Molnlycke Health Care Pty Ltd – Mepitel - Dressing, wound-nonadherent, permeable (ARTG 177725)

Therapeutic Goods Act 1989

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

I, Rowena Love, 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)(1) and (2) when either (A)(1) or (A)(2) are used in their entirety, 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)

1. Mepitel is a soft silicone wound contact layer designed for the management of wounds that have moderate to high amounts of wound fluid including:

   • skin tears
   • skin abrasions
   • sutured wounds
   • partial-thickness burns
   • partial and full thickness grafts
   • diabetic foot ulcers
   • leg ulcers.

   Mepitel is applied directly to the wound with a secondary absorbent dressing then applied on top and can then be secured with a tubular bandage (ie: Tubifast or equivalent).

2. Mepitel (in conjunction with a secondary dressing) can be used as a protective layer on wounds with none to low amounts of fluid including: blisters, fragile skin and exposed fragile tissues.

(B)

• Mepitel - Dressing, wound-nonadherent, permeable (ARTG 177725)

(C)

• Mepitel can be used by lay persons under supervision of Healthcare Professionals.
• If you are concerned about your wound, please contact your Healthcare Professional.

Dated this 5th day of November 2024

Signed electronically

Rowena Love
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.