APVMA VETERINARY USE PERMIT 14793- AFTOPUR DOE/ PIGS, RUMINANTS/ FOOT & MOUTH DISEASE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

vaccine - foot & mouth disease

Available from:

APVMA PERMIT

INN (International Name):

vaccine - foot & mouth disease

Manufactured by:

MERIAL AUSTRALIA

Therapeutic area:

vaccine

Product summary:

For the prevention of the spread of disease in the event of outbreak of foot and mouth disease in pigs and ruminants.

Authorization status:

Registered and available

Authorization date:

2015-07-27

Patient Information leaflet

PER14793
Permit Version 3
Page 1 of 8 PERMIT TO ALLOW EMERGENCY USE AND SUPPLY
OF AN UNREGISTERED AGVET CHEMICAL PRODUCT
PERMIT NUMBER - PER14793
This permit is issued to the Permit Holder in response to an
application granted by the
APVMA under section 112 of the Agvet Codes of the jurisdictions set
out below. This permit
allows a Supplier (as indicated) to possess The Product for the
purposes of supply and to
supply The Product to a person who can use The Product under permit.
If this permit were not
issued, supply of The Product as specified below would constitute an
offence under section 78
of the Agvet Code. This permit also allows a person, as stipulated
below, to use The Product in
the manner specified in this permit in the designated jurisdictions.
This permit also allows the
Permit Holder, the Supplier (if not one and the same) and any person
stipulated below to claim
that The Product can be used in the manner specified in this permit.
THIS PERMIT IS IN FORCE FROM 9 SEPTEMBER 2014 TO 15 DECEMBER 2019.
PERMIT HOLDER:
MERIAL AUSTRALIA PTY LTD
LEVEL 2.01,
16 GIFFNOCK AVENUE,
NORTH RYDE, NSW, 2113
SUPPLIER:
MERIAL ANIMAL HEALTH LTD
BIOLOGICAL LABORATORY
ASH ROAD
PIRBRIGHT
SURREY GU24 0NQ
UNITED KINGDOM
PERSONS WHO CAN USE THE PRODUCT UNDER THIS PERMIT:
Chief Veterinary Officers of the relevant state or territory or
authorised persons acting
under their direction in agreement with the Consultative Committee on
Emergency
Animal Diseases or persons otherwise authorised under state/territory
legislation.
PER14793
Permit Version 3
Page 2 of 8
PRODUCT TO BE USED (THE PRODUCT):
AFTOPUR DOE
Inactivated Vaccine (with Oil Adjuvant) Against Foot and Mouth Disease
in Pigs and
Ruminants
COMPOSITION
Inactivated Foot & Mouth Disease Virus (Antigen) containing one or
several serotypes
as per the supply agreement with Animal Health Australia. Each dose of
vaccine
contains 6 or more PD50 (protective dose for 50% of vaccinates) per
antigen.
DIRECTIONS FOR USE:
ANIMAL
PURPOSE
DOSE
Pigs
Inject 1-3 mLs per animal intramuscularly