COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On July 29 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”), by application of AbbVie Pty Ltd, gave consent to the importation and supply, of:
AUST R No. | Product Name |
94481 | levobupivacaine hydrochloride (CHIROCAINE) 125 mg/200 mL solution for injection bag |
94482 | levobupivacaine hydrochloride (CHIROCAINE) 250 mg/200 mL solution for injection bag |
76815 | levobupivacaine (as hydrochloride) (CHIROCAINE) 25 mg/10 mL injection ampoule. |
76862 | levobupivacaine (as hydrochloride) (CHIROCAINE) 50 mg/10 mL injection ampoule |
76864 | levobupivacaine (as hydrochloride) (CHIROCAINE) 75mg/10mL injection ampoule |
29656 | isoflurane (FORTHANE) 1 mL/ mL inhalation bottle |
140509 | lopinavir (KALETRA) 100 mg and ritonavir 25 mg tablets bottle |
78627 | KALETRA oral solution bottle |
114302 | leuprorelin acetate (LUCRIN DEPOT) 7.5 mg powder for injection prefilled dual-chamber syringe |
that does not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the old sponsor’s name (Abbott) is used instead of the new sponsor’s name (AbbVie) on the labels.
The consent is effective from July 29, 2014 until March 7, 2015 for the following products and batches.
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The consent is effective from July 29, 2014 until March 10, 2015 for the following products and batches.
Product | Strength | Batch Number |
KALETRA | 100 mg/25 mg | 39942TF 38804TF 40110TF |
KALETRA | 80 mg/mL lopinavir, 20 mg/mL ritonavir | 6037361 |
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels for use are those previously approved bearing the details of the previous sponsor of the products.
- Details of the process in place to ensure continuous customer contact with your Company as the sponsor are as described in the Company letter.