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

146765
Product/Active constituent Name

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 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

146746
Product/Active constituent Name

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
Author
M Godden
Title
Executive Summary - DC12-02088162 Nufarm Galaxy Herbicide (92149)
Study date
Dec 2021
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date

Application Date

Application No

Application Number

146751
Product/Active constituent Name

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
Author
APVMA
Title
94767 / 143586 - Oxstar 380 Herbicide
Study date
19 July 2024
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Date

Application Date

Application No

Application Number

146748
Product/Active constituent Name

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

146695
Product/Active constituent Name

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

146783
Product/Active constituent Name

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 166.7 mg/g cloxacillin ophthalmic suspension product for the treatment of keratoconjunctivitis caused by cloxacillin-susceptible bacteria in cattle, sheep, horses, dogs and cats.

Reference details:

35893 - ORBENIN EYE OINTMENT

Active constituents:

Active constituent name
84230 - CLOXACILLIN BENZATHINE

Description of data provided:

Data no
281643
Author
Anon
Title
Product specifications
Study date
2024
Authorising party
Applicant
Auth party contact address
7/20 St Johns Avenue GORDON Australia
Date

Application Date

Application No

Application Number

146718
Product/Active constituent Name

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
Author
India Pesticides Limited
Title
Validation Of Analytical Method, Determination Of Active Ingredient And Impurities In Five Batches Of Dodine Technical, Study No. 13798
Study date
2024
Authorising party
Applicant
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
281721
Author
India Pesticides Limited
Title
Certificate of Analysis (COA) and Declaration of Dodine
Study date
2023
Authorising party
Applicant
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
281718
Author
India Pesticides Limited
Title
Manufacturing Process for Dodine Technical
Study date
2024
Authorising party
Applicant
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
281717
Author
India Pesticides Limited
Title
Part 2 Chemistry and Manufacturing
Study date
2024
Authorising party
Applicant
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
281720
Author
India Pesticides Limited
Title
Declaration of Composition (DoC) of Dodine
Study date
2024
Authorising party
Applicant
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
281722
Author
FAO
Title
Dodine FAO Specification
Study date
1986
Authorising party
Public
Auth party contact address
-
Data no
281723
Author
India Pesticides Limited
Title
Dodine SAFETY DATA SHEET
Study date
2024
Authorising party
Applicant
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 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
Author
Anon
Title
Certificates of analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Data no
281480
Author
Anon
Title
DMF 1
Study date
2024
Authorising party
Applicant
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Data no
281481
Author
Anon
Title
DMF 2
Study date
2024
Authorising party
Applicant
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Date

Application Date

Application No

Application Number

146762
Product/Active constituent Name

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
Author
H. Brouwers
Title
Validation Study
Study date
January 2021
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281573
Author
Virbac
Title
Summary of Meeting Outcomes with APVMA
Study date
April 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281574
Author
J. Fenner
Title
Validation Report
Study date
October 2018
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281575
Author
J. Fenner
Title
Validation Report
Study date
December 2018
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281576
Author
Virbac
Title
Method Transfer Report
Study date
November 2018
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281577
Author
Virbac
Title
Method Transfer Report
Study date
April 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281568
Author
Virbac
Title
Stability Report VSP2016-043
Study date
December 2016
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281569
Author
Virbac
Title
Stability Report VSP2018-005
Study date
December 2017
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281570
Author
Virbac
Title
Stability Report VSP2020-009
Study date
February 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281571
Author
Virbac
Title
Stability Report VSP2021-015
Study date
March 2021
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
281567
Author
Virbac
Title
Cover Letter
Study date
11 December 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date

Application Date

Application No

Application Number

146778
Product/Active constituent Name

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
Author
Emborsky, P.
Title
NOA407855 - AW-222/2 - Determination of NOA407855 in Technical Material by HPLC
Study date
3 November 2014
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281927
Author
Sihvonen, S.
Title
NOA407855- AK-222/4- Determination of Impurities in NOA407855 Technical Material by HPLC and GC
Study date
15 August 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281928
Author
Sihvonen, S.
Title
NOA407855 - Supplementary Statement to Method AK-222/4
Study date
5 October 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281929
Author
Emborsky, P.
Title
NOA407855- AK-222/2- Determination of Impurities in NOA407855 Technical Material by HPLC and GC
Study date
3 November 2014
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281930
Author
Abeysinghe, D.
Title
NOA407855- SB-195/1- Determination of Chlorobenzene and 1-methyl-2-pyrrolidone in NOA407855 Technical by Gas Chromatography
Study date
3 June 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281931
Author
Gates, A.
Title
Pinoxaden Technical (NOA407855) - Validation of Analytical Method AW-222/2
Study date
6 November 2014
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281932
Author
Emborsky, P.
Title
Pinoxaden Technical (NOA407855) - Validation of Analytical Method AK-222/2
Study date
5 November 2014
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281933
Author
Sihvonen, S.
Title
Pinoxaden Technical (NOA-407855) - Validation of Analytical Method AK-222/4 Section 2
Study date
28 August 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281934
Author
Abeysinghe, D.
Title
Pinoxaden Technical (NOA407855) - Validation of Analytical Method SB-195/1
Study date
25 June 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281922
Author
Abeysinghe, D.
Title
Pinoxaden Technical (NOA407855) - Analysis of Five Representative Batches
Study date
11 July 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281923
Author
Abeysinghe, D.
Title
Statement to Provide Details on the Study Pinoxaden Technical (NOA407855) - Analysis of Five Representative Batches (Report No. USGR240290)
Study date
17 July 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281925
Author
Abeysinghe, D.
Title
Pinoxaden Technical (NOA407855) - Analysis of 1-Methyl-2-pyrrolidone (NMP) and Chlorobenzene in Five Representative Batches
Study date
11 July 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281920
Author
Grosenick, H.
Title
Pinoxaden Manufacturing Process
Study date
11 December 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281921
Author
Sison, M.
Title
Pinoxaden - Declaration of Composition
Study date
12 December 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281917
Author
Sison, M.
Title
Part 2 - Chemistry and Manufacture
Study date
12 December 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281918
Author
Abeysinghe, D.
Title
Pinoxaden Technical (NOA407855) ??? Typical Pinoxaden Spectra of Five Representative Batches
Study date
17 July 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
281919
Author
Sihvonen, S.
Title
NOA407855 TYPICAL SPECTRA. Report Amendment 1
Study date
03 June 2024
Data no
281924
Author
Abeysinghe, D.
Title
Statement on UV wavelength screening of Pinoxaden Technical by Diode array
Study date
22 July 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK 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 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.

