For many applications, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required to publish a summary of the application once the applicant has been notified that the application has been accepted for assessment. The summary will be removed once the application is finalised.

The types of applications requiring an application summary include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change in the use, supply or disposal of the product.

The summaries include details of the applications as specified in Divisions 2.1 and 2.2 of the regulations.

Please remember to follow the guidance for preparing information lists when preparing your application to avoid sensitive information being published.

For more information, please see the questions and answers.

Use the filter and links below to find and view application summaries.

Date

Application Date

Application No

Application Number

144799
Product/Active constituent Name

Application Product Name

Vetmec Dectoguard Antiparasitic Injection

Application details

Product name:

Vetmec Dectoguard Antiparasitic Injection

Product number:

95146

Applicant Name:

CHEMVET AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 10 mg/mL doramectin injectable product for the treatment and control of doramectin sensitive internal and external parasites of cattle and pigs.

Reference details:

46128 - DECTOMAX INJECTABLE ENDECTOCIDE

Active constituents:

Active constituent name
55076 - DORAMECTIN

Description of data provided:

Data no
275167
Author
Anon
Title
Finished Product Specification - Vetmec Dectoguard antiparasitic injection
Study date
2024
Authorising party
Applicant
Auth party contact address
1/8 ROCKLEA DRIVE PORT MELBOURNE Australia
Date

Application Date

Application No

Application Number

143806
Product/Active constituent Name

Application Product Name

Imidacloprid

Application details

Product name:

Imidacloprid

Active name:

Imidacloprid

Applicant Name:

JIANGSU JIYU BIO-PHARMACEUTICAL TECHNOLOGY CO., LTD.

Application purpose and description of use:

Approval of Imidacloprid for use in veterinary chemical products.

Description of data provided:

Data no
274087
Author
Anon
Title
CoAs
Study date
March 2023
Authorising party
Applicant
Auth party contact address
No. 20, Yuhe Road, Pukou District NANJING China
Data no
274086
Author
EUROPEAN PHARMACOPOEIA
Title
EImidacloprid for veterinary use
Study date
2024
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

144550
Product/Active constituent Name

Application Product Name

Websters 6 in 1 B12 & Se Vaccine

Application details

Product name:

Websters 6 in 1 B12 & Se Vaccine

Product number:

88862

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Variation of product registration to amend conditions.

Active constituents:

Active constituent name
82177 - CLOSTRIDIUM PERFRINGENS TYPE D TOXOID (INACTIVATED)
Active constituent name
82178 - CLOSTRIDIUM TETANI TOXOID (INACTIVATED)
Active constituent name
82179 - CORYNEBACTERIUM PSEUDOTUBERCULOSIS (INACTIVATED)
Active constituent name
82889 - Clostridium chauvoei, AWC667
Active constituent name
83612 - CLOSTRIDIUM NOVYI TYPE B AWC469
Active constituent name
83615 - CLOSTRIDIUM SEPTICUM AWC471
Active constituent name
83193 - Hydroxocobalamin Acetate
Active constituent name
57604 - SODIUM SELENATE

Description of data provided:

Data no
273675
Author
Virbac
Title
Cover Letter
Study date
June 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date

Application Date

Application No

Application Number

144551
Product/Active constituent Name

Application Product Name

Websters 6 in 1 B12 Vaccine

Application details

Product name:

Websters 6 in 1 B12 Vaccine

Product number:

88864

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Variation of product registration to amend conditions.

Active constituents:

Active constituent name
82177 - CLOSTRIDIUM PERFRINGENS TYPE D TOXOID (INACTIVATED)
Active constituent name
82178 - CLOSTRIDIUM TETANI TOXOID (INACTIVATED)
Active constituent name
82179 - CORYNEBACTERIUM PSEUDOTUBERCULOSIS (INACTIVATED)
Active constituent name
82889 - Clostridium chauvoei, AWC667
Active constituent name
83612 - CLOSTRIDIUM NOVYI TYPE B AWC469
Active constituent name
83615 - CLOSTRIDIUM SEPTICUM AWC471
Active constituent name
83193 - Hydroxocobalamin Acetate

Description of data provided:

Data no
273674
Author
Virbac
Title
Cover Letter
Study date
June 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date

Application Date

Application No

Application Number

144815
Product/Active constituent Name

Application Product Name

Fluroxypyr-meptyl

Application details

Product name:

Fluroxypyr-meptyl

Active name:

Fluroxypyr-meptyl

Applicant Name:

PARIJAT INDUSTRIES (INDIA) PVT LTD

Application purpose and description of use:

Approval of a new source of (Fluroxypyr-meptyl) for use in agricultural chemical products.

