Proposed registration of Vanguard C4 Injectable Vaccine for Dogs containing four new active constituents

The APVMA is considering an application for registration of Vanguard C4 Injectable Vaccine for Dogs containing the four new active constituents, canine distemper virus, strain N-CDV; canine adenovirus type 2, strain Manhattan; canine parainfluenza virus, strain NL-CPI-5; and canine parvovirus, strain NL-35-D.

The product is to be registered for vaccination of healthy dogs 6 weeks of age or older as an aid in preventing canine distemper caused by canine distemper virus, infectious canine hepatitis caused by canine adenovirus type 1, respiratory disease caused by canine adenovirus type 2, canine parainfluenza caused by canine parainfluenza virus, and canine parvoviral enteritis caused by canine parvovirus.

We invite comment from 27 March 2018 to 24 April 2018 on whether the application for approval of the active constituents and registration of the product should be granted.

The APVMA is able to consider comments relating to matters that are required to be taken into consideration in determining whether the safety, efficacy or trade criteria have been met.

This may include aspects of the following:

• work health and safety
• public health
• chemistry and manufacture
• environmental safety
• trade
• efficacy and safety

Please send your written submission by email, post or fax to:

Case Management and Administration Unit
Australian Pesticides and Veterinary Medicines Authority
P O Box 6182
Kingston ACT 2604

Phone: +61 2 6210 4701
Fax: +61 2 6210 4721
Email: enquiries@apvma.gov.au