Reference details:

58532 - CYDECTIN LONG ACTING INJECTION FOR SHEEP

Active constituents:

Active constituent name
85141 - MOXIDECTIN

Description of data provided:

Data no
281644
Author
Anon
Title
Product specifications
Study date
2024
Authorising party
Applicant
Auth party contact address
MQX 4, Level 6 Giffnock Ave Macquarie Park Australia
Data no
283715
Author
Anon
Title
Product specifications
Study date
2025
Authorising party
Applicant
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 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
Author
Not specified
Title
P4 extraction method
Study date
2019
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281745
Author
Not specified
Title
HPLC assay method
Study date
2019
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281746
Author
Not specified
Title
Ulti-Mate - Batch analysis validation
Study date
2021
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281747
Author
Not specified
Title
Ulti-Mate - Batch analysis latest
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281736
Author
Not specified
Title
Batch Manufacturing Record
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281737
Author
Not specified
Title
Assembly record
Study date
2023
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281738
Author
Not specified
Title
Process validation report
Study date
2021
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281739
Author
Not specified
Title
Batch manufacturing and assembly records
Study date
2020
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281741
Author
Not specified
Title
Product quality review
Study date
2023
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281742
Author
Not specified
Title
Manufacturing data
Study date
2023
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281743
Author
Not specified
Title
SOP-027
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281740
Author
Not specified
Title
Packaging
Study date
2020
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281752
Author
Not specified
Title
Excipient supplier name change
Study date
2021
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281730
Author
Not specified
Title
Part 2 Summary
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281731
Author
Rathbone et al
Title
Reengineering of a commercially available bovine intravaginal insert (CIDR insert) containing progesterone.
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
281732
Author
Not specified
Title
Excipient 1 CoA and SDS
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281733
Author
Not specified
Title
Excipient 2 CoA
Study date
2022
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281734
Author
Not specified
Title
Excipient 2 SDS
Study date
2023
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281735
Author
Not specified
Title
Excipient 3 CoA and SDS
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281748
Author
Not specified
Title
Stability data
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281749
Author
Not specified
Title
Stability Batches 206001 206002 206003
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281750
Author
Not specified
Title
Stability Batches 22601 22602
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281751
Author
Not specified
Title
Stability Batches 23617 23618 23619
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281753
Author
Not specified
Title
Stability - Batches 22601-602 - Storeroom temp data
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281754
Author
Not specified
Title
Stability - Batches 22601-602 - Temp log - retention store 1
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281755
Author
Not specified
Title
Stability - Batches 22601-602 - Temp log - retention store 2
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281756
Author
Not specified
Title
Stability - Batches 22601-602 - Temp log - retention store 3
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281757
Author
Not specified
Title
Stability - Batches 206001 and 206003 - R-Report proposed expiry spec
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281765
Author
Graaff and Grimard
Title
Progesterone-releasing devices for cattle estrus induction and synchronization: Device optimization to anticipate shorter treatment durations and new device developments.
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
281766
Author
Not specified
Title
Ulti-Mate - NZ E&S dossier 2021-03
Study date
2021
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281767
Author
Holloway
Title
Ulti-Mate - Bovine retention study 14527 AE application
Study date
2018
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281779
Author
van Werven et al.
Title
Comparison of two intravaginal progesterone releasing devices (PRID-Delta vs CIDR) in dairy cows: Blood progesterone profile and field fertility.
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
281780
Author
George
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
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281769
Author
Young and Lawrence
Title
Using quantitative observational research to assess cow behaviour during treatment with intravaginal progesterone inserts on New Zealand dairy farms.
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
281770
Author
Holloway
Title
Ulti-Mate - Bovine retention study 14527 AE application
Study date
2018
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281771
Author
Holloway
Title
Ulti-Mate - Progesterone release study raw data
Study date
2018
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281772
Author
Agilis Vets Ltd
Title
Non-inferiority Study for registration of Ulti-Mate in a Commercial Dairy Herd
Study date
2020
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281773
Author
Ayad and Iguer-ouada
Title
Electrochemiluminescence immunoassay for progesterone by using a heterologous system in plasma bovine.
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
281775
Author
Shorten et al
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
Authorising party
Public
Auth party contact address
-
Data no
281776
Author
Rogan et al
Title
Progesterone release patterns from Cue-Mate in comparison to other intravaginal progesterone-releasing devices in lactating dairy cows.
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
281777
Author
Rathbone et al
Title
Fertility regulation in cattle.
Study date
1998
Authorising party
Public
Auth party contact address
-
Data no
281778
Author
Ahn and Horenstein
Title
Eigenvalue ratio test for the number of factors.
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
281774
Author
Walker and Nowacki
Title
Understanding equivalence and non-inferiority testing.
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
281781
Author
Ogle
Title
Email correspondence re AU and NZ CIDR
Study date
2023
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281768
Author
Not specified
Title
Ulti-Mate - Vet CV
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281758
Author
Not specified
Title
2024-12-16 - Ulti-Mate - Part 8 - FINAL
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281759
Author
Not specified
Title
Ulti-Mate - NZ label
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
281760
Author
Not specified
Title
CIDR - AU label
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
281761
Author
Not specified
Title
CIDR - US label
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
281762
Author
Not specified
Title
CIDR - UK SPC
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
281763
Author
Rathbone et al.
Title
CIDR - Patent
Study date
2002
Authorising party
Public
Auth party contact address
-
Data no
281764
Author
Agilis International
Title
Ulti-Mate - NZ PV declaration
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281725
Author
Not specified
Title
GMP certificate 1
Study date
2023
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281726
Author
Not specified
Title
GMP certificate 2
Study date
2023
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281727
Author
Not specified
Title
GMP certificate 3
Study date
2023
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281728
Author
Not specified
Title
Finished product specifications
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281729
Author
APVMA
Title
PAA advice 140379
Study date
2023
Authorising party
Applicant
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 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
Author
Not specified
Title
Analytical validation report
Study date
2010
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281782
Author
Not specified
Title
Active constituent CoAs
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Data no
281783
Author
Not specified
Title
Active constituent monograph
Study date
2024
Authorising party
Applicant
Auth party contact address
325 Pages Road Timaru New Zealand
Date

Application Date

Application No

Application Number

145535
Product/Active constituent Name

Application Product Name

Fatrovax RHD Inactivated Vaccine for Rabbits

Application details

Product name:

Fatrovax RHD Inactivated Vaccine for Rabbits

Product number:

95410

Applicant Name:

INVETRO PTY LTD

Application purpose and description of use:

Registration of a RHD suspension for injection product for the immunisation of rabbits, in conjunction with approval of the actives.