Description of data provided:

Data no
275527
Author
Anon
Title
Signed copy of Declaration of Composition (DoC)
Study date
10.6.2024
Authorising party
Applicant
Auth party contact address
M-77, 1st & 2nd Floor M- Block Market Greater Kailash - II NEW DEHLI India
Data no
275525
Author
Anon
Title
Item 17 Application for approval of a new source of fluroxypyr-meptyl
Study date
10.6.2024
Authorising party
Applicant
Auth party contact address
M-77, 1st & 2nd Floor M- Block Market Greater Kailash - II NEW DEHLI India
Data no
275526
Author
Anon
Title
Manufacturing Process
Study date
10.6.2024
Authorising party
Applicant
Auth party contact address
M-77, 1st & 2nd Floor M- Block Market Greater Kailash - II NEW DEHLI India
Date

Application Date

Application No

Application Number

144490
Product/Active constituent Name

Application Product Name

DEFEND SPRAY-ON SHEEP BLOWFLY TREATMENT

Application details

Product name:

DEFEND SPRAY-ON SHEEP BLOWFLY TREATMENT

Product number:

65651

Applicant Name:

NUTRIEN AG SOLUTIONS LIMITED

Application purpose and description of use:

Variation to extend the shelf-life of the product.

Active constituents:

Active constituent name
64467 - DICYCLANIL
Date

Application Date

Application No

Application Number

143920
Product/Active constituent Name

Application Product Name

Thromboguard 100mg/mL Injectable Tranexamic Acid for Horses

Application details

Product name:

Thromboguard 100mg/mL Injectable Tranexamic Acid for Horses

Product number:

94874

Applicant Name:

PROBUS PHARMACEUTICALS PTY LTD

Application purpose and description of use:

Registration of a 100mg/mL tranexamic acid injectable solution product for the control of bleeding in horses.

Reference details:

51210 - ILIUM VASOLAMIN S 100 INJECTION

Active constituents:

Active constituent name
94876 - Tranexamic Acid

Description of data provided:

Data no
271433
Author
JP Morgan
Title
CAM 03 Quality Control
Study date
2024
Authorising party
Applicant
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Data no
271432
Author
JP Morgan
Title
CAM 02 Workflow
Study date
2024
Authorising party
Applicant
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Date

Application Date

Application No

Application Number

143925
Product/Active constituent Name

Application Product Name

Tranexamic Acid

Application details

Product name:

Tranexamic Acid

Active name:

Tranexamic Acid

Applicant Name:

PROBUS PHARMACEUTICALS PTY LTD

Application purpose and description of use:

new source of pharmacopoeia active constituent

Description of data provided:

Data no
271434
Author
Changzhou Yinsheng Parmaceutical Co Ltd
Title
CAM 01 COA
Study date
2023
Authorising party
Applicant
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Date

Application Date

Application No

Application Number

143951
Product/Active constituent Name

Application Product Name

Euthaject 325mg/mL Sterile Injectable Pentobarbitone Sodium for Rapid Euthanasia

Application details

Product name:

Euthaject 325mg/mL Sterile Injectable Pentobarbitone Sodium for Rapid Euthanasia

Product number:

94887

Applicant Name:

PROBUS PHARMACEUTICALS PTY LTD

Application purpose and description of use:

Registration of a 325mg/mL Injectable Pentobarbitone sodium for rapid euthanasia of dogs and cats.

Reference details:

47815 - LETHABARB EUTHANASIA INJECTION

Description of data provided:

Data no
277435
Author
Dr J.P Morgan
Title
Revised product specifications
Study date
August 2024
Authorising party
Applicant
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Data no
271500
Author
Anon
Title
Release Specifications
Study date
2024
Authorising party
Applicant
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Date

Application Date

Application No

Application Number

144501
Product/Active constituent Name

Application Product Name

Fostera Gold PCV Metastim

Application details

Product name:

Fostera Gold PCV Metastim

Product number:

88614

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

The purpose of this applications is to update the approved labels to include an alternative intramuscular method of administration, using needle free devices, for Fostera Gold PCV MH and the registered fallout vaccine, Fostera Gold PCV Metastim.

