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
151609
Product/Active constituent Name
Application Product Name
Gnaw Rodenticide
Application Date
Application Number
151609
Application Product Name
Gnaw Rodenticide
Application details
Product name:
Gnaw Rodenticide
Product number:
94661
Applicant Name:
SYNERGENTIS PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to extend the pack size range and copy claims from a reference product.
Reference details:
94575 - Surefire Cholecal Blocks Rodenticide
Active constituents:
Active constituent name
94872 - Cholecalciferol
Description of data provided:
Data no
300369
Title
Selontra Soft Bait Rodenticide
Study date
2019
Auth party contact address
-
Data no
300370
Title
Surefire Cholecal Blocks Rodenticide
Study date
2025
Auth party contact address
-
Data no
300368
Title
Consent for use of protected information
Study date
13/11/2025
Auth party contact address
4 Satellite Street COORPAROO Australia
Date
Application Date
Application No
Application Number
151653
Product/Active constituent Name
Application Product Name
Sedaxane
Application Date
Application Number
151653
Application Product Name
Sedaxane
Application details
Product name:
Sedaxane
Active name:
Sedaxane
Applicant Name:
KINGTAI CHEMICALS CO., LIMITED
Application purpose and description of use:
Approval of Sedaxane for use in agricultural chemical products.
Description of data provided:
Data no
300486
Title
Part 2 - Chemistry
Study date
January 7, 2026
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
300484
Title
Declaration of Composition
Study date
January 7, 2026
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
300485
Title
Five batch analysis of Sedaxane Technical
Study date
January 7, 2026
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
300483
Title
The Manufacturing Process of Sedaxane Technical
Study date
January 7, 2026
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Date
Application Date
Application No
Application Number
151667
Product/Active constituent Name
Application Product Name
Picoflex 430 Herbicide
Application Date
Application Number
151667
Application Product Name
Picoflex 430 Herbicide
Application details
Product name:
Picoflex 430 Herbicide
Product number:
95280
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product label approval to make various corrections and minor amendments.
Reference details:
95280 - Picoflex 430 Herbicide
Active constituents:
Active constituent name
83588 - Picloram
Description of data provided:
Data no
300618
Title
PICOFLEX 430 Herbicide Protection Statements
Study date
20 January 2026
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
300615
Title
Executive Summary and Justification of Label Amendments
Study date
20 January 2026
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
300616
Title
PICOFELX 430 Herbicide Approved RLP Markup
Study date
23 December 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
300617
Title
PICOFLEX 430 Herbicide Draft Text Label Track Changes
Study date
20 January 2026
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date
Application Date
Application No
Application Number
151664
Product/Active constituent Name
Application Product Name
Rifaway Fire Ant Bait
Application Date
Application Number
151664
Application Product Name
Rifaway Fire Ant Bait
Application details
Product name:
Rifaway Fire Ant Bait
Product number:
94840
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration for minor formulation change.
Active constituents:
Active constituent name
51669 - INDOXACARB AND ITS R-ENANTIOMER (DPX-MP062) MANUFACTURING CONCENTRATE
Description of data provided:
Data no
300607
Title
MINOR CHANGE TO INDOXACARB 0.045 RB FORMULATION
Study date
19 August 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300608
Title
BICON Permit
Study date
14 February 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
151188
Product/Active constituent Name
Application Product Name
N-octyl bicycloheptene dicarboximide
Application Date
Application Number
151188
Application Product Name
N-octyl bicycloheptene dicarboximide
Application details
Product name:
N-octyl bicycloheptene dicarboximide
Active name:
N-octyl bicycloheptene dicarboximide
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of n-octyl bicycloheptene dicarboximide (MGK 264) for use in veterinary chemical products.
Description of data provided:
Data no
298786
Title
Notice of variation to an approved active constituent
Study date
10 April 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
298785
Title
Certificates of Analysis
Study date
November 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date
Application Date
Application No
Application Number
151333
Product/Active constituent Name
Application Product Name
Pyrimethanil
Application Date
Application Number
151333
Application Product Name
Pyrimethanil
Application details
Product name:
Pyrimethanil
Active name:
Pyrimethanil
Applicant Name:
India Pesticides Limited
Application purpose and description of use:
Approval of pyrimethanil for use in agricultural chemical products.
Description of data provided:
Data no
300572
Title
Part 2 Chemistry and Manufacturing
Study date
2025
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
300575
Title
Declaration of Composition (DoC) of Pyrimethanil
Study date
2025
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
300576
Title
Certificates of Analysis (COA) Technical and Reference Standards
Study date
2024
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
300573
Title
Manufacturing Process for Pyrimethanil Technical
Study date
2025
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
300574
Title
Validation Of Analytical Method, Determination Of Active Ingredient And Impurities In Five Batches Of Pyrimethanil Technical
Study date
2025
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
300577
Title
Pyrimethanil MATERIAL SAFETY DATA SHEET
Study date
2025
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Date
Application Date
Application No
Application Number
151626
Product/Active constituent Name
Application Product Name
Haloxyfop-P-methyl
Application Date
Application Number
151626
Application Product Name
Haloxyfop-P-methyl
Application details
Product name:
Haloxyfop-P-methyl
Active name:
Haloxyfop-P-methyl
Applicant Name:
LEAD CHEMICAL CO., LTD.
