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
150376
Product/Active constituent Name
Application Product Name
Porcine circovirus type 2 ORF2 subunit antigen
Application Date
Application Number
150376
Application Product Name
Porcine circovirus type 2 ORF2 subunit antigen
Application details
Product name:
Porcine circovirus type 2 ORF2 subunit antigen
Product number:
96676
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of 751.4 AU/0.2 mL dose Porcine circovirus type 2 ORF2 subunit antigen and 0.72 AU/ 0.2 mL dose Mycoplasma hyopneumoniae, strain J, inactivated vaccine for the active immunisation of pigs against porcine circovirus type 2 and Mycoplasma hyopneumoniae in conjunction with approval of Porcine circovirus type 2 ORF2 subunit antigen active constituent.
Description of data provided:
Data no
292407
Title
PCV2 antigen content test validation, Report CMI-19-47-035
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292408
Title
PCV2 antigen content test validation, Report CMI-19-47-035 Amendment
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292409
Title
SOP TI-5139-0005
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292410
Title
SOP TI-5139-0006
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292423
Title
Validations sterility test M Hyo antigen, Report 093634
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292424
Title
Validations sterility test M Hyo antigen, Report 081860
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292425
Title
Validations sterility test M Hyo antigen, Report 081862
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292426
Title
Validations sterility test PCV2 antigen, Report 096431
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292427
Title
Validations sterility test PCV2 antigen, Report 084227
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292428
Title
Validations sterility test PCV2 antigen, Report 084234
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292444
Title
Control tests during the manufacturing process.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292445
Title
SOP TI-4066-0825
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292446
Title
SOP TI-4066-0824
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292447
Title
SOP TI-4066-0142
Study date
2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292448
Title
SOP TI-4066-0826
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292449
Title
Sterility test on antigen batches, SOP TI-5089-0001
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292450
Title
Sterility test on antigen batches, SOP TI-5089-0002
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292451
Title
SOP TI-4066-0827
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292452
Title
SOP TI-4066-0828
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292453
Title
Validation report No. 2012-PATS-181
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292454
Title
Verification report Document no. : 109624
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292455
Title
SOP 256120-597-02
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292456
Title
Report No. 98010-013R
Study date
2003
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292457
Title
Report No. 98010-013RA1
Study date
2005
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292458
Title
SOP 256120-604-02
Study date
2010
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292431
Title
Master seed protocol M. hyopneumoniae Batch 19022-001
Study date
2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292401
Title
Validation of PCV2 titration assay. Report No. 093954 (V2.0)
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292402
Title
Validation of PCV2 titration assay. Report No. 21R/0019
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292420
Title
Information regarding M hyo batch potency test. Report CMI-20-47-042
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292421
Title
Information regarding M hyo batch potency test. Report CMI-21-47-072
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292422
Title
Information regarding M hyo batch potency test. Report 132661/2
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292400
Title
Study CMI-23-47-134
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292432
Title
Certificate of Analysis, culture medium powder. Lot No. 2307737
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292433
Title
Certificate of Analysis, medium supplement. Lot No. 2402817
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292429
Title
Master seed protocol PCV2b MSV, Batch 02J17
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292411
Title
Information regarding M hyo inactivation, Report 2016-BTS-063 (128650)
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292412
Title
Information regarding M hyo inactivation, Report 2016-BTS-063 (118371)
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292413
Title
Information regarding M hyo inactivation, Report 2016-BTS-063 (107799).
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292414
Title
M Hyo antigen content test validation, Report CMI-20-47-043 (109752).
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292415
Title
M Hyo antigen content test validation, Report 146316
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292416
Title
Information regarding PCV2 batch potency test. Report CMI-19-47-029
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292417
Title
Information regarding PCV2 batch potency test. Report CMI-19-47-029 Amendment
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292418
Title
Information regarding PCV2 batch potency test. Report CMI-22-47-116
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292419
Title
Information regarding PCV2 batch potency test. Report 132661/1
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292459
Title
Using statistical analysis for setting process validation acceptance criteria for Biotech Products.
Study date
2007
Auth party contact address
-
Data no
292460
Title
Statistical tools for setting in-process acceptance criteria
Study date
2003
Auth party contact address
-
Data no
292461
Title
Statistical Intervals for a normal population part I tables, examples and applications.
Study date
1970
Auth party contact address
-
Data no
292434
Title
Certificate of analysis - media. Lot No. 2011835
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292435
Title
Certificate of suitability CEP R1-CEP 2007-159
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292436
Title
Certificate of suitability CEP R1-CEP 2000-284
Study date
2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292437
Title
Certificate of analysis / Conformity Material A, batch No. AD22A00290
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292438
Title
Certificate of Analysis, Batch documentation file, Batch No. 2521661
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292439
Title
Certificate of Analysis Material B, Lot No. 0139950
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292440
Title
Certificate of Analysis Material C, Batch Number 1202475
Study date
2011
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292441
Title
Certificate of suitability CEP R1-CEP 2001-172
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292442
Title
Quality assurance certificate, Material D, Lot No. 1134193
Study date
2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292443
Title
Certificate of Analysis, Material D, Lot No. 1128725
Study date
2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292403
Title
Information regarding PCV2 inactivation, Report 20R/0079
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292404
Title
Information regarding PCV2 inactivation, Report TCB-2151
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292405
Title
Information regarding PCV2 inactivation, Report QCO-2146
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292406
Title
Information regarding PCV2 inactivation, Report 20R/0039
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292430
Title
Subject memo, PCV-1439-009 - stability testing pre-master seed
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
150377
Product/Active constituent Name
Application Product Name
PORCILIS PCV M HYO IDAL INACTIVATED VACCINE FOR PIGS
Application Date
Application Number
150377
Application Product Name
PORCILIS PCV M HYO IDAL INACTIVATED VACCINE FOR PIGS
Application details
Product name:
PORCILIS PCV M HYO IDAL INACTIVATED VACCINE FOR PIGS
Product number:
96677
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of 751.4 AU/0.2 mL dose Porcine circovirus type 2 ORF2 subunit antigen and 0.72 AU/ 0.2 mL dose Mycoplasma hyopneumoniae, strain J, inactivated vaccine for the active immunisation of pigs against porcine circovirus type 2 and Mycoplasma hyopneumoniae in conjunction with approval of Porcine circovirus type 2 ORF2 subunit antigen active constituent.
Reference details:
82241 - PORCILIS PCV M HYO
Active constituents:
Active constituent name
83162 - MYCOPLASMA HYOPNEUMONIAE INACTIVATED STRAIN J
Active constituent name
96676 - Porcine circovirus type 2 ORF2 subunit antigen
Description of data provided:
Data no
292542
Title
Validations sterility test Final product, Report 082129
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292543
Title
Validations sterility test Final product, Report 081931
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292544
Title
Validations sterility test Final product, Report 094694
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292545
Title
Validations Report PATS19-022
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292546
Title
Validations Report 2022-PATS-519
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292547
Title
Production and control of starting materials
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292548
Title
Certificates of analysis for starting materials listed in pharmacopoeia
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292552
Title
SOP TI-4066-0024
Study date
2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292553
Title
Batch-to-batch consistency, Batch protocols Porcilis PCV M Hyo ID
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292554
Title
Batch protocol Porcilis PCV M Hyo ID IP213823.3
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292539
Title
Porcilis PCV M Hyo ID Batch Protocol IP203682.1
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292540
Title
Porcilis PCV M Hyo ID Batch Protocol IP203682.3
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292541
Title
Porcilis PCV M Hyo ID Batch Protocol IP213823.1
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292473
Title
Control tests on the finished product.
Study date
2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292474
Title
SOP TI-4066-0266
Study date
2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292475
Title
SOP TI-4066-0277
Study date
2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292476
Title
SOP TI-4066-0829
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292477
Title
SOP TI-4066-0823
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292478
Title
SOP TI-4066-0797
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292479
Title
SOP TI-4066-0802
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292480
Title
SOP TI-5089-0002
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292481
Title
SOP TI-5089-0001
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292482
Title
Test Verification Report QCO-22144
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292483
Title
Batch protocol A001A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292484
Title
Batch protocol A004A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292485
Title
Batch protocol A005A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292509
Title
Product Release and Shelf-Life Specifications.
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292519
Title
Batch protocol Porcilis PCV M Hyo ID IP203540.
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292520
Title
Batch protocol Porcilis PCV M Hyo ID IP183151-1
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292521
Title
Batch protocol Porcilis PCV M Hyo ID IP203682-5
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292522
Title
Batch protocol Porcilis PCV M Hyo ID IP203583
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292523
Title
Batch protocol Porcilis PCV M Hyo ID IP213767
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292524
Title
Batch protocol Porcilis PCV M Hyo ID IP203682-6
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292525
Title
Batch protocol Porcilis PCV M Hyo ID IP193427
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292526
Title
Batch protocol Porcilis PCV M Hyo ID IP203672-1
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292527
Title
Batch protocol Porcilis PCV M Hyo ID IP203672-2
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292528
Title
Batch protocol Porcilis PCV M Hyo ID IP203471
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292529
Title
Batch protocol Porcilis Lawsonia ID A004A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292530
Title
Batch protocol Porcilis Lawsonia ID A005A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292531
Title
Batch protocol Porcilis Lawsonia ID A012A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292532
Title
Batch protocol Porcilis Lawsonia ID A014A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292533
Title
Batch protocol Porcilis Lawsonia ID A018A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292534
Title
Batch protocol Porcilis Lawsonia ID A011A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292535
Title
Batch protocol Porcilis PCV ID A032A
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292536
Title
Batch protocol Porcilis M Hyo ID ONCE, Batch protocol A033A01
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292537
Title
Batch protocol solvent for Porcilis Lawsonia ID, A004A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292538
Title
Description of the manufacturing method
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292508
Title
Evidence of Good Manufacturing Practice (GMP Compliance).
