Therapeutic Goods (Listing) Notice 2001 (No. 4)

Published in the Commonwealth of Australia Special Gazette No. S 295, 19 July 2001

Therapeutic Goods Act 1989

I, TERRY SLATER, National Manager, Therapeutic Goods Administration, delegate of the Parliamentary Secretary to the Minister for Health and Aged Care, under subsection 17 (5) of the Therapeutic Goods Act 1989, require the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods for listed goods:

1. preparations referred to in item 3 of Schedule 4, Part 1 of the Therapeutic Goods Regulations (the Regulations) that contain, as an active ingredient, the substance (S)-S-Adenosylmethionine in the form of sulfate, tosylate or mixed sulfate/tosylate salts and that are supplied with a label that includes a statement to the following effect:
   • "Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a health practitioner".
2. preparations referred to in item 3 of Schedule 4, Part 1 of the Regulations that contain, as an active ingredient, ademetionine in the form of sulfate, tosylate or mixed sulfate/ tosylate salts and that are supplied with a label that includes a statement to the following effect:
   • "Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a health practitioner".

Dated 17th July 2001

National Manager, Therapeutic Goods Administration
Delegate of the Parliamentary Secretary