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
146680
Product/Active constituent Name
Application Product Name
Vectothor Inzecto Larvicidal Mosquito Chips
Application Date
Application Number
146680
Application Product Name
Vectothor Inzecto Larvicidal Mosquito Chips
Application details
Product name:
Vectothor Inzecto Larvicidal Mosquito Chips
Product number:
95643
Applicant Name:
ENSYSTEX AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a 0.26 g/kg pyriproxyfen tablet for direct application (DT) product for control of mosquitoes in outdoor water containers.
Reference details:
70077 - SUMILARV GRANULAR INSECT GROWTH REGULATOR
Active constituents:
Active constituent name
81104 - Pyriproxyfen
Description of data provided:
Data no
281408
Title
Test report
Study date
25/03/2024
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281402
Title
Certificate of analysis
Study date
29/11/2024
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281407
Title
Determination of Mohs hardness of glazed tiles by scratching tests
Study date
2000
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281403
Title
Information on ingredients
Study date
November 2024
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281404
Title
Inzecto Mosquito Chips G detailed production process description
Study date
2023
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281409
Title
Vectothor Inzecto Mosquito Chip Larvicide
Study date
November 2024
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281410
Title
Part 2 Summary
Study date
November 2024
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281405
Title
Accelerated storage stability test of Inzecto Larvicide Chips G, mosquito chips coated with larvicide
Study date
04/03/2021
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281406
Title
Accelerated storage stability test of Inzecto Larvicide Chips G, mosquito chips coated with larvicide
Study date
18/06/2024
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281411
Title
Efficacy test of a ???Inzecto Larvicide Chips G??? against Aedes albopictus and Culex pipiens ??? simulated rain in catch basins
Study date
30/08/2021
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281412
Title
Larvicidal efficacy test of ???Inzecto Larvicide Double face PBO Chips??? in a field study against Aedes albopictus, Culex pipiens, and Anopheles gambiae larvae
Study date
05/05/2022
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281413
Title
Control of Aedes aegypti using mosquitocidal chips containing the insect growth regulator pyriproxyfen
Study date
2017
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281414
Title
The efficacy testing of Ensystex Inzecto for the control of the Larvae of the dengue vector, Aedes aegypti (Diptera: Culicidae)
Study date
15/08/2024
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281415
Title
Sustainable mosquito control with Inzecto Mosquito Larvicidal Chips
Study date
2017
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
281416
Title
Laboratory evaluation of a novel lethal ovitrap for control of Aedes aegypti
Study date
2017
Auth party contact address
-
Data no
281417
Title
Sumilarv Granular Insect Growth Regulator (70077/110956)
Study date
6/02/2018
Auth party contact address
-
Data no
281418
Title
Part 8 Summary
Study date
November 2024
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Date
Application Date
Application No
Application Number
146456
Product/Active constituent Name
Application Product Name
4FARMERS 24DB HERBICIDE
Application Date
Application Number
146456
Application Product Name
4FARMERS 24DB HERBICIDE
Application details
Product name:
4FARMERS 24DB HERBICIDE
Product number:
95587
Applicant Name:
4 FARMERS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 500g/L 2,4-DB Soluble Concentrate .
Reference details:
87501 - F.S.A. 24DB Herbicide
Active constituents:
Active constituent name
92757 - 2,4-DB
Description of data provided:
Data no
281088
Title
FORMULATION DATA
Study date
31 OCT 2024
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Date
Application Date
Application No
Application Number
146721
Product/Active constituent Name
Application Product Name
Zea Bait
Application Date
Application Number
146721
Application Product Name
Zea Bait
Application details
Product name:
Zea Bait
Product number:
83020
Applicant Name:
IMPORTING INNOVATION AUSTRALASIA PTY. LTD.
Application purpose and description of use:
Variation of label to add pack sizes, restraints and directions of use.
Active constituents:
Active constituent name
57579 - SODIUM CHLORIDE
Description of data provided:
Data no
281884
Title
Variation to label for Zeabait Throw Packs 83020/134676
Study date
11/11/2024
Auth party contact address
227 Were Street BRIGHTON Australia
Date
Application Date
Application No
Application Number
146695
Product/Active constituent Name
Application Product Name
RIDOMIL GOLD 480 SL SYSTEMIC FUNGICIDE
Application Date
Application Number
146695
Application Product Name
RIDOMIL GOLD 480 SL SYSTEMIC FUNGICIDE
Application details
Product name:
RIDOMIL GOLD 480 SL SYSTEMIC FUNGICIDE
Product number:
64812
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add new pack range of 1 L to 1000 L.
