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
151413
Product/Active constituent Name
Application Product Name
APPEAR II Turf Fungicide
Application Date
Application Number
151413
Application Product Name
APPEAR II Turf Fungicide
Application details
Product name:
APPEAR II Turf Fungicide
Product number:
96981
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 335 g/L phosphorous acid present as the mono-di-potassium phosphite in a soluble liquid formulation product for the prevention and control of diseases caused by Pythium spp. in turf.
Reference details:
87962 - Kenso Agcare Ken-Fos 600 Systemic Fungicide
48147 - M-DKP FOLI-R-FOS 400 FUNGICIDE
54430 - AGRI-FOS 600 SYSTEMIC FUNGICIDE
Description of data provided:
Data no
300257
Title
Appear Xtra: Storage Stability Study
Study date
2 May 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300240
Title
Appear II -Part 8 ??? Efficacy and Crop Safety
Study date
9 Dec 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300280
Title
STAMINA: ACUTE TOXICITY TO THE APHID PARASITOID, APHIDIUS RHOPALOSIPHI (HYMENOPTERA, BRACONIDAE) DE STEFANI- PEREZ IN THE LABORATORY
Study date
2001
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300246
Title
Equivalency of Two Fungicide formulations for Pythium Control and Colour
Study date
16 Nov 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300266
Title
Potassium phosphite: Reverse Mutation Assay "Ames Test" Using Salmonella Typhimurium and Escherichia Coli
Study date
18 Oct 1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300260
Title
Vital Green 3: Acute Oral Toxicity Up and Down Procedure in Rats
Study date
11 Oct 2010
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300237
Title
Conclusion on the peer review of the pesticide risk assessment of the active substance potassium phosphonates
Study date
12 June 2013
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300277
Title
POTASSIUM PHOSPHONATES TK: A STUDY ON THE TOXICITY TO FRESHWATER GREEN ALGAE (RAPHIDOCELIS SUBCAPITATA)
Study date
2022
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300269
Title
POTASSIUM PHOSPHITE: AN ACUTE ORAL TOXICITY STUDY WITH THE NORTHERN BOBWHITE
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300243
Title
Demonstrate the efficacy of Appear fungicide to prevent various forms of Pythium spp. in turf and compare to the industry standard phosphonate fungicides.
Study date
28 Aug 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300263
Title
Potassium phosphite: Acute Dermal Irritation Test in the Rabbit
Study date
4 Mar 1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300249
Title
Efficacy of two fungicide formulations for Pythium spp. control and colour.
Study date
5 July 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300238
Title
Ecological Risk Assessment in support of the registration of Vita Green XTRA (EPA 42519-GO) containing 49.41% mono and di potassium salts of phosphorus acid as its active ingredient
Study date
22 Feb 2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300278
Title
POTASSIUM PHOSPHITE: AN ACUTE ORAL TOXICITY STUDY WITH THE HONEY BEE
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300244
Title
Demonstrate the efficacy of Appear fungicide to prevent various forms of Pythium spp. in turf and compare to the industry standard phosphonate fungicides.
Study date
28 Aug 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300252
Title
Manufacturing procedure for Vital Green Xtra
Study date
Jul 2025
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300264
Title
Vital Green 3: Primary Eye Irritation Study in Rabbits
Study date
11 Oct 2010
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300281
Title
ACUTE TOXICITY OF POTASSIUM PHOSPHITE(LBG-01F34) ON EARTHWORMS, EISENIA FETIDA USING AN ARTIFICIAL SOIL TEST
Study date
2006
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300258
Title
Declaration concerning physical chemistry properties of safety items
Study date
2 May 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300235
Title
Final Human Health Risk Assessment in support of the registration of Vita Green XTRA (EPA 42519-GO) containing 49.41% mono and di potassium salts of phosphorus acid (potassium phosphite) as its active ingredient (A.I.)
Study date
1 Mar 2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300275
Title
POTASSIUM PHOSPHITE: A TOXICITY TEST TO DETERMINE THE EFFECTS OF THE TEST SUBSTANCE ON VEGETATIVE VIGOR OF SIX SPECIES OF PLANTS
Study date
2008
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300241
Title
Demonstrate the efficacy of Appear fungicide to prevent various forms of Pythium spp. in turf and compare to the industry standard phosphonate fungicides.
