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
145832
Product/Active constituent Name
Application Product Name
IMTRADE FULCRUM VERIPHY DC INSECTICIDE
Application Date
Application Number
145832
Application Product Name
IMTRADE FULCRUM VERIPHY DC INSECTICIDE
Application details
Product name:
IMTRADE FULCRUM VERIPHY DC INSECTICIDE
Product number:
95491
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 186g/L ACETAMIPRID + 124g/L PYRIPROXYFEN dispersible concentrate product for the control of various pests in Avocados, Citrus, Grapevines, Macadamias and Mango crops and Suppression only of Mediterranean Fruit Fly and Queensland Fruit Fly as specified in the Directions for Use table.
Reference details:
80807 - TRIVOR INSECTICIDE
Active constituents:
Active constituent name
84541 - Acetamiprid
Active constituent name
67716 - PYRIPROXYFEN
Active constituent name
93992 - PYRIPROXYFEN
Description of data provided:
Data no
279444
Title
CoA Acetamiprid Tech
Study date
13/07/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279445
Title
CoA Pyriproxyfen Tech
Study date
10/12/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
285344
Title
CoA - Pyriproxyfen Tech
Study date
08/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279442
Title
Imtrade Acetamiprid 186 + Pyriproxyfen 124 DC Method Validation ??? Mar 2023
Study date
02/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279441
Title
Imtrade Acetamiprid 186 + Pyriproxyfen 124 DC - 1 Batch Analysis ??? Mar 2023
Study date
02/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279439
Title
Method of Manufacture - Imtrade FULCRUM?? VeripHy?? DC Insecticide
Study date
13/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279443
Title
Safety Data Sheets for other Constituents
Study date
02/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
282986
Title
SDS - TERIC 62 Version 2.0
Study date
23/12/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
282987
Title
SDS - TERSPERSE 4894 - Verision 3.0
Study date
17/12/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279446
Title
Argument to satisfy Section 14(3) AgVet Chemicals Code Act 1994 in countering the commercial in confidence aspects of the reference product???s non-protected data
Study date
14/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279440
Title
Formulation and Stability Report - Imtrade FULCRUM?? VeripHy?? DC Insecticide
Study date
13/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279447
Title
Investigation of the Bio-equivalency of IMTRADE FULCRUM?? VeripHy?? DC INSECTICIDE compared to TRIVOR INSECTICIDE for the control of Scale in Lime cv. Tahitian. ??? One Trial, Childers QLD.
Study date
29/01/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279448
Title
Investigation into the Bio-equivalency of IMTRADE FULCRUM?? VeripHy?? DC INSECTICIDE to TRIVOR INSECTICIDE for the control of Red Scale in Orange cv. Valencia. ??? One Trial, Gingin WA.
Study date
16/09/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279449
Title
Investigation of the Bio-equivalency of IMTRADE FULCRUM?? VeripHy?? DC INSECTICIDE to TRIVOR INSECTICIDE for the control of Red Scale in Lemon cv. Eureka. ??? One Trial, Gingin WA.
Study date
18/09/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279450
Title
Investigation of the Bio-equivalency of IMTRADE FULCRUM?? VeripHy?? DC INSECTICIDE in comparison to TRIVOR INSECTICIDE for the control of Mango Scale in Mango cv. R2 ??? One Trial, Gingin WA.
Study date
17/10/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279451
Title
Investigation into the Bio-Equivalency of IMTRADE FULCRUM?? VeripHy?? DC INSECTICIDE to that of TRIVOR INSECTICIDE for the control of Pink Wax Scale in Avocado cv. Hass. ??? One Trial, Childers QLD.
Study date
11/07/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279452
Title
Investigation into the Bio-equivalency of IMTRADE FULCRUM?? VeripHy?? DC INSECTICIDE to that of TRIVOR INSECTICIDE for the control of White Mango Scale in Mango cv. Kensington Pride. ??? One Trial, Childers QLD.
Study date
05/07/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279453
Title
Investigation of the Bio-equivalency of IMTRADE FULCRUM?? VeripHy?? DC INSECTICIDE to that of TRIVOR INSECTICIDE for the control of insect pests in Macadamia cv. A38. ??? One Trial, Redridge QLD.