Application purpose and description of use:
Approval of Haloxyfop-P-methyl for use in agricultural chemical products.
Description of data provided:
Data no
300409
Title
Preliminary Analysis and Enforcement Analytical Methods of Haloxyfop-P-methyl Technical
Study date
11 August, 2025
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300403
Title
Haloxyfop-P-methyl Chemistry And Manufacture
Study date
December 25, 2025
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300406
Title
Preliminary Analysis and Enforcement Analytical Methods of Haloxyfop-P-methyl Technical
Study date
11 August, 2025
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300407
Title
Preliminary Analysis and Enforcement Analytical Methods of Haloxyfop-P-methyl Technical
Study date
11 August, 2025
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300410
Title
Declaration Letter
Study date
December 25, 2025
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300404
Title
Manufacturing Process and Genesis of Impurities for Haloxyfop-P-methyl Technical
Study date
December 25, 2025
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300405
Title
Declaration of Composition
Study date
December 25, 2025
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300408
Title
Preliminary Analysis and Enforcement Analytical Methods of Haloxyfop-P-methyl Technical
Study date
11 August, 2025
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Date
Application Date
Application No
Application Number
151652
Product/Active constituent Name
Application Product Name
IMTRADE ENVIROPINK GB MOLLUSCICIDE
Application Date
Application Number
151652
Application Product Name
IMTRADE ENVIROPINK GB MOLLUSCICIDE
Application details
Product name:
IMTRADE ENVIROPINK GB MOLLUSCICIDE
Product number:
97055
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 120g/kg IRON EDTA COMPLEX granular bait for the control of certain Snails and Slugs in a range of Agricultural and Horticultural situations as specified in the Directions for Use table.
Reference details:
90221 - 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT
Description of data provided:
Data no
300472
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Prietocella barbara) in a native pasture and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Kangarilla, South Australia.
Study date
18/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300466
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Prietocella barbara) in Faba Beans cv. Samira and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Malinong, South Australia.
Study date
29/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300458
Title
Investigation into the Equivalency of IMTRADE ENVIROPINK?? GB MOLLUSCICIDE to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT for the control of Small Pointed Snails (Cochlicella Barbara). - One Trial, Kwinana, Western Australia.
Study date
24/04/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300452
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Conical Snails. - One Trial, Kwinana, Western Australia.
Study date
27/09/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300469
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails (Cernuella virgata) in a garden setting and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Kangarilla, South Australia.
Study date
10/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300446
Title
Imtrade FeNa-EDTA (Iron Chelate) 120 Bait 1 Batch Analysis ??? August 2024
Study date
08/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300449
Title
CoA - FeNa-EDTA (iron chelate)
Study date
20/11/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300455
Title
Investigation into the Equivalency of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT for the control of Common White Snails. - One Trial, Kwinana, Western Australia.
Study date
28/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300447
Title
Imtrade FeNa-EDTA (Iron Chelate)120 Bait Method Validation ??? August 2024
Study date
08/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300470
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Prietocella barbara) in a garden setting and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Kangarilla, South Australia.
Study date
15/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300464
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Prietocella barbara) in Lentils cv. Thunder and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Wasleys, South Australia.
Study date
05/01/2026
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300450
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
03/09/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300444
Title
Method of Manufacture ??? Imtrade Enviropink (FeNa-EDTA (iron chelate) 120g/kg) GB Molluscicide
Study date
29/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300467
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails (Cernuella virgata) in Chickpeas cv. Kalkee and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Serviceton, Victoria.
Study date
22/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300473
Title
Comments to Support Efficacy and Host Crop Safety data submitted
Study date
12/01/2026
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300461
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails (Cernuella virgata) in Canola cv. 44y94 and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Woodchester, South Australia.
Study date
08/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300453
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Garden Snails. - One Trial, Kwinana, Western Australia.
Study date
06/12/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300445
Title
Formulation and Stability Report - Imtrade Enviropink (FeNa-EDTA (iron chelate) 120g/kg) GB Molluscicide
Study date
29/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300468
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Prietocella barbara) in Chickpeas cv. Kalkee and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Serviceton, Victoria.
Study date
24/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300462
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Prietocella barbara) in Canola cv. 44y94 and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Woodchester, South Australia.
Study date
24/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300456
Title
Investigation into the Equivalency of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT for the control of Conical Snails. - One Trial, Kwinana, Western Australia.
Study date
27/11/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300448
Title
Safety Data Sheets
Study date
29/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300465
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails (Cernuella virgata) in Faba Beans cv. Samira and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Malinong, South Australia.
Study date
22/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300459
Title
Investigation into the Equivalency of IMTRADE ENVIROPINK?? GB MOLLUSCICIDE to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT for the control of Common White Snails (Cernuella virgata) in a commercial Canola cv. Bonito crop. - One Trial, Kwinana, Western Australia.
Study date
26/08/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300474
Title
Reference Material for Comments to Support Efficacy & HCS Data submitted
Study date
2002
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300460
Title
Investigation into the equivalency of IMTRADE ENVIROPINK?? GB MOLLUSCICIDE to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT for the control of Small Pointed Snails (Cochlicella Barbara) in a commercial Canola cv. Bonito crop. - One Trial, Kwinana, Western Australia.