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292510
Title
P 2, Chemistry and Manufacture.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292511
Title
Detailed and Critical Summary (Critical expert report) on the quality documentation.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292512
Title
Specifications for containers
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292513
Title
CoA 10mL glass vial
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292514
Title
CoA 10mL PET vial
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292515
Title
CoA 20 mL PET vial
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292516
Title
CoA 40 mL PET vial
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292517
Title
CoA Stopper
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292518
Title
CoA Cap
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292462
Title
The establishment of two cell lines from the insect Spodoptera frugiperda (Lepidoptera; Noctuidae).
Study date
1977
Auth party contact address
-
Data no
292463
Title
Certificate of suitability CEP R1-CEP 2003-124
Study date
2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292464
Title
Certificate of origin - raw material A
Study date
2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292465
Title
Certificate of origin - raw material B
Study date
2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292466
Title
Certificate of analysis - media. Lot No. 1326142
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292467
Title
TSE Table A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292468
Title
TSE Table B
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292469
Title
CEPs - Certificates of suitability of raw materials.
Study date
2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292470
Title
TSE RISK ASSESSMENT
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292471
Title
Statements - Certificates of origin raw materials.
Study date
2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292472
Title
Non biological starting materials not listed in pharmacopoeia. Certificates of analysis
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292556
Title
Identification of a Novel Rhabdovirus in Spodoptera frugiperda Cell Lines.
Study date
2014
Auth party contact address
-
Data no
292557
Title
Identification of a Novel Rhabdovirus in Spodoptera frugiperda Cell Lines.
Study date
2014
Auth party contact address
-
Data no
292549
Title
Cells master seed protocol - Batch 9095140M01
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292550
Title
Master seed Karyology- Batch 9095140M01
Study date
2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292551
Title
Risk assessment EA testing for bovine origin, Batch: 9095140M01
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292555
Title
Stability Memo Testing Study PCV-1439-009.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292486
Title
Stability tests of the finished product.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292487
Title
Stability tests of finished product, batch protocol IP193427
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292488
Title
Stability tests of finished product, Batch protocol IP203540
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292489
Title
Stability tests of finished product, Batch protocol IP203567.2
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292490
Title
Stability tests of finished product, Batch protocol IP203654
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292491
Title
Stability tests of finished product, Batch protocol IP213707
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292492
Title
Stability tests of finished product, Batch protocol IP213767
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292493
Title
Stability tests of finished product, Batch protocol IP223974
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292494
Title
Stability tests of finished product, Batch protocol IP223996
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292495
Title
Stability tests of finished product, Batch protocol IP224007
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292496
Title
Stability tests of finished product, Batch protocol A001A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292497
Title
Stability tests of finished product, Batch protocol A001B
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292498
Title
Stability tests of finished product, Batch protocol A001C
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292499
Title
Stability tests of finished product, Batch protocol A001D
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292500
Title
Stability tests of finished product, Batch protocol A004A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292501
Title
Stability tests of finished product, Batch protocol A004B
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292502
Title
Stability tests of finished product, Batch protocol A005A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292503
Title
Stability tests of finished product, Batch protocol A005B
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292504
Title
Stability tests of finished product, Batch protocol IP203682.5
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292505
Title
Stability tests of finished product, Batch protocol IP203682.7
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292506
Title
Lawsonia ID, Batch protocol A018A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292507
Title
Lawsonia ID, Batch protocol A020A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292694
Title
Epidemiology and transmission of porcine circovirus type 2 (PCV2)
Study date
2012
Auth party contact address
-
Data no
292695
Title
Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals).
Study date
2021
Auth party contact address
-
Data no
292696
Title
Sample size calculations: basic principles and common pitfalls.
Study date
2010
Auth party contact address
-
Data no
292697
Title
TIC-20-47-007, Protocol Amendment 01
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292698
Title
TIC-20-47-007, Study Protocol
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292699
Title
CIA-14-98-1199, Study Report Release No. 14R/0107
Study date
2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292700
Title
Report Release No.: 14R/0086
Study date
2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292701
Title
Report Release No.: 07R/0096
Study date
2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292702
Title
Report Release No.: 07R/0076
Study date
2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292703
Title
Report Release No.: 07R/0062
Study date
2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292704
Title
Report No.: B02-071-01R
Study date
2002
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292705
Title
Efficacy of Two Commercial Ready-To-Use PCV2 and Mycoplasma hyopneumoniae Vaccines under Field Conditions.
Study date
2021
Auth party contact address
-
Data no
292706
Title
Immune B cell responsiveness to single-dose intradermal vaccination against Mycoplasma hyopneumoniae.
Study date
2021
Auth party contact address
-
Data no
292707
Title
High levels of maternally derived antibodies do not significantly interfere with the development of humoral and cell-mediated responses to Porcine circovirus 2 after intradermal vaccination
Study date
2023
Auth party contact address
-
Data no
292708
Title
CVMP assessment report for Mhyosphere PCV ID (EMEA/V/C/005272/0000). Vaccine common name: Mycoplasma hyopneumoniae and porcine circovirus vaccine
Study date
2020
Auth party contact address
-
Data no
292709
Title
CMH11-13-032, Study Report Release No. 12R/0285-01
Study date
2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292710
Title
Clinical evaluation of intradermal vaccination against porcine enzootic pneumonia (Mycoplasma hyopneumoniae).
Study date
2012
Auth party contact address
-
Data no
292711
Title
Vaccination of Sows against Porcine Circovirus Type 2 (PCV2) in a Subclinically Infected Herd Does Not
Impact Reproductive Performance.
Impact Reproductive Performance.
Study date
2020
Auth party contact address
-
Data no
292712
Title
Low prevalence of porcine circovirus type 2 infections in farrowing sows and corresponding pre-suckling piglets in southern German pig farms.
Study date
2016
Auth party contact address
-
Data no
292713
Title
A live-attenuated and an inactivated chimeric porcine circovirus (PCV)1-2 vaccine are both effective at inducing a humoral immune response and reducing PCV2 viremia and intrauterine infection in female swine of breeding age.
Study date
2014
Auth party contact address
-
Data no
292714
Title
Vaccination of gestating sows against M.hyopneumoniae - a useful adjustment to piglet only vaccination?
Study date
2020
Auth party contact address
-
Data no
292715
Title
Reproductive Failure Experimentally Induced in Sows via Artificial Insemination with Semen Spiked with Porcine Circovirus Type 2.
Study date
2009
Auth party contact address
-
Data no
292716
Title
Exploratory field study on the effect of Porcine circovirus 2 (PCV2) sow vaccination on serological, virological and reproductive parameters in a PCV2 subclinically infected sow herd
Study date
2018
Auth party contact address
-
Data no
292717
Title
Influence of long-term vaccination of a breeding herd of pigs against PCV2 on reproductive parameters.
Study date
2012
Auth party contact address
-
Data no
292718
Title
Effects of pre-farrowing sow vaccination against Mycoplasma hyopneumoniae on offspring colonisation and lung lesions.
Study date
2019
Auth party contact address
-
Data no
292719
Title
Effect of multiple vaccinations on transmission and degree of Mycoplasma hyopneumoniae infection in gilts
Study date
2021
Auth party contact address
-
Data no
292720
Title
Transfer of Mycoplasma hyopneumoniae-specific cell mediated immunity to neonatal piglets.
Study date
2021
Auth party contact address
-
Data no
292721
Title
Effect of Mycoplasma hyopneumoniae sow vaccination on piglet colonization at weaning.
Study date
2002
Auth party contact address
-
Data no
292722
Title
Association of porcine circovirus 2 with reproductive failure in pigs: a retrospective study, 1995-1998.
Study date
2001
Auth party contact address
-
Data no
292723
Title
Report Release No.: 12R/0300
Study date
2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292724
Title
Report Release No.: 12R/0295
Study date
2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292725
Title
Revisiting Porcine Circovirus Disease Diagnostic Criteria in the Current Porcine Circovirus 2 Epidemiological Context.
Study date
2022
Auth party contact address
-
Data no
292726
Title
P 4, Efficacy
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292727
Title
Diversity of Mycoplasma hyopneumoniae in pig farms revealed by direct molecular typing of clinical material.
Study date
2007
Auth party contact address
-
Data no
292728
Title
Best practice and future challenges for vaccination against porcine circovirus type 2.