Reference details:

92254 - FILAVAC VHD K C+V INACTIVATED VACCINE FOR RABBITS

Active constituents:

Active constituent name
95409 - Rabbit haemorrhagic disease virus 1 (RHDV1) VP1a
Active constituent name
95408 - Rabbit haemorrhagic disease virus type 2 (RHDV2) VP1ab

Description of data provided:

Data no
278783
Author
Fatro
Title
Detection and quantification of residual Baculovirus DNA in the active substances of Fatrovax RHD
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278784
Author
Fatro
Title
Evaluation of infectious titer in crude extracts
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278821
Author
Fatro
Title
yield-method-validation
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278842
Author
Anon
Title
ea-pcr-method-validation
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278847
Author
Fatro
Title
absence-mycoplasmas-additional-validation-study
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278848
Author
Fatro
Title
purification-polyclonal-sera
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278849
Author
Fatro
Title
protocol-identification-active-substancess-method-validation.
Study date
2017
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278850
Author
Fatro
Title
in-house-purification-method-std
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278851
Author
Fatro
Title
quantification-sds-page-method
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278852
Author
Fatro
Title
identification-active-substances-additional-validation-study
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278853
Author
Fatro
Title
v-mco-125-rev
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278854
Author
Fatro
Title
method-ph-determination
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278855
Author
Fatro
Title
production-coating-antigens
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278893
Author
Fatro
Title
sterility-purified-antigen-method
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278941
Author
Fatro
Title
wb-method-baculovirus-proteins
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278942
Author
Fatro
Title
residual-bv-dna-method
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278937
Author
Fatro
Title
absence-extraneous-agents-method
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278938
Author
Fatro
Title
plaque-count-method-validation
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278939
Author
Fatro
Title
certificate-master-seed-rhdva-131
Study date
2016
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278934
Author
Fatro
Title
certificate-working-seed-rhdv2ab-194
Study date
2017
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278935
Author
Fatro
Title
certificate-master-seed-rhdv2ab-194
Study date
2016
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278936
Author
Fatro
Title
certificate-working-seed-rhdva-131
Study date
2017
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278927
Author
Anon
Title
control-card-t-ni-pupae
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278928
Author
Fatro
Title
certificate-analysis-mcl-fc744
Study date
2016
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278929
Author
Fatro
Title
absence-rhabdovirus-contamination.
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278930
Author
Fatro
Title
-identification-species-spodoptera-frugiperda
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278931
Author
Ajay B Maghodia 1, Christoph Geisler 1, Donald L Jarvis 2
Title
Characterization of an Sf-rhabdovirus-negative Spodoptera frugiperda cell line as an alternative host for recombinant protein production in the baculovirus-insect cell system
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
278932
Author
Fatro
Title
karyotyping-sf-rvn
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279337
Author
Not identified
Title
re-testing RHDV2ab-194
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279338
Author
Not identified
Title
Routine quality control of pupae
Study date
2017
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278846
Author
Fatro
Title
sterility-purified-antigen-method
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
278895
Author
Anon
Title
extractables-study-on-de
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278896
Author
Anon
Title
validation-removal-hypochlorite
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278897
Author
Fatro
Title
inactivation-high-titres
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278843
Author
Anon
Title
coa-pupae-diet-components
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278844
Author
Fatro
Title
risk-assessment-sao
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278836
Author
Fatro
Title
-retesting-master-seeds
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278840
Author
Anon
Title
ea-pcr-method-validation
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278841
Author
Anon
Title
pupae-productivity
Study date
2017
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278818
Author
Fatro
Title
CoA detergents
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278819
Author
Anon
Title
celpure-c300
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278820
Author
Anon
Title
tem-analysis-tff-samples
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278826
Author
Fatro
Title
bv-growth-low-moi
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278827
Author
Anon
Title
antibody-baculovirus-envelope-gp64
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278828
Author
Fatro
Title
wb-images-sensitivity-of-inactivation-control-test.
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278829
Author
Fatro
Title
vlp-monomer-proportion.
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278831
Author
Anon
Title
statement-pI-storage
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278832
Author
Anon
Title
cert-conf-nunc-vials
Study date
2018
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278834
Author
Fatro
Title
pfu-count-method-and-validation
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278814
Author
Fatro
Title
Ausit Final Report
Study date
2016
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278815
Author
Fatro
Title
Study on effect of inoculum titer and incubation timeon protein expression in pupae
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278786
Author
Algenex
Title
Cetrification for pre-Master baculovirus seeds
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278791
Author
Anon
Title
Certificate of Analysis -donor plasmid
Study date
2016
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278782
Author
Burmester T
Title
Evolution and function of the insect hexamerins
Study date
1999
Authorising party
Public
Auth party contact address
-
Data no
278816
Author
Anon
Title
plastic-for-plastic-trays
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278807
Author
Henneberry, Kishaba
Title
Cabbage Loopers
Study date
1966
Authorising party
Public
Auth party contact address
-
Data no
278837
Author
Katharina Peer 1, Michael Taborsky
Title
Outbreeding depression, but no inbreeding depression in haplodiploid Ambrosia beetles with regular sibling mating
Study date
2005
Authorising party
Public
Auth party contact address
-
Data no
278866
Author
Javier Lopez-Vidal 1, Silvia Gomez-Sebastian, Ismael Sanchez-Ramos, Jose M Escribano
Title
Characterization of a Trichoplusia ni hexamerin-derived promoter in the AcMNPV baculovirus vector
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
279339
Author
Not identified
Title
Acceptability range productivity study
Study date
2016
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279349
Author
Not identified
Title
Summary table of antigen batches consistency data
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279341
Author
Not identified
Title
Certificate of conformity
Study date
2018
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279342
Author
Not identified
Title
Comparative analysis - detection of antibodies
Study date
2018
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278933
Author
Fatro
Title
certificate-analysis-mcp-fc737
Study date
2016
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278915
Author
Harald W. Krenn
Title
Feeding Mechanisms of Adult Lepidoptera: Structure, Function, and Evolution of the Mouthparts
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
278919
Author
Y Higashiura 1, M Ishihara, P W Schaefer
Title
Sex ratio distortion and severe inbreeding depression in the gypsy moth Lymantria dispar L. in Hokkaido, Japan
Study date
1999
Authorising party
Public
Auth party contact address
-
Data no
278920
Author
Marc A. DeRose, Derek A. Roff
Title
not supplied
Study date
1999
Authorising party
Public
Auth party contact address
-
Data no
278921
Author
R. T. Roush
Title
Inbreeding Depression and Laboratory Adaptation in Heliothis virescens (Lepidoptera: Noctuidae)
Study date