Active constituents:
Active constituent name
44550 - METALAXYL-M
Date
Application Date
Application No
Application Number
146718
Product/Active constituent Name
Application Product Name
Dodine
Application Date
Application Number
146718
Application Product Name
Dodine
Application details
Product name:
Dodine
Active name:
Dodine
Applicant Name:
India Pesticides Limited
Application purpose and description of use:
Approval of dodine for use in agricultural chemical products.
Description of data provided:
Data no
281719
Title
Validation Of Analytical Method, Determination Of Active Ingredient And Impurities In Five Batches Of Dodine Technical, Study No. 13798
Study date
2024
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
281721
Title
Certificate of Analysis (COA) and Declaration of Dodine
Study date
2023
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
281718
Title
Manufacturing Process for Dodine Technical
Study date
2024
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
281717
Title
Part 2 Chemistry and Manufacturing
Study date
2024
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
281720
Title
Declaration of Composition (DoC) of Dodine
Study date
2024
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
281722
Title
Dodine FAO Specification
Study date
1986
Auth party contact address
-
Data no
281723
Title
Dodine SAFETY DATA SHEET
Study date
2024
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Date
Application Date
Application No
Application Number
146735
Product/Active constituent Name
Application Product Name
DICYCLANIL
Application Date
Application Number
146735
Application Product Name
DICYCLANIL
Application details
Product name:
DICYCLANIL
Active name:
DICYCLANIL
Applicant Name:
JIANGSU QUALITY HORIZONS PHARMTECH CO., LTD.
Application purpose and description of use:
Approval of dicyclanil for use in veterinary chemical products.
Description of data provided:
Data no
281479
Title
Certificates of analysis
Study date
2023
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Data no
281480
Title
DMF 1
Study date
2024
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Data no
281481
Title
DMF 2
Study date
2024
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Date
Application Date
Application No
Application Number
146746
Product/Active constituent Name
Application Product Name
Nufarm Galaxy Herbicide
Application Date
Application Number
146746
Application Product Name
Nufarm Galaxy Herbicide
Application details
Product name:
Nufarm Galaxy Herbicide
Product number:
92149
Applicant Name:
NUFARM AUSTRALIA LIMITED
Application purpose and description of use:
Variation of product registration and label approval to add an additional formulation to the relevant particulars
Active constituents:
Active constituent name
91686 - Pyrasulfotole
Description of data provided:
Data no
281900
Title
Executive Summary - DC12-02088162 Nufarm Galaxy Herbicide (92149)
Study date
Dec 2021
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date
Application Date
Application No
Application Number
146748
Product/Active constituent Name
Application Product Name
Monarch G Insecticide
Application Date
Application Number
146748
Application Product Name
Monarch G Insecticide
Application details
Product name:
Monarch G Insecticide
Product number:
86567
Applicant Name:
TURF CULTURE PTY LTD
Application purpose and description of use:
This application is to change the pack size range
Active constituents:
Active constituent name
58418 - FIPRONIL
Date
Application Date
Application No
Application Number
146749
Product/Active constituent Name
Application Product Name
Maradona 750 Herbicide
Application Date
Application Number
146749
Application Product Name
Maradona 750 Herbicide
Application details
Product name:
Maradona 750 Herbicide
Product number:
95658
Applicant Name:
CROP CULTURE PTY LTD
Application purpose and description of use:
Registration of a 750 g/L MCPA present as the dimethylamine salt aqueous concentrate product for the Selective Control of Broadleaf Weeds in Cereals, Linseed, Oilseed Poppies, Pastures, Rice, Sugarcane and Turf.
Reference details:
94557 - Agro-Essence MCPA 750 Herbicide
Active constituents:
Active constituent name
84746 - MCPA
Date
Application Date
Application No
Application Number
146750
Product/Active constituent Name
Application Product Name
The Big Cheese Ultra Power Bait Blocks Mouse Kill Kit
Application Date
Application Number
146750
Application Product Name
The Big Cheese Ultra Power Bait Blocks Mouse Kill Kit
Application details
Product name:
The Big Cheese Ultra Power Bait Blocks Mouse Kill Kit
Product number:
95659
Applicant Name:
PELGAR INTERNATIONAL (AUS) PTY LTD
Application purpose and description of use:
Registration of a 0.05 g/kg brodifacoum ready to use bait (RB) product for the control of mice in and around buildings in household situations.
Reference details:
81665 - The Big Cheese Ultra Power Mouse Kill Bait Station
Active constituents:
Active constituent name
67386 - BRODIFACOUM
Description of data provided:
Data no
281903
Title
Permit to import conditionally non-prohibited goods
Study date
30/03/2023
Auth party contact address
NORTHBANK PLAZA LEVEL 22, 69 ANN STREET BRISBANE Australia
Date
Application Date
Application No
Application Number
146751
Product/Active constituent Name
Application Product Name
Oxstar Herbicide Coated Fertiliser
Application Date
Application Number
146751
Application Product Name
Oxstar Herbicide Coated Fertiliser
Application details
Product name:
Oxstar Herbicide Coated Fertiliser
Product number:
83464
Applicant Name:
TURF CULTURE PTY LTD
Application purpose and description of use:
Variation of product registration to amend the label text.
Active constituents:
Active constituent name
67959 - OXADIAZON
Description of data provided:
Data no
281904
Title
94767 / 143586 - Oxstar 380 Herbicide
Study date
19 July 2024
Auth party contact address
43 Gap Road Sunbury Australia
Date
Application Date
Application No
Application Number
146762
Product/Active constituent Name
Application Product Name
WEBSTERS 3 IN 1 B12 & SE VACCINE
Application Date
Application Number
146762
Application Product Name
WEBSTERS 3 IN 1 B12 & SE VACCINE
Application details
Product name:
WEBSTERS 3 IN 1 B12 & SE VACCINE
Product number:
54575
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Variation of product registration to extend the product shelf life.
Active constituents:
Active constituent name
55115 - CLOSTRIDIUM TETANI - TOXOID
Active constituent name
55807 - MEPIVACAINE HYDROCHLORIDE
Active constituent name
56553 - VITAMIN B12A = HYDROXOCOBALAMIN
Active constituent name
83193 - Hydroxocobalamin Acetate
Active constituent name
57559 - SELENIUM AS SODIUM SELENATE
Active constituent name
55877 - CLA = CORYNEBACTERIUM PSEUDOTUBERCULOSIS OVIS
Description of data provided:
Data no
281572
Title
Validation Study
Study date
January 2021
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281573
Title
Summary of Meeting Outcomes with APVMA
Study date
April 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281574
Title
Validation Report
Study date
October 2018
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281575
Title
Validation Report
Study date
December 2018
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281576
Title
Method Transfer Report
Study date
November 2018
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281577
Title
Method Transfer Report
Study date
April 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281568
Title
Stability Report VSP2016-043
Study date
December 2016
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281569
Title
Stability Report VSP2018-005
Study date
December 2017
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281570
Title
Stability Report VSP2020-009
Study date
February 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281571
Title
Stability Report VSP2021-015
Study date
March 2021
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281567
Title
Cover Letter
Study date
11 December 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date
Application Date
Application No
Application Number
146763
Product/Active constituent Name
Application Product Name
WEBSTERS 3 IN 1 B12 VACCINE
Application Date
Application Number
146763
Application Product Name
WEBSTERS 3 IN 1 B12 VACCINE
Application details
Product name:
WEBSTERS 3 IN 1 B12 VACCINE
Product number:
81120
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Variation of product registration to extend the product shelf life.
Active constituents:
Active constituent name
56553 - VITAMIN B12A = HYDROXOCOBALAMIN
Active constituent name
83193 - Hydroxocobalamin Acetate
Active constituent name
82178 - CLOSTRIDIUM TETANI TOXOID (INACTIVATED)
Active constituent name
82177 - CLOSTRIDIUM PERFRINGENS TYPE D TOXOID (INACTIVATED)
Active constituent name
82179 - CORYNEBACTERIUM PSEUDOTUBERCULOSIS (INACTIVATED)
Date
Application Date
Application No
Application Number
146765
Product/Active constituent Name
Application Product Name
WEBSTERS 3 IN 1 SE VACCINE
Application Date
Application Number
146765
Application Product Name
WEBSTERS 3 IN 1 SE VACCINE
Application details
Product name:
WEBSTERS 3 IN 1 SE VACCINE
Product number:
51335
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Variation of product registration to extend the product shelf life.