Study date
06/09/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279454
Title
Comments to support Efficacy and HCS data submitted
Study date
22/10/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
282985
Title
Imt FULCRUM? Veriphy? DC Insecticide - RLP_V1 updated 13/11/24
Study date
13/11/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
145886
Product/Active constituent Name
Application Product Name
Owtbac Abamax Plus Broad Spectrum Antiparasitic Oral Drench for Sheep and Lambs
Application Date
Application Number
145886
Application Product Name
Owtbac Abamax Plus Broad Spectrum Antiparasitic Oral Drench for Sheep and Lambs
Application details
Product name:
Owtbac Abamax Plus Broad Spectrum Antiparasitic Oral Drench for Sheep and Lambs
Product number:
95503
Applicant Name:
OWTBAC AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 2.0 g/L Abamectin and 1.0 g/L Selenium (as sodium selenate) oral solution for the treatment and control of abamectin sensitive strains of gastrointestinal roundworms and lungworm in sheep, including benzimidazole and levamisole resistant strains.
For the treatment and control of nasal bot in sheep.
For the treatment and prevention of selenium deficiencies in sheep.
Reference details:
58389 - VETMEC LV PLUS SELENIUM ORAL DRENCH FOR SHEEP
Active constituents:
Active constituent name
82843 - ABAMECTIN
Active constituent name
57604 - SODIUM SELENATE
Description of data provided:
Data no
280642
Title
CoA Abamectin
Study date
19/01/2023
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
280640
Title
CoA Sodium Selenate
Study date
12/2020
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
282799
Title
Product specifications
Study date
January 2025
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
282800
Title
Formulation composition
Study date
January 2025
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
280641
Title
Product Specifications: Abamectin Plus Selenium LV Oral Drench for Sheep
Study date
2024
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
279827
Title
Method of Manufacture
Study date
10/2024
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
282801
Title
s159 responses
Study date
January 2025
Auth party contact address
11 Condor Street Hawthorn East Australia
Date
Application Date
Application No
Application Number
145839
Product/Active constituent Name
Application Product Name
Closantel sodium
Application Date
Application Number
145839
Application Product Name
Closantel sodium
Application details
Product name:
Closantel sodium
Active name:
Closantel sodium
Applicant Name:
ALLEVA ANIMAL HEALTH LTD
Application purpose and description of use:
New source of pharmacopoeia active constituent.
Description of data provided:
Data no
280143
Title
Certificates of analysis
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
280144
Title
Certificates of analysis
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
280145
Title
Certificates of analysis
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Date
Application Date
Application No
Application Number
145838
Product/Active constituent Name
Application Product Name
REFLEX-XTRA BROAD SPECTRUM DRENCH FOR SHEEP WITH BARBERS POLE LONG ACTION
Application Date
Application Number
145838
Application Product Name
REFLEX-XTRA BROAD SPECTRUM DRENCH FOR SHEEP WITH BARBERS POLE LONG ACTION
Application details
Product name:
REFLEX-XTRA BROAD SPECTRUM DRENCH FOR SHEEP WITH BARBERS POLE LONG ACTION
Product number:
95493
Applicant Name:
ALLEVA ANIMAL HEALTH LTD
Application purpose and description of use:
Registration of 50 g/L closantel and 1 g/L abamectin drench product for the control and treatment of roundworms, nasal bot, itch mite and mature & late immature liver fluke in sheep.
Reference details:
63259 - AVOMEC DUEL BROAD SPECTRUM DRENCH FOR SHEEP WITH BARBERS POLE LONG ACTION
Active constituents:
Active constituent name
93344 - Abamectin
Description of data provided:
Data no
280652
Title
Certificates of analysis
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
279463
Title
Formulation
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
279464
Title
Product specifications
Study date
2025
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Date
Application Date
Application No
Application Number
146297
Product/Active constituent Name
Application Product Name
Randlab Glycosan Injection
Application Date
Application Number
146297
Application Product Name
Randlab Glycosan Injection
Application details
Product name:
Randlab Glycosan Injection
Product number:
95539
Applicant Name:
RANDLAB AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a Randlab Glycosan Injection containing 120mg/mL N-Acetylglucosamine, 75mg/mL Pentosan
Polysulfate Sodium, and 3mg/mL Sodium Hyaluronate as an aid in the treatment of non-infectious inflammatory joint disease in horses.
