I don't think is completely connected to Viraleze - this could still be approved.
But I did find it interest on the BV Vivagel:
Purpose: "remove existing restrictions on advertising for preparations containing the substance"
I don't know why the line below is "crossed out"... may want a more generic view on Astodrimer Sodium?Application summary - reasons for proposal
• Astodrimer sodium is currently formulated in a vaginal gel Class IIa medical device that is included on the ARTG, for use in the treatment, relief and prevention of bacterial vaginosis (BV). The indications were recently updated to include the prevention of recurrent BV.
• The applicant proposes that the existing Appendix F and Appendix H entries for astodrimer sodium be updated to accommodate the new broader indication for the vaginal gel, including prevention of BV. The amendments would allow advertising of astodrimer for any indication and create new label warning statements for preventative use.
• The requested amendments to the Poisons Standard related to astodrimer sodium are intended to enable the risks and potential benefits of a non-antibiotic vaginal gel for the prevention of recurrent BV, to be communicated to Australian women through labelling and consumer advertising.
Thoughts? ...
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