Study date
11/08/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300454
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Cochlicella Barbara). - One Trial, Kwinana, Western Australia.
Study date
08/04/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300471
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails (Cernuella virgata) in a native pasture and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Kangarilla, South Australia.
Study date
10/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300457
Title
Investigation into the Equivalency of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT for the control of Garden Snails. - One Trial, Kwinana, Western Australia.
Study date
23/12/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300463
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails (Cernuella virgata) in Lentils cv. Thunder and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Wasleys, South Australia.
Study date
23/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300451
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails. - One Trial, Kwinana, Western Australia.
Study date
16/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
151575
Product/Active constituent Name
Application Product Name
Conquest Vipyr 250 EC Fungicide
Application Date
Application Number
151575
Application Product Name
Conquest Vipyr 250 EC Fungicide
Application details
Product name:
Conquest Vipyr 250 EC Fungicide
Product number:
87896
Applicant Name:
CONQUEST CROP PROTECTION PTY LTD
Application purpose and description of use:
Modify the direction for use for in the current Conquest Vipyr Fungicide label
Reference details:
62753 - OPERA FUNGICIDE
67073 - CONQUEST EPOXIGUARD 125 FUNGICIDE
85527 - SOPRANO 500 FUNGICIDE
Active constituents:
Active constituent name
83671 - pyraclostrobin
Description of data provided:
Data no
300203
Title
(01) - Efficacy and Crop Safety Overview ??? Conquest Vipyr 250 EC
Study date
Nov 2025
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300206
Title
(04) ??? Appendix 8.3 ??? Efficacy and crop safety
Study date
Dec 2024
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300207
Title
(05) ??? Appendix 8.4 ??? Efficacy and crop safety
Study date
Jan 2025
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300204
Title
(02) ??? Appendix 8.1 ??? draft label with comments
Study date
Dec 2025
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300205
Title
(03) ??? Appendix 8.2 ??? Efficacy and crop safety
Study date
Feb 2025
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Date
Application Date
Application No
Application Number
151642
Product/Active constituent Name
Application Product Name
FLUPROX SOLUBLE LIQUID HERBICIDE
Application Date
Application Number
151642
Application Product Name
FLUPROX SOLUBLE LIQUID HERBICIDE
Application details
Product name:
FLUPROX SOLUBLE LIQUID HERBICIDE
Applicant Name:
ABBEY LABORATORIES PTY LTD
Application purpose and description of use:
Registration of a Fluprox Soluble Liquid Herbicide containing Flupropanate (as sodium salt).
Date
Application Date
Application No
Application Number
151643
Product/Active constituent Name
Application Product Name
BroadBlitz 800 Herbicide
Application Date
Application Number
151643
Application Product Name
BroadBlitz 800 Herbicide
Application details
Product name:
BroadBlitz 800 Herbicide
Product number:
80294
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Variation of product registration to add smaller pack sizes and variation of the product label to add details from the reference product label.
Reference details:
40714 - BROADSTRIKE HERBICIDE
Active constituents:
Active constituent name
69465 - FLUMETSULAM
Description of data provided:
Data no
300477
Title
Nominated agent letter
Study date
16 Jan 2026
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
151465
Product/Active constituent Name
Application Product Name
Ulti-Mate Intravaginal Device
Application Date
Application Number
151465
Application Product Name
Ulti-Mate Intravaginal Device
Application details
Product name:
Ulti-Mate Intravaginal Device
Product number:
95688
Applicant Name:
AGILIS INTERNATIONAL LIMITED
Application purpose and description of use:
Variation of product registration to relevant particulars.
Active constituents:
Active constituent name
95689 - Progesterone
Description of data provided:
Data no
298780
Title
Stability
Study date
2025
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
298781
Title
Certificate of analysis
Study date
2025
Auth party contact address
325 Pages Road Timaru New Zealand
Date
Application Date
Application No
Application Number
151625
Product/Active constituent Name
Application Product Name
Garden Basics Weed Kill Concentrate HG
Application Date
Application Number
151625
Application Product Name
Garden Basics Weed Kill Concentrate HG
Application details
Product name:
Garden Basics Weed Kill Concentrate HG
Applicant Name:
PINEGRO PRODUCTS PROPRIETARY LIMITED
Application purpose and description of use:
Registration of a 100 g/L glyphosate (present as the isopropylamine salt) soluble concentrate product for the control of weeds in the home garden.
Date
Application Date
Application No
Application Number
151628
Product/Active constituent Name
Application Product Name
SUREFIRE BROMA GRAIN BAIT RODENTICIDE
Application Date
Application Number
151628
Application Product Name
SUREFIRE BROMA GRAIN BAIT RODENTICIDE
Application details
Product name:
SUREFIRE BROMA GRAIN BAIT RODENTICIDE
Product number:
67142
Applicant Name:
PCT HOLDINGS PTY LTD
Application purpose and description of use:
Variation of product registration to comply with Rodenticide Chemical Review outcome requirements for formulation composition.