Reference details:
65881 - NV PENTOSAN EVOLUTION INJECTION FOR HORSES
Active constituents:
Active constituent name
89209 - N-ACETYL-GLUCOSAMINE
Active constituent name
83629 - Pentosan Polysulfate Sodium
Active constituent name
83586 - Sodium Hyaluronate
Description of data provided:
Data no
280149
Title
Finished Product Specification
Study date
28.10.2024
Auth party contact address
71 Milperra Road Revesby Australia
Data no
286028
Title
FPS Randlab Glycosan Injection for Horses v4
Study date
07 April 2025
Auth party contact address
-
Data no
286029
Title
Covering letter dated 08 April 2025
Study date
08/04/2025
Auth party contact address
71 Milperra Road Revesby Australia
Data no
286119
Title
FPS Randlab Glycosan Injection for Horses v4
Study date
07 April 2025
Auth party contact address
-
Date
Application Date
Application No
Application Number
145764
Product/Active constituent Name
Application Product Name
CIPIOSYN
Application Date
Application Number
145764
Application Product Name
CIPIOSYN
Application details
Product name:
CIPIOSYN
Product number:
85382
Applicant Name:
SYNTEX S.A.
Application purpose and description of use:
Variation of product registration to declare in use period and label approval to include in use period.
Active constituents:
Active constituent name
85381 - Oestradiol Cypionate
Description of data provided:
Data no
279282
Title
TECHNIQUE-PTV-0020-03 Cipiosyn x 50 mL (Australia)_EN
Study date
July 07, 2023
Data no
279283
Title
TECHNIQUE-PTV-0019-04 Cipiosyn x 100 mL (Australia)_EN
Study date
June 24, 2023
Data no
279284
Title
Cipiosyn x 50 mL _ Australia__TEC_PTV_0020_CNC - ESPANOL
Study date
July 07, 2023
Data no
279285
Title
Cipiosyn x 100 mL _ Australia__TEC_PTV_0019_CNC - ESPANOL
Study date
June 24, 2023
Data no
279280
Title
SPECIFICATION_PTV_0020_03 Cipiosyn x 50 mL _ Australia_EN
Study date
July 19, 2023
Data no
279281
Title
SPECIFICATION_PTV_0019_03 Cipiosyn x 100 mL _ Australia_EN
Study date
July 18, 2023
Data no
296489
Title
Cipiosyn_ Australia_EN_SPECIFICATION
Study date
2025
Data no
290510
Title
INF-EST-CI-002-03 In-use Test CI0321 34 m - EN
Study date
Mar 25
Data no
279272
Title
INF-EST-CI-001-02 In-use Test Stability Report Cipiosyn x 50ml CI0221
Study date
September 02, 2024
Data no
279273
Title
INF-EST-CI-001-02 Reporte de Estabilidad Test de Uso Cipiosyn x 50ml CI0221
Study date
September 02, 2024
Data no
279274
Title
INF-EST-CY-001-02 In-use Test Stability Report Cipiosyn x 100ml CY0221
Study date
September 02, 2024
Data no
279275
Title
INF-EST-CY-001-02 Reporte de Estabilidad Test de Uso Cipiosyn x 100ml CY0221
Study date
September 02, 2024
Data no
279276
Title
EST-RD-CI-002-03 In-use Stability Protocol Cipiosyn x 50 mL
Study date
August 28, 2024
Data no
279277
Title
EST-RD-CI-002-03 Protocolo Estabilidad en uso Cipiosyn x 50 mL
Study date
August 28, 2024
Data no
279278
Title
EST-RD-CY-002-02 In-use Stability Protocol Cipiosyn x 100 mL
Study date
August 28, 2024
Data no
279279
Title
EST-RD-CY-002-02 Protocolo Estabilidad en uso Cipiosyn x 100 mL
Study date
August 28, 2024
Data no
290511
Title
Answer to observations from APVMA
Study date
2025
Data no
290512
Title
Drug & health product inspections
Study date
2025
Data no
290513
Title
Draft Part 11 of application form - Manufacturers details
Study date
2025
Data no
290514
Title
Certificate of GMP-1
Study date
2025
Data no
290515
Title
GMP certficate - 2
Study date
2025
Data no
291569
Title
Answer to observations from APVMA_01.09.25
Study date
2025
Date
Application Date
Application No
Application Number
145844
Product/Active constituent Name
Application Product Name
Skin2P Body No Perfume
Application Date
Application Number
145844
Application Product Name
Skin2P Body No Perfume
Application details
Product name:
Skin2P Body No Perfume
Product number:
93558
Applicant Name:
CALLINGTON HAVEN PTY LTD
Application purpose and description of use:
Variation of product claims and label approval to "Up to 8 HOURS long lasting protection against mosquitoes Repels mosquitoes, flies, sandflies, ticks & other biting insects".
