Supply of products by AbbVie Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On September 7 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 following products by AbbVie Pty Ltd, Botany, NSW (“the Company”):

• Leuprorelin acetate (Lucrin) 5 mg/mL injection multidose vial [Aust R 29658]
• Leuprorelin acetate (Lucrin Depot) 7.5 mg powder for injection pre-filled dual chamber syringe with 23G needle [Aust R 114302]
• Leuprorelin acetate (Lucrin Depot 3 - month) 22.5 mg powder for injection pre-filled dual chamber syringe with 23G needle [Aust R 114303]
• Leuprorelin acetate (Lucrin Depot 4 - month) 30 mg powder for injection pre-filled dual chamber syringe with 23G needle [Aust R 114304]
• Levodopa/carbidopa (Duodopa) 20 mg/mL and 5 mg/mL intestinal gel PVC bag [Aust R 133452]
• Levobupivacaine (as hydrochloride) (Chirocaine) 25 mg/10 mL injection ampoule [Aust R 76815]
• Levobupivacaine (as hydrochloride) (Chirocaine) 50 mg/10 mL injection ampoule [Aust R 76862]
• Levobupivacaine (as hydrochloride) (Chirocaine) 75 mg/10 mL injection ampoule [Aust R 76864]
• Levobupivacaine (as hydrochloride) (Chirocaine) 125 mg/200 mL solution for injection bag [Aust R 94481]
• Levobupivacaine (as hydrochloride) (Chirocaine) 250 mg/200 mL solution for injection bag [Aust R 94482]
• Isoflurane (Forthane) inhalation liquid 250 mL bottle [Aust R 29656]
• Sevoflurane (Sevorane) inhalation liquid 250 mL bottle [Aust R 51919]

That do not conform with paragraph 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the previous name of the sponsor (Abbot) is listed on the labels on the cartons, bags, ampoules, vials and bottles, instead of the new sponsor name (AbbVie).

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 to supply applies for a period of two years from the date of consent, September 7 2012.
2. The labels to be used are identical to those submitted by the Company in correspondence dated August 16 2012.
3. No other changes have been made to the products listed at (a).
4. Details of the process in place to ensure continuous customer contact with the Company are described in correspondence from the Company dated August 16 2012.