Study date
2015
Auth party contact address
-
Data no
292729
Title
Study protocol S20254 amendment 05
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292730
Title
Study protocol S20254 amendment 04
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292731
Title
Study protocol S20254 amendment 03
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292732
Title
Study protocol S20254 amendment 02
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292733
Title
Study protocol S20254 amendment 01
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292734
Title
Study Protocol S20254-00
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292735
Title
Mixed Lawsonia ID Study Report S20254-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292736
Title
Study protocol S20223 amendment 04
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292737
Title
Study protocol S20223 amendment 03
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292738
Title
Study protocol S20223 amendment 02
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292739
Title
Study protocol S20223 amendment 01
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292740
Title
Study protocol S20223
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292741
Title
Field efficacy study report S20223
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292742
Title
Clinical trials
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292743
Title
Health certificates farms
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292744
Title
Study protocol TIC-20-47-001 Amendment 02
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292745
Title
Study protocol TIC-20-47-001 Amendment 01
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292746
Title
Study protocol TIC-20-47-001
Study date
2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292747
Title
Study report TIC-20-47-001
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292748
Title
Study protocol CMI-20-47-039 Amendment 02
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292749
Title
Study protocol CMI-20-47-039 Amendment 01
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292750
Title
Study protocol CMI-20-47-039
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292751
Title
Study report CMI-20-47-039
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292752
Title
Study protocol CMI-21-47-085
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292753
Title
Study report CMI-21-47-085
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292754
Title
Study protocol CMI-22-47-113 Amendment 01
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292755
Title
Study protocol CMI-22-47-113
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292756
Title
Subject-Report CMI-22-47-113
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292757
Title
Study protocol CMI-20-47-060
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292758
Title
Study report CMI-20-47-060
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292759
Title
Study protocol CMI-21-47-072 Amendment 01
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292760
Title
Study protocol CMI-21-47-072
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292761
Title
Study report CMI-21-47-072
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292762
Title
Study protocol TIC-19-47-004 Amendment 02
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292763
Title
Study protocol TIC-19-47-004 Amendment 01
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292764
Title
Study protocol TIC-19-47-004
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292765
Title
Study Report TIC-19-47-004
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292766
Title
Study protocol TIC-19-47-003 Amendment 01
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292767
Title
Study Protocol TIC-19-47-003
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292768
Title
Study Report TIC-19-47-003
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292769
Title
Study protocol CMI-22-47-116 Amendment 1
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292770
Title
Study Protocol CMI-22-47-116
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292771
Title
Laboratory Study Report CMI-22-47-116
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292772
Title
Study report 132151
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292773
Title
Study report 128778
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292774
Title
Study protocol CMI-22-47-108
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292775
Title
Study report CMI-22-47-108
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292776
Title
Study protocol CMI-22-47-107
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292777
Title
Study report CMI-22-47-107
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292778
Title
Study protocol TIC-19-47-005 deviation 01
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292779
Title
Study protocol TIC-19-47-005
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292780
Title
Study report TIC-19-47-005
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292781
Title
Study protocol CMI-22-47-104 amendment 04
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292782
Title
Study protocol CMI-22-47-104 amendment 03
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292783
Title
Study protocol CMI-22-47-104 amendment 02
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292784
Title
Study protocol CMI-22-47-104 amendment 01
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292785
Title
Study protocol CMI-22-47-104
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292786
Title
Study report CMI-22-47-104
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292787
Title
Pre-clinical studies
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292788
Title
Population dynamics and ORF3 gene evolution of porcine circovirus type 2 circulating in Korea.
Study date
2012
Auth party contact address
-
Data no
292789
Title
Genotypic Change of Porcine Circovirus Type 2 on Japanese Pig Farms as Revealed by Restriction Fragment Length Polymorphism Analysis.
Study date
2008
Auth party contact address
-
Data no
292790
Title
Distribution of ORF2 and ORF3 genotypes of porcine circovirus type 2 (PCV-2) in wild boars and domestic pigs in Germany.
Study date
2011
Auth party contact address
-
Data no
292791
Title
Molecular diversity of Brazilian strains of porcine circovirus type 2 (PCV-2).
Study date
2008
Auth party contact address
-
Data no
292792
Title
Genotypic Change and Phylogenetic Analysis of Porcine Circovirus Type 2 in Taiwanese Pig Herds
Study date
2012
Auth party contact address
-
Data no
292793
Title
Genomic analysis of PCV2 isolates from Danish archives and a current PMWS case control study supports
a shift in genotypes with time
a shift in genotypes with time
Study date
2008
Auth party contact address
-
Data no
292794
Title
Genetic variation analysis of Chinese strains of porcine circovirus type 2
Study date
2009
Auth party contact address
-
Data no
292795
Title
Quantification of porcine circovirus type 2 (PCV2) DNA in serum and tonsillar, nasal, tracheo-bronchial, urinary and faecal swabs of pigs with and without postweaning multisystemic wasting syndrome (PMWS).
Study date
2005
Auth party contact address
-
Data no
292796
Title
Porcine circovirus-2 DNA concentration distinguishes wasting from nonwasting pigs and is correlated with lesion distribution, severity, and nucleocapsid staining intensity.
Study date
2008
Auth party contact address
-
Data no
292797
Title
Comparison of porcine circovirus type 2 load in serum quantified by a real time PCR in postweaning multisystemic wasting syndrome and porcine dermatitis and nephropathy syndrome naturally affected pigs.
Study date
2004
Auth party contact address
-
Data no
292798
Title
One dose of a porcine circovirus 2 subunit vaccine induces humoral and cell-mediated immunity and protects against porcine circovirus-associated disease under field conditions.
Study date
2011
Auth party contact address
-
Data no
292799
Title
Genetic analysis of porcine circovirus type 2 (PCV2) strains isolated between 2001 and 2009: genotype PCV2b predominate in postweaning multisystemic wasting syndrome occurrences in eastern China
Study date
2010
Auth party contact address
-
Data no
292800
Title
Comparison of efficacy of commercial one dose and two dose PCV2 vaccines using a mixed PRRSV PCV2 SIV clinical infection model 2 3-months post vaccination.
Study date
2009
Auth party contact address
-
Data no
292801
Title
The effect of vaccination against porcine circovirus type 2 in pigs suffering from porcine respiratory disease complex.
Study date
2008
Auth party contact address
-
Data no
292802
Title
Porcine circovirus type 2 (PCV2) vaccination of conventional pigs prevents viremia against PCV2 isolates of different genotypes and geographic origins.
Study date
2008
Auth party contact address
-
Data no
292803
Title
Evaluation of virulence of Mycoplasma hyopneumoniae field isolates.
Study date
2003
Auth party contact address
-
Data no
292804
Title
Chromosomal Heterogeneity of Various Mycoplasma hyopneumoniae Field Strains.
Study date
1992
Auth party contact address
-
Data no
292805
Title
Genetic analysis of porcine circovirus type 2 (PCV2) strains between 2002 and 2016 reveals PCV2 mutant predominating in porcine population in Guangxi, China.
Study date
2019
Auth party contact address
-
Data no
292806
Title
Global molecular genetic analysis of porcine circovirus type 2 (PCV2) sequences confirms the presence of four main PCV2 genotypes and reveals a rapid increase of PCV2d.
Study date
2015
Auth party contact address
-
Data no
292807
Title
Detection of two porcine circovirus type 2 genotypic groups in United States swine herds.
Study date
2007
Auth party contact address
-
Data no
292808
Title
Porcine Circovirus 2 Genotypes, Immunity and Vaccines: Multiple Genotypes but One Single Serotype
Study date
2020
Auth party contact address
-
Data no
292809
Title
Solvent for Porcilis Lawsonia ID Batch protocol A004A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292810
Title
Porcilis PCV ID, Batch protocol A032A
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292811
Title
Porcilis M Hyo ID ONCE, Batch protocol A033A01
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292812
Title
Porcilis Lawsonia ID Batch protocol A011A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292813
Title
Porcilis Lawsonia ID Batch protocol A018A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292814
Title
Porcilis Lawsonia ID Batch protocol A005A
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292815
Title
Batch protocol IP213767
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292816
Title
Batch protocol IP203583
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292817
Title
Batch protocol IP193427
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292818
Title
Batch protocol IP203540
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292819
Title
Batch protocol IP203682.6
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292820
Title
Batch protocol IP203682.5
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292821
Title
Batch protocol IP203471
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292822
Title
Batch protocol IP203672.2
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292823
Title
Batch protocol IP203672.1
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292824
Title
Detailed description of challenge models.
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292825
Title
PCV2 ELISA Validation Report 13R/0239
Study date
2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292826
Title
PCV2 ELISA Validation Report 08R/0239
Study date
2009
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292827
Title
PCV2 ELISA SOP 256120-338-03
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292828
Title
Lawsonia Report Report LFD-VAL-14-16-001
Study date
2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292829
Title
Lawsonia Report RAPP181
Study date
2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292830
Title
Lawsonia validation report, LIV-13-38-010-Study Report-13R0085
Study date
2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292831
Title
SOP Lawsonia - GLPSOP 256160-081
Study date
2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292832
Title
SOP Lawsonia - SOP 256400-122
Study date
2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292833
Title
SOP Lawsonia - GLPSOP 256220-227
Study date
2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292834
Title
SOP 256120-445-03
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292835
Title
SOP 256120-385-04
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292836
Title
Report PCV-11-12-260 (14R/0072)
Study date
2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292837
Title
Report PCV-08-12-204 (09R/0105)
Study date
2009
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292838
Title
Report PCV-08-12-204 (13R/0069)
Study date
2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292839
Title
Efficacy documentation - General requirements
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292601
Title
Part 4, Efficacy data, Table of Contents.
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292602
Title
Part 3, Safety data, Table of Contents
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292655
Title
Detailed and Critical Summary (Critical expert report) on the Efficacy documentation.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292656
Title
Detailed and Critical Summary (Critical expert report) on the safety documentation.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292598
Title
Appendix Q9c. Individual results S20254-00. Document No. 160231.
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292599
Title
Appendix Q9b. Individual results S20254-00. Document No. 160230.