Active constituents:
Active constituent name
44493 - PICARIDIN
Date
Application Date
Application No
Application Number
145845
Product/Active constituent Name
Application Product Name
Skin2P Body
Application Date
Application Number
145845
Application Product Name
Skin2P Body
Application details
Product name:
Skin2P Body
Product number:
93559
Applicant Name:
CALLINGTON HAVEN PTY LTD
Application purpose and description of use:
Variation of product claims and label approval to "Up to 8 HOURS long lasting protection against mosquitoes
Repels mosquitoes, flies, sandflies, ticks & other biting insects"..
Active constituents:
Active constituent name
44493 - PICARIDIN
Date
Application Date
Application No
Application Number
145757
Product/Active constituent Name
Application Product Name
HYDROXOCOBALAMIN ACETATE
Application Date
Application Number
145757
Application Product Name
HYDROXOCOBALAMIN ACETATE
Application details
Product name:
HYDROXOCOBALAMIN ACETATE
Active name:
HYDROXOCOBALAMIN ACETATE
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Approval of HYDROXOCOBALAMIN ACETATE for use in veterinary chemical products.
Description of data provided:
Data no
279236
Title
Active constituent manufacturers list
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
279237
Title
Active Constituent Batch Analyses
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
279234
Title
Active constituent monograph
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
279235
Title
Active constituent specifications
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
145751
Product/Active constituent Name
Application Product Name
MILBEMAX TASTY CHEWS FOR SMALL DOGS AND PUPPIES
Application Date
Application Number
145751
Application Product Name
MILBEMAX TASTY CHEWS FOR SMALL DOGS AND PUPPIES
Application details
Product name:
MILBEMAX TASTY CHEWS FOR SMALL DOGS AND PUPPIES
Product number:
66278
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product label approval to increase dose frequency, enhance clarity and incorporate sustainability initiatives in disposal section.
Active constituents:
Active constituent name
84391 - PRAZIQUANTEL
Date
Application Date
Application No
Application Number
145793
Product/Active constituent Name
Application Product Name
Defend Extra Spray-on Sheep Blowfly Treatment
Application Date
Application Number
145793
Application Product Name
Defend Extra Spray-on Sheep Blowfly Treatment
Application details
Product name:
Defend Extra Spray-on Sheep Blowfly Treatment
Product number:
95482
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Registration of a 65g/L dicycanil emulsion product for the protection of sheep, either off-shears or with any length wool, against fly strike (caused by dicyclanil-susceptible strains of blowflies (Lucilia cuprina)), for up to 29 weeks. For the protection of mulesing and marking wounds on sheep against fly strike (caused by dicyclanil-susceptible strains of blowflies (Lucilia cuprina)), during the wound healing process.
Reference details:
91837 - CLiK Extra Spray-On Sheep Blowfly Treatment
Active constituents:
Active constituent name
86855 - DICYCLANIL
Description of data provided:
Data no
279367
Title
Product Specification
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
284516
Title
Product Specification
Study date
2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
284517
Title
Correspondence
Study date
2025
Data no
284515
Title
s159 response
Study date
14.2.2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
145736
Product/Active constituent Name
Application Product Name
Spirotetramat
Application Date
Application Number
145736
Application Product Name
Spirotetramat
Application details
Product name:
Spirotetramat
Active name:
Spirotetramat
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Approval of a new source of spirotetramat for use in agricultural chemical products.
Description of data provided:
Data no
279931
Title
Spirotetramate technical ??? assay and impurities methods partial validation and 5 batch analysis
Study date
30/01/2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
279933
Title
Safety Data Sheet (SDS) - For the constituents used in formulation of Spirotetramate Technical
Study date
15/09/2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
279934
Title
Manufacturing Process ??? Spirotetramat technical
Study date
May 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
279932
Title
Safety Data Sheet ??? Spirotetramat technical
Study date
20/05/2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
279930
Title
Part 2 - Chemistry and Manufacture
Study date
Oct 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date
Application Date
Application No
Application Number
145747
Product/Active constituent Name
Application Product Name
MILBEMAX TASTY CHEWS FOR DOGS
Application Date
Application Number
145747
Application Product Name
MILBEMAX TASTY CHEWS FOR DOGS
Application details
Product name:
MILBEMAX TASTY CHEWS FOR DOGS
Product number:
66277
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product label approval to increase dose frequency, enhance clarity and incorporate sustainability initiatives in disposal section.
Active constituents:
Active constituent name
84391 - PRAZIQUANTEL
Date
Application Date
Application No
Application Number
145729
Product/Active constituent Name
Application Product Name
fluxapyroxad
Application Date
Application Number
145729
Application Product Name
fluxapyroxad
Application details
Product name:
fluxapyroxad
Active name:
fluxapyroxad
Applicant Name:
CROPNOSYS INDIA PRIVATE LIMITED
Application purpose and description of use:
Approval of fluxapyroxad for use in agricultural chemical products.
Description of data provided:
Data no
279908
Title
Five Batch Analysis of FLUXAPYROXAD Technical Study No: AG-G3368
Study date
8 September 2024
Auth party contact address
9th Floor, Northstar Yelahanka Bengaluru India
Data no
279910
Title
Declaration of Composition
Study date
September 2024
Auth party contact address
9th Floor, Northstar Yelahanka Bengaluru India
Data no
279909
Title
Fluxapyroxad formulation process
Study date
September 2024
Auth party contact address
9th Floor, Northstar Yelahanka Bengaluru India
Data no
279907
Title
Part 2 Chemistry and Manufacture
Study date
September 2024
Auth party contact address
9th Floor, Northstar Yelahanka Bengaluru India
Date
Application Date
Application No
Application Number
145770
Product/Active constituent Name
Application Product Name
DORMIDINE INJECTION FOR DOGS AND CATS
Application Date
Application Number
145770
Application Product Name
DORMIDINE INJECTION FOR DOGS AND CATS
Application details
Product name:
DORMIDINE INJECTION FOR DOGS AND CATS
Product number:
95476
Applicant Name:
VETPHARM LABORATORIES IP PTY LTD
Application purpose and description of use:
Registration of 1 mg/mL medetomidine hydrochloride injectable product for use as sedative or analgesic in the restraint of dogs and cats.
Reference details:
40613 - DOMITOR SEDATIVE AND ANALGESIC FOR DOGS AND CATS
Active constituents:
Active constituent name
85832 - MEDETOMIDINE HYDROCHLORIDE
Description of data provided:
Data no
279298
Title
Product specifications
Study date
2024
Auth party contact address
7/20 St Johns Avenue GORDON Australia
Data no
294268
Title
Agvet chemical voluntary safety recall
Study date
2023
Auth party contact address
-
Data no
294269
Title
Summary of product characteristics
Study date
2017
Auth party contact address
-
Data no
294270
Title
Summary of product characteristics
Study date
2016
Auth party contact address
-
Data no
294271
Title
Veterinary Drug Handbook ? Medetomidine
Study date
2017
Auth party contact address
-
Data no
294272
Title
Medetomidine
Study date
2017
Auth party contact address
-
Data no
294273
Title
s8S response
Study date
2025
Auth party contact address
7/20 St Johns Avenue GORDON Australia
Date
Application Date
Application No
Application Number
145914
Product/Active constituent Name
Application Product Name
SUMITOMO SHIELD SYSTEMIC INSECTICIDE
Application Date
Application Number
145914
Application Product Name
SUMITOMO SHIELD SYSTEMIC INSECTICIDE
Application details
Product name:
SUMITOMO SHIELD SYSTEMIC INSECTICIDE
Product number:
60689
Applicant Name:
SUMITOMO CHEMICAL AUSTRALIA PTY. LIMITED
Application purpose and description of use:
Variation of product registration and label approval to extend the use to include Soybeans, Mung beans and Navy beans for the control of Green vegetable bug, Redbanded shield bug and Brown shield bug.
Active constituents:
Active constituent name
54438 - CLOTHIANIDIN
Active constituent name
66933 - CLOTHIANIDIN
Active constituent name
86719 - CLOTHIANIDIN
Description of data provided:
Data no
280171
Title
Evaluation of Shield (20% clothianidin) against Green vegetable bug Nezara viridula, Redbanded shield bug Piezodorus oceanicus and Brown stink bug Dictyotus caenosus in soybeans. [I09-004-5008-SOY]
Study date
2009
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280172
Title
Shield Evaluation trial GRDC Project DAQ00153 DEEDI Kingaroy 2010. [I10-010-5008-SOY]
Study date
2010
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280173
Title
The evaluation of SCAL 5008 for efficacy and safety in Soybeans. Oakey, Queensland, 4401. 2024.[I23-004-5008-SOY]
Study date
May-2024
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280174
Title
The evaluation of SCAL 5008 for efficacy and safety in Soybeans. Condong, New South Wales, 2484. 2024.[I23-005-5008-Soy]
Study date
May-24
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280175
Title
The evaluation of SCAL 5008 for efficacy and safety in Mung beans. Foreset Hill, Queensland, 4342. 2024.[I23-006-5008-MUNG]
Study date
May-24
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280176
Title
The evaluation of SCAL 5008 for efficacy and safety in Mung beans. Clifton, Queensland, 4361 2024. [I23-007-5008-MUNG]
Study date
May-24
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280177
Title
Efficacy and Crop Safety of SCAL 5008 on Pod Sucking Bugs in Soybean. Gin Gin, Wide Bay Burnett QLD 2023.[I23-009-5008-SOY]
Study date
May-24
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280178
Title
Efficacy and Crop Safety of SCAL 5008 on Pod Sucking Bugs in Mung bean. Gin Gin, Wide Bay Burnett QLD 2023. [I23-010-5008-MUNG]
Study date
May-24
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280180
Title
EVALUATION OF TI435 (CLOTHIANIDIN) AND SUMI ALPHA FLEX (ESFENVALERATE) FOR THE CONTROL OF GREEN VEGETABLE BUGS (Nezara veridula) IN SOYBEANS. ONE TRIAL, GUNNEDAH, NEW SOUTH WALES, AUSTRALIA, 2003. [I02-104-435-SOY]
Study date
Jun 2023
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280181
Title
EVALUATION OF SCAL-5008 FOR THE CONTROL OF GREEN VEGETABLE BUGS (Nezara viridula) IN MUNGBEANS. ONE TRIAL, NEW SOUTH WALES, AUSTRALIA, 2008. [I08-002-5008-COT]
Study date
16-Jul-2008
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
287422
Title
29-May-2025 Response to S159 Efficacy questions - SUMITOMO SHIELD SYSTEMIC INSECTICIDE. [29-May-2025 Response to S159]
Study date
29-May-2025
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280182
Title
Shield Systemic Insecticide DC14-64606168 Part 8 Efficacy and Crop safety
Study date
29-Oct-2024
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280188
Title
Sumitomo Shield Systemic Insecticide draft label
Study date
28-Oct-2024
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280189
Title
Sumitomo Shield Systemic Insecticide draft label highlighted
Study date
28-Oct-2024
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280179
Title
Skope weblabel Dec 2020
Study date
Dec 2020
Auth party contact address
-
Data no
280187
Title
Pre-application assistance ( APVMA written assistance Sumitomo Chemical Australia Pty Limited SUMITOMO SHIELD SYSTEMIC INSECTICIDE. [PAA 134428]
Study date
4-May-2022
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280185
Title
Clothianidin Residues on Soybean and Soybean Processed Commodities from Trials Conducted in the United States in 2007. [THR-0585]
Study date
25-Apr-2008
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280186
Title
DETERMINATION OF RESIDUES OF CLOTHIANIDIN IN MUNG BEANS AND SOY BEANS AFTER TWO FOLIAR APPLICATIONS WITH A 14 DAY RETREATMENT INTERVAL AND 21 DAY WITHHOLDING PERIOD AUSTRALIA, 2023-2024. [S23-0409]
Study date
22-Aug-2024
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280183
Title
Shield Systemic Insecticide DC14-64606168 Part 5 Residues
Study date
29-Oct-2024
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
280184
Title
Shield Systemic Insecticide DC14-64606168 Part 5b Trade
Study date
29-Oct-2024
Auth party contact address
51 RAWSON STREET EPPING Australia
Date
Application Date
Application No
Application Number
146304
Product/Active constituent Name
Application Product Name
Blindside XLR8 Yield & Quality Enhancer
Application Date
Application Number
146304
Application Product Name
Blindside XLR8 Yield & Quality Enhancer
Application details
Product name:
Blindside XLR8 Yield & Quality Enhancer
Product number:
95544
Applicant Name:
CROP CULTURE PTY LTD
Application purpose and description of use:
Registration of a 250 g/L trinexapac-ethyl emulsifiable concentrate product to Increases Yield in Ryegrass Seed Crops, Improves the Percent of Thebaine in Poppies and Increases the CCS in Sugarcane.
Reference details:
67883 - POTUS YIELD & QUALITY ENHANCER
Active constituents:
Active constituent name
65916 - TRINEXAPAC-ETHYL
Description of data provided:
Data no
280600
Title
CoA - Trinexapac-ethyl TC
Study date
14 June 2024
Auth party contact address
43 Gap Road Sunbury Australia
Date
Application Date
Application No
Application Number
146343
Product/Active constituent Name
Application Product Name
Briskway Growth Regulator
Application Date
Application Number
146343
Application Product Name
Briskway Growth Regulator
Application details
Product name:
Briskway Growth Regulator
Product number:
95559
Applicant Name:
TURF CULTURE PTY LTD
Application purpose and description of use:
Registration of a 250 g/L trinexapac-ethyl emulsifiable concentrate product for the reduction of leaf and stem growth of grass species, as an aid in turf management, and as an aid in winter grass management.
Reference details:
64369 - ASTRO 250 EC GROWTH REGULATOR
Active constituents:
Active constituent name
65916 - TRINEXAPAC-ETHYL
Description of data provided:
Data no
280602
Title
CoA - Trinexapac-ethyl TC
Study date
14 June 2024
Auth party contact address
43 Gap Road Sunbury Australia
Date
Application Date
Application No
Application Number
146302
Product/Active constituent Name
Application Product Name
FARMALINX STUKA FLEXI HERBICIDE
Application Date
Application Number
146302
Application Product Name
FARMALINX STUKA FLEXI HERBICIDE
Application details
Product name:
FARMALINX STUKA FLEXI HERBICIDE
Product number:
66952
Applicant Name:
FARMALINX PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to extend the pack range.
Active constituents:
Active constituent name
53929 - PICLORAM
Date
Application Date
Application No
Application Number
145577
Product/Active constituent Name
Application Product Name
Double Nozzle Technology Raid Max Multi-Insect Killer
Application Date
Application Number
145577
Application Product Name
Double Nozzle Technology Raid Max Multi-Insect Killer
Application details
Product name:
Double Nozzle Technology Raid Max Multi-Insect Killer
Product number:
95419
Applicant Name:
S.C. JOHNSON & SON PTY LTD
Application purpose and description of use:
Registration of a 1.0 g/kg transfluthrin, 0.3 g/kg imiprothrin aerosol insecticide for the control of flying and crawling insects in household situations.
