I, Michael Shum, as a delegate of the Secretary to the Department of Health, Disability and Ageing, on receipt of an application from Coloplast 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), when the statements identified in paragraph (C) are prominently displayed or communicated[1] in the advertisement in which the restricted representations are used.
(A)
Representations to the effect that Peristeen Plus is high volume Transanal Irrigation (TAI) system indicated for people with bowel dysfunction, including neurogenic bowel dysfunction, resulting in faecal incontinence and/or constipation, who do not find relief from conservative treatments.
(B)
- Peristeen Plus – Bowel Irrigation System Catheter (ARTG 135450)
(C)
- Consult your Healthcare Professional who can decide whether Peristeen Plus is a suitable treatment. If Peristeen Plus is appropriate, you will require specialist training in its use
- Peristeen Plus should not be used in children younger than 3 years.
Dated this 3rd day of March 26
Signed electronically
Michael Shum
Delegate of the Secretary to the Department of Health, Disability and Ageing
Education Policy and Guidance Section
Regulatory Compliance Branch
[1] prominently displayed or communicated, in relation to a statement in an advertisement, means:
either:
for a visual statement—easily read from a reasonable viewing distance for the particular media type in the context in which the advertisement is intended to be viewed; or
for a spoken statement—able to be clearly heard and understood; and
repeated as often as necessary to be noticed by a viewer or listener.