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Molnlycke Health Care Pty Ltd – Melgisorb Ag - Dressing, highly-absorbent, hydrophilic gel-forming, antimicrobial (ARTG 308789)

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, Disability and Ageing, 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 in advertisements in which the restricted representation is used.

(A)

Melgisorb Ag is intended for use on the following: medium to high fluid wounds, including those showing signs of infection. 

  • venous leg ulcers
  • diabetic foot ulcers
  • pressure injuries.

(B)

Melgisorb Ag - Dressing, highly-absorbent, hydrophilic gel-forming, antimicrobial (ARTG 308789)

(C)

  • Melgisorb Ag should be used under the supervision of a qualified Healthcare Professional
  • If you are concerned about your wound, please contact your Healthcare Professional.

Dated this 17th day of June 26

Signed electronically

Rowena Love  
Delegate of the Secretary to the Department of Health, Disability and Ageing
Education Policy and Guidance Section
Regulatory Compliance Branch

  1. prominently displayed or communicated, in relation to a statement in an advertisement, means:
     (a) either:
          (i)  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
         (ii)   for a spoken statement—able to be clearly heard and understood; and
    (b) repeated as often as necessary to be noticed by a viewer or listener 

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