Reference details:
64850 - SUREFIRE BROMA PELLETS RODENTICIDE
Active constituents:
Active constituent name
47790 - BROMADIOLONE MANUFACTURING CONCENTRATE
Description of data provided:
Data no
300443
Title
Certificate of analysis
Study date
18/03/2022
Date
Application Date
Application No
Application Number
151654
Product/Active constituent Name
Application Product Name
F.S.A. Saflufenacil 700 WG Herbicide
Application Date
Application Number
151654
Application Product Name
F.S.A. Saflufenacil 700 WG Herbicide
Application details
Product name:
F.S.A. Saflufenacil 700 WG Herbicide
Applicant Name:
FOUR SEASONS AGRIBUSINESS PTY LTD
Application purpose and description of use:
Registration of a 700 g/kg water dispersible granule formulation of saflufenacil for the control of a range of broadleaf weeds prior to establishment of crops and
forestry plantations, fallows, established citrus, pome and almond orchards, and around commercial, industrial, and agricultural buildings and yards, harvest-aid application in pulse crops, and late application in cereals; as per the DIRECTIONS FOR USE table.
Date
Application Date
Application No
Application Number
151655
Product/Active constituent Name
Application Product Name
F.S.A. Aminopyralid 240 SL Herbicide
Application Date
Application Number
151655
Application Product Name
F.S.A. Aminopyralid 240 SL Herbicide
Application details
Product name:
F.S.A. Aminopyralid 240 SL Herbicide
Applicant Name:
FOUR SEASONS AGRIBUSINESS PTY LTD
Application purpose and description of use:
Registration of a 240 g/L soluble liquid formulation of aminopyralid For control of black bindweed/climbing buckwheat in wheat and barley.
Date
Application Date
Application No
Application Number
150207
Product/Active constituent Name
Application Product Name
Mirtazapine
Application Date
Application Number
150207
Application Product Name
Mirtazapine
Application details
Product name:
Mirtazapine
Product number:
96640
Applicant Name:
DECHRA REGULATORY B.V.
Application purpose and description of use:
Registration of a 20 mg/g mirtazapine ointment product for cats for body weight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions, in conjunction with approval of mirtazapine.
Description of data provided:
Data no
293473
Title
General Information
Study date
2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292122
Title
Mirtazapine
Study date
09 May 2025
Auth party contact address
-
Data no
293479
Title
Packaging
Study date
2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293476
Title
Impurities
Study date
2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293477
Title
Control of the Drug Substance
Study date
2018
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292123
Title
Mirtazapine certificates of analysis
Study date
March 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293474
Title
Method of Manufacture
Study date
2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293480
Title
Stability
Study date
2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293471
Title
Certificate of Analysis
Study date
6 March 2018
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293475
Title
Structure Elucidation and Confirmation
Study date
2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
300144
Title
Restricted DMF
Study date
2025
Data no
293472
Title
Certificate of Analysis
Study date
27 August 2019
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293469
Title
Certificate of Analysis
Study date
28 July 2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292124
Title
Mirtazapine residual solvents test method and validation
Study date
20 June 2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293481
Title
Drug Substance Specification
Study date
2 July 2018
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
294323
Title
Open DMF
Study date
2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293470
Title
Certificate of Analysis
Study date
17 December 2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293478
Title
Reference Standards
Study date
2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
300145
Title
Letter of Access
Study date
7 November 2025
Date
Application Date
Application No
Application Number
150208
Product/Active constituent Name
Application Product Name
Mirataz Transdermal Ointment for Cats
Application Date
Application Number
150208
Application Product Name
Mirataz Transdermal Ointment for Cats
Application details
Product name:
Mirataz Transdermal Ointment for Cats
Product number:
96641
Applicant Name:
DECHRA REGULATORY B.V.
Application purpose and description of use:
Registration of a 20 mg/g mirtazapine ointment product for cats for body weight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions, in conjunction with approval of mirtazapine.
Description of data provided:
Data no
300140
Title
Raw Material Specification RMS A1701
Study date
24 September 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292308
Title
Mirtazapine may be useful in treating nausea and insomnia of cancer chemotherapy
Study date
2001
Auth party contact address
-
Data no
292320
Title
kb119
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292268
Title
Excipient 4 SDS
Study date
23 January 2025
Auth party contact address
-
Data no
292314
Title
Effects of risperidone treatment on the expression of hypothalamic neuropeptide in appetite regulation in Wistar rats
Study date
2015
Auth party contact address
-
Data no
292214
Title
Declaration of Compliance
Study date
20 November 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292231
Title
Laboratory Study: Randomized, Multi-dose Pharmacokinetics, Pharmacodynamics, and Tolerance Study of Two Doses of Mirtazapine Administered Topically (Transdermally) to Adult Cats
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292208
Title
Stability Protocol TN:24-066
Study date
15 May 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292274
Title
KB100PK
Study date
2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292225
Title
Pharmacokinetics of mirtazapine and its main metabolites in Beagle dogs: A pilot study
Study date
2012
Auth party contact address
-
Data no
292202
Title
Certificates of Analysis
Study date
August 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292251
Title
Mirtazapine exposure in pregnancy and foetal safety: A nationwide cohort study
Study date
2022
Auth party contact address
-
Data no
292300
Title
Stahl's essential psychopharmacology: neuroscientific basis and practical applications a
Study date
2008
Auth party contact address
-
Data no
292245
Title
A Pilot Laboratory Safety Study of 2% Mirtazapine Ointment Administered Topically (Transdermally) to Adult Cats at 5x the Target Therapeutic Dosage
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292294
Title
Megestrol Acetate and Mirtazapine for the Treatment of Unplanned Weight Loss in the Elderly
Study date
2009
Auth party contact address
-
Data no
292237
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292288
Title
Drug exposure and clinical effect of transdermal mirtazapine in healthy young cats: a pilot study
Study date
2016
Auth party contact address
-
Data no
292194
Title
GMP Inspection Report
Study date
2 April 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292265
Title
Excipient 1 SDS
Study date
20 February 2017
Auth party contact address
-
Data no
292217
Title
Certificate of Test
Study date
07 June 2023
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
300143
Title
Justification of System Suitability Criteria
Study date
02 September 2020
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292271
Title
Excipient 7 SDS
Study date
15 November 2017
Auth party contact address
-
Data no
292211
Title
Validation of Stability indicating Assay for Quantification of Mirtazapine and its Degradants in KIN010 Topical Ointment.