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292600
Title
P 3, Target animal safety
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292603
Title
Study protocol S20254 Amendment 05
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292604
Title
Study protocol S20254 Amendment 04
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292605
Title
Study protocol S20254 Amendment 03
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292606
Title
Study protocol S20254 Amendment 02
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292607
Title
Study protocol S20254 Amendment 01
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292608
Title
Field Safety Study Protocol S20254
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292609
Title
Field Safety Study in sows, Study Report S20254
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292610
Title
Study protocol S20223 Amendment 04
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292611
Title
Study protocol S20223 Amendment 03
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292612
Title
Study protocol S20223 Amendment 02
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292613
Title
Study protocol S20223 Amendment 01
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292614
Title
Field safety study Protocol S20223
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292615
Title
Field safety study in piglets, Study Report S20223
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292616
Title
Study protocol S20247 Amendment 05
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292617
Title
Study protocol S20247 Amendment 04
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292618
Title
Study protocol S20247 Amendment 03
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292619
Title
Study protocol S20247 Amendment 02
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292620
Title
Study protocol S20247 Amendment 01
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292621
Title
Field Safety Study Protocol S20247
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292622
Title
Field safety study in sows, Study Report S20247
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292623
Title
Study Protocol S20222
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292624
Title
Field safety study in piglets, Study Report S20222
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292625
Title
Clinical Trials
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292626
Title
Study Protocol CMI-20-47-058
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292627
Title
Pilot Safety in sows, Study Report CMI-20-47-058
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292628
Title
Pilot Safety in piglets, Study Report CMI-19-47-024
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292629
Title
Study protocol CMI-20-47-054 Amendment 03
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292630
Title
Study protocol CMI-20-47-054 Amendment 02
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292631
Title
Study protocol CMI-20-47-054 Amendment 01
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292632
Title
Study Protocol CMI-20-47-054
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292633
Title
GLP Safety in sows, Study Report CMI-20-47-054
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292634
Title
Study Protocol CMI-20-47-053 Amendment 05
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292635
Title
Study Protocol CMI-20-47-053 Amendment 04
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292636
Title
Study Protocol CMI-20-47-053 Amendment 03
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292637
Title
Study Protocol CMI-20-47-053 Amendment 02
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292638
Title
Study Protocol CMI-20-47-053 Amendment 01
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292639
Title
Study Protocol CMI-20-47-053, Document No. 067127
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292640
Title
GLP safety in piglets, Study Report CMI-20-47-053, Document No. 074755
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292641
Title
Pre-clinical studies
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292642
Title
Solvent for Porcilis Lawsonia ID, Batch protocol A004A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292643
Title
Porcilis Lawsonia ID, Batch protocol A018A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292644
Title
Porcilis Lawsonia ID, Batch protocol A014A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292645
Title
Porcilis Lawsonia ID, Batch protocol A012A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292646
Title
Porcilis Lawsonia ID, Batch protocol A005A
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292647
Title
Porcilis Lawsonia ID, Batch protocol A004A
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292648
Title
Batch protocol IP183151.2
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292649
Title
Batch protocol IP213767
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292650
Title
Batch protocol IP203583
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292651
Title
Batch protocol IP203682.5
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292652
Title
Batch protocol IP183151.1
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292653
Title
Batch protocol IP203540
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292654
Title
Safty General requirements
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292559
Title
Applicant s Responses to the List of Questions at Day 120.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292566
Title
Certificates of Suitability for European Pharmacopoeia (Ph. Eur.) monographs for starting materials.
Study date
2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292568
Title
Declaration for the absence of specified animal diseases from New Zealand
Study date
2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292597
Title
TSE Declaratation
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292595
Title
Summary of the dossier
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292560
Title
Application Executive Summary.
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292561
Title
APVMA Application for Registration of a Chemical Product, Advice Summary
Study date
2009
Auth party contact address
-
Data no
292562
Title
APVMA Pre-application Written Assistance.
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292563
Title
APVMA Project Plan
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292564
Title
Best practice and future challenges for vaccination against porcine circovirus type 2.
Study date
2015
Auth party contact address
-
Data no
292565
Title
Breeds of Livestock - Large White Swine
Study date
2015
Auth party contact address
-
Data no
292567
Title
DAFF Import permit application
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292571
Title
Dossier Volume 1, Australian Data and Summary.
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292572
Title
Dossier Volume 2, European Original Dossier
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292573
Title
Dossier Volume 3 (A), European Consolidated Dossier.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292574
Title
Dossier Volume 3 (B), Consolidated Dossier (European Structure).
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292580
Title
Flow Chart for the Manufacturers of the actives and finished product.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292581
Title
General Table of Contents of the EU Consolidated Dossier.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292582
Title
Genetic characterisation of Australian strains of porcine circovirus types 1 and 2.
Study date
2006
Auth party contact address
-
Data no
292583
Title
GMP Compliance
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292558
Title
A summary document outlining the overall structure of the dossier documents.
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292596
Title
Summary of the Pharmacovigilance System Master File.
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292578
Title
Exemption from GMO Assessment.
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292585
Title
M+PAC Mycoplasma Hyopneumoniae Inactivated Vaccine for Pigs, APVMA Advice Summary.
Study date
2009
Auth party contact address
-
Data no
292586
Title
P1, General and admin information.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292587
Title
Pig farming in the European Union: considerable variations from one Member State to another, Eurostat - Statistics in focus 15/2014.
Study date
2014
Auth party contact address
-
Data no
292588
Title
Porcine Circovirus 2 Genotypes, Immunity and Vaccines: Multiple Genotypes but One Single Serotype.
Study date
2020
Auth party contact address
-
Data no
292589
Title
Product E- Label (RLPs).
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292590
Title
Queensland pig industry
Study date
2015
Auth party contact address
-
Data no
292591
Title
Sales and Pharmacovigilance data
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292592
Title
Scientific justification on the relevance of the overseas data.
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292593
Title
Spreadsheet outlines changes between original dossier and consolidated dossier.
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292594
Title
Summary of Product Characteristics, Labelling and Package Leaflet.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292584
Title
List of Outstanding Questions and Applicant s Responses at Day 180.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292575
Title
Dossier Volume 4, EU International Assessment and List of Questions and Applicant Responses.
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292576
Title
EMEA Scientific overview of Porcilis PCV M Hyo IDAL application and Rapporteur s (co-rapporteur s) Assessment Report and Questions (Day 120).
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292569
Title
Documents (new or updated) related to Applicant s responses at Day 120.
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292570
Title
Documents (new or updated) related to Applicant s responses at Day 180.
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292579
Title
Exemption from Residues tests
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292577
Title
Environmental risk assessment
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
150525
Product/Active constituent Name
Application Product Name
Mimic PRO Insect Growth Regulator Larvicide
Application Date
Application Number
150525
Application Product Name
Mimic PRO Insect Growth Regulator Larvicide
Application details
Product name:
Mimic PRO Insect Growth Regulator Larvicide
Product number:
96727
Applicant Name:
SUNDEW SOLUTIONS PTY LTD
Application purpose and description of use:
Registration of a 10 g/L pyriproxyfen SL product for use with an adulticide to control cockroaches and fleas in domestic, industrial and public health situations, and nuisance fly larvae in animal housing and feedlots, and control of mosquitoes in non-natural water sources such as potable water tanks, household water containers and other areas these insects breed. Breaks the breeding cycle.
Reference details:
45923 - SUMILARV INSECT GROWTH REGULATOR
70077 - SUMILARV GRANULAR INSECT GROWTH REGULATOR
Active constituents:
Active constituent name
67716 - PYRIPROXYFEN
Description of data provided:
Data no
295413
Title
CoA pyriproxyfen
Study date
1 August 2024
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295411
Title
Method AM-22-28: Determination of Pyriproxyfen in RF-081 Method number AM-22-28
Study date
26 October 2022
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295412
Title
Validation of an Analytical Method for Determining Pyriproxyfen Content in RF-081
Study date
2October 2022
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295407
Title
Manufacturing and QC procedures for RF-081
Study date
28 October 2022
Data no
295408
Title
Physical and chemical properties of RF-091
Study date
31 October 2022
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295409
Title
Manufacturing Specification for RF-081 (10 g/L Pyriproxyfen Soluble Concentrate)
Study date
4 November 2022
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295404
Title
Mimic Part 2 chemistry
Study date
14 October 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295405
Title
SDS for Non-Active Constituents for RF-081
Study date
31 October 2022
Auth party contact address
4 Swans Road Bell Block, New Plymouth 4312 New Zealand
Data no
295406
Title
Composition of RF-081
Study date
28 October 2022
Auth party contact address
4 Swans Road Bell Block, New Plymouth 4312 New Zealand
Data no
295410
Title
Accelerated Stability of RF-081 10 g/L Pyriproxyfen Soluble Concentrate (SL) in HDPE Packaging for 2 weeks at 54??C
Study date
6 October 2022
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295414
Title
Mimic Part 8 Efficacy
Study date
14 October 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295415
Title
Laboratory trial to test efficacy of Mimic Pro SC (10 g/L pyriproxyfen) against German cockroach nymphs
Study date
9 August 2022
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295416
Title
Laboratory trial to test efficacy of Mimic Pro SC (10 g/L pyriproxyfen) against American cockroach nymphs
Study date
9 September 2022
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295417
Title
Laboratory trial to test efficacy of Mimic Pro SC (10 g/L pyriproxyfen) against housefly maggots
Study date
20 April 2023
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295418
Title
Laboratory trial to test efficacy of Mimic Pro SC (10 g/L pyriproxyfen) against mosquito larvae
Study date
12 August 2023
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295419
Title
Laboratory testing of an insect growth regulator (Mimic Pro) against immature stages of the yellow fever mosquito, Aedes aegypti
Study date
September 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
295403
Title
Mimic AA letter
Study date
13 October 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Date
Application Date
Application No
Application Number
150633
Product/Active constituent Name
Application Product Name
Assassin Liquid Termite Bait
Application Date
Application Number
150633
Application Product Name
Assassin Liquid Termite Bait
Application details
Product name:
Assassin Liquid Termite Bait
Product number:
96771
Applicant Name:
TERMSEAL AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 0.45g/kg fipronil gel liquid formulation product for the control of subterranean termites as per the proposed label directions
Reference details:
64884 - COUNTRY FIPRONIL RESIDUAL TERMITICIDE AND INSECTICIDE
Description of data provided:
Data no
295664
Title
Method Validation
Study date
2025
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295662
Title
Safety Data Sheets
Study date
October 2025
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295661
Title
Chemistry and Manufacture
Study date
October 2025
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295663
Title
Stability
Study date
2025
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295674
Title
Efficacy Data
Study date
2023
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295673
Title
Efficacy
Study date
October 2025
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295660
Title
Executive Summary
Study date
October 2025
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295668
Title
OHS
Study date
October 2025
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295669
Title
Chemical Review on Fipronil
Study date
June 2011
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295670
Title
Safety Data Sheets
Study date
2025
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295671
Title
Toxicology review on Fipronil
Study date
2009
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295672
Title
Safety Data Sheet - Assassin Liquid Termite Bait
Study date
May 2024
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295665
Title
Toxicology
Study date
October 2025
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295666
Title
Chemical Review on Fipronil
Study date
June 2011
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
295667
Title
Safety Data Sheets
Study date
2025
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Date
Application Date
Application No
Application Number
150418
Product/Active constituent Name
Application Product Name
Luna Experience Fungicide
Application Date
Application Number
150418
Application Product Name
Luna Experience Fungicide
Application details
Product name:
Luna Experience Fungicide
Product number:
87841
Applicant Name:
BAYER CROPSCIENCE PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to allow use on various crops and reduce the plant back interval.