Active constituents:

Active constituent name
83556 - Porcine Circovirus Type 1-Type 2a Chimera Inactivated
Active constituent name
87926 - Porcine Circovirus Type 1-Type 2b Chimera Inactivated
Date

Application Date

Application No

Application Number

144502
Product/Active constituent Name

Application Product Name

Fostera Gold PCV MH

Application details

Product name:

Fostera Gold PCV MH

Product number:

87927

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

The purpose of this applications is to update the approved labels to include an alternative intramuscular method of administration, using needle free devices, for Fostera Gold PCV MH and the registered fallout vaccine, Fostera Gold PCV Metastim.

Active constituents:

Active constituent name
83556 - Porcine Circovirus Type 1-Type 2a Chimera Inactivated
Active constituent name
87926 - Porcine Circovirus Type 1-Type 2b Chimera Inactivated
Active constituent name
83587 - MYCOPLASMA HYOPNEUMONIAE INACTIVATED

Description of data provided:

Data no
273460
Author
Anon
Title
B920R-US-22-B80 Study report
Study date
May 2022
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273461
Author
Anon
Title
B920R-US-22-B81 Study report
Study date
May 2022
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273462
Author
Anon
Title
B920R-US-22-B82 Study report
Study date
May 2022
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273463
Author
H. Cho, Y. Ahn, T. Oh, J. Suh and C. Chae
Title
Non-Inferiority Field Study Comparing the Administrations by Conventional Needle-Syringe and Needle-Free Injectors of a Trivalent Vaccine Containing Porcine Circovirus Types 2a/2b and Mycoplasma hyopneumoniae
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
273457
Author
Anon
Title
Applicant's response to questions
Study date
19 Apr 2023
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273448
Author
Anon
Title
Part 8 Efficacy and Safety Summary
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273465
Author
Anon
Title
Certificate of Analysis B/N 413369A
Study date
2020
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273466
Author
Anon
Title
Certificate of Analysis B/N 565224A
Study date
2022
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273467
Author
Anon
Title
Manufacturer's declaration
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273468
Author
Anon
Title
OOP 49K5.R7
Study date
Oct 2023
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273469
Author
Anon
Title
OOP 19K5.R1
Study date
Oct 2023
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273470
Author
World Health Organization & Food and Agriculture Organization of the United Nations
Title
Food Hygiene (Basic Texts), Fourth Edition
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
273471
Author
J. Carcel-Carrasco, M. Pascual-Guillamon, F. Salas-Vicente
Title
Composition of some metallic fragments found in food that are undetectable by magnetic or eddy currents equipment: A case study
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
273472
Author
K. Heaton & C. Bagley
Title
FOREIGN OBJECT CONTAMINATION IN BEEF CATTLE
Study date
2002
Authorising party
Public
Auth party contact address
-
Data no
273473
Author
J. Eadie
Title
Prevention of Needlestick Injuries in Livestock Production
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
273474
Author
UPPER MIDWEST AGRICULTURAL SAFETY AND HEALTH CENTER
Title
PREVENTING NEEDLESTICK INJURIES
Study date
2019
Authorising party
Public
Auth party contact address
-
Data no
273475
Author
A.L. Hafer, R.L. Langley, M. Morrow & J.J. Tulis
Title
Occupational hazards reported by swine veterinarians in the United States
Study date
1996
Authorising party
Public
Auth party contact address
-
Data no
273476
Author
F. McKeith, D. Meeker & D. Buege
Title
Pork Chain Quality Audit
Study date
1994
Authorising party
Public
Auth party contact address
-
Data no
273477
Author
C.S. Daniels & J.A. Funk
Title
Prevalence of carcass defects in sows at harvest
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
273478
Author
B. Imeah, E. Penz, M. Rana & C. Trask
Title
