Ivermectin is not banned in Australia, but is only approved for treatment of roundworm, scabies and inflammatory rosacea.
Neither Australia nor any OECD country has approved Ivermectin for COVID-19 treatment.
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"The TGA strongly discourages self-medication and self-dosing with Ivermectin for COVID-19 as it may be dangerous to your health," the organisation said in a release.
"There is insufficient evidence to validate the use of Ivermectin in patients with COVID-19."
The TGA warned that doctors who prescribed Ivermectin off-label must consider the potential risks and benefits, and obtain informed consent from patients about the condition and treatment options.
"More evidence-based research is required to determine if Ivermectin could be used as an antiviral medicine to fight against COVID-19 disease," the TGA said.
"There is a need for larger and consistent randomised controlled clinical trials."
Cochrane Reviews provides globally recognised systematic reviews of research in healthcare and health policy.
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On July 28, a review of Ivermectin for preventing and treating COVID-19 was published.
It found no evidence to support the use of Ivermectin for treating or preventing COVID-19 infection, and noted that the evidence base was limited.