Study date
25 Aug 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300261
Title
POTASSIUM PHOSPHITE: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT
Study date
4 Mar 1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300255
Title
Potassium phosphite technical specifications
Study date
Jul 2025
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300259
Title
Appear II - Part 3 ??? Toxicology
Study date
Dec 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300236
Title
Science Review in Support of the Registration of Potassium Phosphite Technical (EPA File 42519-GA), Containing 99% Mono- & di- Potassium Salts of Phosphorous. Review Product Chemistry, Acute Toxicity, and Non-Target Organisms Studies.
Study date
7 Oct 2011
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300276
Title
TESTING OF TOXIC EFFECTS OF STAMINA ON THE SINGLE CELL GREEN ALGA DESMODESMUS SUBSPICATUS
Study date
2001
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300270
Title
POTASSIUM PHOSPHITE: A DIETARY LC50 STUDY WITH THE NORTHERN BOBWHITE
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300250
Title
Evaluate the efficacy of A14658D on Pythium in CEU and SEU - PT (GEP)
Study date
08 March 2017
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300256
Title
Potassium phosphite specifications CoA
Study date
Jul 2025
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300239
Title
Ecological Toxicity Review for Potassium Salts of Phosphorus Acid
Study date
28 March 1997
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300273
Title
POTASSIUM PHOSPHITE: A 48-HOUR FLOWTHROUGH ACUTE TOXICITY TEST WITH THE CALDOCERAN (DAPHINA MAGNA)
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300279
Title
POTASSIUM PHOSPHITE: AN ACUTE CONTACT TOXICITY STUDY WITH THE HONEY BEE
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300247
Title
Equivalency of Two Fungicide formulations for Pythium Control and Colour
Study date
16 Nov 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300267
Title
Appear II - Part 6 ??? Occupational Health and Safety
Study date
16 Dec 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300253
Title
Vital Green Xtra - formulation composition
Study date
Jul 2025
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300234
Title
Vital Green Extra: Acute Toxicology Summary
Study date
2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300282
Title
EFFECTS OF POTASSIUM PHOSPHONATES TK ON THE REPRODUCTION OF THE EARTHWORM EISENIA ANDREI IN ARTIFICIAL SOIL
Study date
2022
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300274
Title
ASSESSMENT OF TOXIC EFFECTS OF POTASSIUM PHOSPHITE ON DAPHNIA MAGNA USING THE 21 DAY REPRODUCTION TEST
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300248
Title
Equivalency of Two Fungicide formulations for Pythium Control and Colour
Study date
2 Dec 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300268
Title
Appear II - Part 7.2 ????????Environmental Toxicology
Study date
Dec 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300242
Title
Demonstrate the efficacy of Appear fungicide to prevent various forms of Pythium spp. in turf and compare to the industry standard phosphonate fungicides.
Study date
24 Aug 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300262
Title
Potassium phosphite: Acute Inhalation Toxicity (Nose Only) Study in the Rat
Study date
3 Nov1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300254
Title
List of SDS
Study date
Jul 2025
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300245
Title
Demonstrate the crop safety on a variety of warm and cool season turf with Appear fungicide.
Study date
27 Aug 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300271
Title
POTASSIUM PHOSPHITE: A DIETARY LC50 STUDY WITH THE MALLARD
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300265
Title
Potassium phosphite: Magnusson & Kligman Maximization Study in the Guinea Pig
Study date
4 Mar 1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300251
Title
Appear II - Part 2 Chemistry and Manufacture
Study date
Dec 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
151690
Product/Active constituent Name
Application Product Name
Titan Titanium Herbicide
Application Date
Application Number
151690
Application Product Name
Titan Titanium Herbicide
Application details
Product name:
Titan Titanium Herbicide
Product number:
92218
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of label approval to add a new use for the control of a range of weeds with over-the-top application into XtendFlex cotton.
Reference details:
81975 - ROUNDUP READY PL HERBICIDE
81975 - Roundup Ready PL Herbicide With Plantshield Technology
Active constituents:
Active constituent name
62532 - GLYPHOSATE
Description of data provided:
Data no
300695
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
7.1.2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300701
Title
Trial ??? Titan Titanium Bioequivalence in XtendFlex Cotton
Study date
April 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300698
Title
Titan Titanium Herbicide Efficacy and Crop Safety Module 8.2
Study date
23.1.2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300693
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
16.9.2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300699
Title
Bioequivalence of Titan Titanium 570 with Roundup Ready PL with Plantshield for Weed Control and Crop Safety in XtendFlex Cotton
Study date
28.9.2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300696
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
3.12.2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300702
Title
Titan Titanium Herbicide draft label
Study date
January 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300697
Title
Titan Titanium Herbicide draft label
Study date
January 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300694
Title
To Determine the Residues of Glyphosate in XtendFlex
Study date
13.9.2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300692
Title
Titan Titanium Herbicide Residues Module 5.4
Study date
23.1.2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300700
Title
Bioequivalence of Titan Titanium 570 with Roundup Ready PL with Plantshield for Crop Safety in XtendFlex Cotton.
Study date
14.10.2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
151868
Product/Active constituent Name
Application Product Name
Genfarm Pyrox 850 WG Herbicide
Application Date
Application Number
151868
Application Product Name
Genfarm Pyrox 850 WG Herbicide
Application details
Product name:
Genfarm Pyrox 850 WG Herbicide
Product number:
91310
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Variation of product registration to adda 850 g/kg pyroxasulfone WG formulation for the pre-emergence control of annual ryegrass, barley grass, annual phalaris, silver grass and toad rush and suppression of certain grass weeds in wheat (not durum wheat), triticale and certain winter legume crops.
Reference details:
91741 - WINGER 850 WG HERBICIDE
Active constituents:
Active constituent name
90545 - Pyroxasulfone
Active constituent name
64067 - PYROXASULFONE
Active constituent name
80051 - Pyroxasulfone
Active constituent name
80847 - Pyroxasulfone
Description of data provided:
Data no
301481
Title
Supporting documentation
Study date
Feb-2026
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
301482
Title
CCI access
Study date
Feb-2026
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
150306
Product/Active constituent Name
Application Product Name
Sedator Injection
Application Date
Application Number
150306
Application Product Name
Sedator Injection
Application details
Product name:
Sedator Injection
Product number:
82623
Applicant Name:
RANDLAB AUSTRALIA PTY LTD
Application purpose and description of use:
Item 12 Appplication for the inclusion of overseas manufacturer in addition to the currently approved manufacturers in Australia.
Active constituents:
Active constituent name
83583 - Detomidine Hydrochloride
Active constituent name
83583 - Detomidine Hydrochloride
Description of data provided:
Data no
292126
Title
Certificate of GMP Manufacturer
Study date
17/02/2025
Auth party contact address
71 Milperra Road Revesby Australia
Data no
292127
Title
Finished Product Specification
Study date
03/11/2020
Auth party contact address
71 Milperra Road Revesby Australia
Date
Application Date
Application No
Application Number
151613
Product/Active constituent Name
Application Product Name
Dexmedetomidine hydrochloride
Application Date
Application Number
151613
Application Product Name
Dexmedetomidine hydrochloride
Application details
Product name:
Dexmedetomidine hydrochloride
Active name:
Dexmedetomidine hydrochloride
Applicant Name:
INTAS PHARMACEUTICALS LIMITED
Application purpose and description of use:
New source of pharmacopoeia active constituent
Description of data provided:
Data no
300334
Title
Certificates of Analysis
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Date
Application Date
Application No
Application Number
151686
Product/Active constituent Name
Application Product Name
PLEVAC PARVOVIRUS/LEPTOSPIROSIS/ERYSIPELAS VACCINE FOR PIGS
Application Date
Application Number
151686
Application Product Name
PLEVAC PARVOVIRUS/LEPTOSPIROSIS/ERYSIPELAS VACCINE FOR PIGS
Application details
Product name:
PLEVAC PARVOVIRUS/LEPTOSPIROSIS/ERYSIPELAS VACCINE FOR PIGS
Product number:
46164
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of label approval to update the product RLP.
Active constituents:
Active constituent name
85954 - Leptospira interrogans serovar pomona
Active constituent name
85955 - Porcine parvovirus
Description of data provided:
Data no
300619
Title
Cover Letter for application
Study date
January 2026
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
151946
Product/Active constituent Name
Application Product Name
ECOVACLE-E.COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
Application Date
Application Number
151946
Application Product Name
ECOVACLE-E.COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
Application details
Product name:
ECOVACLE-E.COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
Product number:
46409
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of label approval to update the product RLP.
Active constituents:
Active constituent name
85949 - Whole cell E. coli including fimbrial antigens K88, K99 and 987P
Active constituent name
85954 - Leptospira interrogans serovar pomona
Description of data provided:
Data no
301362
Title
Cover Letter for application
Study date
February 2026
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
151947
Product/Active constituent Name
Application Product Name
ECOVAC E COLI VACCINE FOR PIGS
Application Date
Application Number
151947
Application Product Name
ECOVAC E COLI VACCINE FOR PIGS
Application details
Product name:
ECOVAC E COLI VACCINE FOR PIGS
Product number:
35779
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of label approval to update the product RLP.
Active constituents:
Active constituent name
85949 - Whole cell E. coli including fimbrial antigens K88, K99 and 987P
Description of data provided:
Data no
301355
Title
Cover Letter for application
Study date
February 2026
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
151612
Product/Active constituent Name
Application Product Name
DEXMEDETOMIDINE HYDROCHLORIDE 0.5 MG/ML SOLUTION FOR INJECTION
Application Date
Application Number
151612
Application Product Name
DEXMEDETOMIDINE HYDROCHLORIDE 0.5 MG/ML SOLUTION FOR INJECTION
Application details
Product name:
DEXMEDETOMIDINE HYDROCHLORIDE 0.5 MG/ML SOLUTION FOR INJECTION
Product number:
97038
Applicant Name:
INTAS PHARMACEUTICALS LIMITED
Application purpose and description of use:
Registration of a 0.5 mg/mL dexmedetomidine hydrochloride solution for injection for sedation and analgesia in the restraint of dogs and cats.
Reference details:
64563 - DEXDOMITOR 0.5 MG/ML INJECTABLE SEDATIVE AND ANALGESIC FOR DOGS AND CATS
Active constituents:
Active constituent name
65797 - FLUROXYPYR-MEPTYL
Active constituent name
97039 - Dexmedetomidine hydrochloride
Description of data provided:
Data no
300137
Title
GMP Certificate
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
300138
Title
GMP Certificate
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
300136
Title
Product specifications
Study date
2026
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Date
Application Date
Application No
Application Number
151737
Product/Active constituent Name
Application Product Name
Alpha-Cypermethrin
Application Date
Application Number
151737
Application Product Name
Alpha-Cypermethrin
Application details
Product name:
Alpha-Cypermethrin
Active name:
Alpha-Cypermethrin
Applicant Name:
DHARMAJ CROP GUARD LIMITED
Application purpose and description of use:
Approval of Alpha-Cypermethrin for use in agricultural chemical products.
Description of data provided:
Data no
301299
Title
Declaration of Batches
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301276
Title
Alpha-cypermethrin Technical: Laboratory Study of Flammability & Amendment
Study date
28/09/2024
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301268
Title
Determination of the Relative Density of Alpha-cypermethrin Technical
Study date
22/03/2023
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301265
Title
Summary on physical and chemical properties for Alpha-Cypermethrin
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301285
Title
MSDS - Active
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301279
Title
Alpha-cypermethrin Technical: Laboratory Study of Photodegradation
Study date
03/02/2025
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301302
Title
Letter on Analytical reference standards
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301262
Title
Table of contents
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301282
Title
Summary on Stability data
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301288
Title
MSDS - Raw material - Sodium Cyanide
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301274
Title
Alpha-cypermethrin Technical: Laboratory Study of Hydrolysis in Buffer Solutions of pH 4, 7 and 9
Study date
04/01/2025
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301280
Title
Alpha-cypermethrin Technical: Laboratory Study of Oxidizing properties & Amendment
Study date
27/09/2024
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301297
Title
Declaration of Composition
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301303
Title
Packaging details of Technical
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301263
Title
Overall Summary
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301283
Title
Accelerated Storage Stability and Corrosion Characteristics of Alphacypermethrin Technical
Study date
23/03/2023
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301291
Title
MSDS - Raw material - Soda Ash
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301277
Title
Justification for Auto-flammability test
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301300
Title
Analytical methods: Summary Analytical methods
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301271
Title
Vapor Pressure of Alphacypermethrin Technical
Study date
10/03/2023
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301294
Title
MSDS - Raw material - Triethylamine
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301301
Title
Validation data: Summary
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301278
Title
Alpha-cypermethrin Technical: Determination of Explosive Properties & Amendment
Study date
24/09/2024
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301272
Title
Solubility in water and organic solvents (Acetone and n-Hexane) of Alphacypermethrin Technical
Study date
27/03/2023
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301289
Title
MSDS - Raw material - Hexane
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301295
Title
MSDS - Raw material - Sulphuric Acid
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301298
Title
Batch analysis data: Qualitative and Quantitative Profile of Alphacypermethrin Technical (Five Batch Analysis)
Study date
27/02/2023
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301275
Title
Alpha-cypermethrin Technical: Laboratory Study of Dissociation Constant & Amendment
Study date
23/09/2024
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301269
Title
Review report for the active substance Alpha-cypermethrin
Study date
2026
Auth party contact address
-
Data no
301266
Title
Physical State, Appearance, Color, and Odor of Alpha-cypermethrin Technical
Study date
22/03/2023
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301286
Title
MSDS - Raw material - MPB
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301292
Title
MSDS - Raw material -Acetic Acid
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301270
Title
Determination of the pH value of an aqueous solution of Alphacypermethrin Technical
Study date
22/03/2023
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301267
Title
Melting point or range of Alpha-cypermethrin Technical
Study date
22/03/2023
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301281
Title
Justification of Auto-ignition temperature test
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301293
Title
MSDS - Raw material - Sodium Hypochlorite
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301287
Title
MSDS - Raw material - CMAC
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301273
Title
Partition coefficient (N-Octanol/water) of Alphacypermethrin Technical
Study date
23/03/2023
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301264
Title
Information on identification of the active constituent
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301290
Title
MSDS - Raw material - TEBA
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301284
Title
Documents for Manufacturing Process
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301296
Title
QC Data
Study date
2026
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Date
Application Date
Application No
Application Number
145008
Product/Active constituent Name
Application Product Name
Arbor Spray E15 Emamectin Tree Injection
Application Date
Application Number
145008
Application Product Name
Arbor Spray E15 Emamectin Tree Injection
Application details
Product name:
Arbor Spray E15 Emamectin Tree Injection
Product number:
95218
Applicant Name:
Arbor Spray Pty Ltd
Application purpose and description of use:
Registration of a 15 g/L EMAMECTIN BENZOATE liquid formulation, a ready to use liquid formulation for use via trunk or stem injection for the control of Elm Leaf Beetle.
Reference details:
88692 - EMA-JECT RTU TREE INJECTABLE INSECTICIDE
Active constituents:
Active constituent name
69065 - EMAMECTIN BENZOATE
Description of data provided:
Data no
276648
Title
Emamectin Benzoate - CoAl
Study date
28 February 2023
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276651
Title
Excipient SDSs
Study date
April 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276654
Title
Part 8 - Efficacy & Crop Safety
Study date
August 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276652
Title
Part 3 - Heath
Study date
July 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276649
Title
Part 2 - Chemistry & Manufacture
Study date
April 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276655
Title
Evaluation of Arbor Spray E15 Emamectin Tree Injection for the Control of Elm Leaf Beetle (Pyrrahalta luteola) in Elm trees
Study date
15 February 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276650
Title
The Formulation of an Emamectin Benzoate RTU Tree Injectable Insecticide
Study date
April 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276656
Title
Evaluation of Arbor Spray E15 Emamectin Tree Injection for the Control of Elm Leaf Beetle (Pyrrahalta luteola) in Elm trees
Study date
20 February 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276653
Title
SDS - Arbor Spray E15 Emamectin Tree Injection
Study date
July 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276647
Title
Method Validation for the determination of emamectin benzoate* in Emamectin benzoate Tree Injectable RTU
Study date
23 April 2024
Auth party contact address
21 Albert Rd Drouin Australia
Date
Application Date
Application No
Application Number
151768
Product/Active constituent Name
Application Product Name
F.S.A. Glyphosate 600 Herbicide
Application Date
Application Number
151768
Application Product Name
F.S.A. Glyphosate 600 Herbicide
Application details
Product name:
F.S.A. Glyphosate 600 Herbicide
Applicant Name:
FOUR SEASONS AGRIBUSINESS PTY LTD
Application purpose and description of use:
Registration of a 600 g/L soluble concentrate of glyphosate for the control of a range of annual and perennial weeds as indicated in the directions for use.
Date
Application Date
Application No
Application Number
151377
Product/Active constituent Name
Application Product Name
SHENZI INSECTICIDE
Application Date
Application Number
151377
Application Product Name
SHENZI INSECTICIDE
Application details
Product name:
SHENZI INSECTICIDE
Product number:
92656
Applicant Name:
UPL AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to include the control of Fall armyworm (Spodoptera frugiperda) in Sweetcorn.
Active constituents:
Active constituent name
90705 - chlorantraniliprole
Description of data provided:
Data no
299988
Title
Part 8 - Efficacy and crop safety
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
299991
Title
EVALUATION OF SHENZI INSECTICIDE FOR THE CONTROL OF FALL ARMYWORM IN SWEET CORN
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
299989
Title
Investigation of the efficacy and crop safety of UPL CTPR formulations against Fall Armyworm in Sweet Corn
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
299990
Title
EVALUATION OF SHENZI INSECTICIDE FOR THE CONTROL OF FALL ARMYWORM IN SWEET CORN
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Date
Application Date
Application No
Application Number
151752
Product/Active constituent Name
Application Product Name
TITAN Fluazinam 500 SC Fungicide
Application Date
Application Number
151752
Application Product Name
TITAN Fluazinam 500 SC Fungicide
Application details
Product name:
TITAN Fluazinam 500 SC Fungicide
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Registration of a 500 g/L fluazinam suspension concentrate product for the control of white root rot in apples, club root of broccoli, Brussels sprouts, cabbage, cauliflower and kohlrabi; Eutypa dieback and the pre-bud burst suppression of phomopsis cane and leaf blight in grapevines, and the control of late blight and sclerotinia in potatoes.
Date
Application Date
Application No
Application Number
151681
Product/Active constituent Name
Application Product Name
AVET Amoxiclav 250 mg Tablets
Application Date
Application Number
151681
Application Product Name
AVET Amoxiclav 250 mg Tablets
Application details
Product name:
AVET Amoxiclav 250 mg Tablets
Product number:
94107
Applicant Name:
AVET HEALTH LIMITED
Application purpose and description of use:
Variation of product registration and label approval to vary the relevant particulars.
Active constituents:
Active constituent name
92215 - AMOXICILLIN TRIHYDRATE
Active constituent name
91684 - DILUTED POTASSIUM CLAVULANATE
Description of data provided:
Data no
300581
Title
GMP
Study date
2024
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
300587
Title
Flowchart
Study date
2025
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
300584
Title
Responses
Study date
2024
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
300585
Title
Declaration
Study date
2025
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
300582
Title
GMP
Study date
2024
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
300583
Title
Audit report
Study date
2024
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
300586
Title
Declaration
Study date
2025
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
303591
Title
GMP
Study date
2025
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
151682
Product/Active constituent Name
Application Product Name
AVET Amoxiclav 50 mg Tablets
Application Date
Application Number
151682
Application Product Name
AVET Amoxiclav 50 mg Tablets
Application details
Product name:
AVET Amoxiclav 50 mg Tablets
Product number:
94115
Applicant Name:
AVET HEALTH LIMITED
Application purpose and description of use:
Variation of product registration and label approval to vary the relevant particulars.