Active constituents:
Active constituent name
44205 - TEBUCONAZOLE
Active constituent name
63735 - FLUOPYRAM
Active constituent name
90823 - Fluopyram
Active constituent name
89272 - Tebuconazole
Description of data provided:
Data no
294597
Title
Evaluation of AEC656948 co formulation fungicides for the control of Blossom Blight in Almonds, McLaren Flat, South Australia, 2008
Study date
01/05/2009
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294598
Title
Evaluation of AEC656948 co formulation fungicides for the control of Blossom Blight in Almonds, Angle Vale, South Australia, 2008
Study date
18/06/2009
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294599
Title
Evaluation of AEC656948 500 SC for the control of blossom blight in cherries. Shadforth, New South Wales, 2008
Study date
27/04/2009
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294600
Title
Evaluation of AEC656948 for the control of blossom blight in stone fruit. Wandin, Victoria, Australia, 2008
Study date
08/05/2009
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294601
Title
AEC656948 for control of blossom blight and shot hole of stone fruit, Swan Hill,
Victoria, 2008
Victoria, 2008
Study date
29/06/2009
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294602
Title
Luna Experience / Almond / Early season diseases
Study date
05/06/2019
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294603
Title
Luna Experience - Chestnut tree - Monilinia sp. efficacy and crop safety
Study date
29/12/2021
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294605
Title
Evaluation of fungicides for the control of anthracnose in avocado. Ravensbourne, Queensland. 2016
Study date
08/07/2016
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294606
Title
Evaluation of Luna Privilege 500 SC and Serenade Prime SC for the control of anthracnose in mango
Study date
24/03/2017
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294607
Title
Evaluation of fungicides for the control of anthracnose in mango. Bowen, Queensland. 2016.
Study date
15/07/2018
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294608
Title
Evaluation of fungicides for the control of disease in litchi. Haikou City, Hainan, China. 2018
Study date
04/11/2019
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294609
Title
Evaluation of fungicides in mango for disease control. Redhill Farms, Queensland. 2018
Study date
04/11/2019
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294610
Title
Evaluation of fungicides for the control of disease in avocado. Childers, Queensland. 2018-19.
Study date
06/10/2019
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294611
Title
Evaluation of the efficacy of Luna Experience and Luna Sensation for the control of anthracnose in custard apple. South Kolan, Queensland. 2019
Study date
03/05/2019
Auth party contact address
Level 7, 141 Walker St, North Sydney, NSW, 2060
Data no
294612
Title
Evaluation of a fungicide for the control of anthracnose in custard apple. Beerwah, Queensland. 2020
Study date
07/05/2020
Auth party contact address
Level 7, 141 Walker St, North Sydney, NSW, 2060
Data no
294613
Title
Evaluation of the efficacy of Luna Experience and Luna Sensation for the control of anthracnose in persimmon Ravensbourne, Queensland. 2018
Study date
30/10/2019
Auth party contact address
Level 7, 141 Walker St, North Sydney, NSW, 2060
Data no
294614
Title
Evaluation of the efficacy of Luna Experience and Luna Sensation for the control of anthracnose in persimmon
Study date
12/09/2018
Auth party contact address
Level 7, 141 Walker St, North Sydney, NSW, 2060
Data no
294615
Title
Evaluation of the efficacy of Luna Experience and Luna Sensation for the control of anthracnose in olives. Latrobe, Tasmania. 2019
Study date
08/07/2019
Auth party contact address
Level 7, 141 Walker St, North Sydney, NSW, 2060
Data no
294616
Title
Evaluation of fungicide for crop safety in avocado and mango. Queensland. 2014-18
Study date
04/12/2019
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294617
Title
Evaluation of fungicides for the control of disease in avocado Childers, Queensland, 2018/19
Study date
12/06/2019
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294618
Title
Evaluation of fungicides for the control of disease in avocado Isis, Queensland. 2017-18.
Study date
01/08/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294621
Title
Efficacy and crop safety of Luna Experience Fungicide for disease control in chestnuts, tropical fruit and fruiting vegetables
Study date
September 2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294622
Title
Crop safety in aubergine
Study date
22/09/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294623
Title
Aubergine crop safety
Study date
22/09/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294624
Title
Crop safety in okra
Study date
22/09/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294625
Title
Crop safety on okra
Study date
22/09/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294627
Title
Crop safety in okra
Study date
22/09/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294619
Title
Crop safety in aubergine
Study date
22/09/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294604
Title
Chestnut crop safety
Study date
3/7/2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294620
Title
Consent to release reports containing protected data to Bayer CropScience Pty Ltd
Study date
16/9/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294585
Title
Determination of fluopyram, tebuconazole and trifloxystrobin residues in mango and litchi following applications of Luna Experience 400 SC or Luna Sensation 500 SC
Study date
25/06/2019
Data no
294581
Title
Luna Experience Fungicide draft label.
Study date
02/09/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294628
Title
Luna Sensation Fungicide label
Study date
Sep2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294626
Title
Luna Experience Fungicide label
Study date
Sep2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294634
Title
Luna Experience Fungicide - updated draft label.
Study date
27/06/2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294629
Title
Pre-application assistance (PAA) - APVMA written assistance.
Study date
1/9/2022
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294630
Title
Residues and trade evaluation report - Luna Sensation Fungicide.
Study date
03/2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294631
Title
Residues and trade evaluation report: Luna Sensation Fungicide.
Study date
11/2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294632
Title
Residues and trade evaluation report - Luna Experience Fungicide.
Study date
05/2022
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294579
Title
Residues and trade evaluation report - Luna Experience Fungicide.
Study date
May 2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294580
Title
Residues and trade evaluation report - Luna Experience Fungicide.
Study date
05/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294635
Title
Supplement to the residue methods 00442/M003 and 00112/M001 for the determination of residues of SZX 0722, tolylfluanid, DMST and tebuconazole in/on various raw agricultural and processed commodities by liquid chromatography using mass spectroscopic detection.
Study date
3/9/1998
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294638
Title
Analytical Method 01013 for the simultaneous determination of residues of the active items BYF00587, prothioconazole, tebuconazole, trifloxystrobin and the metabolites BYF00587-desmethyl, JAU6476-desthio (SXX0665) andCGA321113 in/on plant material by HPLC-MS/MS. Study No. MR-06/138
Study date
3/2/2017
Data no
294639
Title
An analytical method for the determination of residues of AE C656948 in crop matrices using LC-MS/MS.
Study date
7/2/2008
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294636
Title
Determination of residues of tebuconazole and tolylfluanid in/on head lettuce following spray application of Folicur EM (50 WP) in Italy and France.
Study date
12/4/1999
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294637
Title
Determination of residues of tebuconazole, tolylfluanid and DMST on head lettuce after spray application of Folicur EM 50 WP in the field in Spain, France, Italy, Portugal and Greece.
Study date
6/2/2001
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294633
Title
Determination of fluopyram and trifloxystrobin residues in leafy vegetables (leafy lettuce, head lettuce, spinach and leafy brassica) following two applications of Luna Sensation 500 SC at 800 or 1000 mL/ha.
Study date
18/2/2020
Data no
294641
Title
Determination of the residues of tebuconazole and trifloxystrobin in/on curly kale after spray application of Tebuconazole & Trifloxystrobin WG 75 in the field in Germany, United Kingdom, the Netherlands and northern France.
Study date
5/3/2013
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294642
Title
Determination of fluopyram and tebuconazole residues in leafy vegetables (leafy lettuce, head lettuce, spinach and leafy brassica) following two applications of Luna Experience 400 SC at 1000 or 1250 mL/ha.
Study date
31/8/2018
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294643
Title
Determination of fluopyram, tebuconazole and trifloxystrobin residues in avocado following applications of Luna Experience 400 SC or Luna Sensation 500 SC.