1986
Authorising party
Public
Auth party contact address
-
Data no
278922
Author
Ilik J Saccheri 1 2, Paul M Brakefield 1, Richard A Nichols 3
Title
SEVERE INBREEDING DEPRESSION AND RAPID FITNESS REBOUND IN THE BUTTERFLY BICYCLUS ANYNANA (SATYRIDAE)
Study date
1996
Authorising party
Public
Auth party contact address
-
Data no
278923
Author
Lu Peng, Mingmin Zou, Nana Ren, Miao Xie, Liette Vasseur, Yifan Yang, Weiyi He, Guang Yang, Geoff M. Gurr, Youming Hou, Shijun You & Minsheng You
Title
Generation-based life table analysis reveals manifold effects of inbreeding on the population fitness in Plutella xylostella
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
278924
Author
Janana De Nardin, Luciana Da Silva, Aldo Mellender De Arajo
Title
Comparative effects of inbreeding and outbreeding on the ontogeny of Heliconius erato phyllis (Lepidoptera: Nymphalidae)
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
278925
Author
Vath et al
Title
Minimum Viable Population
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
278926
Author
Katharina Peer 1, Michael Taborsky
Title
Outbreeding depression, but no inbreeding depression in haplodiploid Ambrosia beetles with regular sibling mating
Study date
2005
Authorising party
Public
Auth party contact address
-
Data no
278894
Author
Anon
Title
pupae-storage-pre-inoculation
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278839
Author
Anon
Title
stability-pupae-before-inoculation
Study date
2017
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278856
Author
Fatro
Title
stability-coating-antigens-and-standards
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278863
Author
Fatro
Title
stability-purified-antigens-rev
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278817
Author
Fatro
Title
stability-of-infected-frozen-pupae
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278833
Author
Fatro
Title
working-seeds-stability-report
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278811
Author
Fatro
Title
statistics-on-potency-from-stability-study
Study date
2018
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278797
Author
Fatro
Title
sarkosyl-determination-method-validation
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278860
Author
Fatro
Title
elisa-validation-protocol.
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278861
Author
Fatro
Title
elisa-method-revised
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278862
Author
Fatro
Title
revised-sterility-test
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278858
Author
Fatro
Title
potency-validation-report-track-version
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278891
Author
Fatro
Title
sop-v173
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278887
Author
Fatro
Title
degradation-products
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278888
Author
Fatro
Title
plaque-count-method
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278889
Author
Fatro
Title
staining-protocols-pfu-titration
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278949
Author
Fatro
Title
-potency-validation-report-rev-1
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278950
Author
Fatro
Title
elisa-validation-report-rev-1
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278951
Author
Fatro
Title
determination-adjuvant-method-validation
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278952
Author
Fatro
Title
determination-preservative-method-validation
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278953
Author
Fatro
Title
sterility-test-method-validation
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278943
Author
Fatro
Title
validation-report-inactivation-rev-1
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278944
Author
fatro
Title
quantification-sds-page-method-rev-1
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278945
Author
Fatro
Title
identification-active-substances-method-validation
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278946
Author
Fatro
Title
absence-mycoplasmas-method-validation
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278947
Author
Fatro
Title
sterility-purified-antigen-method-validation
Study date
2018
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278954
Author
Fatro
Title
-batch-consist
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278955
Author
Fatro
Title
bpr-consistency-batches
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278956
Author
Fatro
Title
2-bpr-additional-batches
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278957
Author
Fatro
Title
-bpr-sub-potent
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279350
Author
Fatro
Title
Batch review committment-batches
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279340
Author
Not identified
Title
CoA - starting material
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278882
Author
Fatro
Title
coa-1803.
Study date
2018
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278903
Author
Fatro
Title
bpr-batches-used-in-studies
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278909
Author
Fatro
Title
process-validation-report
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278910
Author
Fatro
Title
start-mat-in-ph
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278890
Author
Fatro
Title
bpr-template
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278859
Author
Fatro
Title
specificity-elisa-validation-report
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278869
Author
Fatro
Title
compatibility-study
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278857
Author
Fatro
Title
management-reagents
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278838
Author
G. McDonnell, A.D. Russell
Title
Antiseptics and Disinfectants: Activity, action and resistance
Study date
1999
Authorising party
Public
Auth party contact address
-
Data no
278801
Author
Anon
Title
validation-sterilisation-primary-packaging
Study date
2018
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278804
Author
Fatro
Title
integrated-tip-cap
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278805
Author
Anon
Title
documentation-needles
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278822
Author
Fatro
Title
validation-protocol-bv-inactivation.
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278835
Author
Silvia Gomez-Sebastian, 1 Javier Lopez-Vidal, 1 and Jose M. Escribano 2 ,
Title
Significant Productivity Improvement of the Baculovirus Expression Vector System by Engineering a Novel Expression Cassette
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
278796
Author
CBM Electrom Microscopy unit
Title
Analysis of the ratio T1/T3 in recombinant RHDV VLPs preparations
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278758
Author
Eudra
Title
GMP Certificate
Study date
March 2023
Authorising party
Public
Auth party contact address
-
Data no
279336
Author
Not identified
Title
Details - primary packaging
Study date
2018
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278948
Author
Fatro
Title
test-fin-prod
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278940
Author
Fatro
Title
contr-manuf
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278908
Author
Fatro
Title
manuf
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278994
Author
Fatro
Title
approved-end-shelf-life-specifications
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278789
Author
D M Perez-Filgueira 1, P Resino-Talavn, C Cubillos, I Angulo, M G Barderas, J Barcena, J M Escribano
Title
Development of a low-cost, insect larvae-derived recombinant subunit vaccine against RHDV
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
278825
Author
Margot N. Pearson
Title
Characterization of a Baculovirus-Encoded Protein That Is Associated with Infected-Cell Membranes and Budded Virions
Study date
2001
Authorising party
Public
Auth party contact address
-
Data no
278892
Author
Anon
Title
coa-wheat-germ-with-translation
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278911
Author
Fatro
Title
certificates-of-analysis
Study date
2018
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278912
Author
Fatro
Title
start-mat-not-in-ph
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278913
Author
Anon
Title
certificate-esf-af-medium
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278902
Author
Fatro
Title
qual-quant-partic
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278868
Author
Fatro
Title
stability-study-protocol-additiona
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278870
Author
Fatro
Title
in-use-shelf-life-broached-vial-test.
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278864
Author
Fatro
Title
finished-product-stability-report.
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279351
Author
Fatro
Title
Stability Study report - pilot and commercial batch
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279352
Author
Fatro
Title
Fatrovax finished product stability report for shelf life extension
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278958
Author
Fatro
Title
stab
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278959
Author
Fatro
Title
-finished-product-stability-report
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278960
Author
Fatro
Title
in-use-shelf-life-broached-vial-test
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278961
Author
Fatro
Title
preservative-efficacy-study-rev.
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278916
Author
not identified
Title
Baculovirus Host-Range
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
278917
Author
V. Prasad, S. Srivastana
Title
Baculovirus host-range
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
278969
Author
Fatro
Title
field-stud
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278970
Author
Fatro
Title
04co-3pc-1-clinical-study-dwarf-rabbit-rev-1
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278972
Author
Fatro
Title
gen-requ
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278973
Author
Fatro
Title
lab-trials
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278985
Author
Fatro
Title
field-trials
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278996
Author
Fatro
Title
individual-anatomo-patological-data
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278975
Author
Fatro
Title
study-report-04co-4lab3-doi
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278865
Author
Michael J. Conway,1 Tonya M. Colpitts,2 and Erol Fikrig3,4
Title
Role of the Vector in Arbovirus Transmission
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
278871
Author
Miguel Carneiro 1 2, Dou Hu 3, John Archer 4, Chungang Feng 5, Sandra Afonso 4, Congying Chen 5 6, Jose A Blanco-Aguiar 4 7, Herv Garreau 8, Samuel B
Title
Dwarfism and Altered Craniofacial Development in Rabbits Is Caused by a 12.1 kb Deletion at the HMGA2 Locus
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
278872
Author
Fatro
Title
comparative-serology-study-04co-34lab2
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278873
Author
Anon
Title
p17rhdk1-ingezim-rabbit-prototype
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278874
Author
Fatro
Title
comparative-serology-study-064-17
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278845
Author
Abha Saxena 1, Prasanna Kumar Byram 1, Suraj Kumar Singh 1, Jayanta Chakraborty 2, David Murhammer 3, Lopamudra Giri 1
Title
A structured review of baculovirus infection process: integration of mathematical models and biomolecular information on cell-virus interaction
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
278881
Author
B A Peri, R M Rothberg
Title
Transmission of maternal antibody prenatally and from milk into serum of neonatal rabbits
Study date
1986
Authorising party
Public
Auth party contact address
-
Data no
278904
Author
Barcena J., Verdaguer N., Roca R., Morales M., Angulo I., Risco C., Carrascosa J.L., Torres J.M., Caston J.R.
Title
The coat protein of Rabbit hemorrhagic disease virus contains a molecular switch at the N-terminal region facing the inner surface of the capsid.
Study date
2004
Authorising party
Public
Auth party contact address
-
Data no
278905
Author
Ghislaine Le Gall-Recul 1, Antonio Lavazza, Stphane Marchandeau, Stphane Bertagnoli, Francoise Zwingelstein, Patrizia Cavadini, Nicola Martinelli,
Title
Emergence of a new lagovirus related to Rabbit Haemorrhagic Disease Virus
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
278906
Author
Juan Barcena, Beatriz Guerra, Ivn Angulo, Julia Gonzalez, Flix Valcrcel, Carlos P. Mata, Jose R. Castn, Esther Blanco & Al Alejo
Title
Comparative analysis of rabbit hemorrhagic disease virus (RHDV) and new RHDV2 virus antigenicity, using specific virus-like particles
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
278907
Author
Le gall Recule et al
Title
Detection of a new variant of RHDV in France
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
278790
Author
J Barcena 1, M Morales, B Vazquez, J A Boga, F Parra, J Lucientes, A Pags-Mant, J M Sanchez-Vizcano, R Blasco, J M Torres
Title
Horizontal transmissible protection against myxomatosis and rabbit hemorrhagic disease by using a recombinant myxoma virus
Study date
2000
Authorising party
Public
Auth party contact address
-
Data no
278792
Author
K.A. Hanley, S.C. Weaver
Title
Arbovirus Evolution
Study date
2008
Authorising party
Public
Auth party contact address
-
Data no
278793
Author
Scott C Weaver 1, Alan D T Barrett
Title
Transmission cycles, host range, evolution and emergence of arboviral disease
Study date
2004
Authorising party
Public
Auth party contact address
-
Data no
278794
Author
Juan Barcena 1, Nuria Verdaguer, Ramn Roca, Monica Morales, Ivn Angulo, Cristina Risco, Jose L Carrascosa, Juan M Torres, Jose R Castn
Title
The coat protein of Rabbit hemorrhagic disease virus contains a molecular switch at the N-terminal region facing the inner surface of the capsid
Study date
2004
Authorising party
Public
Auth party contact address
-
Data no
278795
Author
Xue Wang 1, Fengting Xu, Jiasen Liu, Bingquan Gao, Yanxin Liu, Yujia Zhai, Jun Ma, Kai Zhang, Timothy S Baker, Klaus Schulten, Dong Zheng, Hai Pang, F
Title
Atomic model of rabbit hemorrhagic disease virus by cryo-electron microscopy and crystallography
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
278769
Author
Fatro S.p.A.
Title
genetic-comparison-with-rhdv2-australian-strains
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278763
Author
Alves JM, Carneiro M, Day JP, Welch JJ, Duckworth JA, Cox TE, Letnic M, Strive T, Ferrand N, Jiggins FM.
Title
A single introduction of wild rabbits triggered the biological invasion of Australia
Study date
August 2022
Authorising party
Public
Auth party contact address
-
Data no
278764
Author
Ramsey, D.S.; Patel, K.K.; Campbell, S.; Hall, R.N.; Taggart, P.L.; Strive, T.
Title
Sustained Impact of RHDV2 on Wild Rabbit Populations across Australia Eight Years after Its Initial Detection
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
278765
Author
Sun Z, An Q, Li Y, Gao X, Wang H.
Title
Epidemiological characterization and risk assessment of rabbit haemorrhagic disease virus 2 (RHDV2/b/GI.2) in the world.
Study date
March 2024
Authorising party
Public
Auth party contact address
-
Data no
278766
Author
Abrantes J, van der Loo W, Le Pendu J, Esteves PJ.
Title
Rabbit haemorrhagic disease (RHD) and rabbit haemorrhagic disease virus (RHDV): a review.
Study date
February 2012
Authorising party
Public
Auth party contact address
-
Data no
278771
Author
CSIRO
Title
Recombination in Australian rabbit caliciviruses
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
278772
Author
O'Connor TW, Read AJ, Hall RN, Strive T, Kirkland PD.
Title
Immunological Cross-Protection between Different Rabbit Hemorrhagic Disease Viruses-Implications for Rabbit Biocontrol and Vaccine Development.
Study date
April 2022
Authorising party
Public
Auth party contact address
-
Data no
278773
Author
Mahar JE, Read AJ, Gu X, et al.
Title
Detection and Circulation of a Novel Rabbit Hemorrhagic Disease Virus in Australia
Study date
March 2018
Authorising party
Public
Auth party contact address
-
Data no
278806
Author
O'reilly et al
Title
Virus-host interations
Study date
1992
Authorising party
Public
Auth party contact address
-
Data no
278802
Author
SYLVIE LAURENT,' JEAN-FRAN(COIS VAUTHEROT,' MARIE-FRANCOISE MADELAINE,l
Title
Recombinant Rabbit Hemorrhagic Disease Virus Capsid ProteinExpressed in Baculovirus Self-Assembles into ViruslikeParticles and Induces Protection
Study date
1994
Authorising party
Public
Auth party contact address
-
Data no
278803
Author
not identified
Title
Recombinant VP60 in the form of virion-like particles as a potential vaccine against rabbit hemorrhagic disease virus
Study date
2006
Authorising party
Public
Auth party contact address
-
Data no
278800
Author
S. Boucher, G.Le Gall-Recule, G.Plassiart, B. Sraka
Title
clinical necroscopic and histological description of viral haemorrhagic disease/ Variant RHD Virus in young rabbits Spain
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
278808
Author
Osvaldo Lovisolo 1, Roger Hull, Oscar Rsler
Title
Coevolution of viruses with hosts and vectors and possible paleontology
Study date
2003
Authorising party
Public
Auth party contact address
-
Data no
278809
Author
Y.P. Chen, J,J, Becnel, S.M.Valles
Title
RNA viruses infecting pest insects
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
278810
Author
Siyi Chen a b 1
Title
Altered antigenicity and immunogenicity of human papillomavirus virus-like particles in the presence of thimerosal
Study date
2019
Authorising party
Public
Auth party contact address
-
Data no
278823
Author
Fatro
Title
maximum-volume-on-sf21-for-ki
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278824
