroprusside Concentrated Injection”
• Warning statements concerning the product are not included on the labels on the cartons and vials
• The storage conditions listed on the labels on the cartons and vials are expressed differently to that of the approved form
• The presence of the excipient water is not stated on the labels on the cartons and vials
• The name of the registered trade mark of the Australian sponsor/supplier is not included on the labels on the cartons and vials
• The quantity of the active ingredient is expressed differently to that of the approved form

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 to batch number 163803A.
2. The labels to which this consent applies are identical to those submitted by the Company in correspondence dated August 23 2012, being those used for the USA version of the product (“Nitropress”), which has previous been supplied in Australia under Section 19A of the Act. The products will have an oversticker with the Australian sponsor’s address details and the Aust R number, as agreed in correspondence from the Company dated September 21 2012.
3. No other changes have been made to the product sodium nitroprusside (DBL Sodium Nitroprusside Concentrated Injection) 25 mg/mL concentrated injection vial [Aust R 177111 ] in connexion with this submission
4. The Dear Healthcare Professional letter supplied by the company in correspondence dated September 21 2012, which outlines the circumstances behind this consent to supply, will be included with the supplied product.
5. The USA patent leaflet in the goods will be replaced with the Australian product information.