Active constituents:
Active constituent name
92215 - AMOXICILLIN TRIHYDRATE
Active constituent name
91684 - DILUTED POTASSIUM CLAVULANATE
Description of data provided:
Data no
300589
Title
GMP
Study date
2024
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
300592
Title
Declaration
Study date
2025
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
303590
Title
GMP
Study date
2025
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
300593
Title
Declaration
Study date
2025
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
300590
Title
Audit report
Study date
2024
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
300591
Title
Responses
Study date
2024
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
300588
Title
GMP
Study date
2024
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
300594
Title
Flowchart
Study date
2025
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
151688
Product/Active constituent Name
Application Product Name
SPINOMAX PO for Sheep
Application Date
Application Number
151688
Application Product Name
SPINOMAX PO for Sheep
Application details
Product name:
SPINOMAX PO for Sheep
Product number:
97065
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Registration of a 20g/L spinosad liquid pour-on product for the control of spinosad-susceptible lice (Bovicola ovis), including strains resistant to Synthetic Pyrethroids (SPs), in sheep up to 7 days off-shears and sheep with long wool.
Reference details:
60117 - ELANCO AH0493 EXTINOSAD POUR-ON FOR SHEEP
Active constituents:
Active constituent name
89208 - SPINOSAD
Description of data provided:
Data no
300628
Title
Product Specification
Study date
21/04/2022
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
300629
Title
Flow diagram
Study date
22/04/2022
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
151723
Product/Active constituent Name
Application Product Name
Supapy-natural Pyrethrin Insecticide
Application Date
Application Number
151723
Application Product Name
Supapy-natural Pyrethrin Insecticide
Application details
Product name:
Supapy-natural Pyrethrin Insecticide
Product number:
97084
Applicant Name:
SUPAGAS PTY LIMITED
Application purpose and description of use:
Registration of a 4g/Kg pyrethrin's compressed gas product for control of flying insects and crawling insects.
Reference details:
64288 - SUPAPY INSECTICIDE WITH NATURAL PYRETHRUM
Active constituents:
Active constituent name
65954 - PIPERONYL BUTOXIDE
Description of data provided:
Data no
301377
Title
Supapy registration certificate
Study date
01/07/2025
Auth party contact address
5 Benson Rd Ingleburn Australia
Date
Application Date
Application No
Application Number
151736
Product/Active constituent Name
Application Product Name
Titan Snipa 750 WG Herbicide
Application Date
Application Number
151736
Application Product Name
Titan Snipa 750 WG Herbicide
Application details
Product name:
Titan Snipa 750 WG Herbicide
Product number:
95444
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of label approval to add a new use for the control or suppression of a range of broadleaf weeds in cereals when tank mixed with Titan Triforto EC Herbicide.
Reference details:
85692 - QUADRANT HERBICIDE
93011 - Titan Triforto EC Herbicide
Active constituents:
Active constituent name
92896 - Picolinafen
Description of data provided:
Data no
301351
Title
Titan Snipa 750 WG Herbicide draft label 29012026
Study date
29 January 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
151766
Product/Active constituent Name
Application Product Name
YATES GRUB KILL & PROTECT FOR LAWNS UP TO 6 MONTHS PROTECTION AGAINST CURL GRUB
Application Date
Application Number
151766
Application Product Name
YATES GRUB KILL & PROTECT FOR LAWNS UP TO 6 MONTHS PROTECTION AGAINST CURL GRUB
Application details
Product name:
YATES GRUB KILL & PROTECT FOR LAWNS UP TO 6 MONTHS PROTECTION AGAINST CURL GRUB
Product number:
88464
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to vary the product name and modify claims
Active constituents:
Active constituent name
61539 - CHLORANTRANILIPROLE
Description of data provided:
Data no
301395
Title
Executive Summary - Decision ID DC12-95920840
Study date
30 Jan 2026
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia