Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by
Medistar 2 Pty Ltd as Trustee for the JVOT Family Trust T/a Medistar
I, Michael Shum, as a delegate of the Secretary to the Department of Health and Aged Care, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in paragraph (A), for use in advertising the product identified in paragraph (B) to consumers.
- In Australia, GammaCore is indicated for the treatment and/or prevention of primary headache conditions (such as migraine and cluster headache) in adults (the Representation).
The Representation will always be accompanied by the following advisory statements:
- GammaCore is available in Australia on authorisation by a registered healthcare professional.
- It is important to discuss your suitability for GammaCore nVNS therapy, with your healthcare professional.
- GammaCore - Migraine-therapy vagus nerve electrical stimulator (ARTG 355575)
Dated this 23rd day of October 2023
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