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
142930
Product/Active constituent Name
Application Product Name
Doramectin
Application Date
Application Number
142930
Application Product Name
Doramectin
Application details
Product name:
Doramectin
Active name:
Doramectin
Applicant Name:
TROY LABORATORIES PTY LTD
Application purpose and description of use:
Approval of doramectin for use in veterinary chemical products.
Description of data provided:
Data no
267341
Title
Part 2: Chemistry and Manufacture
Study date
2024
Auth party contact address
37 GLENDENNING ROAD GLENDENNING Australia
Data no
271441
Title
Att 1-Doramectin Additional Info
Study date
2024
Data no
271442
Title
2024-05-19 Doramectin response
Study date
2024
Auth party contact address
37 GLENDENNING ROAD GLENDENNING Australia
Date
Application Date
Application No
Application Number
142913
Product/Active constituent Name
Application Product Name
Yates Weed 'n' Feed Weed Killer & Lawn Fertiliser
Application Date
Application Number
142913
Application Product Name
Yates Weed 'n' Feed Weed Killer & Lawn Fertiliser
Application details
Product name:
Yates Weed 'n' Feed Weed Killer & Lawn Fertiliser
Product number:
94599
Applicant Name:
DULUXGROUP (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 85.6 g/L MCPA, present as the dimethylamine salt and 13.1 g/L DICAMBA, present as the dimethylamine salt for use in lawns to control bindii, clover & common broadleaf weeds.
Reference details:
93094 - Yates Weed 'N' Feed Weed Killer and Lawn Fertiliser Hose On
58022 - YATES LAWNWEEDKILLER BINDII & CLOVER CONCENTRATE
Active constituents:
Active constituent name
69520 - SPALDING MCPA 750 SELECTIVE HERBICIDE
Active constituent name
60505 - Nufarm MCPA Amine 750 Herbicide
Active constituent name
67363 - ACCENSI MCPA 750 SELECTIVE HERBICIDE
Active constituent name
53893 - ADAMA MCPA 750 HERBICIDE
Active constituent name
80984 - Spalding Dicamba 500 Selective Herbicide
Active constituent name
54792 - CUTLASS 500 SELECTIVE HERBICIDE
Active constituent name
55597 - ACCENSI DICAMBA 500 SELECTIVE HERBICIDE
Description of data provided:
Data no
267296
Title
Validation report
Study date
2023
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
267292
Title
Chemistry Dossier
Study date
8 Feb 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
267293
Title
Formulation details
Study date
6 Feb 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
267294
Title
SDS for non-active
Study date
2015
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
267295
Title
Stability Report
Study date
2023
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
267297
Title
Efficacy dossier
Study date
6 Feb 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
267298
Title
Efficacy Trial 1
Study date
2023
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
267299
Title
Efficacy Trial 2
Study date
2023
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
267290
Title
Executive summary
Study date
15 Feb 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
267291
Title
Formulation details
Study date
6 Feb 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Date
Application Date
Application No
Application Number
142615
Product/Active constituent Name
Application Product Name
Fenmezoditiaz
Application Date
Application Number
142615
Application Product Name
Fenmezoditiaz
Application details
Product name:
Fenmezoditiaz
Product number:
94507
Applicant Name:
BASF AUSTRALIA LTD.
Application purpose and description of use:
Registration of a fenmezoditiaz containing suspension concentrate formulated product for control of aphid in cereals in conjunction with approval of fenmezoditiaz.
Description of data provided:
Data no
267060
Title
Analytical Method APL0768/01 - Determination of the Active Ingredient in Reg.No.: 6044689 TGAI (BAS 560 I)
Study date
2020-02-14
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267061
Title
Validation of the Analytical Method APL0768/01: Determination of the Active Ingredient in Reg.No.: 6044689 TGAI (BAS 560 I)
Study date
2020-03-05
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267062
Title
APL0817/01: Determination of Impurity in Reg.No.: 6044689 TGAI (BAS 560 I)
Study date
2022-01-28
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267063
Title
Validation of the analytical method APL0817/01: "Determination of Impurity in Reg.No.: 6044689 TGAI (BAS 560 I)"
Study date
2022-01-28
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267064
Title
Analytical Method APL0816/01: Determination of Reg.No. 25218 and Reg.No. 211342 in Fenmezoditiaz (Reg. No. 6044689, BAS 560 I, TGAI) by GC-MS
Study date
2021-12-13
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267065
Title
Validation of the Analytical Method APL0816/01: Determination of Reg.No. 25218 and Reg.No. 211342 in Fenmezoditiaz (Reg. No. 6044689, BAS 560 I, TGAI) by GC-MS
Study date
2021-12-13
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267052
Title
Characterization of Five Batches of Technical Grade Active Ingredient Fenmezoditiaz (BAS 560 I, Reg.No.: 6044689)
Study date
2022-05-16
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267053
Title
Characterization of Reg.No.: 6044689, batch COD-002513
Study date
2022-04-11
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267054
Title
Characterization of Reg.No.: 6044689, batch COD-002411
Study date
2022-04-11
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267055
Title
Characterization of Reg.No.: 6044689, batch COD-002358
Study date
2022-04-21
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267056
Title
Characterization of Reg.No.: 6044689, batch L2017-038
Study date
2022-04-28
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267057
Title
Characterization of Reg.No.: 6044689, batch COD-002853
Study date
2021-12-15
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267058
Title
Determination of Reg.No. 25218, Reg.No. 211342 and water in Reg.No. 6044689, Batch COD-002853
Study date
2023-10-16
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267059
Title
Revised Final Report No. 1 - Determination of Reg.No. 25218, Reg.No. 211342 and water in Reg.No. 6044689, Batch COD-002853
Study date
2023-10-16
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267051
Title
Fenmezoditiaz - TGAI BAS 560 I - Description of the Manufacturing Process (BASF SE)
Study date
2022-08-13
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267075
Title
Fenmezoditiaz - Document JCA - Confidential information
Study date
2024-01-22
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267076
Title