Economic analysis of new workplace technology including productivity and injury: The case of needle-less injection in swine
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
273479
Author
USDA
Title
NAHEMS GUIDELINES: VACCINATION FOR CONTAGIOUS DISEASES
Study date
Oct 2014
Authorising party
Public
Auth party contact address
-
Data no
273480
Author
S.R. Baker, E. Mondaca, D. Polson & S.A. Dee
Title
Evaluation of a needle-free injection device to prevent hematogenous transmission of porcine reproductive and respiratory syndrome virus
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
273481
Author
C.C.L. Chase, C.S. Daniels, R. Garcia, F. Milward & T. Nation
Title
Needle-free injection technology in swine: Progress toward vaccine efficacy and pork quality
Study date
2008
Authorising party
Public
Auth party contact address
-
Data no
273482
Author
C.S. Daniels
Title
Needle-Free Injection: Pros and Cons
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
273483
Author
S. Mitragotri
Title
Current status and future prospects of needle-free liquid jet injectors
Study date
2006
Authorising party
Public
Auth party contact address
-
Data no
273484
Author
S. Mitragotri
Title
IMMUNIZATION WITHOUT NEEDLES
Study date
2005
Authorising party
Public
Auth party contact address
-
Data no
273485
Author
A.T. Kroger, W.L. Atkinson & L.K. Pickering
Title
8 - General immunization practices
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
273486
Author
L. Diggle, J.J. Deeks & A.J. Pollard
Title
Effect of needle size on immunogenicity and reactogenicity of vaccines in infants: randomised controlled trial
Study date
2006
Authorising party
Public
Auth party contact address
-
Data no
273487
Author
R. Jolie & T. Hoover
Title
Short-term Efficacy Study with RespiSure-One Administered with a Needle-free Device
Study date
2004
Authorising party
Public
Auth party contact address
-
Data no
273488
Author
L. Gergen, B. Eddy, K. Menassa, C. McGregor & T. Wasmoen
Title
Intramuscular and Intradermal Vaccination of Swine for Swine Influenza Virus and Mycoplasma hyopneumoniae Using a Needle-Free Device
Study date
2002
Authorising party
Public
Auth party contact address
-
Data no
273489
Author
T.A. Houser, J.G. Sebranek, B.J. Thacker, T.J. Baas, D. Nilubol, E.L. Thacker & F. Kruse
Title
Effectiveness of transdermal, needle-free injections for reducing pork carcass defects
Study date
2004
Authorising party
Public
Auth party contact address
-
Data no
273490
Author
G. Schagemann, M. Leyhausen, O.G. Duran
Title
Field testing of a new needle-free, intramuscular injection device for pigs
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
273491
Author
D.L. Cook, F. Kruse, R. Phillips, F. Sick, K. Okkinga, D. Polson & G. Demontis
Title
PULSE 200 EFFECTIVE APPLICATION METHOD FOR PRRS VACCINE IN GILTS
Study date
2003
Authorising party
Public
Auth party contact address
-
Data no
273492
Author
E. Rosales, M. Martens, A. Vargas, S. Torres, R. Flores, E. Flores & M. Quijano
Title
A comparison of the efficacy of conventional and needle-free administration of Porcilis (R) APP as assessed by ELISA concentrations of antibody concentration to APX I, APX II, APX III and OMP
Study date
2006
Authorising party
Public
Auth party contact address
-
Data no
273493
Author
B. Thacker, F. Kruse & A. Loskutoc
Title
Safety evaluation of a modified live pseudorabies virus vaccine administered using a needle-free, transdermal injection device
Study date
2003
Authorising party
Public
Auth party contact address
-
Data no
273494
Author
Anon
Title
Ph Eur Monograph 2448
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
273495
Author
M.J. Sarno, E. Blase, N. Galindo, R. Ramirez, C.L. Schirmer & D.F. Trujillo-Juarez
Title
Clinical immunogenicity of measles, mumps and rubella vaccine delivered by the Injex jet injector: comparison with standard syringe injection
Study date
2000
Authorising party
Public
Auth party contact address
-
Data no
273496
Author
C.S. Daniels
Title
Survey of Injection Methodologies and Carcass Defects in Pork Production NPB #07-219
Study date
2008
Authorising party
Public
Auth party contact address
-
Data no
273497
Author
Anon
Title
Boehringer Ingelheim partners with Henke-Sass, Wolf to develop innovative needle free injection device for pigs
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
273498
Author
J. Eadie
Title
Pulse Needle Free Launches the Worlds First Disposable Needle-Free Injector for Livestock
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
273499
Author
Anon
Title
The AcuShot Gen 2 Advantage
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
273500
Author
Anon
Title
The IDAL Way, 20 Years and Counting
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
273501
Author
Anon
Title
Hipra: We are pleased to announce the launch of our new Hipradermic website!
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
273502
Author
P. H. Hemsworth & G.J. Coleman
Title
HUMAN LIVESTOCK INTERACTIONS, SECOND EDITION
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
273503
Author
E.J. McDowell, D. Holtkamp & C.S. Daniels
Title
Heart rate variability and vocalization as a measure of stress response in pigs to needle-free injections versus needle and syringe
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
273504
Author
D. Temple, D. Escribano, M. Jimnez, E. Mainau, J.J. Cern & X. Manteca
Title
Effect of the needle-free intra dermal application of liquids vaccination on the welfare of pregnant sows
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
273505
Author
G. Royer, C. Charreyre, F. Milward & R. Howser
Title
Efficacy and safety of needle-free transdermal delivery of a novel Mycoplasma hyopneumoniae bacterin
Study date
2006
Authorising party
Public
Auth party contact address
-
Data no
273506
Author
E.Y. Ko, J. Cho, J.H. Cho, K. Jo, S.H. Lee, Y.J. Chung & S. Jung
Title
Reduction in Lesion Incidence in Pork Carcass Using Transdermal Needle-free Injection of Foot-and- Mouth Disease Vaccine
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
273507
Author
G. Paquin & T. Toburen
Title
The first effective transdermal, needle-free injections in Canada
Study date
2005
Authorising party
Public
Auth party contact address
-
Data no
273508
Author
J. Keenliside, C. Wilkinson, J. Poiron, M. Schmidt, J. Goller & Jay Willis
Title
Comparison of injection sites between needlefree injections and needle injections in swine
Study date
2005
Authorising party
Public
Auth party contact address
-
Data no
273509
Author
Withheld
Title
Letter of Support 1
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273510
Author
Withheld
Title
Letter of Support 2
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273464
Author
Anon
Title
B924N-ES-23-C32 Study report
Study date
Feb 2023
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273447
Author
Anon
Title
Part 1 Application Overview
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273449
Author
Anon
Title
RLP approved Fostera Gold PCV MH, 87927/134267
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
273450
Author
Anon
Title
RLP proposed Fostera Gold PCV MH, tracked changes
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273451
Author
Anon
Title
RLP proposed Fostera Gold PCV MH, clean copy
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273452
Author
Anon
Title
RLP approved Fostera Gold PCV Metastim, 88614/134268
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
273453
Author
Anon
Title
RLP proposed Fostera Gold PCV Metastim, tracked changes
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273454
Author
Anon
Title
RLP proposed Fostera Gold PCV Metastim, clean copy
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273455
Author
EMA/CVMP
Title
Summary of opinion (post authorisation) CircoMax Myco
Study date
6 Oct 2023
Authorising party
Public
Auth party contact address
-
Data no
273456
Author
EMA/CVMP
Title
CVMP assessment report for a worksharing variation requiring assessment for CircoMax and CircoMax Myco (EMEA/V/C/WS2429)
Study date
5 Oct 2023
Authorising party
Public
Auth party contact address
-
Data no
273458
Author
Anon
Title
SPC for CircoMax Myco emulsion for injection for pigs
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
273459
Author
Anon
Title
SPC for CircoMax emulsion for injection for pigs
Study date
2023
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

