THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On March 18 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 her consent to GlaxoSmithKline Australia Pty Ltd Abbotsford, VIC (“the Company”) for:
(a) the supply of the following products:
- nadroparin calcium (FRAXIPARINE) 1900 IU anti-Xa/0.2mL injection syringe (AUST R 51308)
- nadroparin calcium (FRAXIPARINE) 2850 IU anti-Xa/0.3mL injection syringe (AUST R 51309)
- nadroparin calcium (FRAXIPARINE) 3800 IU anti-Xa/0.4mL injection syringe (AUST R 51310)
- nadroparin calcium (FRAXIPARINE) 5700 IU anti-Xa/0.6mL injection syringe (AUST R 513011)
- nadroparin calcium (FRAXIPARINE) 7600 IU anti-Xa/0.8mL injection syringe (AUST R 51312)
- nadroparin calcium (FRAXIPARINE) 9500 IU anti-Xa/1.0mL injection syringe (AUST R 51313)
- nadroparin calcium (FRAXIPARINE FORTE) 19,000 anti-Xa IU/1.0mL injection syringe (AUST R 67145)
- nadroparin calcium (FRAXIPARINE FORTE) 15,200 anti-Xa IU/0.8mL injection syringe (AUST R 67148)
- nadroparin calcium (FRAXIPARINE FORTE) 11,400 anti-Xa IU/0.6mL injection syringe (AUST R 67149)
That do not conform with paragraphs 3(1)(b)(ii) and 3(10)(g) of Therapeutic Goods Order (TGO) 69, in that the letter height on the syringe labels is less than 1.5 millimetres, and the information about the name of the source animal on the syringe labels is incomplete.