Study date
14 January 2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292317
Title
kb110pk
Study date
2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292257
Title
Mirtazapine fatal poisoning
Study date
2017
Auth party contact address
-
Data no
292311
Title
Ghrelin and leptin pathophysiology in chronic kidney disease
Study date
2013
Auth party contact address
-
Data no
292277
Title
Study KB111PK
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292205
Title
Freeze Thaw Results
Study date
23 September 2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292254
Title
SSRI and SNRI use during pregnancy and the risk of persistent pulmonary hypertension of the newborn
Study date
2017
Auth party contact address
-
Data no
292297
Title
The Pharmacologic Profile of Mirtazapine
Study date
1996
Auth party contact address
-
Data no
292228
Title
The Pharmacokinetics of Mirtazapine in Cats with Chronic Kidney Disease and In Age-Matched Control Cats
Study date
2011
Auth party contact address
-
Data no
292248
Title
Molecular Consequences of Depression Treatment: A Potential In Vitro Mechanism for Antidepressants-Induced Reprotoxic Side Effects
Study date
2021
Auth party contact address
-
Data no
292234
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292191
Title
Chemistry and Manufacture
Study date
August 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292291
Title
Study KB104P
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292289
Title
Evaluation of Weight Loss Over Time in Cats with Chronic Kidney Disease
Study date
2016
Auth party contact address
-
Data no
292266
Title
Excipient 2 SDS
Study date
21 November 2020
Auth party contact address
-
Data no
292243
Title
Pfizer product monograph (mirtazapine orally disintegrating tablets 15 mg, 30 mg, and 45 mg)
Study date
2012
Auth party contact address
-
Data no
292220
Title
Toxicology
Study date
June 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292197
Title
Excipient monographs and certificates of analysis
Study date
July 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292212
Title
Method Validation of BHT in KIN010 Topical Ointment, 2%
Study date
20 October 2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292260
Title
The Rat - Drug Metabolism
Study date
2016
Auth party contact address
-
Data no
292272
Title
kb119
Study date
26 September 2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292306
Title
Efficacy of mirtazapine in preventing intrathecal morphine-induced nausea and vomiting after orthopaedic surgery
Study date
2010
Auth party contact address
-
Data no
292312
Title
5-HT2C Receptor Agonists and the Control of Appetite
Study date
2012
Auth party contact address
-
Data no
292206
Title
Photostability Results
Study date
23 September 2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292229
Title
Drug exposure and clinical effect of transdermal mirtazapine in healthy young cats: a pilot study
Study date
2016
Auth party contact address
-
Data no
292280
Title
KB115T part c
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292249
Title
Exposure to Mirtazapine During Pregnancy: A Prospective, Comparative Study of Birth Outcomes
Study date
2006
Auth party contact address
-
Data no
292323
Title
kb118
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292200
Title
Topical and Transdermal Drug Products - Product Quality Tests
Study date
12 May 2025
Auth party contact address
-
Data no
292286
Title
KB115T part i
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292292
Title
Mirtazapine toxicity in cats: retrospective study of 84 cases (2006, 2011)
Study date
2016
Auth party contact address
-
Data no
300141
Title
Raw material method RMM A1701
Study date
26 September 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292223
Title
Mirtazapine - a Review of its Pharmacology and Therapeutic Potential in the Management of Major Depression
Study date
1996
Auth party contact address
-
Data no
292269
Title
Excipient 5 SDS
Study date
18 March 2021
Auth party contact address
-
Data no
292209
Title
Stability Summary Tables
Study date
May 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292309
Title
Low-dose mirtazapine may be successful treatment option for severe nausea and vomiting
Study date
2006
Auth party contact address
-
Data no
292315
Title
Involvement of hypothalamic histamine H1 receptor in the regulation of feeding rhythm and obesity
Study date
2004
Auth party contact address
-
Data no
292263
Title
Work Health and Safety
Study date
June 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292232
Title
A Laboratory, Randomized, Cross-Over Pharmacokinetic Study of Orally and Topically (Transdermal) Administered Mirtazapine 2% Ointment in Adult Cats
Study date
2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292203
Title
Part 2F2
Study date
26 March 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292303
Title
Pharmacological appetite stimulation - rational choices in the inappetent cat
Study date
2014
Auth party contact address
-
Data no
292252
Title
Mirtazapine in pregnancy and lactation: A systematic review of adverse outcomes
Study date
2025
Auth party contact address
-
Data no
292326
Title
ACOG Guidelines on Psychiatric Medication Use during Pregnancy and Lactation
Study date
2008
Auth party contact address
-
Data no
292226
Title
Pharmacokinetics of Mirtazapine and its Main Metabolites after Single Oral Administration in Fasting/Fed Horses.