Fenmezoditiaz - Document L-CA, Section 4 - Analytical methods - Reference list
Study date
2024-01-22
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267078
Title
Fenmezoditiaz - Document L-CA, Section 10 - Classification and labelling of the active substance - Reference list
Study date
2024-01-22
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267079
Title
Fenmezoditiaz - Document M-CA, Section 4 - Analytical methods
Study date
2024-01-22
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272737
Title
Physical properties of BAS 560 I (Reg. No. 6044689) Pure Active Ingredient (PAI)
Study date
2018-12-11
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272738
Title
Physical and chemical properties of BAS 560 I (Reg.No. 6044689) Technical Grade Active Ingredient (TC/TGAI) - Accelerated Storage Stability up to 2 weeks at 54?C
Study date
2020-11-09
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272739
Title
Henry's Law Constant for BAS 560 I (Reg.No. 6044689)
Study date
2019-10-22
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272740
Title
Mass, NMR, IR and UV/VIS Spectra of BAS 560I (Reg.No. 6044689)
Study date
2019-05-17
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272741
Title
Water solubility of BAS 560I (Reg.No. 6044689)
Study date
2019-10-01
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272742
Title
Solubility of Reg.No. 6044689 (BAS 560I) in organic solvents
Study date
2019-08-01
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272743
Title
Partition coefficient n-octanol/water (log Pow) of BAS 560 I (Reg.No. 6044689)
Study date
2019-05-08
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272744
Title
Dissociation constant (pKa) of BAS 560I (Reg.No. 6044689)
Study date
2019-05-07
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272745
Title
Determination of physico-chemical properties according to UN Transport Regulation and Directive 94/37/EC (Regulation (EC) No. 440/2008)
Study date
2019-09-25
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272747
Title
Dissociation Constants in Water for the BAS 560 I Metabolite M560I001 (Reg. No. 6127225)
Study date
2022-06-01
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272748
Title
Determination of n-Octanol / Water Partition Coefficient (Log Pow Value) for the BAS 560 I Metabolite M560I001 (Reg. No. 6127225)
Study date
2022-05-31
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272749
Title
Vapour Pressure and Melting Point of Reg.No. 6127225 - Metabolite M560I001 of BAS 560 I
Study date
2022-11-02
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272750
Title
Water Solubility for the Metabolite M560I001 (Reg. No 6127225)
Study date
2022-06-13
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272751
Title
Dissociation Constant in Water for the Metabolite M560I002 (Reg. No. 6127847)
Study date
2021-08-04
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272752
Title
Partition Coefficient of the Metabolite M560I002 (Reg.No. 6127847) (HPLC Method)
Study date
2021-08-06
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272753
Title
Vapour Pressure and Melting Point of Reg.No. 6127847 - Metabolite M560I002 of BAS 560 I
Study date
2022-01-17
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272754
Title
Water solubility for the Metabolie M560I002 (Reg.No. 6127847)
Study date
2021-08-04
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272755
Title
Dissociation Constants in Water for the BAS 560 I Metabolite M560I004 (Reg. No. 6127526)
Study date
2022-06-01
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272756
Title
Determination of n-Octanol / Water Partition Coefficient (Log Pow Value) for the BAS 560 I Metabolite M560I004 (Reg. No. 6127526)
Study date
2022-05-18
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272757
Title
Vapour Pressure and Melting Point of Reg.No. 6127526 - Metabolite M560I004 of BAS 560 I
Study date
2022-07-25
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272758
Title
Water Solubility for the Metabolite M560I004 (Reg. No. 6127526)
Study date
2022-06-13
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272759
Title
Dissociation Constants in Water for the BAS 560 I Metabolite M560I006 (Reg. No. 6137732)
Study date
2022-06-02
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272760
Title
Determination of n-Octanol / Water Partition Coefficient (Log Pow Value) for the BAS 560 I Metabolite M560I006 (Reg. No. 6137732)
Study date
2022-05-31
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272761
Title
Vapour Pressure and Melting Point of Reg.No. 6137732 - Metabolite M560I006 of BAS 560 I
Study date
2022-07-21
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272762
Title
Water Solubility for the BAS 560 I Metabolite M560I006 (Reg. No. 6137732)
Study date
2022-06-14
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272763
Title
Determination of dissociation constant, pKa by UV-Vis method of test item M560I010, Reg. No. 6151825
Study date
2022-05-11
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272764
Title
Determination of partition coefficient (n-octanol/water) by high performance liquid chromatography (HPLC) method of test item M560I010, Reg. No. 6151825
Study date
2022-04-20
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272765
Title
Vapour Pressure and Melting Point of Reg.No. 6151825 - Metabolite M560I010 of BAS 560 I
Study date
2022-05-25
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272766
Title
Determination of water solubility by shake flask method of test item M560I010, Reg. No. 6151825
Study date
2022-08-29
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272767
Title
Determination of dissociation constant, pKa by UV-Vis method of test item M560I011, Reg. No. 6151824
Study date
2022-05-19
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272768
Title
Determination of partition coefficient (n-octanol/water) by high performance liquid chromatography (HPLC) method of test item M560I011, Reg. No. 6151824
Study date
2022-04-20
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272769
Title
Vapour Pressure and Melting Point of Reg.No. 6151824 - Metabolite M560I011 of BAS 560 I
Study date
2022-05-09
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272770
Title
Determination of water solubility by shake flask method of test item M560I011, Reg. No. 6151824
Study date
2022-08-29
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272771
Title
Determination of dissociation constant, pKa by titration method of test item M560I012, Reg. No. 4300884
Study date
2022-05-16
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272772
Title
