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Molnlycke Health Care Pty Ltd – Exufiber Ag+ (ARTG 370959)

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 representation 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 representation is used (including on the label and packaging of the goods), subject to the conditions identified in paragraph (D).

(A)

  • Exufiber Ag+ is intended to be used on the following, medium to high fluid wounds, including if these wounds are showing signs of infection.
    • Venous leg ulcers
    • Diabetic foot ulcers
    • Pressure injuries
  • Exufiber Ag+ absorbs and retains wound fluid and inactivates a variety of wound-related germs.

in its entirety, (the Representation).

(B)

  • Exufiber Ag+ - Dressing, highly-absorbent, hydrophilic gel-forming, antimicrobial (ARTG 370959)

(C)

  • Exufiber Ag+ should be used by or under the supervision of a qualified Healthcare Professional. It is not a replacement for comprehensive infection management by a health professional;
  • If you are concerned about your wound, please contact your Healthcare Professional.

(D)

  • Advertisements in which the Representation is used must comply with the Therapeutic Goods Advertising Code (the Code).

Dated this 6th day of February 2025

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.

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