Active constituents:
Active constituent name
55115 - CLOSTRIDIUM TETANI - TOXOID
Active constituent name
55807 - MEPIVACAINE HYDROCHLORIDE
Active constituent name
57559 - SELENIUM AS SODIUM SELENATE
Active constituent name
55877 - CLA = CORYNEBACTERIUM PSEUDOTUBERCULOSIS OVIS
Date
Application Date
Application No
Application Number
146766
Product/Active constituent Name
Application Product Name
WEBSTERS LOW VOLUME 3 IN 1 VACCINE (INCLUDING CHEESY GLAND) FOR SHEEP AND LAMBS
Application Date
Application Number
146766
Application Product Name
WEBSTERS LOW VOLUME 3 IN 1 VACCINE (INCLUDING CHEESY GLAND) FOR SHEEP AND LAMBS
Application details
Product name:
WEBSTERS LOW VOLUME 3 IN 1 VACCINE (INCLUDING CHEESY GLAND) FOR SHEEP AND LAMBS
Product number:
50633
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Variation of product registration to extend the product shelf life, change product name and other label variations.
Active constituents:
Active constituent name
55115 - CLOSTRIDIUM TETANI - TOXOID
Active constituent name
55087 - CLOSTRIDIUM PERFRINGENS TYPE D TOXOID
Active constituent name
55807 - MEPIVACAINE HYDROCHLORIDE
Active constituent name
55877 - CLA = CORYNEBACTERIUM PSEUDOTUBERCULOSIS OVIS
Date
Application Date
Application No
Application Number
146778
Product/Active constituent Name
Application Product Name
Pinoxaden
Application Date
Application Number
146778
Application Product Name
Pinoxaden
Application details
Product name:
Pinoxaden
Active name:
Pinoxaden
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of pinoxaden for use in agricultural chemical products.
Description of data provided:
Data no
281926
Title
NOA407855 - AW-222/2 - Determination of NOA407855 in Technical Material by HPLC
Study date
3 November 2014
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281927
Title
NOA407855- AK-222/4- Determination of Impurities in NOA407855 Technical Material by HPLC and GC
Study date
15 August 2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281928
Title
NOA407855 - Supplementary Statement to Method AK-222/4
Study date
5 October 2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281929
Title
NOA407855- AK-222/2- Determination of Impurities in NOA407855 Technical Material by HPLC and GC
Study date
3 November 2014
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281930
Title
NOA407855- SB-195/1- Determination of Chlorobenzene and 1-methyl-2-pyrrolidone in NOA407855 Technical by Gas Chromatography
Study date
3 June 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281931
Title
Pinoxaden Technical (NOA407855) - Validation of Analytical Method AW-222/2
Study date
6 November 2014
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281932
Title
Pinoxaden Technical (NOA407855) - Validation of Analytical Method AK-222/2
Study date
5 November 2014
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281933
Title
Pinoxaden Technical (NOA-407855) - Validation of Analytical Method AK-222/4 Section 2
Study date
28 August 2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281934
Title
Pinoxaden Technical (NOA407855) - Validation of Analytical Method SB-195/1
Study date
25 June 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281922
Title
Pinoxaden Technical (NOA407855) - Analysis of Five Representative Batches
Study date
11 July 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281923
Title
Statement to Provide Details on the Study Pinoxaden Technical (NOA407855) - Analysis of Five Representative Batches (Report No. USGR240290)
Study date
17 July 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281925
Title
Pinoxaden Technical (NOA407855) - Analysis of 1-Methyl-2-pyrrolidone (NMP) and Chlorobenzene in Five Representative Batches
Study date
11 July 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281920
Title
Pinoxaden Manufacturing Process
Study date
11 December 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281921
Title
Pinoxaden - Declaration of Composition
Study date
12 December 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281917
Title
Part 2 - Chemistry and Manufacture
Study date
12 December 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281918
Title
Pinoxaden Technical (NOA407855) ??? Typical Pinoxaden Spectra of Five Representative Batches
Study date
17 July 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281919
Title
NOA407855 TYPICAL SPECTRA. Report Amendment 1
Study date
03 June 2024
Data no
281924
Title
Statement on UV wavelength screening of Pinoxaden Technical by Diode array
Study date
22 July 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
146783
Product/Active constituent Name
Application Product Name
CLOXALLIN EYE OINTMENT
Application Date
Application Number
146783
Application Product Name
CLOXALLIN EYE OINTMENT
Application details
Product name:
CLOXALLIN EYE OINTMENT
Product number:
95672
Applicant Name:
VETPHARM LABORATORIES IP PTY LTD
Application purpose and description of use:
Registration of a 500 mg cloxacillin eye ointment product for the treatment of cloxacillin susceptible bacterial keratoconjunctivitis in cattle, sheep, horses, dogs and cats. Â
Reference details:
