Apotex - Apohealth iron tablets

Therapeutic Goods Act 1989

Approval under section 42DG for use of restricted representations by Apotex Pty Ltd

I, Nicole McLay, Delegate of the Secretary to the Department of Health, on receipt of an application on behalf of Apotex Pty Ltd, have approved under section 42DG(2) of the Therapeutic Goods Act 1989 (the Act) the use of the below stated restricted representations in advertisements directed to consumers, for the following registered medicines:

APOHEALTH IRON TABLETS ferrous fumarate 200mg film coated tablets blister pack (AUST R 286619)

1. "Source of iron for the treatment and prevention of medically diagnosed iron deficiency and iron deficiency anaemias"; and/or
2. "For use when iron deficiency anaemia has been diagnoses by your doctor and a therapeutic oral iron supplement is recommended as treatment or for ongoing prevention".

APOHEALTH IRON TABLETS WITH FOLIC ACID ferrous fumarate 310mg and folic acid 0.35mg film coated tablets blister pack (AUST R 291162)

1. "Source of iron and folic acid for the prevention and treatment of medically diagnosed iron deficiency and folic acid deficiency anaemias"; and/or
2. "For use when iron deficiency and folic acid deficiency anaemias have been diagnoses by your doctor and a therapeutic oral iron and folic acid supplement is recommended as treatment or for ongoing prevention"; and/or
3. "For the treatment and prevention of medically diagnosed iron deficiency and folic acid deficiency anaemia".

Dated this 19th day of October 2020

Signed electronically

Nicole McLay
Delegate of the Secretary to the Department of Health
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch