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 use of restricted representations described in paragraph (A), in advertisements for the product identified in paragraph (B), when the statements identified in paragraph (C) are prominently displayed or communicated[1] when either one or both of the restricted representations in paragraph (A) are used.
(A)
- Exufiber is intended to be used on a wide range of wounds for management of moderate to high amounts of wound fluid.
- Exufiber forms a gel when in contact with wound fluid and is intended to be used on the following wounds with moderate to high amounts of fluid:
- Leg and foot ulcers
- Pressure ulcers
- Partial thickness burns
- Surgical wounds
- Donor sites
(B)
- Exudate-absorbent dressing, hydrophilic-gel (ARTG 368514)
(C)
- Exufiber 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 22nd day of January 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] As defined in the applicable version of the Therapeutic Goods Advertising Code, as amended from time to time.