COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On December 18, 2013 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”) gave his consent to:
(a) the supply of the product filgrastim (rbe) (NIVESTIM) 480 microgram/ 0.5 mL injection solution prefilled syringe [Aust R 160107]
by Hospira Pty Ltd, Melbourne, VIC (“the Company”);
That do not conform with paragraphs 3(2)(c), 3(2)(e) and 3(10)(f) of Therapeutic Goods Order (TGO) 69, in that the product is supplied with the UK syringe label.
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 applies only to lots 1853083D (2245 syringes), 1862083B (1555 syringes), 1853083B (1310 syringes), 1853103B (890 syringes).
- The UK sourced syringes must be repackaged to:
- add the blister label to the packed plaster trays
- placed in the currently registered Australian carton
- packaged with currently approved Australian PI
- Repackaging must take place at the registered secondary packaging site Hospira Zagreb d.o.o., Prudnicka cesta 60, Prigorje Brdovecko, Croatia;
- Apart from the syringe label the UK product seeking to be supplied must be identical to that which is currently registered in Australia;
- A “Dear Health Care Professional” letter will be supplied to the pharmacists in charge at all hospitals and community pharmacies who have ordered the Product and all Product wholesalers. This letter will be the same as that which was provided to the TGA in the electronic mail dated December 17, 2013.