Determination of partition coefficient (n-octanol/water) by high performance liquid chromatography (HPLC) method of test item M560I012, Reg. No. 4300884
Study date
2022-04-07
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272773
Title
Vapour Pressure and Melting Point of Reg.No. 4300884 - Metabolite M560I012 of BAS 560 I
Study date
2022-04-05
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272774
Title
Determination of water solubility by shake flask method of test item M560I012, Reg. No. 4300884
Study date
2022-05-04
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272775
Title
Determination of dissociation constant, pKa by titration method of test item M560I014, Reg. No. 4249371
Study date
2022-05-19
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272776
Title
Determination of partition coefficient (n-octanol/water) by high performance liquid chromatography (HPLC) method of test item M560I014, Reg. No. 4249371
Study date
2022-04-07
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272777
Title
Vapour Pressure and Melting Point of Reg.No. 4249371 - Metabolite M560I014 of BAS 560 I
Study date
2022-04-20
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272778
Title
Determination of water solubility by shake flask method of test item M560I014, Reg. No. 4249371
Study date
2022-05-04
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272779
Title
Dissociation Constants in Water for the BAS 560 I Metabolite M560I017 (Reg. No. 6211127)
Study date
2022-06-02
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272780
Title
Determination of n-Octanol / Water Partition Coefficient (Log Pow Value) for the BAS 560 I Metabolite M560I017 (Reg. No. 6211127)
Study date
2022-05-31
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272781
Title
Vapour Pressure and Melting Point of Reg.No. 6211127 - Metabolite M560I017 of BAS 560 I
Study date
2022-12-14
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272782
Title
Water Solubility for the Metabolite M560I017 (Reg. No. 6211127)
Study date
2022-06-14
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267081
Title
Fenmezoditiaz - Document M-CA, Section 10 - Classification and labelling of the active substance
Study date
2024-01-22
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272746
Title
Storage Stability of Fenmezoditiaz (BAS 560 I, Reg.No. 6044689) TC when stored for 4 years at 20?C and 30?C - 104 week report -
Study date
2022-6-09
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267067
Title
BAS 560 I - Acute dermal toxicity study in rats
Study date
2019-09-30
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267070
Title
BAS 560 I - Acute eye Irritation in rabbits
Study date
2019-09-26
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267071
Title
Amendment 1: BAS 560 I - Acute eye Irritation in rabbits
Study date
2021-07-19
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267068
Title
BAS 560 I - Acute inhalation toxicity study in Wistar rats 4-hour dust exposure (nose only)
Study date
2019-06-27
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267074
Title
BAS 560 I - Acute oral toxicity study in rats
Study date
2022-11-10
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267066
Title
BAS 560 I - Acute oral toxicity study in rats
Study date
2019-09-26
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267082
Title
BAS 560 00 I - Document L-CP, Section 7 - Toxicological studies on the plant protection product - Reference list
Study date
2024-01-22
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267069
Title
BAS 560 I - Acute dermal Irritation / corrosion in rabbits
Study date
2019-09-26
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267072
Title
BAS 560 I - Local Lymph Node Assay (LLNA)
Study date
2019-09-30
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267073
Title
BAS 560 I - BUEHLER Test in guinea pigs
Study date
2022-08-18
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267080
Title
Fenmezoditiaz - Document M-CA, Section 5 - Toxicological and metabolism studies on the active substance
Study date
2024-01-22
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267077
Title
Fenmezoditiaz - Document L-CA, Section 5 - Toxicological and metabolism studies on the active substance - Reference list
Study date
2024-01-22
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Date
Application Date
Application No
Application Number
142976
Product/Active constituent Name
Application Product Name
1,3-dichloropropene
Application Date
Application Number
142976
Application Product Name
1,3-dichloropropene
Application details
Product name:
1,3-dichloropropene
Active name:
1,3-dichloropropene
Applicant Name:
TRICAL AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of 1,3-dichloropropene for use in agricultural chemical products.
Description of data provided:
Data no
267494
Title
Analysis and certification of active ingredients and impurities in five batches of Technical 1,3-dichloropropene (1,3-D) stabilized with epoxidized soybean oil.
Study date
15/12/2023
Auth party contact address
4 Gidgie Court Edinburgh Australia
Data no
267495
Title
Manufacturing process of 1,3-Dichloropropene
Study date
January 2024
Auth party contact address
4 Gidgie Court Edinburgh Australia
Data no
278478
Title
To Whom it may concern
Study date
13/09/2024
Auth party contact address
4 Gidgie Court Edinburgh Australia
Data no
278479
Title
Certificate of analysis
Study date
24/09/2024
Auth party contact address
4 Gidgie Court Edinburgh Australia
Data no
278480
Title
Rationale for the formation of impurities including C 6 derivatives
Study date
September 2024
Auth party contact address
4 Gidgie Court Edinburgh Australia
Data no
278481
Title
Part 2 Summary revised
Study date
September 2024
Auth party contact address
4 Gidgie Court Edinburgh Australia
Data no
267496
Title
Part 2 Summary
Study date
February 2024
Auth party contact address
4 Gidgie Court Edinburgh Australia
Data no
278477
Title
Response to S159 Notice for application 94619/142976 1,3-dichloropropene
Study date
September 2024
Auth party contact address
4 Gidgie Court Edinburgh Australia
Date
Application Date
Application No
Application Number
142419
Product/Active constituent Name
Application Product Name
MAC Slay Residual
Application Date
Application Number
142419
Application Product Name
MAC Slay Residual
Application details
Product name:
MAC Slay Residual
Product number:
94433
Applicant Name:
Arandee Limited
Application purpose and description of use:
Registration of 20g/kg d-Phenothrin aerosol with 20kg Permethrin for the control of various Lepidopteran pests.
Reference details:
50745 - CALLINGTON 1-SHOT INSECTICIDE
Active constituents:
Active constituent name
58238 - D-PHENOTHRIN
Active constituent name
89258 - Permethrin
Active constituent name
50871 - D-PHENOTHRIN
Description of data provided:
Data no
264225
Title
Certificate of Analysis
Study date
12/07/2022
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
264226
Title
Certificate of Analysis
Study date
23/11/2022
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
264224
Title
Chemistyr & Manufacture
Study date
21/12/2023
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
264229
Title
Product Specification
Study date
20/12/2023
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
264230
Title
Quality Control Record
Study date
29/11/2023
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
264227
Title
ISO9001:2015 Certificate
Study date
5/1/2021
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
264228
Title
ISO9001:2015 Certificate
Study date
27/09/2023
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
264221
Title
MAC Slay Residual Application Decision
Study date
1/11/2019
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
264222
Title
APPROVAL and RECOGNITION of Dairy Maintenance Compound
Study date
18/12/2020
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
264223
Title
Approval of a non-dairy maintenance compound
Study date
29/07/2020
Auth party contact address
108 Rockfield Road Penrose New Zealand
Date
Application Date
Application No
Application Number
142894
Product/Active constituent Name
Application Product Name
Titan Saflufenacil 700 WG Herbicide
Application Date
Application Number
142894
Application Product Name
Titan Saflufenacil 700 WG Herbicide
Application details
Product name:
Titan Saflufenacil 700 WG Herbicide
Product number:
94597
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Registration of a 700 g/kg water dispersible granule product for control of weeds in ceral crops andtils as per directions for use
Reference details:
62853 - SHARPEN HERBICIDE
Active constituents:
Active constituent name
90583 - Saflufenacil
Description of data provided:
Data no
267251
Title
CERTIFICATE OF ANALYSIS
Study date
August 2021
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267243
Title
Manufacturing process
Study date
October 2021
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267244
Title
Release Specification
Study date
October 2021
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267246
Title
Section 1 Identification of the material and supplier
Study date
December 2016
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267247
Title
Material Safety Data Sheet
Study date
January 2018
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267248
Title
Safety Data Sheet
Study date
December 2016
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267249
Title
Safety Data Sheet
Study date
August 2020
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267250
Title
Safety Data Sheet
Study date
May 2017
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267242
Title
Storage Stability of Titan Saflufenacil 700 WG
Study date
October 2021
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267245
Title
BIOEQUIVALENCE OF TITAN SAFLUFENACIL WITH SHARPEN HERBICIDE FOR CONTROL OF SOWTHISTLE IN FALLOW
Study date
August 2021
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272070
Title
BIOEQUIVALENCE OF TITAN SAFLUFENACIL WITH SHARPEN HERBICIDE FOR CONTROL OF SOWTHISTLE IN FALLOW
Study date
August 2021
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267252
Title
BIOEQUIVALENCE OF TITAN SAFLUFENACIL 700 WITH SHARPEN HERBICIDE FOR FALLOW WEED CONTROL
Study date
February 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267253
Title
BIOEQUIVALENCE OF TITAN SAFLUFENACIL WITH SHARPEN FOR PRE-PLANTING KNOCKDOWN WEED CONTROL AND CROP SAFETY IN BARLEY
Study date
January 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267254
Title
BIOEQUIVALENCE OF TITAN SAFLUFENACIL 700 WITH SHARPEN HERBICIDE FOR CONTROL OF FLEABANE IN FALLOW
Study date
January 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267255
Title
Knockdown herbicide for grass and broadleaf weed control Evaluate Titan Saflufenacil for crop safety and control of grass and broadleaf weeds when applied as a knockdown ahead of lentils
Study date
December 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267256
Title
Knockdown herbicide for grass and broadleaf weed control Evaluate Titan Saflufenacil for crop safety and control of grass and broadleaf weeds when applied as a knockdown ahead of spring whea
Study date
December 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267257
Title
Overview of efficacy: Titan Saflufenacil 700 WG Herbicide
Study date
February 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272072
Title
RESPONSE: Titan Saflufenacil 700 WG Herbicide (94597/142894)
Study date
May 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272071
Title
Overview of efficacy: Titan Saflufenacil 700 WG Herbicide
Study date
May 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279831
Title
DO NOT USE: Response: Titan Saflufenacil 700 WG Herbicide (94597/142894)
Study date
October 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279871
Title
Response: Titan Saflufenacil 700 WG Herbicide (94597/142894)
Study date
October 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
142892
Product/Active constituent Name
Application Product Name
Titan Pyrasulfotole + Bromoxynil Herbicide
Application Date
Application Number
142892
Application Product Name
Titan Pyrasulfotole + Bromoxynil Herbicide
Application details
Product name:
Titan Pyrasulfotole + Bromoxynil Herbicide
Product number:
94596
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Registration of a 210 g/L BROMOXYNIL AS ITS OCTANOIC ACID ESTERS 37.5 g/L PYRASULFOTOLE CROP SAFENER: 9.4 g/L MEFENPYR-DIETHYL SOLVENT: 381 g/L HYDROCARBON LIQUID Emulsifiable Concentrate product for the post-emergent control of certain broadleaf weeds in wheat, barley, cereal rye and triticale as specified in the DIRECTIONS FOR USE table
Reference details:
62444 - VELOCITY SELECTIVE HERBICIDE
Active constituents:
Active constituent name
86766 - Mefenpyr-diethyl
Active constituent name
88239 - BROMOXYNIL OCTANOATE
Active constituent name
93751 - Pyrasulfotole
Description of data provided:
Data no
267234
Title
CERTIFICATE OF ANALYSIS
Study date
October 2022
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267235
Title
Certificate of analysis
Study date
November 2022
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267236
Title
Certificate of analysis
Study date
October 2022
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267237
Title
HPLC DETERMINATION OF PYRASULFOTOLE, BROMOXYNIL OCTANOATE AND MEFENPYR DIETHYL VALIDATION REPORT
