Proposed approval of the new active constituent itraconazole

The APVMA is considering an application for approval of the new active constituent itraconazole. There is no associated application for registration of a product.

We invite comments from 2 June 2020 to 30 June 2020 on whether the application for approval of itraconazole should be granted.

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

• public health
• chemistry and manufacture.

For more information, see page 23 of Gazette No. 11, 2 June 2020.

Please send your written submission by email or post to:

Director of Chemistry and Manufacture
Risk Assessment Capability Unit
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2300
Email: enquiries@apvma.gov.au