Molnlycke Health Care Pty Ltd – Mepilex Up - Dressing, wound-nonadherent, absorbent (ARTG 329580)

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Molnlycke Health Care Pty Ltd

I, Michael Shum, as a delegate of the Secretary to the Department of Health and Aged Care, on receipt of an application from Molnlycke Health Care 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 (including on the label and packaging of the goods).

(A)

• Mepilex Up is intended for a wide range of acute and hard-to-heal wounds with low to high wound fluid such as leg and foot ulcers, pressure injuries and traumatic wounds.

(the Representation).

(B)

• Mepilex Up - Dressing, wound-nonadherent, absorbent (ARTG 329580).

(C)

• Mepilex Up can be used by laypersons under supervision of health care professionals.
• If you are concerned about your wound, please contact your health care professional.

Dated this 9th day of December 24

Signed electronically

Michael Shum
Delegate of the Secretary to the Department of Health and Aged Care
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch

^[1] prominently displayed or communicated, in relation to a statement in an advertisement, means:

1.  either:

   1. 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

   2. for a spoken statement—able to be clearly heard and understood; and

2. repeated as often as necessary to be noticed by a viewer or listener.