Study date
January 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272729
Title
DFN 391 FORMULATION FOLDER 37.5 g/L PYRASULFOTOLE +
210 g/L BROMOXYNIL (PRESENT AS THE OCTANOATE ESTER)
+ 9.4 g/L MEFENPYR-DIETHYL EMULSIFIABLE CONCENTRATE
210 g/L BROMOXYNIL (PRESENT AS THE OCTANOATE ESTER)
+ 9.4 g/L MEFENPYR-DIETHYL EMULSIFIABLE CONCENTRATE
Study date
January 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272730
Title
SAFETY DATA SHEET
Study date
MAy 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272731
Title
SAFETY DATA SHEET
Study date
April 2021
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272732
Title
SAFETY DATA SHEET
Study date
July 2022
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272733
Title
Safety Data Sheet
Study date
August 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272734
Title
Safety Data Sheet
Study date
April 2020
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267238
Title
PRODUCT STABILITY REPORT 37.5 g/L PYRASULFOTOLE + 210 g/L BROMOXYNIL (PRESENT AS THE OCTANOATE ESTER) + 9.4 g/L MEFENPYR-DIETHYL EMULSIFIABLE CONCENTRATE Luke Badby Opal Australasia P/L
Study date
January 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267239
Title
Trial Report PST+Brom Bioequivalence to Velocity in Wheat
Study date
January 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267240
Title
Trial Report PST+Brom Bioequivalence to Velocity in Barley
Study date
January 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267241
Title
Overview of efficacy data: Titan Pyrasulfotole + Bromoxynil Herbicide
Study date
February 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272735
Title
RESPONSE: Titan Pyrasulfotole + Bromoxynil Herbicide (94596/142892)
Study date
June 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272736
Title
Notice of recategorization of application
Study date
June 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
142744
Product/Active constituent Name
Application Product Name
[Wagg & Purr] Milbemycin and Praziquantel Tablets for Small Cats
Application Date
Application Number
142744
Application Product Name
[Wagg & Purr] Milbemycin and Praziquantel Tablets for Small Cats
Application details
Product name:
[Wagg & Purr] Milbemycin and Praziquantel Tablets for Small Cats
Product number:
94549
Applicant Name:
AVET HEALTH LIMITED
Application purpose and description of use:
Registration of 10 mg praziquantel tablets and 4 mg milbemycin oxime for the treatment and control of roundworm, hookworm and tapeworm, and the prevention of heartworm in cats.
Reference details:
54264 - MILBEMAX TABLETS FOR SMALL CATS
Active constituents:
Active constituent name
94564 - Milbemycin oxime
Active constituent name
94565 - Praziquantel
Description of data provided:
Data no
267273
Title
Product specifications
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
142800
Product/Active constituent Name
Application Product Name
Milbemycin oxime
Application Date
Application Number
142800
Application Product Name
Milbemycin oxime
Application details
Product name:
Milbemycin oxime
Active name:
Milbemycin oxime
Applicant Name:
AVET HEALTH LIMITED
Application purpose and description of use:
New source of pharmacopoeia active constituent.
Description of data provided:
Data no
267258
Title
Milbemycin oxime certificates of analysis
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
267259
Title
Active CEPs
Study date
2020
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
267260
Title
Milbemycin oxime specifications
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
267261
Title
Active origin information
Study date
2021
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
267262
Title
Active origin information
Study date
2021
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
267263
Title
Active safety data sheet
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
142802
Product/Active constituent Name
Application Product Name
Praziquantel
Application Date
Application Number
142802
Application Product Name
Praziquantel
Application details
Product name:
Praziquantel
Active name:
Praziquantel
Applicant Name:
AVET HEALTH LIMITED
Application purpose and description of use:
New source of pharmacopoeia active constituent.
Description of data provided:
Data no
267264
Title
Praziquantel certificates of analysis
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
267266
Title
Active CEPs
Study date
2020
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
267265
Title
Praziquantel specifications
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
142929
Product/Active constituent Name
Application Product Name
Nexcel Powder for Injection, Injectable Antibiotic
Application Date
Application Number
142929
Application Product Name
Nexcel Powder for Injection, Injectable Antibiotic
Application details
Product name:
Nexcel Powder for Injection, Injectable Antibiotic
Product number:
94223
Applicant Name:
RANDLAB AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration for Nexcel Powder for Injection (94223) label approval to the storage conditions.
Active constituents:
Active constituent name
88036 - Ceftiofur Sodium
Description of data provided:
Data no
271078
Title
Stability study and chemistry data for Ceftiofur sodium Injection
Study date
08/04/2024
Auth party contact address
71 Milperra Road Revesby Australia
Data no
272710
Title
Stability study and Analysis Ceftiofur sodium for injection
Study date
07/04/2024
Auth party contact address
71 Milperra Road Revesby Australia
Data no
277067
Title
Stability Test Results-In Use
Study date
21/08/2024
Auth party contact address
71 Milperra Road Revesby Australia
Data no
267339
Title
Finished Product Specification Lyphoilised Ceftiofur Sodium
Study date
19/10/2023
Auth party contact address
71 Milperra Road Revesby Australia
Data no
267340
Title
Finished Product Specification Reconstituted solution
Study date
26/10/2023
Auth party contact address
71 Milperra Road Revesby Australia
Data no
267338
Title
Stability studies
Study date
10/10/2023
Auth party contact address
71 Milperra Road Revesby Australia
Date
Application Date
Application No
Application Number
142727
Product/Active constituent Name
Application Product Name
[Wagg & Purr] Milbemycin and Praziquantel Tablets for Cats
Application Date
Application Number
142727
Application Product Name
[Wagg & Purr] Milbemycin and Praziquantel Tablets for Cats
Application details
Product name:
[Wagg & Purr] Milbemycin and Praziquantel Tablets for Cats
Product number:
94540
Applicant Name:
AVET HEALTH LIMITED
Application purpose and description of use:
Registration of 40 mg praziquantel and 16 mg milbemycin oxime tablets for the treatment and control of roundworm, hookworm and tapeworm, and the prevention of heartworm in cats.