Study date
2/12/2019
Data no
294644
Title
Determination of fluopyram and tebuconazole and trifloxystrobin residues in avocado following applications of Luna Experience 400 SC or Luna Sensation 500 SC.
Study date
18/4/2019
Data no
294645
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop corn after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in the Netherlands, Germany, southern France and Spain. Study No. E19RC016
Study date
24/7/2022
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294646
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop wheat and soil after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in Spain and southern France.
Study date
22/9/2022
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294647
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop rape and soil after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in the Netherlands, Belgium, southern France and Spain.
Study date
28/7/2022
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294648
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop pea and soil after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in Belgium, Germany, southern France and Spain.
Study date
21/6/2022
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294649
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop spring wheat and soil after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in Germany and northern France.
Study date
6/9/2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294650
Title
Determination of fluopyram in plant back crops following the application of a fluopyram containing product to bare earth several months prior to planting.
Study date
27/6/2022
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294651
Title
Determination of fluopyram and tebuconazole residues in chestnuts following applications of Luna Experience 400 SC.
Study date
8/9/2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294582
Title
Determination of fluopyram, tebuconazole and trifloxystrobin residues in passionfruit and rambutan following applications of Luna Experience 400 SC or Luna Sensation 500 SC
Study date
02/12/2019
Data no
294583
Title
Determination of fluopyram, tebuconazole and trifloxystrobin residues in mango and litchi following applications of Luna Experience 400 SC or Luna Sensation 500 SC
Study date
22/11/2019
Data no
294584
Title
Determination of fluopyram, tebuconazole and trifloxystrobin residues in passionfruit and kiwifruit following applications of Luna Experience 400 SC or Luna Sensation 500 SC
Study date
20/11/2019
Data no
294640
Title
AE C656948 500 SC - Magnitude of the residue in/on grass forage, fodder, and hay (Crop Group 17) and grass for seed.
Study date
24/04/2008
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294652
Title
Part 5 - Residues: fluopyram and tebuconazole in various crops (amended).
Study date
27/6/2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294586
Title
Part 5 Residues: fluopyram and tebuconazole in Tropical and sub-tropical fruits - inedible peel crops
Study date
September 2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Date
Application Date
Application No
Application Number
150352
Product/Active constituent Name
Application Product Name
OH2 Ornamental Herbicide
Application Date
Application Number
150352
Application Product Name
OH2 Ornamental Herbicide
Application details
Product name:
OH2 Ornamental Herbicide
Product number:
90587
Applicant Name:
EVERRIS AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration to make changes to the formulation.
Active constituents:
Active constituent name
48920 - OXYFLUORFEN
Active constituent name
44379 - PENDIMETHALIN
Description of data provided:
Data no
293236
Title
Data Sheets for Non-Active Constituents
Study date
24/09/2025
Auth party contact address
-
Data no
293237
Title
OH2 Ornamental Herbicide Proposed Basic and Alternative Formulations
Study date
25/09/2025
Auth party contact address
SUITE 211/33 LEXINGTON DRIVE BELLA VISTA Australia
Data no
293234
Title
Pre-application assistance (PAA) ? APVMA written assistance
Study date
08/08/2025
Auth party contact address
SUITE 211/33 LEXINGTON DRIVE BELLA VISTA Australia
Data no
293235
Title
Safety Data Sheets for Non-Active Constituents
Study date
24/09/2025
Auth party contact address
-
Date
Application Date
Application No
Application Number
150632
Product/Active constituent Name
Application Product Name
Quantum Indoxacarb 300 WG Insecticide
Application Date
Application Number
150632
Application Product Name
Quantum Indoxacarb 300 WG Insecticide
Application details
Product name:
Quantum Indoxacarb 300 WG Insecticide
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 312.5 g/kg indoxacarb (96:4) sufficient to provide 300g/kg active s-isome WATER DISPERSIBLE GRANULE for the control of insect pests in Azuki beans, Chickpeas, Cotton, Faba beans, Mungbeans, Soybeans and in certain vegetable and fruit crops as per the Directions for Use table
Date
Application Date
Application No
Application Number
150492
Product/Active constituent Name
Application Product Name
IMTRADE PLIER WG HERBICIDE
Application Date
Application Number
150492
Application Product Name
IMTRADE PLIER WG HERBICIDE
Application details
Product name:
IMTRADE PLIER WG HERBICIDE
Product number:
96715
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 375g/kg AMINOPYRALID + 300g/kg METSULFURON-METHYL water dispersible granule product for the control or suppression of weeds in Winter Cereals, Pastures, Non-Agricultural Areas, Commercial and Industrial Areas and Rights-of-Way as specified in the Directions for Use table.
Reference details:
88260 - Salve Herbicide
Active constituents:
Active constituent name
88366 - Aminopyralid
Active constituent name
54948 - METSULFURON-METHYL
Description of data provided:
Data no
294729
Title
CoA - Aminopyralid Tech
Study date
10/01/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294730
Title
CoA - Metsulfuron-methyl Tech
Study date
10/02/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294724
Title
Method of Manufacture - Imtrade Aminopyralid 375 to Metsulfuron-methyl 300 WG Herbicide
Study date
23/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294727
Title
Imtrade Aminopyralid 375+Metsulfuron-methyl 300 WG Method Validation ??? March 2023
Study date
21/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294726
Title
Imtrade Aminopyralid 375+Metsulfuron-methyl 300 WG 1 Batch Analysis - March 2023
Study date
21/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294728
Title
Safety Data Sheets for other Constituents
Study date
22/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294731
Title
Argument to satisfy AgVet Chemicals Code Act 1994 (Cth) s.14(3) in countering the commercial in confidence aspects of the reference product???s non-protected data
Study date
23/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294725
Title
Formulation and Stability Report ??? Imtrade Aminopyralid 375 to Metsulfuron-methyl 300 WG Herbicide
Study date
23/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294732
Title
Investigation into the Bio-equivalency of IMTRADE PINCER?? WG HERBICIDE compared to SALVE HERBICIDE for the control of weeds in pasture, Cocksfoot, cv. Savvy. ??? One Trial, Bridgetown WA.
Study date
17/03/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294733
Title
Investigation into the Bio-equivalency of IMTRADE PINCER?? WG HERBICIDE compared to SALVE HERBICIDE for the control of weeds in Wheat. ??? One Trial, Meandarra QLD.
Study date
29/11/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294734
Title
Investigation into the Bio-equivalency of IMTRADE PINCER?? WG HERBICIDE compared to SALVE HERBICIDE for the control of weeds in Barley. ??? One Trial, Meandarra QLD.
Study date
06/12/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294735
Title
Investigation into the Bio-equivalency of IMTRADE PINCER?? WG HERBICIDE compared to SALVE HERBICIDE for the control of weeds in Wheat cv. Sunmax. ??? One Trial, Meandarra QLD.
Study date
12/08/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294736
Title
Investigation into the Bio-equivalency of IMTRADE PINCER?? WG HERBICIDE compared to SALVE HERBICIDE for the control of weeds in Barley cv. Planet. ??? One Trial, Meandarra QLD.
Study date
18/08/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294737
Title
Investigation into the Bio-equivalency of IMTRADE PINCER?? WG HERBICIDE compared to SALVE HERBICIDE for the control of Woody Weeds. ??? One Trial, Meandarra QLD.
Study date
23/09/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294738
Title
Investigation into the Bio-equivalency of IMTRADE PINCER?? WG HERBICIDE compared to SALVE HERBICIDE for the control of weeds in Pasture. ??? One Trial, Meandarra QLD.
Study date
16/09/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
294739
Title
Comments to Support Efficacy and Host Crop Safety Data submitted
Study date
06/10/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
150529
Product/Active constituent Name
Application Product Name
IMTRADE LINKAGE VeripHy EC GRAIN PROTECTANT
Application Date
Application Number
150529
Application Product Name
IMTRADE LINKAGE VeripHy EC GRAIN PROTECTANT
Application details
Product name:
IMTRADE LINKAGE VeripHy EC GRAIN PROTECTANT
Product number:
96728
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 600g/L FENITROTHION + 60g/L s-METHOPRENE emulsifiable concentrate product for the control of of insect pests in stored cereal grains including Malting Barley as specified in the Directions for Use table.
Reference details:
67567 - FREEZONE SMART GRAIN DUAL INSECTICIDE
Active constituents:
Active constituent name
59428 - (S)-METHOPRENE
Active constituent name
96314 - FENITROTHION
Description of data provided:
Data no
295513
Title
Fenitrothion 600 + s-Methoprene 60 VeripHy EC Method Validation ??? Oct 2023
Study date
19/10/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295512
Title
Fenitrothion 600 + s-Methoprene 60 VeripHy EC 1 Batch Analysis ??? Oct 2023
Study date
19/10/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295510
Title
Method of Manufacture - Imtrade Fenitrothion 600 + s-Methoprene 60 VeripHy EC Insecticide
Study date
25/10/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295514
Title
Safety Data Sheets
Study date
25/11/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295515
Title
CoA - s-Methoprene Tech
Study date
11/04/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295516
Title
Argument to satisfy AgVet Chemicals Code Act 1994 (Cth) s.14(3) in countering the commercial in confidence aspects of the reference product???s non-protected data
Study date
26/10/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295511
Title
Imtrade Fenitrothion 600 + s-Methoprene 60 VeripHy EC Insecticide Formulation & Supporting Report
Study date
17/11/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295527
Title
Investigation into the Bio-equivalence of IMTRADE LINKAGE?? VeripHy?? GRAIN PROTECTANT to that of FREEZONE SMART GRAIN DUAL INSECTICIDE for the control of Rice Weevil in stored Wheat. ??? One Trial, Kwinana WA.
Study date
04/12/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295528
Title
Investigation into the Bio-equivalence of IMTRADE LINKAGE?? VeripHy?? GRAIN PROTECTANT to that of FREEZONE SMART GRAIN DUAL INSECTICIDE for the control of Rice Weevil in stored Barley. ??? One Trial, Kwinana, WA.
Study date
04/12/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295519
Title
Investigation into the Bio-equivalence of IMTRADE LINKAGE?? 660 VeripHy?? EC GRAIN PROTECTANT to that of FREEZONE SMART GRAIN DUAL INSECTICIDE for the control of Rice Weevil in stored Oats cv. Bannister ??? One Trial, Kwinana WA.
Study date
18/11/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295520
Title
Investigation into the Bio-equivalence of IMTRADE LINKAGE?? 660 VeripHy?? EC GRAIN PROTECTANT to that of FREEZONE SMART GRAIN DUAL INSECTICIDE for the control of Rice Weevil in stored Millet cv. French White ??? One Trial, Kwinana WA.
Study date
18/11/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295521
Title
Investigation into the Bio-equivalence of IMTRADE LINKAGE?? 660 VeripHy?? EC GRAIN PROTECTANT to that of FREEZONE SMART GRAIN DUAL INSECTICIDE for the control of Rust Red Flour Beetle in stored Wheat cv. Scepter ??? One Trial, Kwinana WA.
Study date
18/11/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295522
Title
Investigation into the Bio-equivalence of IMTRADE LINKAGE?? 660 VeripHy?? EC GRAIN PROTECTANT to that of FREEZONE SMART GRAIN DUAL INSECTICIDE for the control of Rust Red Flour Beetle in stored Barley cv. Maximus ??? One Trial, Kwinana WA.
Study date
18/11/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295529
Title
Comments to Support Efficacy and Host Crop Safety data submitted
Study date
02/10/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295517
Title
Investigation into the Host Crop Safety of IMTRADE LINKAGE?? 660 VeripHy?? EC GRAIN PROTECTANT to that of FREEZONE SMART GRAIN DUAL INSECTICIDE as a grain storage treatment applied to Wheat cv. Scepter ??? One Trial, Kwinana WA.
Study date
27/10/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295518
Title
Investigation into the Host Crop Safety of IMTRADE LINKAGE?? 660 VeripHy?? EC GRAIN PROTECTANT to that of FREEZONE SMART GRAIN DUAL INSECTICIDE as a grain storage treatment applied to Barley cv. Maximus ??? One Trial, Kwinana WA.
Study date
27/10/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295523
Title
Investigation into the Host Crop Safety of IMTRADE LINKAGE?? 660 VeripHy?? EC GRAIN PROTECTANT to that of FREEZONE SMART GRAIN DUAL INSECTICIDE as a grain storage treatment applied to Popcorn ??? One Trial, Kwinana, WA
Study date
24/11/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295524
Title
Investigation into the Host Crop Safety of IMTRADE LINKAGE?? 660 VeripHy?? EC GRAIN PROTECTANT to that of FREEZONE SMART GRAIN DUAL INSECTICIDE as a grain storage treatment applied to Sorghum cv. Kalo ??? One Trial, Kwinana WA
Study date
24/11/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295525
Title
Investigation into the Host Crop Safety of IMTRADE LINKAGE?? VeripHy?? GRAIN PROTECTANT to that of FREEZONE SMART GRAIN DUAL INSECTICIDE as a grain storage treatment applied to Oats. ??? One Trial, Kwinana WA.
Study date
08/12/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295526
Title
Investigation into the Host Crop Safety of IMTRADE LINKAGE?? VeripHy?? GRAIN PROTECTANT to that of FREEZONE SMART GRAIN DUAL INSECTICIDE as a grain storage treatment applied to Millet. ??? One Trial, Kwinana WA.
Study date
08/12/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
150472
Product/Active constituent Name
Application Product Name
PAW PURE ANIMAL WELLBEING NUTRIDERM REPLENISHING CONDITIONER
Application Date
Application Number
150472
Application Product Name
PAW PURE ANIMAL WELLBEING NUTRIDERM REPLENISHING CONDITIONER
Application details
Product name:
PAW PURE ANIMAL WELLBEING NUTRIDERM REPLENISHING CONDITIONER
Product number:
91972
Applicant Name:
PAW PET SUPPLEMENT INTERNATIONAL PTY LTD
Application purpose and description of use:
Variation of product registration to extend the shelf life
Active constituents:
Active constituent name
88035 - Colloidal oatmeal
Description of data provided:
Data no
293105
Title
Stability Report-1
Study date
2025
Auth party contact address
A1/35 – 39 Bourke Road Alexandria Australia
Data no
293106
Title
Stability Report-2
Study date
2025
Auth party contact address
A1/35 – 39 Bourke Road Alexandria Australia
Data no
293107
Title
Stability Report-3
Study date
2025
Auth party contact address
A1/35 – 39 Bourke Road Alexandria Australia
Data no
293108
Title
Stability Report-4
Study date
2025
Auth party contact address
A1/35 – 39 Bourke Road Alexandria Australia
Data no
293109
Title
Stability Report-5
Study date
2025
Auth party contact address
A1/35 – 39 Bourke Road Alexandria Australia
Data no
293104
Title
Summary
Study date
2025
Auth party contact address
A1/35 – 39 Bourke Road Alexandria Australia
Date
Application Date
Application No
Application Number
150969
Product/Active constituent Name
Application Product Name
Maroway 10mg/mL injection
Application Date
Application Number
150969
Application Product Name
Maroway 10mg/mL injection
Application details
Product name:
Maroway 10mg/mL injection
Product number:
96856
Applicant Name:
HEADWAY INVESTMENTS PTY LTD
Application purpose and description of use:
Registration of a 10 mg/mL Maropitant injection product for prevention and treatment of vomiting in Dogs and Cats
Reference details:
90801 - Prevomax 10 mg/mL Solution for Injection
Active constituents:
Active constituent name
94371 - Maropitant
Description of data provided:
Data no
295754
Title
Finished Product Specifications
Study date
Oct 2025
Auth party contact address
2 Kippax St GREYSTANES Australia
Data no
295755
Title
Overseas GMP Compliance letter1
Study date
Nov 2025
Auth party contact address
2 Kippax St GREYSTANES Australia
Data no
295756
Title
Overseas GMP Compliance letter-2
Study date
Nov 2025
Auth party contact address
2 Kippax St GREYSTANES Australia
Date
Application Date
Application No
Application Number
150561
Product/Active constituent Name
Application Product Name
Swan Chlorpyrifos 500 Insecticide
Application Date
Application Number
150561
Application Product Name
Swan Chlorpyrifos 500 Insecticide
Application details
Product name:
Swan Chlorpyrifos 500 Insecticide
Product number:
96274
Applicant Name:
SWAN CHEMICAL HOLDINGS PTY LTD
Application purpose and description of use:
Variation of product registration to amend the product registration.
Reference details:
94481 - Agro-Essence Chlorpyrifos 500 Insecticide
Active constituents:
Active constituent name
62025 - CHLORPYRIFOS
Date
Application Date
Application No
Application Number
150642
Product/Active constituent Name
Application Product Name
Safex Pyroxasulfone 850 WG Herbicide
Application Date
Application Number
150642
Application Product Name
Safex Pyroxasulfone 850 WG Herbicide
Application details
Product name:
Safex Pyroxasulfone 850 WG Herbicide
Product number:
96777
Applicant Name:
SAFEX CHEMICALS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 850 g/kg pyroxasulfone water dispersible granule (WG) product for Pre-Emergence Control of Annual Ryegrass, Barley Grass, Annual Phalaris, Silver Grass and Toad Rush and Suppression of Certain Grass Weeds in Wheat (not Durum Wheat), Triticale and Certain Winter Legume Crops.
Reference details:
63998 - SAKURA 850 WG HERBICIDE
Active constituents:
Active constituent name
96410 - pyroxasulfone
Description of data provided:
Data no
295748
Title
DETERMINATION OF ACCELERATED STORAGE STABILITY AND CORROSION CHARACTERISTICS OF ???PYROXASULFONE 85% WG???
Study date
21 July 2025
Auth party contact address
Unit 903 50 Clarence Street SYDNEY Australia
Data no
295749
Title
A Method for Manufacturing a water-dispersible Granules PYROXASULFONE 85% WG
Study date
July 2025
Auth party contact address
Unit 903 50 Clarence Street SYDNEY Australia
Data no
295750
Title
Pyroxasufonre 850
Study date
15 May 2025
Auth party contact address
Unit 903 50 Clarence Street SYDNEY Australia
Data no
295751
Title
Pyroxasulfone 850 WG - DoC
Study date
23 September 2025
Auth party contact address
Unit 903 50 Clarence Street SYDNEY Australia
Data no
295752
Title
Excipient - SDSs
Study date
2025
Auth party contact address
Unit 903 50 Clarence Street SYDNEY Australia
Date
Application Date
Application No
Application Number
150359
Product/Active constituent Name
Application Product Name
Indaziflam
Application Date
Application Number
150359
Application Product Name
Indaziflam
Application details
Product name:
Indaziflam
Active name:
Indaziflam
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Approval of new Indaziflam technical from Agan Ltd source for use in agricultural chemical product Endurance 500SC (500g/L Indaziflam).