Study date
2013
Auth party contact address
-
Data no
292283
Title
KB115T part f
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292295
Title
Let Them Eat During Dialysis: An Overlooked Opportunity to Improve Outcomes in Maintenance Hemodialysis Patients
Study date
2013
Auth party contact address
-
Data no
292246
Title
Full prescribing information - Remeron
Study date
November 2021
Auth party contact address
-
Data no
292240
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292218
Title
Pre-application Assistance APVMA Written Assistance
Study date
19 October 2021
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292241
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292195
Title
License to Manufacture Veterinary Chemical Products
Study date
11 October 2023
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292224
Title
Pharmacokinetics of mirtazapine and its main metabolites after single intravenous and oral administrations in rats at two dose rates.
Study date
2014
Auth party contact address
-
Data no
292258
Title
High blood mirtazapine concentration in a newborn ???????? A case of suspected postpartum infanticide
Study date
2021
Auth party contact address
-
Data no
292318
Title
KB108T
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292310
Title
The role of histaminergic H1 and H3 receptors in food intake: a mechanism for atypical antipsychotic-induced weight gain?
Study date
2010
Auth party contact address
-
Data no
292264
Title
Mirataz SDS
Study date
20 March 2020
Auth party contact address
-
Data no
292278
Title
KB115T part a
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292255
Title
Antidepressant use during pregnancy and risk of adverse neonatal outcomes: A comprehensive investigation of previously identified associations
Study date
2022
Auth party contact address
-
Data no
292227
Title
Studies on the pharmacokinetics and pharmacodynamics of mirtazapine in healthy young cats.
Study date
2010
Auth party contact address
-
Data no
292298
Title
The Role of Hypothalamic H1 Receptor Antagonism in Antipsychotic-Induced Weight Gain
Study date
2013
Auth party contact address
-
Data no
292304
Title
Cancer chemotherapy and cachexia: mirtazapine and olanzapine are 5-HT3 antagonists with good antinausea effects
Study date
2007
Auth party contact address
-
Data no
292204
Title
Stability Summary Tables
Study date
September 2019
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292321
Title
Mirtazapine (Plumbs Veterinary Medication Guides)
Study date
2017
Auth party contact address
-
Data no
292235
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292247
Title
Developing rat testicular organoid models for assessing the reproductive toxicity of antidepression drugs in vitro
Study date
2022
Auth party contact address
-
Data no
292284
Title
KB115T part g
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292192
Title
Certificate of GMP Compliance of a Manufacturer
Study date
12 August 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292290
Title
Study KB105
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292267
Title
Excipient 3 SDS
Study date
31 August 2021
Auth party contact address
-
Data no
292244
Title
Laboratory, Safety Study of Topical (Transdermal) Mirtazapine 2% Ointment Dosed Orally in Cats at 5X the Targeted Label Dose
Study date
2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292221
Title
Mirtazapine (Plumbs Veterinary Medication Guides)
Study date
2017
Auth party contact address
-
Data no
292198
Title
PRO-SK-MS&T0021
Study date
24 February 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292307
Title
Premedication with mirtazapine reduces preoperative anxiety and postoperative nausea and vomiting
Study date
2008
Auth party contact address
-
Data no
292215
Title
Tube Drawing
Study date
12 September 2022
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292261
Title
Pharmacokinetics of a Single Transdermal Dose of Mirtazapine in Rhesus Macaques (Macaca mulatta)
Study date
2023
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292301
Title
Stahl's essential psychopharmacology: neuroscientific basis and practical applications b
Study date
2008
Auth party contact address
-
Data no
292207
Title
In use stability results
Study date
01 December 2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292201
Title
Antimicrobial Agents - Content
Study date
12 May 2025
Auth party contact address
-
Data no
292275
Title
Study KB101PK
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292324
Title
kb116
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292281
Title
KB115T part d
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292238
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292287
Title
Studies on the pharmacokinetics and pharmacodynamics of mirtazapine in healthy young cats
Study date
2010
Auth party contact address
-
Data no
292193
Title
Certificate of GMP Compliance of a Manufacturer
Study date
16 June 2023
Auth party contact address
-
Data no
300142
Title
Method Transfer Report V-OS-065/EE-24/1
Study date
10 September 2020
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292222
Title
Metabolism of the Antidepressant Mirtazapine In Vitro: Contribution of Cytochromes P-450 1A2, 2D6, and 3A4
Study date
2000
Auth party contact address
-
Data no
292199
Title
Elemental Impurities Product Risk Assessment
Study date
26 June 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292270
Title
Excipient 6 SDS
Study date
13 May 2019
Auth party contact address
-
Data no
292316
Title
The Pharmacokinetics of Mirtazapine in Cats with Chronic Kidney Disease and In Age-Matched Control Cats
Study date
2011
Auth party contact address
-
Data no
292210
Title
Antimicrobial Effectiveness Testing
Study date
13 May 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292216
Title
Barrier properties of Polyfoil laminate tubes
Study date
2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292262
Title
Determination of KIND-010 2% Ointment Dislodged upon Petting Following Repeated Topical (Transdermal) Administrations in Cats
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292325
Title
Mirtazapine exposure in pregnancy and foetal safety: A nationwide cohort study
Study date
2022
Auth party contact address
-
Data no
292253
Title
Risk of congenital anomalies associated with pyschotropic medications: a review of neonatal reports in the FDA adverse event reporting system
Study date
2024
Auth party contact address
-
Data no
292302
Title
H1-histamine receptor affinity predicts weight gain with antidepressants
Study date
2016
Auth party contact address
-
Data no
292276
Title
Study KB103PK
Study date
2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292296
Title
Clinical Pharmacokinetics of Mirtazapine
Study date
2000
Auth party contact address
-
Data no
292282
Title
KB115T part e
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292233
Title
A Laboratory, Randomized, Effectiveness and Pharmacokinetic Study of Topically (Transdermal) Administered Mirtazapine Ointment at 0.5 mg/kg and 2 mg/kg in Adult Cats
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292239
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292242
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292313
Title
Eating disorder and epilepsy in mice lacking 5-HT2c serotonin receptors
Study date
1995
Auth party contact address
-
Data no
300139
Title
Finished product method FPM 806M
Study date
12 September 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292196
Title
Mirtazapine Transdermal Ointment Development Pharmaceutics Report
Study date
13 August 2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292219
Title
Environment
Study date
August 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292319
Title
Cachexia and Sarcopenia: Emerging Syndromes of Importance in Dogs and Cats
Study date
2012
Auth party contact address
-
Data no
292259
Title
Mirtazapine overdose is unlikely to cause major toxicity
Study date
2014
Auth party contact address
-
Data no
292305
Title
Mirtazapine as an appetite stimulant and anti-emetic in cats with chronic kidney disease: A masked placebo-controlled crossover clinical trial
Study date
2013
Auth party contact address
-
Data no
292213
Title
Test Method Transfer Report for the Analytical Method for the Assay & Identification of Mirtazapine, Related Substances & Butylated Hydroxytoluene
Study date
May 2023
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292230
Title
Laboratory Study: Pharmacokinetics of Mirtazapine Administered In Single Doses Orally and Topically (Transdermally) to Adult Cats
Study date
2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292279
Title
KB115T part b
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292256
Title
Mirtazapine in pregnancy and lactation ???????? A systematic review
Study date
2016
Auth party contact address
-
Data no
292322
Title
kb117
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292273
Title
Efficacy and Safety
Study date
June 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292250
Title
Pregnancy Outcome Following Maternal Exposure to Mirtazapine A Multicenter, Prospective Study
Study date
2015
Auth party contact address
-
Data no
292299
Title
Ghrelin's Orexigenic Effect Is Modulated via a Serotonin 2C Receptor Interaction
Study date
2015
Auth party contact address
-
Data no
292236
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292293
Title
Phase II trial of mirtazapine for cancer-related cachexia and anorexia
Study date
2010
Auth party contact address
-
Data no
292285
Title
KB115T part h
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Date
Application Date
Application No
Application Number
151528
Product/Active constituent Name
Application Product Name
ProFume Fumigant
Application Date
Application Number
151528
Application Product Name
ProFume Fumigant
Application details
Product name:
ProFume Fumigant
Product number:
59952
Applicant Name:
DOUGLAS PRODUCTS & PACKAGING COMPANY
Application purpose and description of use:
Variation of product registration and label approval to extend the product use in pulse and oilseeds.
