THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On February 20 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:
- vinflunine ditartrate (JAVLOR) 250 mg/10 mL concentrated injection vial [AUST R 166773]
- vinflunine ditartrate (JAVLOR) 50 mg/2 mL concentrated injection vial [AUST R 166767]
by Pierre Fabre Medicament Australia Pty Ltd North Ryde, NSW (“the Company”);
That does not conform with paragraphs 3(2)(e), 3(2)(j) and 4(7)(c) of Therapeutic Goods Order (TGO) 69, in that the labels that are being used will be UK labels for Javlor 250 mg/10 mL for a six month period and for Javlor 50 mg/2 mL a four month period.
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 for a period of 6 months from the date of the Company letter for the 250mg in 10mL product and for 4 months for the 50mg in 2mL product.
2. The labels for use are identical to those submitted with the application dated January 30 2013, viz the UK carton and vial labels, but with an over-sticker on the carton label containing the correct Aust R number for each of the affected products, and the local sponsor name and address.
3. No other changes have been made to the products:
- vinflunine ditartrate (JAVLOR) 250 mg/10 mL concentrated injection vial [AUST R 166773]
- vinflunine ditartrate (JAVLOR) 50 mg/2 mL concentrated injection vial [AUST R 166767]
4. Each pack of the product is to be supplied with the Australian product information (PI) together with the “Dear Doctor/Pharmacist/Healthcare Professional” letter provided with correspondence from the Company.