Author
Fatro
Title
maximum-volume-on-sf21-interference-storage-buffer.
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278760
Author
Fatro S.p.A.
Title
Sales and Pharmacovigilance Data
Study date
July 2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278914
Author
Fanny Balique,1,2 Herv Lecoq,2 Didier Raoult,1,3 and Philippe Colson1,3,*
Title
Can Plant Viruses Cross the Kingdom Border and Be Pathogenic to Human
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
278885
Author
Fatro
Title
reference-serum-control-charts
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278875
Author
A G Bradbury 1, G J E Dickens 2
Title
Appropriate handling of pet rabbits: a literature review
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
278876
Author
Sonia Cabezas 1, Julio Blas, Tracy A Marchant, Sacramento Moreno
Title
Physiological stress levels predict survival probabilities in wild rabbits
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
278877
Author
Fatro
Title
validation-report-elisa-rhdv-rhdv2-izsler
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278878
Author
Fatro
Title
challenge-strains.
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278879
Author
Anon
Title
-immunochromatographic-kit.
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278880
Author
Fatro
Title
validation-pcr-rhdv2
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279343
Author
Not identified
Title
Efficacy study - duration of immunity
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279344
Author
Not identified
Title
Validation pcr-rhdv
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278974
Author
Fatro
Title
serology-competitive-elisa
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278977
Author
Fatro
Title
statistics-on-006-18-007-18
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278978
Author
Fatro
Title
study-report-006-007-18-rev-1
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278979
Author
Fatro
Title
statistics-on-04co-34lab2-rev-1
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278980
Author
Fatro
Title
study-report-04co-34lab2-rev-1
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278981
Author
Fatro
Title
statistics-on-04co-4lab1
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278967
Author
Fatro
Title
statistics-on-04co-34lab2-rev-1
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278968
Author
Fatro
Title
04co-34lab2-safety-single-dose-rev-1.
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278918
Author
B. A. Federici
Title
Ascoviruses
Study date
2008
Authorising party
Public
Auth party contact address
-
Data no
278962
Author
Fatro
Title
gen-requ
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278963
Author
Fatro
Title
-lab-tests
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278964
Author
Fatro
Title
f020217hk-safey-intradermic-route
Study date
2017
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278965
Author
Fatro
Title
-statistics-on-study-064-17.
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278966
Author
Fatro
Title
safety-does-rev-2
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278982
Author
Fatro
Title
study-report-04co-4lab1-rev-1
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278983
Author
Fatro
Title
study-report-04co-4rs2-rev-1
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278799
Author
Fatro
Title
04co-3lab3-safety-dwarf-rabbit
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278798
Author
Fatro
Title
npeo-determination-method-validation
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278812
Author
Ministry of Trade Madrid
Title
Alternative gene expression certification
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278813
Author
Bureau Veritas
Title
certificate-algenex-iso-9001
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278830
Author
Anon
Title
certification-algenex-on-generation-and-transfer-recombinant-bv
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278787
Author
Ministry of Agiculture
Title
GMO certification
Study date
2017
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278788
Author
Ministry of Science and innovation
Title
Certification of plasmid origin
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278785
Author
Fatro
Title
Fatrovax RHD Additional study on validation of inactivation of baculovirus
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278886
Author
Fatro
Title
committment-pam
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278883
Author
Fatro
Title
12-month-doi-challenge
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278899
Author
Fatro
Title
committment-pam
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278984
Author
Fatro
Title
1-study-report-04co-4rs1-rev-1
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278976
Author
Fatro
Title
study-report-bef74-1-doi
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278991
Author
Fatro
Title
letter-of-authorisation.
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278993
Author
Fatro
Title
cover-letter
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278428
Author
InVetro Pty Ltd
Title
Application Overview
Study date
September 2024
Data no
278759
Author
Anon
Title
Letter of Support
Study date
October 2023
Data no
278767
Author
European Union
Title
EU Directive No 37/2010
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
278768
Author
European Pharmacopeia
Title
European Pharmacopeia Monograph 0062
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
278761
Author
InVetro Pty Ltd
Title
Import Permit Application
Study date
September 2023
Data no
278762
Author
InVetro Pty Ltd
Title
Data List Summary
Study date
September 2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278990
Author
Fatro
Title
flow-chart
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278986
Author
Fatro
Title
ddps
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278987
Author
Fatro
Title
qp-declaration-active-substances
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278988
Author
Fatro
Title
mock-ups
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278989
Author
EUDRA
Title
GMP Certificate
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
278992
Author
EEA
Title
proof-establishment-eea
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278995
Author
EUDRA
Title
manufacturing-authorisation
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
279345
Author
EMA
Title
2024-07-12_Fatrovax_CVMP-opinion
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279346
Author
EMA
Title
Fatrovax RHD - marketing authorisation validity
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279347
Author
EMA
Title
Fatrovax RHD Updated SPC following variation approval
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279348
Author
Fatro
Title
Fatrovax variation application
Study date
2024
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278770
Author
European Union
Title
Official Journal of the EU extract - Fatrovax Marketing Authorisation
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
278774
Author
European Commission
Title
admin info
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278775
Author
Fatro/EMA
Title
spc
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
278776
Author
Fatro
Title
Concise deatiled and critical summary on analytical, safety and efficacy documenttion
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278777
Author
Fatro
Title
Concise deatiled and critical summary on analytical, safety and efficacy documenttion
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278778
Author
Fatro/ EMA
Title
LOQ responses
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278779
Author
Fatro
Title
DDPS
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278780
Author
Health Ministry
Title
GMP Certificate
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278781
Author
Fatro
Title
Purity Method Validation
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278900
Author
EMA
Title
fatrovax-rhd-loi-and-so
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278901
Author
EMA
Title
fatrovax-rhd-d120-loq-and-so
Study date
2020
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278898
Author
EMA
Title
cvmp-summary-positive-opinion-fatrovax-rhd_en
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278884
Author
Fatro/EMA
Title
responses-to-the-loi
Study date
2021
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278867
Author
W.G.Hesselink
Title
Concise detailed and critical summary on analytical, safety and efficacy documentation
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278756
Author
APVMA
Title
PAA Advice
Study date
September 2024
Data no
278757
Author
APVMA
Title
Project Plan
Study date
September 2024
Data no
278971
Author
Fatro
Title
era
Study date
2019
Authorising party
Applicant
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Date

