https://www.tga.gov.au/sites/defaul...ms-joint-accs-acms-meetings-november-2021.pdf
One can probably deduce that the Viraleze application is in at the TGA, however the dates for ‘consultation’ aren’t until November 7th so I am not sure I would expect a TGA Approval anytime soon ?
1 Proposed amendments referred for scheduling advice to ACMS #35
1.1 Astodrimer sodium
Proposal
The applicant has proposed amendment of the existing Appendix F and Appendix H entries for astodrimer to include new warning statements for preventative use, and to remove existing restrictions on advertising for preparations containing the substance.
CAS Number:
676271-69-5
Alternative names
2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino- hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt; SPL7013
Applicant
Private applicant
Current scheduling
Astodrimer sodium is currently listed in Schedule 3 of the Poisons Standard:
Schedule 3
ASTODRIMER SODIUM except in a condom lubricant.
Index
ASTODRIMER SODIUM
Schedule 3 Appendix F, Part 3 Appendix H
It is also included under the entries for ASTODRIMER SODIUM in Appendix F and
Appendix H as follows:
Appendix F, Part 3 WARNING STATEMENTS
64 See a doctor (or) (dentist) if no better after (Insert number of days as per
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