35893 - ORBENIN EYE OINTMENT
Active constituents:
Active constituent name
84230 - CLOXACILLIN BENZATHINE
Description of data provided:
Data no
281643
Title
Product specifications
Study date
2024
Auth party contact address
7/20 St Johns Avenue GORDON Australia
Date
Application Date
Application No
Application Number
146784
Product/Active constituent Name
Application Product Name
Farmers’ Own Moxidectin Long Acting Injection for Sheep
Application Date
Application Number
146784
Application Product Name
Farmers’ Own Moxidectin Long Acting Injection for Sheep
Application details
Product name:
Farmers’ Own Moxidectin Long Acting Injection for Sheep
Product number:
95673
Applicant Name:
ARROVET PTY LTD
Application purpose and description of use:
Registration of a 20 g/L moxidectin injectable product for the treatment and control of roundworms, nasal bot and itchmite in sheep and for the protection against severe challenge by barber's pole worm for up to 4 months. Â
Reference details:
58532 - CYDECTIN LONG ACTING INJECTION FOR SHEEP
Active constituents:
Active constituent name
85141 - MOXIDECTIN
Description of data provided:
Data no
281644
Title
Product specifications
Study date
2024
Auth party contact address
MQX 4, Level 6 Giffnock Ave Macquarie Park Australia
Date
Application Date
Application No
Application Number
146885
Product/Active constituent Name
Application Product Name
Ulti-Mate Intravaginal Device
Application Date
Application Number
146885
Application Product Name
Ulti-Mate Intravaginal Device
Application details
Product name:
Ulti-Mate Intravaginal Device
Product number:
95688
Applicant Name:
AGILIS INTERNATIONAL LIMITED
Application purpose and description of use:
Registration of a 1.1 g progesterone per insert intravaginal device product for controlled breeding in cattle.
Reference details:
50694 - CIDR CATTLE INSERT
49840 - EAZI-BREED CIDR CATTLE DEVICE
Active constituents:
Active constituent name
95689 - Progesterone
Description of data provided:
Data no
281744
Title
P4 extraction method
Study date
2019
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281745
Title
HPLC assay method
Study date
2019
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281746
Title
Ulti-Mate - Batch analysis validation
Study date
2021
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281747
Title
Ulti-Mate - Batch analysis latest
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281736
Title
Batch Manufacturing Record
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281737
Title
Assembly record
Study date
2023
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281738
Title
Process validation report
Study date
2021
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281739
Title
Batch manufacturing and assembly records
Study date
2020
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281741
Title
Product quality review
Study date
2023
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281742
Title
Manufacturing data
Study date
2023
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281743
Title
SOP-027
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281740
Title
Packaging
Study date
2020
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281752
Title
Excipient supplier name change
Study date
2021
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281730
Title
Part 2 Summary
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281731
Title
Reengineering of a commercially available bovine intravaginal insert (CIDR insert) containing progesterone.
Study date
2022
Auth party contact address
-
Data no
281732
Title
Excipient 1 CoA and SDS
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281733
Title
Excipient 2 CoA
Study date
2022
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281734
Title
Excipient 2 SDS
Study date
2023
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281735
Title
Excipient 3 CoA and SDS
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281748
Title
Stability data
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281749
Title
Stability Batches 206001 206002 206003
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281750
Title
Stability Batches 22601 22602
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281751
Title
Stability Batches 23617 23618 23619
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281753
Title
Stability - Batches 22601-602 - Storeroom temp data
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281754
Title
Stability - Batches 22601-602 - Temp log - retention store 1
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281755
Title
Stability - Batches 22601-602 - Temp log - retention store 2
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281756
Title
Stability - Batches 22601-602 - Temp log - retention store 3
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281757
Title
Stability - Batches 206001 and 206003 - R-Report proposed expiry spec
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281765
Title
Progesterone-releasing devices for cattle estrus induction and synchronization: Device optimization to anticipate shorter treatment durations and new device developments.
