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. |
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) 75 mg/10 mL injection ampoule |
94481 | levobupivacaine hydrochloride (CHIROCAINE) 125 mg/200 mL solution for injection bag |
94482 | levobupivacaine hydrochloride (CHIROCAINE) 250 mg/200 mL solution for injection bag |
133452 | levodopa/carbidopa (DUODOPA) 20 mg/mL and 5 mg/mL intestinal gel PVC bag |
29656 | isoflurane (FORTHANE) 1 mL/mL inhalation bottle |
140509 | lopinavir (KALETRA) 100 mg and ritonavir 25 mg tablets bottle |
121055 | lopinavir (KALETRA) 200 mg and ritonavir 50 mg tablets bottle |
78627 | KALETRA oral solution bottle |
114303 | leuprorelin acetate (LUCRIN DEPOT 3 – MONTH) 22.5 mg powder for injection prefilled dual-chamber syringe |
114304 | leuprorelin acetate (LUCRIN DEPOT 4-MONTH) 30 mg powder for injection prefilled dual-chamber syringe |
114302 | leuprorelin acetate (LUCRIN DEPOT) 7.5 mg powder for injection prefilled dual-chamber syringe |
29658 | leuprorelin acetate (LUCRIN) 5 mg/mL injection multidose vial |
158301 | ritonavir (NORVIR) 100 mg tablet bottle |
55004 | ritonavir (NORVIR) 600 mg/7.5 mL oral liquid bottle |
51919 | sevoflurane (SEVORANE) anaesthetic inhalation bottle |
121762 | paricalcitol (ZEMPLAR) 2 micrograms capsule blister pack |
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 sponsor’s old address (AbbVie Pty Ltd, 32-34 Lord St Botany NSW 2019) is used instead of the sponsor’s new address as of September 1, 2014 (AbbVie Pty Ltd, 241 O’Riordan St Mascot NSW 2020) on the labels.
The consent is effective from July 29, 2014 until September 1, 2016 for the products listed in the table above.
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 sponsor’s old address.
- Details of the process in place to ensure continuous customer contact with your Company as the sponsor are as described in the letter.