Reference details:
91308 - Mortein Powergard Multi Insect Killer
89092 - Double Nozzle Technology Raid Max Multi Insect Killer
91281 - ATLAS KILL & PROTECT HIGH PERFORMANCE INDOOR FLY & MOSQUITO SHIELD
86370 - Hovex Vaporgard Multi Insect Killer
70363 - RAID MAX AUTOMATIC ADVANCED MULTI-INSECT SYSTEM
58663 - BAYGON ODOURLESS FLYING INSECT SPRAY
90265 - MORTEIN POWERGARD MULTI INSECT KILLER DUAL PROTECTION SPRAY
88192 - Mortein Powergard The Expert's Multi Insect Killer Household Protection
61609 - MORTEIN KABOOM! ALL INSECT KILLER HOUSEHOLD PROTECTION
Active constituents:
Active constituent name
50876 - IMIPROTHRIN MANUFACTURING CONCENTRATE
Active constituent name
47544 - TRANSFLUTHRIN
Description of data provided:
Data no
279402
Title
Example Batch Analyses for active constituents
Study date
29 July 2024
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279407
Title
Method Validation for the determination of transfluthrin and imiprothrin in MIK EMMA* (ACS-VR-373)
Study date
23 January 2024
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279404
Title
Manufacturing Process
Study date
13 February 2024
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279405
Title
Certificate of Analysis Double Nozzle Technology Raid Max Multi-Insect Killer
Study date
15 May 2024
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279403
Title
MSDSs and specifications for constituents
Study date
26 March 2012
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279408
Title
Safety Data Sheet
Study date
24 September 2024
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279421
Title
Summary Part 2 Chemistry and Manufacture
Study date
September 2024
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
279406
Title
Stability testing of Double Nozzle Technology Raid Max Multi-Insect Killer
Study date
July 2024
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279411
Title
Direct Spray Efficacy of a Test Substance (Study Number EM-SB E4)
Study date
9 May 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279412
Title
Direct Spray Efficacy of a Test Substance (Study Number EM-SB E16)
Study date
13-September-2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279413
Title
Direct Spray Efficacy of a Test Substance (Study Number EM-SB E3)
Study date
09-May-2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279414
Title
Laboratory Study to Determine the Direct Spray Efficacy of Two Aerosol Formulations Against the Coastal Brown Ant and the Black House Ant
Study date
10-August-2024
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279415
Title
Direct Spray Efficacy of a Test Substance (Study Number EM-SB E1)
Study date
09-May-2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279416
Title
Direct Spray Efficacy of a Test Substance (Study Number EM-SB E2)
Study date
28-November-2022
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279417
Title
Peet-Grady Chamber Study to Compare the Efficacy of Two Aerosol Formulations as a Space Spray Treatment Against Musca domestica, Culex quinquefasciatus and Aedes aegypti
Study date
24-August-2024
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279418
Title
Laboratory study to determine the residual efficacy of two aerosol formulations against common Australian domestic mosquitoes (Culex quinquefasciatus and Aedes aegypti)
Study date
29-August-2024
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279419
Title
Direct Spray Efficacy of a Test Substance (Study Number EM-SB E10)
Study date
09-May-2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279420
Title
Efficacy explanatory document
Study date
September-2024
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279475
Title
Space Spray Efficacy of a Test Substance (Study Number EM-SB E7)
Study date
9 May 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279476
Title
Direct Spray Efficacy of a Test Substance (Study Number EM-SB E5)
Study date
9 May 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279477
Title
Space Spray Efficacy of a Test Substance (Study Number EM-SB E6)
Study date
9 May 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279478
Title
Space Spray Efficacy of a Test Substance in a Large Chamber with Curtain Barriers and Covered Tables (Study Number EM-SB E13)
Study date
9 May 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279479
Title
Direct Spray Efficacy of a Test Substance (Study Number EM-SB E12)
Study date
9 May 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279480
Title
Direct Spray Efficacy of a Test Substance (Study Number EM-SB E8)
Study date
9 May 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279423
Title
Summary Part 8 Efficacy and Safety
Study date
September 2024
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
279470
Title
EM-SB Act. Int.: Acute Dermal Toxicity in Rats
Study date
4 March 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279472
Title
EM-SB: Primary Eye Irritation in Rabbits
Study date
4 March 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279471
Title
EM-SB Act. Int.: Acute Inhalation Toxicity in Rats
Study date
4 March 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
296159
Title
Tox Technical Response Letter
Study date
24 September 2024
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279469
Title
EM-SB Act. Int.: Acute Oral Toxicity ??? Up-And-Down Procedure in Rats
Study date
4 March 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279473
Title
EM-SB Act. Int.: Primary Skin Irritation in Rabbits
Study date
4 March 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279474
Title
EM-SB Act. Int.: Dermal Sensitization Test in Guinea Pigs - Buehler Method
Study date
4 March 2019
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
279422
Title
Summary Part 3 Toxicology
Study date
September 2024
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
279409
Title
Toxicological Database
Study date
September 2024
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
279410
Title
Toxicological explanatory document
Study date
2 September 2024
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.