Active constituents:
Active constituent name
60001 - SULFURYL FLUORIDE
Description of data provided:
Data no
300111
Title
Communication made with APVMA on various aspects in residue
Study date
2026
Auth party contact address
1550 EAST OLD 210 HWY LIBERTY MISSOURI United States
Data no
300114
Title
Efficacy Of Sulphuryl Fluoride Against Eggs and One Post-Embryonic Stage of the Cowpea Weevil and the Dried Bean Beetle At 20??C, 25??C And 30??C
Study date
31-July-2006
Auth party contact address
1550 EAST OLD 210 HWY LIBERTY MISSOURI United States
Data no
300115
Title
CONFIRMATION OF GERMINATION OF PULSE SEED (LUPIN, CHICKPEA, AND FABA BEAN) AND OILSEED (CANOLA, COTTONSEED, PEANUT AND SUNFLOWER) FOLLOWING TREATMENT WITH SULFURYL FLUORIDE
Study date
5 Jan 2026
Auth party contact address
1550 EAST OLD 210 HWY LIBERTY MISSOURI United States
Data no
300109
Title
Fate of fluoride in livestock that consumed commodities fumigated with sulfuryl fluoride
Study date
09-JUL-2004
Auth party contact address
1550 EAST OLD 210 HWY LIBERTY MISSOURI United States
Data no
300106
Title
Part 5 Residue
Study date
5 Jan 2026
Auth party contact address
1550 EAST OLD 210 HWY LIBERTY MISSOURI United States
Data no
300112
Title
Part 8 Efficacy and crop safety
Study date
27 Nov 2025
Auth party contact address
1550 EAST OLD 210 HWY LIBERTY MISSOURI United States
Data no
300113
Title
Factors affecting the efficacy of sulphuryl fluoride as a fumigant
Study date
2006
Auth party contact address
-
Data no
300107
Title
PAA written response
Study date
16 September 2024
Auth party contact address
1550 EAST OLD 210 HWY LIBERTY MISSOURI United States
Data no
300110
Title
SULFURYL FLUORIDE JMPR Evaluation report
Study date
2005
Auth party contact address
-
Data no
300116
Title
APVMA FTR Efficacy and crop safety risk assessment report
Study date
2015
Auth party contact address
1550 EAST OLD 210 HWY LIBERTY MISSOURI United States
Data no
300108
Title
DETERMINATION OF RESIDUES OF SULFURYL FLUORIDE AND FLUORIDE ION IN OILSEEDS (CANOLA, COTTONSEED, AND PEANUT) AND PULSES (LUPIN, CHICKPEA, AND FABA BEAN)
Study date
September 9, 2025
Auth party contact address
1550 EAST OLD 210 HWY LIBERTY MISSOURI United States
Date
Application Date
Application No
Application Number
151576
Product/Active constituent Name
Application Product Name
RAPPORT HERBICIDE
Application Date
Application Number
151576
Application Product Name
RAPPORT HERBICIDE
Application details
Product name:
RAPPORT HERBICIDE
Product number:
97019
Applicant Name:
UPL AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 33g/L Imazamox as the ammonium salt and 15 g/L imazapyr present as the ammonium salt product in a soluble concentrates (SL) formulation for the early post-emergence control of certain grass and broadleaf weeds as part of the Clearfield Production System for Clearfield Plus wheat, Clearfield barley, Clearfield canola and igrowth herbicide tolerant grain sorghum, as specified in the Directions for use.
Reference details:
59735 - INTERVIX HERBICIDE
Active constituents:
Active constituent name
91027 - Imazamox
Active constituent name
62015 - IMAZAPYR
Description of data provided:
Data no
300340
Title
Stability of Rapport herbicide (equivalent to Imazamox 3.10% + Imazapyr 1.40% w/w SL) at low temperature
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300346
Title
Safety and Compatibility of UPL formulations with mixing partners in Clearfield cereal
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300360
Title
Imazamox + Imaxapyr Sorghum Bioequivalence
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300352
Title
Efficacy and bioequivalence of UPL formulations for grass weed control in barley cv. Commodus
Study date
2026
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300363
Title
Bioequivalency of UPL formulations of Imazamox + Imaxapyr
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300343
Title
Bioequivalence of UPL formulations in Clearfield Cereals- Wheat
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300349
Title
Bioequivalence of UPL formulations in Clearfield Cereals- Barley
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300364
Title
Bioequivalency of UPL formulations in Clearfield canola
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300338
Title
Manufacturing information
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300344
Title
Bioequivalency of UPL formulations in Clearfield cereals
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300358
Title
BIOEQUIVALENCE OF UPL FORMULATIONS IN CLEARFIELD CANOLA
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300335
Title
Rapport Herbicide label
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300361
Title
Bioequivalence of UPL formulations of Imazamox + Imaxapyr
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300341
Title
Validation of Analytical method for determination of active ingredient content of Rapport herbicide (equivalent to Imazamox 3.10% + Imazapyr 1.40% w/w SL)
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300347
Title
Safety and Compatibility of UPL formulations with mixing partners in Clearfield wheat
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300355
Title
Crop safety and compatibility of UPL formulations with mixing partners in canola cv. PY520TC
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300336
Title
Part 2 Chemistry and Manufacture
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300362
Title
EFFICACY OF UPL FORMULATIONS OF IMAZAMOX + IMAXAPYR
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300342
Title
Part 8 Efficacy and Safety
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300350
Title
Crop safety and compatibility of UPL formulations with mixing partners in barley cv. Maximus
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300356
Title
Bioequivalency of UPL formulations in Clearfield canola
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300339
Title
Accelerated storage stability and corrosion characteristics of Rapport herbicide (equivalent to Imazamox 3.10% + Imazapyr 1.40% w/w SL)
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300359
Title
Safety and Compatibility of UPL formulations with mixing partners in Clearfield canola
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300353
Title
Safety and compatibility of UPL formulations with mixing partners in Clearfield Canola
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300348
Title
Safety and compatibility of UPL formulations with mixing partners in Clearfield cereal
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300354
Title
Bioequivalency of UPL formulations in Clearfield canola
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300337
Title
Doc J
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300345
Title
BIOEQUIVALENCY OF UPL FORMULATIONS IN CLEARFIELD CEREALS
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300357
Title
BIOEQUIVALENCY OF UPL FORMULATIONS IN CLEARFIELD CANOLA
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
300351
Title
Bioequivalency of UPL formulations in Clearfield cereal
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia