Consent given pursuant to Sections 14 and 14A for the importation and supply of the therapeutic goods specified by Sanofi-Aventis Australia

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 15 April 2015, 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”), on the application of               Sanofi-Aventis Australia Pty Ltd, gave consent to the importation and supply of

• sevelamer carbonate (SEVELAMER CARBONATE SANOFI) 800 mg tablet bottle

[AUST R 220888]

• sevelamer carbonate (SEVELAMER CARBONATE WINTHROP) 800 mg tablet bottle

[AUST R 220891]

• sevelamer carbonate (RENVEL) 800 mg tablet bottle [AUST R 220892]

that does not conform with the requirements of paragraph 11(b) of the                                                      Therapeutic Goods Order No. 78 Standard for tablets and capsules, in that the assay limits do not comply with the requirements of 92.5-107.5%.

The consent is effective from 15 April 2015 until an individual BP monograph for the finished product comes into effect.

The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. The products conform to the agreed assay titratable amines limit using the agreed assay titratable amines test.
2. The limits to be applied for the content of sevelamer carbonate shall be 90-110% of labelled claim.