144511
Product/Active constituent Name

Application Product Name

Equicort QLD Itch Treatment for Horses

Application details

Product name:

Equicort QLD Itch Treatment for Horses

Product number:

93039

Applicant Name:

DERMCARE-VET PTY. LTD.

Application purpose and description of use:

Variation of product label approval to amend Dosage and Administration instructions.

Active constituents:

Active constituent name
86010 - PERMETHRIN (25:75 CIS:TRANS)
Active constituent name
82110 - Budesonide

Description of data provided:

Data no
273532
Author
Dermcare-Vet
Title
ApplicationDoseDeriv_2018
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
273533
Author
Dermcare-Vet
Title
Handsizestudy_2018
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
273531
Author
Dermcare-Vet
Title
Summary for label changes
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Date

Application Date

Application No

Application Number

144746
Product/Active constituent Name

Application Product Name

Boostimin Injection for Cattle

Application details

Product name:

Boostimin Injection for Cattle

Product number:

87905

Applicant Name:

NUTRIEN AG SOLUTIONS LIMITED

Application purpose and description of use:

Variation of product registration details

Active constituents:

Active constituent name
83582 - Copper Carbonate
Active constituent name
83576 - EDTA (acid)
Active constituent name
83580 - Manganese Carbonate
Active constituent name
83575 - Sodium Selenite
Active constituent name
83577 - DISODIUM ZINC EDTA
Active constituent name
83578 - DISODIUM MANGANESE EDTA
Active constituent name
83581 - DISODIUM COPPER EDTA

Description of data provided:

Data no
274398
Author
Not identified
Title
Letter of support
Study date
October 2024
Authorising party
Manufacturer
Date

Application Date

Application No

Application Number

144748
Product/Active constituent Name

Application Product Name

Nutriject Injection for Cattle

Application details

Product name:

Nutriject Injection for Cattle

Product number:

87829

Applicant Name:

NUTRIEN AG SOLUTIONS LIMITED

Application purpose and description of use:

Variation of product registration details

Active constituents:

Active constituent name
83580 - Manganese Carbonate
Active constituent name
83582 - Copper Carbonate
Active constituent name
83576 - EDTA (acid)
Active constituent name
83581 - DISODIUM COPPER EDTA
Active constituent name
83575 - Sodium Selenite
Active constituent name
83577 - DISODIUM ZINC EDTA
Active constituent name
83578 - DISODIUM MANGANESE EDTA
Date

Application Date

Application No

Application Number

144699
Product/Active constituent Name

Application Product Name

Quad Multi-Combination Sheep Drench

Application details

Product name:

Quad Multi-Combination Sheep Drench

Applicant Name:

FOUR SEASONS AGRIBUSINESS PTY LTD

Application purpose and description of use:

Registration of a 37.5 g/L closantel, 34 g/L levamisole (as levamisole hydrochloride), 25 g/L albendazole, 1 g/L abamectin oral suspension product for the treatment and control of worms in sheep.
Date

Application Date

Application No

Application Number

144753
Product/Active constituent Name

Application Product Name

clodinafop propargyl

Application details

Product name:

clodinafop propargyl

Active name:

clodinafop propargyl

Applicant Name:

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use:

Approval of Clodinafop-propargyl for use in agricultural products.

Description of data provided:

Data no
274405
Author
Patil, J.A.
Title
Analytical Method SA-67/2 for Clodinafop-propargyl (CGA 184927) tech. - Assay by capillary GC / chiral HPLC
Study date
06 December 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274406
Author
Patil, J.A.
Title
Analytical Method 58-67/2 for Clodinafop-propargyl (CGA184927) tech. By-products and supplementary tests
Study date
06 December 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274404
Author
Gosavi, P.V.
Title
Clodinafop-propargyl - Analysis of Five Representative Batches
Study date
29 January 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274402
Author
Grosenick, H.
Title
MANUFACTURING PROCESS, CLODINAFOP-PROPARGYL
Study date
07 June 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274403
Author
Nayyar, P.
Title
Declaration of composition
Study date
08 July 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274400
Author
Nayyar, P.
Title
Part 2 - Chemistry and Manufacture
Study date
11 July 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274401
Author
Patil, J.A.
Title
Report on NMR Spectra
Study date
04 June 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274407
Author
Gosavi, P.V.
Title
Clodinafop-propargyl ??? Validation of Analytical Method SA-67/2
Study date
23 November 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274408
Author
Gosavi, P.V.
Title
Clodinafop-propargyl ??? Validation of Analytical Method SB-67/2
Study date
05 December 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

144281
Product/Active constituent Name

Application Product Name

The Plant Runner Hormone Rooting Liquid

Application details

Product name:

The Plant Runner Hormone Rooting Liquid

Applicant Name:

THE PLANT RUNNER PTY LTD

Application purpose and description of use:

Registration of a 4 g/L Indole butyric acid liquid concentrate product used to strike and accelerate roots on most plant cuttings.
Date

Application Date

Application No

Application Number

144540
Product/Active constituent Name

Application Product Name

Take Control Conquer Moth Balls

Application details

Product name:

Take Control Conquer Moth Balls

Product number:

95044

Applicant Name:

YATSAL DISTRIBUTORS PTY LTD

Application purpose and description of use:

Registration of a 990 g/kg naphthalene slow release generator product for household control of moths and silverfish.

