THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On May 22, 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 products listed in the following table by Bristol-Myers Squibb Australia Pty Ltd MT Waverley, VIC (“the Company”);
That do not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the sponsor address details on the labels are those of the previous address.
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:
- The consent to supply applies until the end of December 2013.
- The labels to which this consent applies are those currently used for the product, bearing the previous address details, 556 Princes Highway Noble Park Victoria 3174 instead of the new address, 4 Nexus Court, Mulgrave Victoria 3170.
- No other changes have been made to the products listed in the following table.
- Arrangements are in please so that consumer queries or complaints are promptly forwarded to the new address.
Aust R | Product |
90925 | aripiprazole (ABILIFY) 5 mg tablet blister pack |
90997 | aripiprazole (ABILIFY) 10 mg tablet blister pack |
90998 | aripiprazole (ABILIFY) 15 mg tablet blister pack |
91000 | aripiprazole (ABILIFY) 30 mg tablet blister pack |
14032 | aztreonam (AZACTAM) 1g powder for injection vial |
116852 | entecavir monohydrate (BARACLUDE) 0.5 mg film coated blister pack |
116853 | entecavir monohydrate (BARACLUDE) 1 mg film coated blister pack |
19252 | lomustine (CEENU) 10 mg capsule bottle |
19249 | lomustine (CEENU) 40 mg capsule bottle |
19250 | lomustine (CEENU) 100 mg capsule bottle |
47486 | hydroxyurea (HYDREA) 500 mg capsule bottle |
19263 | fluphenazine decanoate (MODECATE) 12.5mg/0.5 mL injection ampoule |
47023 | fluphenazine decanoate (MODECATE) 25 mg/1 mL injection ampoule |
47024 | fluphenazine decanoate (MODECATE) 50 mg/2 mL injection ampoule |
68968 | fosinopril / hydrochlorothiazide (MONOPLUS) 10 mg/12.5 mg tablets bottle |
68970 | fosinopril / hydrochlorothiazide (MONOPLUS) 20 mg/12.5 mg tablet bottle |
46475 | fosinopril (MONOPLUS) 10 mg tablets bottle |
46473 | fosinopril (MONOPLUS) 20 mg tablets bottle |
157907 | saxagliptin (as hydrochloride) (ONGLYZA) 5 mg film coated tablet blister pack |
99870 | paracetamol (PERFALGAN) 500 mg/ 50 mL injection vial |
99869 | paracetamol (PERFALGAN) 1 g/ 100 mL injection vial |
165096 | naltrexone hydrochloride (REVIA) 50 mg tablet blister pack |
99055 | atazanavir (REYATAZ) 150 mg capsule bottle |
99056 | atazanavir (REYATAZ) 200 mg capsule bottle |
134967 | atazanavir (REYATAZ) 300 mg capsule bottle |
125557 | dasatinib (SPRYCEL) 20 mg tablet bottle |
125559 | dasatinib (SPRYCEL) 50 mg tablet bottle |
125561 | dasatinib (SPRYCEL) 70 mg tablet bottle |
157352 | dasatinib (SPRYCEL) 100 mg tablet bottle |
78351 | didanosine (VIDEX EC) 125 mg capsule bottle |
78353 | didanosine (VIDEX EC) 200 mg capsule bottle |
78355 | didanosine (VIDEX EC) 250 mg capsule bottle |
78357 | didanosine (VIDEX EC) 400 mg capsule bottle |
19286 | teniposide (VUMON) 50 mg/5mL injection ampoule |
54299 | stavudine (ZERIT) 20 mg capsule bottle |
53400 | stavudine (ZERIT) 30 mg capsule bottle |
53401 | stavudine (ZERIT) 40 mg capsule bottle |