 |
|
 |
 |
 |
 |
 |
Gazette APVMA 5, 1 May 2007 - Page 13
Back to Gazette APVMA 5
NOTICE
Moraxella Bovis in the product:
Coopers Piliguard Pinkeye-1 Trivalent Vaccine (Inactivated)
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it applications from Schering Plough Animal Health Australia, for the approval of new active constituents, Moraxella Bovis Strain EPP 63, Moraxella Bovis Strain FLA 64 and Moraxella Bovis Strain SAH38.
The APVMA also has before it an application from the same applicant, for the registration of a new product Coopers Piliguard Pinkeye-1 Trivalent Vaccine (Inactivated) containing the above active constituents. The product is for use as an aid in the prevention of pinkeye in cattle associated with infection by Moraxella bovis expressing pili similar to those expressed by isolates Schering-Plough referred to as strains EPP63, FLA 64 and SAH 38.
In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the applications for approval of these active constituents and the application for the registration of the product Coopers Piliguard Pinkeye-1 Trivalent Vaccine (Inactivated) should be granted. Submissions should state the grounds on which they are based. Such grounds should relate only to matters outlined below that the APVMA is required to take into account in deciding whether to grant the approval and registration. Comments must be received by the APVMA within 28 days of the date of this Gazette.
Particulars of Application
| Common name | Moraxella bovis | ||
| Strain/serotype | Strain EPP 63, FLA 64, and SAH 38 | ||
| Identity and purity | Microbiological differentiation as per manufacturer’s standard | ||
| Sterility | As per manufacturer’s standard | ||
| Extraneous agents | As per European Pharmacopoeia | ||
| Mycoplasma | Not tested | ||
| Mode of action | Inducing immunological responses | ||
| Site of manufacture | Recognised by the APVMA | ||
| Gene technology | Not applicable | ||
| Applicant name | Schering Plough Animal Health Australia | ||
| Applicant ACN | 000 235 245 | ||
| Summary of use | As an aid in the prevention of pinkeye in cattle associated with infection by Moraxella bovis expressing pili similar to those expressed by isolates Schering-Plough refers to as strains EPP63, FLA 64 and SAH 38. | ||
Particulars of Product
| Proposed product name | Coopers Piliguard Pinkeye-1 Trivalent Vaccine (Inactivated) | ||
| Active Constituents | Moraxella Bovis Strain EPP 63, Strain FLA 64 and Strain SAH38 | ||
| Applicant name | Schering Plough Animal Health Australia | ||
| Applicant ACN | 000 235 245 | ||
| Summary of use | As an aid in the prevention of pinkeye in cattle associated with infection by Moraxella bovis expressing pili similar to those expressed by isolates Schering-Plough refers to as strains EPP63, FLA 64 and SAH 38. | ||
| Withholding period | Nil | ||
| Label approval no. | 60802/20/0407 and 60802/100/0407. | ||
Summary of the APVMA’s Evaluation of the Active Constituents and the Product
The chemistry and manufacturing aspects of Moraxella bovis Strain EPP 63, FLA 64, and SAH 38 and the product, including starting materials, master seed organism (source, isolation, identification, testing), culture medium, vaccine production, storage, quality control and batch release analysis, have been evaluated and found to be acceptable.
The APVMA is satisfied that the proposed use of Moraxella bovis Strain EPP 63, FLA 64, and SAH 38 in Coopers Piliguard Pinkeye-1 Trivalent Vaccine (Inactivated) as an aid in the prevention of pinkeye would not be likely to have an effect that is harmful to human beings, environment or trade.
In relation to its assessment of efficacy and safety in target animals the APVMA is satisfied that the data supporting the efficacy and safety of Coopers Piliguard Pinkeye-1 Trivalent Vaccine (Inactivated) adequately demonstrates that this product is likely to be effective under Australian conditions when used as directed according to the label instructions.
Written submissions on the APVMA’s proposal to grant the application for approval of the active constituents Moraxella bovis Strain EPP 63, FLA 64, and SAH, and the registration of the product Coopers Piliguard Pinkeye-1 Trivalent Vaccine (Inactivated) of should be addressed in writing to:
Dr. John Owusu
Manager Vaccines and Antibiotics
Veterinary Medicines Program
The Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
Phone: (02) 6210 4730
Fax: (02) 6210 4741
email: john.owusu@apvma.gov.au