THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On July 16, 2012 , 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 following products by Phebra Pty Ltd, Hunters Hill, NSW, “the Company”:
- fluorescein sodium (RETINOFLUOR) 10% injection 500 mg/5 mL vial [Aust R 121873]
- fluorescein sodium (RETINOFLUOR) 10% injection 1 g/10 mL vial [Aust R 23130]
- fluorescein sodium (RETINOFLUOR) 25% injection (1.25 g/5 mL) vial [Aust R 23138]
That do not conform with the current British Pharmacopoeia (BP) monograph for fluorescein sodium drug substance in that the pH specifications of the active pharmaceutical ingredient are different (8.0 – 10.0) to those required by the BP monograph (7.0 – 9.0)
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:
- This consent applies indefinitely;
- The finished products remain in compliance with the BP monograph for fluorescein injection, including the specified pH limits; and
- No other changes have been made to the following products, except for those approved for the submission from the Company dated May 4, 2012. (The pH limit applied to the drug substance is 8.0 – 10.0):
- fluorescein sodium (RETINOFLUOR) 10% injection 500 mg / 5 mL vial [Aust R 121873]
- fluorescein sodium (RETINOFLUOR) 10% injection 1 g / 10 mL vial [Aust R 23130]
- fluorescein sodium (RETINOFLUOR) 25% injection 1.25 g / 5 mL vial [Aust R 23138]