Reference details:
54265 - MILBEMAX TABLETS FOR CATS
Active constituents:
Active constituent name
94564 - Milbemycin oxime
Active constituent name
94565 - Praziquantel
Description of data provided:
Data no
266425
Title
EU 2e2 1
Study date
2019
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266426
Title
EU 2e2 2
Study date
2019
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266427
Title
EU 2e2 3
Study date
2019
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266428
Title
EU 2e2 5
Study date
2019
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266429
Title
EU 2e4
Study date
2019
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266430
Title
EU 2e2 2e4
Study date
2019
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266424
Title
Batch analysis
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266421
Title
EU 2b
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266422
Title
EU 2c3
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266423
Title
EU 2e1
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266406
Title
Part 2 dossier
Study date
2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266407
Title
EU 1c1
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266413
Title
Excipients certificates of analysis
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266414
Title
Excipient 1
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266415
Title
Excipient 2
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266419
Title
Excipient 6
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266420
Title
EU 2a4
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
279812
Title
Explanation letter
Study date
2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266431
Title
EU 2f2
Study date
2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266433
Title
EU 1c3 1
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266434
Title
EU 1c3 2
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266435
Title
EU 1c3 3
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266437
Title
EU 4a1 1a
Study date
2014
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266438
Title
EU 4a1 1b
Study date
2014
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266439
Title
EU 4a1 2
Study date
2014
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266440
Title
EU 4a1 3
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266441
Title
EU 4a1 4
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266442
Title
Safety report
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266432
Title
Part 8 Efficacy and Safety
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266446
Title
Handbook of Pharmaceutical Excipients
Study date
2017
Auth party contact address
-
Data no
266447
Title
Excipient 1 safety
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266448
Title
Excipient 1 paper
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
267611
Title
Excipient 2 info
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
267612
Title
Excipient 2 GMP
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
267613
Title
EMA Guidelines
Study date
2020
Auth party contact address
-
Data no
267614
Title
EU 2a4
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266445
Title
Praziquantel summary report
Study date
1996
Auth party contact address
-
Data no
266436
Title
EU 1c2
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266443
Title
EU 4a3 1
Study date
2014
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266444
Title
EU 4a3 2
Study date
2014
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
279816
Title
GMP compliance
Study date
2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
279813
Title
GMP audit report
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
279814
Title
GMP certificate
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
279815
Title
GMP cover letter
Study date
2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
277377
Title
GMP 1 part 2
Study date
2023
Auth party contact address
-
Data no
266399
Title
GMP 1 part 1
Study date
2021
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266400
Title
GMP 1 part 2
Study date
2021
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266401
Title
GMP 2 part 1
Study date
2021
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266402
Title
GMP 2 part 2
Study date
2021
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266403
Title
GMP 3 part 1
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266404
Title
GMP 3 part 2
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
266405
Title
GMP audit report
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
142705
Product/Active constituent Name
Application Product Name
TITAN BESUTO 480 LIQUID HERBICIDE
Application Date
Application Number
142705
Application Product Name
TITAN BESUTO 480 LIQUID HERBICIDE
Application details
Product name:
TITAN BESUTO 480 LIQUID HERBICIDE
Product number:
90984
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration to add an alternate formulation to registration details
Active constituents:
Active constituent name
64067 - PYROXASULFONE
Active constituent name
90545 - Pyroxasulfone
Description of data provided:
Data no
266330
Title
HPLC DETERMINATION OF PYROXASULFONE IN TITAN PYROXASULFONE 480 SC FORMULATION
Study date
March 2021
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
266331
Title
Chemistry & Manufacture Titan Besuto 480 SC
Study date
January 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
266332
Title
Safety data sheet
Study date
June 2017
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
266333
Title
Safety data sheet
Study date
December 2015
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
266334
Title
Safety data sheet
Study date
February 2015
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
266335
Title
Safety data sheet
Study date
June 2014
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
266336
Title
Safety data sheet
Study date
February 2019
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
266337
Title
Safety data sheet
Study date
September 2018
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
266329
Title
Storage Stability of Titan Besuto 480 SC
Study date
January 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
142552
Product/Active constituent Name
Application Product Name
David Grays Brodifacoum Wax Block Rat Bait
Application Date
Application Number
142552
Application Product Name
David Grays Brodifacoum Wax Block Rat Bait
Application details
Product name:
David Grays Brodifacoum Wax Block Rat Bait
Product number:
94477
Applicant Name:
DAVID GRAY & CO. PTY LIMITED
Application purpose and description of use:
Registration of a 0.05g/kg Brodifacoum bait formula to control rats and mice in and around industrial, commercial,
agricultural and domestic buildings, exterior and interior of buildings and structures.
Reference details:
59876 - SUREFIRE ALL WEATHER BLOCKS RODENTICIDE
Active constituents:
Active constituent name
62292 - BRODIFACOUM
Description of data provided:
Data no
265066
Title
Method Validation for the Determination Brodifacoum Content in David Grays Brodifacoum Wax Block Rat Bait
Study date
19/10/21
Auth party contact address
Sponsor - Nantong Chem-Base Co. Ltd
Data no
265065
Title
Manufacturing Process of David Grays Brodifacoum Wax Block Rat Bait
Study date
28/8/22
Auth party contact address
RM 403, Huali Building 6 Gongnong Road, Nantong 226007 China
Data no
265067
Title
Storage Stability Test of David Grays Brodifacoum Wax Block Rat Bait
Study date
28/4/22
Auth party contact address
Sponsor - Nantong Chem-Base Co. Ltd
Data no
278191
Title
Efficacy of David Grays Brodifacoum Wax Block Rat Bait
against Rodents in and around agricultural, commercial,
domestic and industrial buildings, exterior and interior of
buildings and structures
against Rodents in and around agricultural, commercial,
domestic and industrial buildings, exterior and interior of
buildings and structures
Study date
10/12/2021
Auth party contact address
2 RAWLINSON ST O'CONNOR Australia
Data no
265062
Title
Efficacy of David Grays Brodifacoum Wax Block Rat Bait against Rodents in Farmland and Residential Households
Study date
16/12/21
Auth party contact address
Sponsor: Nanttong Chem-Base Co. Ltd
Data no
265063
Title
Efficacy of David Grays Brodifacoum Wax Block Rat Bait against Rodents in Farm and House
Study date
10/12/21
Auth party contact address
Sponsor: Nanttong Chem-Base Co. Ltd
Data no
265064
Title
Brodifacoum TGAC consent for the registration of David Grays Brodifacoum Wax Block Rat Bait
Study date
04/05/23
Auth party contact address
35 McDowell Street, Welshpool Western Australia 6106
Date
Application Date
Application No
Application Number
142867
Product/Active constituent Name
Application Product Name
Thiamethoxam
Application Date
Application Number
142867
Application Product Name
Thiamethoxam
Application details
Product name:
Thiamethoxam
Active name:
Thiamethoxam
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of Thiamethoxam for use in agricultural chemical products.