Application Date

Application No

Application Number

146677
Product/Active constituent Name

Application Product Name

ATEKA 480 SC Insecticide

Application details

Product name:

ATEKA 480 SC Insecticide

Product number:

95641

Applicant Name:

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a 480 g/L Spirotetramat Suspension concentrate for uses as proposed in the Directions for Use.

Reference details:

61864 - MOVENTO 240 SC INSECTICIDE

Active constituents:

Active constituent name
94010 - SPIROTETRAMAT

Description of data provided:

Data no
281361
Author
Reddy, G. R.
Title
Analytical Method validation and Active Ingredient Content Determination of Spirotetramat 480 SC, Sponsor Study No: 000112030. RCC Study Number 13171
Study date
28 Jul 2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281358
Author
Mirilashvili, S.
Title
Formulation Process of Spirotetramat 480 SC ADM.04150.I.1.A
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281356
Author
Adama Australia
Title
Safety Data Sheets (SDS) for the constituents used in formulation of ATEKA 480 SC Insecticide
Study date
Nov 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281357
Author
Adama
Title
Safety Data Sheet for Spirotetramat 480 SC
Study date
25 Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281354
Author
Adama Australia
Title
Part-2 Chemistry and Manufacture
Study date
Nov 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281355
Author
Adama Australia
Title
ATEKA 480 SC INSECTICIDE - draft label
Study date
Nov 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281362
Author
Reddy, G. R.
Title
Physical & Chemical Properties of Spirotetramat 480 g/L SC, Sponsor Study No: 000115494. RCC Study Number 13172
Study date
03 Aug 2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281359
Author
Reddy, G. R.
Title
Physical & Chemical Properties, Accelerated Storage Stability and Container Content Compatibility of Spirotetramat 480 g/L SC, Sponsor Study No: 000115284. RCC Study Number 13174
Study date
26 Jul 2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281360
Author
Reddy, G. R.
Title
Low Temperature Stability (0C) Test for Spirotetramat 480 g/L SC, Sponsor Study No: 000115283. RCC Study Number 13189
Study date
26 Jul 2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281369
Author
Adama Australia
Title
Part 8 - efficacy and Crop Safety
Study date
Nov 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281370
Author
Litzow, D.
Title
BIOEQUIVALENCE OF ADM.04150.I.1.A WITH MOVENTO ON SILVERLEAF WHITEFLY IN COTTON. Macalister, Queensland, 2021. Document reference: AD-AU-21-I01-1, Trial No.: ADAMA2104
Study date
22/8/2022
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281371
Author
Litzow, D.
Title
AD-AU-21-I01-2 BIOEQUIVALENCE OF ADM.04150.I.1.A WITH MOVENTO ON SILVERLEAF WHITEFLY IN COTTON. Coominya, Queensland, 2021.
Study date
22/5/2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281372
Author
Peters, A.
Title
AD-AU-21-I01-3 Bioequivalence of ADM.04150.I.1.A prototypes with Movento for DBM control in Brassica. Nobby, QLD, 2021.
Study date
28/2/2022
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281373
Author
Hall, Z.
Title
AD-AU-21-I01-4b Bioequivalence of ADM.04150.I.1.A prototypes with Movento for DBM control in Brassica. Gatton, QLD, 2022.
Study date
8/11/2022
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281374
Author
Hutcheon, E.
Title
AD-AU-22-I09-2 Comparison of ADM.04150.I.1 480 SC with Movento 240 SC for the control of diamondback moth (Plutella xylostella) in Chinese cabbage (Brassica rapa pekinensis) cv. Matilda. Wanneroo, Western Australia, 2022.
Study date
30/7/2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281375
Author
Braybrook, D. and Mannes, L.
Title
AD-AU-22-I11-1 Evaluation of ADM.02100.I.5.A on long tailed mealybug in grapes. Iraak, Victoria, 2022.
Study date
June 2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281376
Author
Themsen, C. and Parker, D.
Title
AD-AU-23-I05-07a Evaluation of Cormoran and Trivor for the control of silver leaf whitefly in cotton. Lefthand Branch, Queensland, 2023.
Study date
October 2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281377
Author
Themsen, C. and Parker, D.
Title
AD-AU-23-I12-06 Evaluation of ADM.04150.I.1.A in cotton for aphids. Lefthand Branch, Queensland, 2024.
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281378
Author
Simon S.
Title
AD-AU-23-I12-07 To evaluate ADM.04150.I.1.A for the control of mango scale (Aulacaspis tubercularis) in mango cv. Kensington Pride. Childers, Queensland, 2024.
Study date
27/5/2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281379
Author
Braybrook, D. and Dr Villalta, O.
Title
AD-AU-23-I12-08a Evaluation of various insecticides for grapevine scale control wine grapes Faraday, Victoria, 2023-2024.
Study date
May 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281380
Author
Themsen, C. and Parker, D.
Title
AD-AU-23-I12-12 Evaluation of ADM.04150.I.1.A in cucurbits for aphids. Lefthand Branch, Queensland, 2024.
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281381
Author
Themsen, C. and Parker, D.
Title
AD-AU-23-I12-17 Evaluation of ADM.04150.I.1.A in lettuce. Lefthand Branch, Queensland, 2024.
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281382
Author
Cookson, L.
Title
AD-AU-23-I13-03 Evaluation of ADI-69 for the Control of Aphids. Bowen, Queensland, 2023
Study date
20/12/2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281383
Author
Themsen, C. and Parker, D.
Title
AD-AU-23-I13-02 Evaluation of ADI-69 for the control of aphids in watermelon. Lefthand Branch, Queensland, 2024.
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281384
Author
Tancred, S.
Title
AD-AU-23-I17-01 Comparison of ADM.04150.I.1.A 480 SC, ADM.05050.I.2.C 400 SC +/- Warlock 17 EC and ADM.04151.I.4.B 400 SC with Versys 100 DC +/- Chess 500 WG, Chess, Clasto 200 WG, Mainman 500 WG +/- Chess and Efficon 120 SL for the control of green peach aphid (Myzus persicae) in capsicum cv. Plato. Ballandean near Stanthorpe, Queensland, 2023-24.
Study date
7/6/2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281385
Author
Tancred, S.
Title
AD-AU-23-I17-02 Comparison of ADM.04150.I.1.A 480 SC plus Hasten 704 SC, ADM.04151.I.4.B 400 SC plus Hasten and ADM.05050.I.2.C 400 SC plus Hasten +/- Warlock 17 EC with Versys 100 DC plus Hasten +/- Chess 500 WG, Chess plus Hasten, Clasto 200 WG plus Hasten, Mainman 500 WG plus Hasten +/- Chess and Efficon 120 SL for the control of green peach aphid (Myzus persicae) and cabbage aphid
Study date
28/6/2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281386
Author
Litzow, D.
Title
AD-AU-23-I17-04 CHORDOTONAL ORGAN DISRUPTOR EFFICACY SCREEN ON SILVERLEAF WHITEFLY IN GREEN BEANS. Lowood, Queensland, 2024.
Study date
3/7/2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281387
Author
Marnes du Preez
Title
ADM.04150.I.1.A_Citrus_RS_CC2 The Efficacy and Crop Tolerance of ADM.04150.I.1.A for the control of red scale (Aonidiella aurantii) in Citrus in the Western Cape Province of South Africa. Citrusdal, Western Cape, 2023.
Study date
17/5/2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281388
Author
T.L.Klerck
Title
EVALUATION OF ADM.04150.I.1.A FOR CONTROL OF WOOLLY APPLE APHID. Stellenbosch, Western Cape, 2023. Screeners Development CC South Africa Document reference: ADM.04150.I.1.A_apple_waa_22
Study date
31/3/2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281389
Author
Theron, S.
Title
Field trial to determine efficacy and crop safety of ADM.04150.I.1.A for control of red scale in citrus in South Africa. Ashton, Western Cape, 2023. ADAMA South Africa Document reference: ZA23IEYCITR022
Study date
26/3/2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281390
Author
Jon McCarthy
Title
AD-AU-21-IS04-3 Evaluation of new miticides on couch mite. Nudgee, Queensland, 2021.
Study date
31/8/2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281391
Author
Harvey, S. and George, C.
Title
AD-AU-21-IS04-4 Evaluation of new Adama miticides products on couch mite in turf. Terry Hills, New South Wales, 2021.
Study date
31/5/2022
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281392
Author
Martinez, R. and Harvey, S.
Title
AD-AU-22-IS05-4 Evaluation of new miticides on couch mite. Oxley, Queensland, 2023.
Study date
17/1/2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281393
Author
Martinez, R. and Harvey, S.
Title
AD-AU-22-IS05-5 Evaluation of new miticides on couch mite. Terry Hills, New South Wales, 2023.
Study date
22/2/2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281394
Author
Martinez, R. and Harvey, S.
Title
AD-AU-22-IS05-6 Evaluation of new miticides on couch mite. Terry Hills, New South Wales, 2023.
Study date
22/2/2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281395
Author
Cookson, L.
Title
AD-AU-23-I12-09 Evaluation of ADM.04150.I.1.A for the control of thrips in capsicum. Bowen, Queensland, 2024
Study date
16/9/2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281396
Author
Themsen, C. and Parker, D.
Title
AD-AU-23-I12-10 Evaluation of ADM.04150.I.1.A in onions. Lefthand Branch, Queensland, 2024
Study date
September 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281397
Author
Themsen, C. and Parker, D.
Title
AD-AU-23-I12-01 Evaluation of ADM.04150.I.1.A in brassica vegetables for silverleaf whitefly. Bundeburg, Queensland, 2024
Study date
November 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281398
Author
Cookson, L. and Cookson, C.
Title
AD-AU-23-I18-09 Evaluation of ADM.04050.I.1.D for the control of thrips in capsicum. Bowen, Queensland, 2024
Study date
September 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281399
Author
Adama Australia
Title
Ateka 480 SC Insecticide - draft label
Study date
Nov 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281400
Author
Anon
Title
Movento Brassicas Crop Guide
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
281401
Author
Anon.
Title
Movento crop guide for citrus
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281364
Author
Kumar, B.
Title
SPIROTETRAMAT 480 SC: ACUTE DERMAL TOXICITY STUDY IN WISTAR RATS (FIXED DOSE PROCEDURE) STUDY No.: G25316 SPONSOR REFERENCE NUMBER: 000110318
Study date
16 Mar 2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281367
Author
Yogeesh, B.S.
Title
SPIROTETRAMAT 480 G/L SC: EYE IRRITATION / CORROSION STUDY IN NEW ZEALAND WHITE RABBITS STUDY No.: G25319 SPONSOR REFERENCE NO. 000110323
Study date
29 May 2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281365
Author
Kuna, B.
Title
SPIROTETRAMAT 480 SC: ACUTE INHALATION TOXICITY STUDY IN WISTAR RATS STUDY No.: G25317 SPONSOR REFERENCE NUMBER: 000110320
Study date
27 Feb 2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281363
Author
Kumar, B.
Title
SPIROTETRAMAT 480 SC: ACUTE ORAL TOXICITY STUDY (ACUTE TOXIC CLASS METHOD) IN WISTAR RATS STUDY No.: G25315 SPONSOR REFERENCE NUMBER: 000110321
Study date
27 Mar 2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281366
Author
Yogeesh, B.S.
Title
SPIROTETRAMAT 480 SC: ACUTE DERMAL IRRITATION / CORROSION STUDY IN NEW ZEALAND WHITE RABBITS STUDY No.: G25318 SPONSOR REFERENCE NUMBER: 000110319
Study date
31 May 2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
281368
Author
Mohan Kumar, S.B.
Title
SPIROTETRAMAT 480 SC: LOCAL LYMPH NODE ASSAY (LLNA) IN CBA/Ca MICE STUDY No.: G25320 SPONSOR REFERENCE NUMBER: 000110322
Study date
15 Mar 2023
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date

