Molnlycke Health Care Pty Ltd – Mepore, Mepore Film and Pad and Mepore Pro - Adhesive bandage (ARTG 205811)

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)

• Mepore is intended for use on low to moderately fluid wounds, such as surgical wounds, cuts and abrasions.
• Mepore Film & Pad is intended for use on low to moderately fluid wounds, such as surgical wounds, cuts and abrasions.
• Mepore Pro is intended for use on low to moderately fluid wounds, such as surgical wounds, cuts and abrasions.

(B)

• ARTG 205811 - Adhesive bandage

(C)

• [One or more of the following product names: Mepore / Mepore Film & Pad / Mepore Pro] can be used by lay persons under supervision of Healthcare Professionals.
• If you are concerned about your wound, please contact your Healthcare Professional

together, (the Representations).

Dated this 23rd day of October 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