I have uploaded all the Reference files (Ref 01, Ref 02 and Ref 03) in the Sig box.
Description of data provided:
Data no
267207
Title
Analysis of Five Representative Active Production Batches of Thiamethoxam Technical Grade Active Ingredient (TGAI) to Identify and Quantify Thiamethoxam and its Associate Impurities
Study date
09 May 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
267208
Title
Manufacturing Process Description CGA293343, Thiamethoxam
Study date
22 December 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
267209
Title
Declaration of Composition
Study date
10 February 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
267206
Title
Part 2 - Chemistry and Manufacture
Study date
13 February 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
142869
Product/Active constituent Name
Application Product Name
Picolinafen
Application Date
Application Number
142869
Application Product Name
Picolinafen
Application details
Product name:
Picolinafen
Active name:
Picolinafen
Applicant Name:
CROPNOSYS INDIA PRIVATE LIMITED
Application purpose and description of use:
Approval of picolinafen for use in agricultural chemical products.
Description of data provided:
Data no
267190
Title
Five Batch Analysis of PICOLINAFEN Technical Study No: AG-G1514
Study date
28/04/2023
Auth party contact address
9th Floor, Northstar Yelahanka Bengaluru India
Data no
267191
Title
Picolinafen formulation process
Study date
November 2023
Auth party contact address
9th Floor, Northstar Yelahanka Bengaluru India
Data no
267192
Title
Declaration of Composition
Study date
23 May 2023
Auth party contact address
9th Floor, Northstar Yelahanka Bengaluru India
Data no
267189
Title
Part 2 Chemistry and Manufacture
Study date
30 January 2024
Auth party contact address
9th Floor, Northstar Yelahanka Bengaluru India
Date
Application Date
Application No
Application Number
142840
Product/Active constituent Name
Application Product Name
Surefire Cholecal Blocks Rodenticide
Application Date
Application Number
142840
Application Product Name
Surefire Cholecal Blocks Rodenticide
Application details
Product name:
Surefire Cholecal Blocks Rodenticide
Product number:
94575
Applicant Name:
PCT HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 0.75 g/kg cholecalciferol bait product for control of introduced rodents.
Reference details:
48246 - RAMPAGE RAT AND MOUSE BAIT
81767 - SELONTRA SOFT BAIT RODENTICIDE
59876 - SUREFIRE ALL WEATHER BLOCKS RODENTICIDE
59875 - ALL WEATHER PCT FIRST FORMULA BLOCKS RODENTICIDE
64849 - SUREFIRE BROMA BLOCKS RODENTICIDE
80124 - All Weather PCT Pro Formula Blocks Rodenticide
69911 - SUREFIRE DIFENATE ALL WEATHER BLOCKS RODENTICIDE
Description of data provided:
Data no
267006
Title
Certificate of analysis
Study date
31/03/2023
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
267012
Title
Ph Eur. Monograph extract
Study date
2018
Auth party contact address
-
Data no
267010
Title
Method validation for the determination of cholecalciferol in Surefire Cholecalciferol wax blocks
Study date
12/05/2023
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
267007
Title
Information on ingredients
Study date
August 2023
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
267008
Title
Surefire Cholecal Blocks Rodenticide production process summary.
Study date
20/05/2022
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
267011
Title
SDS
Study date
2023
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
267013
Title
Part 2 Summary
Study date
December 2023
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
267009
Title
Stability testing report
Study date
26/05/2023
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
267014
Title
A FIELD TRIAL TO EVALUATE PCT SUREFIRE CHOLECALCIFEROL RODENTICIDE IN AND AROUND A MACADAMIA ORCHARD
Study date
December 2023
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
267015
Title
An urban site field trial to evaluate PCT Cholecalciferol Rodenticide
Study date
December 2023
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
267016
Title
Evaluating alternative rodenticides for island conservation: roof rat eradication from the San Jorge Islands, Mexico
Study date
2003
Auth party contact address
-
Data no
267017
Title
Cholecalciferol: a unique toxicant for rodent control
Study date
1984
Auth party contact address
-
Data no
267018
Title
Field evaluation of Quintox (Cholecalciferol) for controlling commensal rodents
Study date
1988
Auth party contact address
-
Data no
267019
Title
Toxicity of cholecalciferol to rats in a multi-species bait
Study date
27/01/2010
Auth party contact address
-
Data no
278753
Title
Evaluation of the palatability to rats of experimental bait formulations containing no active constituents under laboratory conditions one trial, Bundaberg, Queensland, Australia, 2019
Study date
15/11/2019
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
278754
Title
Efficacy of rodenticide baits with decreased concentrations of brodifacoum: Validation of the impact of the new EU anticoagulant regulation
Study date
2019
Auth party contact address
-
Data no
279117
Title
Supplement to Appendix 8-1
Study date
December 2023
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
267020
Title
Non-target and secondary poisoning risks associated with cholecalciferol
Study date
2000
Auth party contact address
-
Data no
267021
Title
Part 8 Summary
Study date
February 2024
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
278751
Title
Surefire Cholecal Blocks Rodenticide (94575/142840) Response to S159 Notice dated 9 September 2024
Study date
03/10/2024
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
278752
Title
Discussion paper
Study date
02/10/2024
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
278750
Title
Consent for use of protected information
Study date
6/9/2024
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Date
Application Date
Application No
Application Number
142670
Product/Active constituent Name
Application Product Name
Atinvicitinib
Application Date
Application Number
142670
Application Product Name
Atinvicitinib
Application details
Product name:
Atinvicitinib
Product number:
94527
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of 30 g/kg Atinvicitinib Oral Tablets for Dogs for the control of pruritus associated with allergic and atopic dermatitis in dogs in conjunction with approval of the active constituent Atinvicitinib.