Application Date

Application No

Application Number

146683
Product/Active constituent Name

Application Product Name

STRAVIA Tebuthiuron 200 GR Herbicide

Application details

Product name:

STRAVIA Tebuthiuron 200 GR Herbicide

Product number:

95645

Applicant Name:

WINFARMS PTY. LTD.

Application purpose and description of use:

Registration of a 200 g/kg granular formulation (GR) for control of Brigalow Regrowth, Tea Tree Regrowth, Mimosa Pigra and Certain Problem Woody Weeds on Grazing Lands as by Hand, Aerial and Ground Application

Reference details:

65316 - PACIFIC TEBUTHIURON 200GR HERBICIDE

Active constituents:

Active constituent name
57789 - TEBUTHIURON
Date

Application Date

Application No

Application Number

146554
Product/Active constituent Name

Application Product Name

Marino 400 Herbicide

Application details

Product name:

Marino 400 Herbicide

Product number:

95630

Applicant Name:

TURF CULTURE PTY LTD

Application purpose and description of use:

Registration of a 400 g/L metribuzin suspension concentrate (SC) product for selective post-emergent weed control in turf.

Reference details:

68564 - METRIC HERBICIDE

Active constituents:

Active constituent name
64058 - AGRISMART SIMAZINE 900WG HERBICIDE
Active constituent name
65048 - METRIBUZIN

Description of data provided:

Data no
281301
Author
Xia Wan
Title
Metribuzin - CoA
Study date
26 August 2024
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Date

Application Date

Application No

Application Number

146584
Product/Active constituent Name

Application Product Name

4FARMERS PARAQUAT 250 HERBICIDE

Application details

Product name:

4FARMERS PARAQUAT 250 HERBICIDE

Product number:

95637

Applicant Name:

4 FARMERS AUSTRALIA PTY LTD

Application purpose and description of use:

Paraquat 250g/L SL for the Control of a Wide Range of Grasses and Broadleaf Weeds as per Directions for Use

Active constituents:

Active constituent name
54043 - PARAQUAT DICHLORIDE MANUFACTURING CONCENTRATE

Description of data provided:

Data no
281674
Author
APVMA -Engagement and Communication
Title
product renewal information
Study date
02.07.2024
Authorising party
Applicant
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Date

Application Date

Application No

Application Number

146685
Product/Active constituent Name

Application Product Name

Swan Pyroxasulfone 850 WG Herbicide

Application details

Product name:

Swan Pyroxasulfone 850 WG Herbicide

Product number:

94202

Applicant Name:

SWAN CHEMICAL HOLDINGS PTY LTD

Application purpose and description of use:

Variation of product details.

Reference details:

90448 - Smart SAYONARA 850 WG Herbicide

Active constituents:

Active constituent name
88915 - pyroxasulfone

Description of data provided:

Data no
281432
Author
K Clancy
Title
Consent -Swan Pyroxasulfone 850 WG Herbicide
Study date
21 November 2024
Authorising party
Applicant
Auth party contact address
14 Pinea Turn ELLENBROOK Australia