Description of data provided:
Data no
294403
Title
INDAZIFLAM technical ??? methods validation of analytical methods for active constituents and product of 5 batches analysis. Study report no: K1035/LL. Sponsor reference number: 000119518.
Study date
14.06.2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294397
Title
INDAZIFLAM technical ??? methods validation of analytical methods for active constituents and product of 5 batches analysis. Study report no: K1012/LL. Sponsor reference number: 000119514.
Study date
14.06.2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294400
Title
INDAZIFLAM technical ??? methods validation of analytical methods for active constituents and product of 5 batches analysis. Study report no: K1024/LL. Sponsor reference number: 000119519
Study date
14.06.2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294404
Title
Statement on the batch size of INDAZIFLAM TECHNICAL, Study report no. 000119519
Study date
May 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294396
Title
Indaziflam (TMSCl)_Specification signed copy
Study date
Sep 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294402
Title
INDAZIFLAM technical ???Product identity, composition and analysis. Study report no: 000120291
Study date
May 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294398
Title
Manufacturing Process ??? INDAZIFLAM Technical. Study Sponsor No.: 000120479.
Study date
May 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294399
Title
Certificate of Analysis (CoA) - INDAZIFLAM technical batch P-487.
Study date
May 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294394
Title
Part 2 - Chemistry and Manufacture
Study date
25 Sep 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294395
Title
INDAZIFLAM Technical Safety Data Sheet.
Study date
May 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294401
Title
GLP Certificate of Analysis (CoA) - INDAZIFLAM technical batch P-444.
Study date
08.05.2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294405
Title
UV_Vis absorption spectra of Indaziflam technical batch P-221, Study report no/; K1038/LL, Sponsor reference number: 000119966
Study date
13.05.2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294406
Title
Bulk density determinaion of Indaziflam technical batch P-221, Study report no/; K1039/LL, Sponsor reference number: 000119968
Study date
13.05.2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294407
Title
Determination of partition coefficient (n-Octanol/water) of Indaziflam technical batch P-221by HPLC method, Study report no/; K1040/LL, Sponsor reference number: 000119516
Study date
13.05.2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294408
Title
Melting point determination of Indaziflam batch P-221, Study report no/; K1037/LL, Sponsor reference number: 000119967
Study date
13.05.2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294409
Title
Water solubility determination of Indaziflam technical batch P-221, Study report no/; K1036/LL, Sponsor reference number: 000119517
Study date
13.05.2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294410
Title
Determination of dissociation constant of Indaziflam technical batch P-221, Study report no/; K1041/LL, Sponsor reference number: 000119515
Study date
13.05.2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294411
Title
Vapour pressure of Indaziflam technical, Study report no/; 24A-0813, Sponsor reference number: 000119736
Study date
4 June 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294412
Title
Oxidation Reduction study of Indaziflam technical, Study report no/; R C4241, Sponsor reference number: 000119726
Study date
22 May 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294413
Title
Raw materials sds combined.
Study date
May 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294414
Title
Bacterial Reverse Mutation Test of INDAZIFLAM Technical of P-444 batch using Salmonella typhimurium, Charles river, Study no. 000119468
Study date
25 Mar 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294415
Title
In silico genotoxicity, carcinogenicity, reproductive toxicity and skin sensitisation assessment of Indaziflam and nine impurities, Study no. 000120517.
Study date
15 May 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294416
Title
Ames - An in vitro Micronucleus Assay with Indaziflam technical batch P-444 in Cultured Peripheral Human Lymphocytes, Study no. 000119469
Study date
23 Mar 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294433
Title
Dermal Tox Waiver Request Indaziflam tech 000120466 (US only)
Study date
5 May 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294426
Title
INDAZIFLAM technical: An Acute Irritation Study of Indaziflam Technical by Ocular Administration in Rabbits. Sponsor Reference Number 000119414.
Study date
2 June 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294425
Title
INDAZIFLAM technical: An Acute Inhalation Study of Indaziflam Technical in CD (Sprague Dawley) IGS Rats. Sponsor Reference Number 000119411.
Study date
9 May 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294424
Title
INDAZIFLAM technical: An Acute Toxicity Study of Indaziflam Technical by Oral Gavage in Rats. Sponsor Reference Number 000119413.
Study date
2 June 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294419
Title
INDAZIFLAM: In silico genotoxicity, carcinogenicity, reproductive toxicity and skin sensitisation assessment of Indaziflam and nine impurities. Sponsor Reference Number 000120517.
Study date
22 July 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294420
Title
INDAZIFLAM: Evaluation of the Mutagenic Activity of Indaziflam technical in the Salmonella typhimurium Reverse Mutation Assay. Sponsor Reference Number 000119468.
Study date
25 March 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294423
Title
INDAZIFLAM technical: An Acute Dermal Irritation Study of Indaziflam technical in New Zealand White Rabbits. Sponsor Reference Number 000119410.
Study date
20 Mar 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294422
Title
INDAZIFLAM technical: A Skin Sensitization Test (Local Lymph Node Assay) of Indaziflam tech.in the Mouse, amendment 1. Sponsor Reference Number 000119415.
Study date
28 Apr 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294421
Title
INDAZIFLAM technical: An in vitro Micronucleus Assay with Indaziflam technical in Cultured Peripheral Human Lymphocytes. Sponsor Reference Number 000119469.
Study date
13 June 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294427
Title
INDAZIFLAM technical: Indaziflam: Statement on the toxicological properties of impurities cited in a new technical specification for Indaziflam. Sponsor Reference Number 000120592.
Study date
20 Mar 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294428
Title
INDAZIFLAM technical: GLP certificate of analysis. Sponsor Reference Number K10124/LL.
Study date
23 May 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294429
Title
Public document-APVMA Indaziflam technical public release summary
Study date
November 2015
Auth party contact address
-
Data no
294430
Title
Public document - US EPA Indaziflam technical toxicity page 1-50
Study date
26 July 2010
Auth party contact address
-
Data no
294431
Title
Indaziflam TS tox statement 20250722 - 250725
Study date
26 July 2010
Auth party contact address
-
Data no
294432
Title
Indaziflam TS tox statement 20250722 - 250725
Study date
22 July 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294417
Title
Part 3- Toxicology health
Study date
25 Sep 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294418
Title
INDAZIFLAM Technical Safety Data Sheet.
Study date
29 May 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
294434
Title
Raw Materials SDS combined
Study date
17 July 2018
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date
Application Date
Application No
Application Number
150617
Product/Active constituent Name
Application Product Name
QA Propyzamide 500 SC Herbicide
Application Date
Application Number
150617
Application Product Name
QA Propyzamide 500 SC Herbicide
Application details
Product name:
QA Propyzamide 500 SC Herbicide
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 500 g/L Propyzamide,suspension concentrate for selective control of certain grasses and broad leaf weeds in Lettuce, Sports Turf, Home Lawns and Legumes Seed Crops and Pastures, as per the Direction for Use
Date
Application Date
Application No
Application Number
150619
Product/Active constituent Name
Application Product Name
QA Flumioxazin 500 WG Herbicide
Application Date
Application Number
150619
Application Product Name
QA Flumioxazin 500 WG Herbicide
Application details
Product name:
QA Flumioxazin 500 WG Herbicide
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 500 g/kg Flumioxazin, Water disperse for the control of fungal diseases on Macadamia Nuts, Chickpeas, Faba Beans, Lentils and Vetch, as per the Directions for Use Table.
Date
Application Date
Application No
Application Number
150620
Product/Active constituent Name
Application Product Name
Quantum Prosulfocarb 800 EC Herbicide
Application Date
Application Number
150620
Application Product Name
Quantum Prosulfocarb 800 EC Herbicide
Application details
Product name:
Quantum Prosulfocarb 800 EC Herbicide
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 800 g/L PROSULFOCARB, emulsifiable concentrate for the control of f Annual Ryegrass (Lolium rigidum) and other grass and broadleaf weeds in Barley and Wheat as specified in the Directions for Use Table
Date
Application Date
Application No
Application Number
150621
Product/Active constituent Name
Application Product Name
QA Wetter 600
Application Date
Application Number
150621
Application Product Name
QA Wetter 600
Application details
Product name:
QA Wetter 600
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 600g/L Nonyl Phenol Ethylene oxide condensate for tuse with insecticides, fungicides and herbicides
Date
Application Date
Application No
Application Number
150622
Product/Active constituent Name
Application Product Name
ESCALATE 500 SC COTTON DEFOLIANT
Application Date
Application Number
150622
Application Product Name
ESCALATE 500 SC COTTON DEFOLIANT
Application details
Product name:
ESCALATE 500 SC COTTON DEFOLIANT
Product number:
55126
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product Escalate 500 SC Cotton Defoliant (500 g/L THIDIAZURON) application (APVMA no. 55126) to amend the adjuvant in the Directions for Use table.
Active constituents:
Active constituent name
54251 - THIDIAZURON
Active constituent name
44129 - THIDIAZURON
Description of data provided:
Data no
295650
Title
Draft Escalate 500SC Cotton Defoliant label
Study date
15 Oct 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date
Application Date
Application No
Application Number
150624
Product/Active constituent Name
Application Product Name
QA Propiconazole 625 EC Fungicide
Application Date
Application Number
150624
Application Product Name
QA Propiconazole 625 EC Fungicide
Application details
Product name:
QA Propiconazole 625 EC Fungicide
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 625 g/L Propiconazole, emulsifiable concentrate for the control of certain fungal diseases of Bananas, Peanuts, Perennial Ryegrass, Pineapples, Stone Fruit, Sugar Cane, Turf, Wheat and other crops in certain states as
specified in the DIRECTIONS FOR USE.