Mometamax Ultra Ear Drops Suspension for Dogs containing posaconazole

This consultation closed on 25 July 2023

Consultation period

27 June 2023 to 25 July 2023

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is considering an application for approval of the new active constituent posaconazole and registration of the product Mometamax Ultra Ear Drops Suspension for Dogs, containing 2.1 mg/mL mometasone furoate (as monohydrate), 2.6 mg/mL posaconazole, and 8.6 mg/mL gentamicin (as sulfate). This is a single-application anti-inflammatory, antifungal and broad-spectrum antibacterial suspension indicated for the treatment of canine otitis externa associated with strains of bacteria susceptible to gentamicin (Staphylococcus pseudintermedius, Proteus spp., Streptococcus spp., Escherichia coli), and fungi susceptible to posaconazole (Malassezia pachydermatis).

We invite comments from 27 June 2023 to 25 July 2023 on whether approval of the active constituent and registration of the product should be granted.

The APVMA is able to consider comments relating to the legislative grounds, including:

  • chemistry and manufacture
  • occupational health and safety
  • public health
  • environmental safety
  • efficacy and target animal safety.

For more information see page 12, APVMA Gazette No. 13, 27 June 2023.

Please note: submissions will be published on the APVMA’s website unless you have asked for the submission to remain confidential, or if the APVMA chooses at its discretion not to publish any submissions received (refer to the public consultation coversheet).

Please lodge your submission using the public consultation coversheet, which provides options for how your submission will be published.

Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.

Please send your written submission and coversheet by email or post to:

Case Management and Administration Unit
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2300


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