Reference details:

90862 - Brunnings Moth Balls

Description of data provided:

Data no
273684
Author
Yatsal Pty Ltd
Title
Packaging example
Study date
June 2024
Authorising party
Applicant
Auth party contact address
2A Murray Jones Drive BANKSTOWN AERODROME Australia
Date

Application Date

Application No

Application Number

144481
Product/Active constituent Name

Application Product Name

Thiamethoxam

Application details

Product name:

Thiamethoxam

Active name:

Thiamethoxam

Applicant Name:

HEBEI DE RICK CHEMICAL CO., LTD

Application purpose and description of use:

Approval of Thiamethoxam technical grade material for use in agricultural chemical products.

Description of data provided:

Data no
273289
Author
Ling Fu
Title
Final report Preliminary Analysis and Enforcement Analytical Method of Thiamethoxam Technical
Study date
12/04/2024
Authorising party
Applicant
Auth party contact address
No 1, Road No 1 New Industrial Zone Gaocheng District, Shijiazhuang China
Data no
273290
Author
Ling Fu
Title
Final report Confidential attachment Preliminary Analysis and Enforcement Analytical Method of Thiamethoxam Technical
Study date
12/04/2024
Authorising party
Applicant
Auth party contact address
No 1, Road No 1 New Industrial Zone Gaocheng District, Shijiazhuang China
Data no
273291
Author
Ziyao Li
Title
Declaration of Composition
Study date
14/05/2024
Authorising party
Applicant
Auth party contact address
No 1, Road No 1 New Industrial Zone Gaocheng District, Shijiazhuang China
Data no
273292
Author
Hebei De Rich Chemical Co., Ltd.
Title
Chemistry & Manufacture For Approval of New Source of Thiamethoxam
Study date
07/05/2024
Authorising party
Applicant
Auth party contact address
No 1, Road No 1 New Industrial Zone Gaocheng District, Shijiazhuang China
Date

Application Date

Application No

Application Number

144685
Product/Active constituent Name

Application Product Name

Bixafen

Application details

Product name:

Bixafen

Active name:

Bixafen

Applicant Name:

Shandong Rainbow International Co Ltd

Application purpose and description of use:

Approval of Bixafen for use in agricultural chemical products

Description of data provided:

Data no
274150
Author
Mr. Stephen Chen
Title
Five Batch Analysis of Bixafen Technical
Study date
23/10/2020
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274153
Author
anon
Title
DoC
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274154
Author
anon
Title
The Statement of Batch Size of Bixafen Technical in 5-Batch Report
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274152
Author
Anon
Title
THE JUSTIFICATION OF IMPURITIES OF BIXAFEN TECHNICAL
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274151
Author
anon
Title
MANUFACTURE PROCESS OF BIXAFEN TECHNICAL
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274149
Author
Yasser Sokeirik
Title
-
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274160
Author
Anon
Title
Excutive summary
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274156
Author
RANJU V., M.Sc., Ph.D
Title
BIXAFEN TECHNICAL: BACTERIAL REVERSE MUTATION TEST
Study date
20/10/2020
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274157
Author
Aasavari Karmarkar
Title
Salmonella typhimurium, Reverse Mutation Assay of 3',4'-dichloro-5-fluoro-[1,1'-biphenyl]-2-amine
Study date
13/01/2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274158
Author
Jaideep Kanhere
Title
In vitro Mammalian Cell Micronucleus Test of 3',4' dichloro-5-fluoro-[1,1'-biphenyl]-2-amine using Human Lymphoblastoid Cell Line (TK6)
Study date
13/01/2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274159
Author
Jane Xu and Jack Guo
Title
QSAR analysis for Bixafen and the related impurity 1
Study date
27 July 2021
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274155
Author
European Commission
Title
Evaluation report on the equivalence of technical material for the active substance
Study date
21/02/2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China