Study date
2018
Auth party contact address
-
Data no
281766
Title
Ulti-Mate - NZ E&S dossier 2021-03
Study date
2021
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281767
Title
Ulti-Mate - Bovine retention study 14527 AE application
Study date
2018
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281779
Title
Comparison of two intravaginal progesterone releasing devices (PRID-Delta vs CIDR) in dairy cows: Blood progesterone profile and field fertility.
Study date
2013
Auth party contact address
-
Data no
281780
Title
Conception rate in beef cattle to determine non-inferiority of Ulti-Mate (1.1g progesterone/device) to Eazi-Breed CIDR (1.9g progesterone/device)
Study date
2023
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281769
Title
Using quantitative observational research to assess cow behaviour during treatment with intravaginal progesterone inserts on New Zealand dairy farms.
Study date
2014
Auth party contact address
-
Data no
281770
Title
Ulti-Mate - Bovine retention study 14527 AE application
Study date
2018
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281771
Title
Ulti-Mate - Progesterone release study raw data
Study date
2018
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281772
Title
Non-inferiority Study for registration of Ulti-Mate in a Commercial Dairy Herd
Study date
2020
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281773
Title
Electrochemiluminescence immunoassay for progesterone by using a heterologous system in plasma bovine.
Study date
2014
Auth party contact address
-
Data no
281775
Title
A mathematical model of the interaction between bovine blastocyst developmental stage and progesterone-stimulated uterine factors on differential embryonic development observed on Day 15 of gestation.
Study date
2018
Auth party contact address
-
Data no
281776
Title
Progesterone release patterns from Cue-Mate in comparison to other intravaginal progesterone-releasing devices in lactating dairy cows.
Study date
2007
Auth party contact address
-
Data no
281777
Title
Fertility regulation in cattle.
Study date
1998
Auth party contact address
-
Data no
281778
Title
Eigenvalue ratio test for the number of factors.
Study date
2013
Auth party contact address
-
Data no
281774
Title
Understanding equivalence and non-inferiority testing.
Study date
2010
Auth party contact address
-
Data no
281781
Title
Email correspondence re AU and NZ CIDR
Study date
2023
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281768
Title
Ulti-Mate - Vet CV
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281758
Title
2024-12-16 - Ulti-Mate - Part 8 - FINAL
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281759
Title
Ulti-Mate - NZ label
Study date
2024
Auth party contact address
-
Data no
281760
Title
CIDR - AU label
Study date
2024
Auth party contact address
-
Data no
281761
Title
CIDR - US label
Study date
2024
Auth party contact address
-
Data no
281762
Title
CIDR - UK SPC
Study date
2024
Auth party contact address
-
Data no
281763
Title
CIDR - Patent
Study date
2002
Auth party contact address
-
Data no
281764
Title
Ulti-Mate - NZ PV declaration
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281725
Title
GMP certificate 1
Study date
2023
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281726
Title
GMP certificate 2
Study date
2023
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281727
Title
GMP certificate 3
Study date
2023
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281728
Title
Finished product specifications
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281729
Title
PAA advice 140379
Study date
2023
Auth party contact address
325 Pages Road Timaru New Zealand
Date
Application Date
Application No
Application Number
146886
Product/Active constituent Name
Application Product Name
Progesterone
Application Date
Application Number
146886
Application Product Name
Progesterone
Application details
Product name:
Progesterone
Active name:
Progesterone
Applicant Name:
AGILIS INTERNATIONAL LIMITED
Application purpose and description of use:
Approval of a new source of pharmacopoeia active
Description of data provided:
Data no
281784
Title
Analytical validation report
Study date
2010
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281782
Title
Active constituent CoAs
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281783
Title
Active constituent monograph
Study date
2024
Auth party contact address
325 Pages Road Timaru New Zealand