Arrotex Pharmaceuticals Pty Ltd – Clinical chemistry-specific protein IVDs (ARTG 431610)

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Arrotex Pharmaceuticals Pty Ltd

I, Rowena Love, as a delegate of the Secretary to the Department of Health, Disability and Ageing, on receipt of an application from Arrotex Pharmaceuticals Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in paragraph (A), for use in advertisements for the product identified in paragraph (B).

(A)

• Restricted representations to the effect:
  • Low ferritin can be indicative of iron deficiency or iron deficiency anaemia and a follow up consult with a physician is recommended.

(B)

• Clinical chemistry-specific protein IVDs (ARTG 431610).

Dated this 11^th day of June 2025

Signed electronically

Rowena Love
Delegate of the Secretary to the Department of Health, Disability and Ageing
Education Policy and Guidance Section
Regulatory Compliance Branch