Description of data provided:
Data no
266348
Title
Atinvicitinib Drug Master File (Open Part), Batch analysis, physiochemical properties, stability, analytical validation data and packaging.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
266346
Title
Analytical Reference Standard Documentation.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
266347
Title
Atinvicitinib Drug Master File (Open Part), Manufacturing process and Characterisation including Impurities.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
266349
Title
Atinvicitinib Quality Overall Summary (Open Part).
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
266350
Title
Quality Overall Summary - Restricted Part
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
266351
Title
Cover Letter
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
266352
Title
Quality DMF - Restricted Part
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
266354
Title
TSE/BSE Declaration
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
266355
Title
Statement of Commitment
Study date
2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
266356
Title
International Information
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
266357
Title
Manufacturer GMP Certificate
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269455
Title
Atinvicitinib: In Vitro Dermal Absorption using Rat Skin. MSD Animal Health Study No. S22110-00-JKD-TOX-NA.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269456
Title
Atinvicitinib: In Vitro Dermal Absorption using Human and Rat Skin. MSD Animal Health Study No. S21228-00-JKD-TOX-NA.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269457
Title
Assessment of Acute Dermal Toxicity in the Wistar Han Rat (Fixed Dose Procedure). MSD Animal Health Study No. S20120-00-JKD-TOX-RO.
Study date
2020
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269458
Title
Atinvicitinib: Toxicity Study by Dermal Administration (6 Hours a Day, Semi-Occlusive) to Sprague Dawley Rats for 4 Weeks. MSD Animal Health Study No. S21226-00-JKD-TOX-RO.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269459
Title
Atinvicitinib: 13-Week Dermal Toxicity (6 Hours a Day, Semi-Occlusive) and Toxicokinetic Study in Sprague Dawley Rats. MSD Animal Health Study No. S21227-00-JKD-TOX-RO.
Study date
2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269460
Title
Evaluation of the Eye Hazard Potential of Atinvicitinib using the Bovine Corneal Opacity and Permeability Test (BCOP Test). MSD Animal Health Study No. S20121-00-JKD-TOX-NA.
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269461
Title
Evaluation of the Eye Hazard Potential with Atinvicitinib Using the EpiOcular Cornea Epithelial Model. MSD Animal Health Study No. S20122-00-JKD-TOX-NA.
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269462
Title
Acute Oral Toxicity Study in the Rat - Fixed Dose Method. MSD Animal Health Study No. S19233-00-JKD-TOX-NA.
Study date
2020
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269463
Title
Atinvicitinib: Extended acute oral toxicity study in Han Wistar Rats for the determination of an Acute Reference Dose. MSD Animal Health Study No. S21229-00-JKD-TOX-RO.
Study date
2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269464
Title
Atinvicitinib: A 14-Day Repeated Dose Preliminary Toxicity Study by Oral Gavage Administration to Han Wistar Rats. MSD Animal Health Study No. S19231-00-JKD-TOX-RO.
Study date
2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269465
Title
Atinvicitinib: Toxicity Study by Oral Gavage Administration to Han Wistar Rats for 4 Weeks. MSD Animal Health Study No. S20238-00-JKD-TOX-RO.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269466
Title
Atinvicitinib: Toxicity Study by Oral Administration to Han Wistar Rats for 13 Weeks. MSD Animal Health Study No. S20250-00-JKD-TOX-RO.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269467
Title
Atinvicitinib: Maximum Tolerated Dose Study in the New Zealand White Rabbit by Oral Gavage Administration. MSD Animal Health Study No. S19234-00-JKD-TOX-NA.
Study date
2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269468
Title
In vitro Skin Irritation Test with Atinvicitinib using a Human Skin Model. MSD Animal Health Study No. S20125-00-JKD-TOX-NA.
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269469
Title
In vitro Skin Corrosion Test with Atinvicitinib using a Human Skin Model. MSD Animal Health Study No. S20124-00-JKD-TOX-NA.
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269470
Title
Assessment of Skin Sensitization to Atinvicitinib in the Mouse (Local Lymph Node Assay). MSD Animal Health Study No. S20127-00-JKD-TOX-RO.
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Date
Application Date
Application No
Application Number
142673
Product/Active constituent Name
Application Product Name
ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE L: 21.6 MG ATINVICITINIB
Application Date
Application Number
142673
Application Product Name
ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE L: 21.6 MG ATINVICITINIB
Application details
Product name:
ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE L: 21.6 MG ATINVICITINIB
Product number:
94530
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of 30 g/kg Atinvicitinib Oral Tablets for Dogs for the control of pruritus associated with allergic and atopic dermatitis in dogs in conjunction with approval of the active constituent Atinvicitinib.
Description of data provided:
Data no
266228
Title
Atinvicitinib Oral Tablets for Dogs Application Executive Summary.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Date
Application Date
Application No
Application Number
142674
Product/Active constituent Name
Application Product Name
ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE M: 7.2 MG ATINVICITINIB
Application Date
Application Number
142674
Application Product Name
ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE M: 7.2 MG ATINVICITINIB
Application details
Product name:
ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE M: 7.2 MG ATINVICITINIB
Product number:
94531
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of 30 g/kg Atinvicitinib Oral Tablets for Dogs for the control of pruritus associated with allergic and atopic dermatitis in dogs in conjunction with approval of the active constituent Atinvicitinib.
Description of data provided:
Data no
266229
Title
Atinvicitinib Oral Tablets for Dogs Application Executive Summary.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia