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

142363
Product/Active constituent Name

Application Product Name

Campbell Chino 400SC Turf Fungicide

Application details

Product name:

Campbell Chino 400SC Turf Fungicide

Product number:

94408

Applicant Name:

COLIN CAMPBELL (CHEMICALS) PTY LTD

Application purpose and description of use:

Registration of a 400g/L cyazofamid as a suspension concentrate product for control of Pythium diseases in turf.

Reference details:

86803 - Segway 400 SC Fungicide

Active constituents:

Active constituent name
93499 - cyazofamid

Description of data provided:

Data no
264027
Author
J.A. Patel
Title
C of A for the active
Study date
11 December 2023
Authorising party
Cropnosys (India) Pvt. Ltd.
Auth party contact address
9th Floor, Arliga NorthStar Opposite Police Station (Beside RMZ Galleria Mall)Yelahanka, Bangalore 560064. Karnataka INDIA
Data no
264028
Author
Anon
Title
SDS for inerts in the formulation
Study date
November 2023
Authorising party
Cropnosys (India) Pvt. Ltd.
Auth party contact address
9th Floor, Arliga NorthStar Opposite Police Station (Beside RMZ Galleria Mall)Yelahanka, Bangalore 560064. Karnataka INDIA
Data no
264029
Author
Anon
Title
Formulation Process
Study date
December 2023
Authorising party
Cropnosys (India) Pvt. Ltd.
Auth party contact address
9th Floor, Arliga NorthStar Opposite Police Station (Beside RMZ Galleria Mall)Yelahanka, Bangalore 560064. Karnataka INDIA
Data no
264026
Author
K.S. Kishora
Title
Determination of Relative Density of Cyazofamid 400 g/L SC
Study date
12 September 2023
Authorising party
Cropnosys (India) Pvt. Ltd.
Auth party contact address
9th Floor, Arliga NorthStar Opposite Police Station (Beside RMZ Galleria Mall)Yelahanka, Bangalore 560064. Karnataka INDIA
Data no
264030
Author
K.S. Kishora
Title
Final Report Accelerated Storage Stability of Cyazofamid 400 g/L SC
Study date
1 September 2023
Authorising party
Cropnosys (India) Pvt. Ltd.
Auth party contact address
9th Floor, Arliga NorthStar Opposite Police Station (Beside RMZ Galleria Mall)Yelahanka, Bangalore 560064. Karnataka INDIA
Data no
264031
Author
K.S. Kishora
Title
Final Report Low Temperature Stability of Cyazofamid 400 g/L SC
Study date
7 September 2023
Authorising party
Cropnosys (India) Pvt. Ltd.
Auth party contact address
9th Floor, Arliga NorthStar Opposite Police Station (Beside RMZ Galleria Mall)Yelahanka, Bangalore 560064. Karnataka INDIA
Data no
264023
Author
Harvey, S.
Title
Evaluation of fungicides for control of Pythium spp in turf - 2022
Study date
29 June 2022
Authorising party
Applicant
Auth party contact address
5 Blackfriar Place WETHERILL PARK Australia
Data no
264024
Author
Harvey, S.
Title
Evaluation of fungicides for control of Pythium spp in turf - 2023
Study date
4 July 2023
Authorising party
Applicant
Auth party contact address
5 Blackfriar Place WETHERILL PARK Australia
Data no
264025
Author
Anon.
Title
Part 8 Efficacy Summary
Study date
2023
Authorising party
Applicant
Auth party contact address
5 Blackfriar Place WETHERILL PARK Australia
Date

Application Date

Application No

Application Number

141689
Product/Active constituent Name

Application Product Name

SEDdex Injection

Application details

Product name:

SEDdex Injection

Product number:

94143

Applicant Name:

PARNELL TECHNOLOGIES PTY LTD

Application purpose and description of use:

Registration of a Dexmedetomidine Hydrochloride Injection, 0.5 mg/mL, 10 mL vial. Intended for use as a Sedative, analgesic for use in the restraint of dogs and cats.

Reference details:

64563 - DEXDOMITOR 0.5 MG/ML INJECTABLE SEDATIVE AND ANALGESIC FOR DOGS AND CATS

Active constituents:

Active constituent name
94144 - Dexmedetomidine hydrochloride

Description of data provided:

Data no
263454
Author
Not identified
Title
GMP Evidence
Study date
7 November 2023
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
263455
Author
Not identified
Title
GMP Evidence
Study date
2023
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
272727
Author
Anon
Title
Stability Data-Attachment 1
Study date
Oct 23
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
272728
Author
Anon
Title
Prpoposed Specification-Attachemnt 2
Study date
May 24
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
260211
Author
Not identified
Title
Finished Product_Manufacturer GMP_Drug Establishments Current Registration Site
Study date
2023
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271693
Author
Anon
Title
Parnell response-Attachment 1
Study date
October 2019
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
260212
Author
Not Identified
Title
Flow Diagram of Dexmedetomidine Hydrochloride Injection (Compounding and Filling)
Study date
2023
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
260208
Author
PARNELL TECHNOLOGIES PTY LTD
Title
Cover letter_Applicable to Dexmedetomidine Hydrochloride Injection
Study date
2023
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
260210
Author
Anon
Title
Exeutive summary_Dexmedetomidine Hydrochloride Injection
Study date
July 2023
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271694
Author
Anon
Title
Exeutive summary_Dexmedetomidine Hydrochloride Injection
Study date
July 2023
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271695
Author
Anon
Title
Parnell response-Attachment 3
Study date
April 2024
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271692
Author
Parnell Technology Pty Ltd
Title
s159-Parnell?s response letter-Word file
Study date
April 2024
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
272726
Author
Parnell Technology Pty Ltd
Title
s8-Parnell?s response letter-PDF file
Study date
May 24
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271696
Author
Anon
Title
Parnell response-GMP-Attachment 4
Study date
April 2024
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Date

Application Date

Application No

Application Number

141927
Product/Active constituent Name

Application Product Name

Atipamezole hydrochloride

Application details

Product name:

Atipamezole hydrochloride

Active name:

Atipamezole hydrochloride

Applicant Name:

PARNELL TECHNOLOGIES PTY LTD

Application purpose and description of use:

New source of active constituent

Description of data provided:

Data no
262933
Author
Not identified
Title
COA_Atipamezole Hydrochloride
Study date
March 2020
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
263729
Author
Not identified
Title
Atipamezole hydrochloride CoAs
Study date
2022
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271861
Author
Anon
Title
COA-API Supplier
Study date
Nov 2023
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271862
Author
Anon
Title
Parnell response-Attachment 1
Study date
September 2021
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271860
Author
Parnell Technology Pty Ltd
Title
s159-Parnell?s response letter-Word file
Study date
May 2024
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Date

Application Date

Application No

Application Number

141924
Product/Active constituent Name

Application Product Name

CONTRASED Specific reverser of medetomidine and dexmedetomidine for dogs and cats

Application details

Product name:

CONTRASED Specific reverser of medetomidine and dexmedetomidine for dogs and cats

Product number:

94258

Applicant Name:

PARNELL TECHNOLOGIES PTY LTD

Application purpose and description of use:

Registration of a CONTRASED Specific reverser of medetomidine and dexmedetomidine for dogs and cats (5 mg /mL ATIPAMEZOLE HYDROCHLORIDE) solution for injection. The finished product contains 5 mg /mL ATIPAMEZOLE HYDROCHLORIDE per mL, intended for use as reversing and abolishing the effects of medetomidine.

Reference details:

40612 - ANTISEDAN SPECIFIC REVERSER OF MEDETOMIDINE AND DEXMEDETOMIDINE FOR DOGS AND CATS

Active constituents:

Active constituent name
94259 - Atipamezole hydrochloride

Description of data provided:

Data no
261829
Author
PARNELL TECHNOLOGIES PTY LTD
Title
Flow Diagram_CONTRASED
Study date
2023
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
261826
Author
PARNELL TECHNOLOGIES PTY LTD
Title
Cover letter_Applicable to CONTRASED
Study date
2023
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
261828
Author
PARNELL TECHNOLOGIES PTY LTD
Title
Exeutive summary_CONTRASED
Study date
2023
Authorising party
Applicant
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Date

Application Date

Application No

Application Number

142028
Product/Active constituent Name

Application Product Name

Greenzone Termite Paint

Application details

Product name:

Greenzone Termite Paint

Product number:

93121

Applicant Name:

GREEN ZONE PTY LTD

Application purpose and description of use:

Variation of the product registration and label approval of a product, Greenzone Termite Paint (93121), to remove the exclusion of Mastotermes darwiniensis from the Directions for Use table.

Reference details:

61290 - HOMEGUARD COLLARS
62739 - TERM-SEAL SEALANT ACTIVE TERMITE AND WATERPROOF BARRIER
62740 - TERM-SEAL MULTI-PURPOSE ACTIVE TERMITE AND WATERPROOF BARRIER
62741 - TERM-SEAL PRM ACTIVE TERMITE AND WATERPROOF BARRIER
63002 - TERM-SEAL URA-FEN ACTIVE TERMITE BARRIER
63003 - TERM-SEAL URA-FEN MAJOR TERMITE BARRIER PART B
64037 - TERM-SEAL URA-FEN SHIELD TWB TERMITE AND WATERPROOF BARRIER
70455 - TERM-SEAL URA-FEN TERMITE RESISTANT ADHESIVE
80186 - TERM-SEAL AQUA BLOCK PLUS SEALANT TERMITE BARRIER
80607 - TERM-SEAL AQUA BLOCK PLUS TERMITE BARRIER
82052 - Trithor Maxx Contact Adhesive Spray
82052 - Trithor Maxx Termiticidal Contact Adhesive Spray
89294 - Greenzone Perimeter System
89294 - Greenzone Termite Perimeter System

Active constituents:

Active constituent name
55301 - BIFENTHRIN

Description of data provided:

Data no
262266
Author
Anon
Title
8.0 Efficacy Dossier
Study date
November 2023
Authorising party
Applicant
Auth party contact address
25, 479 Warrical Road Moorabbin East Australia
Data no
262265
Author
Anon
Title
1.1 Executive Summary
Study date
November 2023
Authorising party
Applicant
Auth party contact address
25, 479 Warrical Road Moorabbin East Australia
Date

Application Date

Application No

Application Number

142336
Product/Active constituent Name

Application Product Name

Tri-Sulfox Injection

Application details

Product name:

Tri-Sulfox Injection

Product number:

91644

Applicant Name:

RANDLAB AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration Tri-Sulfox Injection for minor formulation variation.

Active constituents:

Active constituent name
89577 - Sulfadoxine
Active constituent name
83554 - Trimethoprim

Description of data provided:

Data no
271079
Author
various
Title
Certificate of Analysis
Study date
12/03/2024
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
263960
Author
Various
Title
Formulation sheet
Study date
01/12/2023
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
263961
Author
Various
Title
Finished Product Specification
Study date
20/09/2021
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
271080
Author
Various
Title
Tri-Sulfox Inj letter
Study date
22/03/2024
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Date

Application Date

Application No

Application Number

142330
Product/Active constituent Name

Application Product Name

Mecoprop-P

Application details

Product name:

Mecoprop-P

Active name:

Mecoprop-P

Applicant Name:

Shandong Rainbow International Co Ltd

Application purpose and description of use:

Approval of MECOPROP-P Technical for use in agricultural chemical products.

Description of data provided:

Data no
263946
Author
Gang Sun, Ph.D.
Title
PRELIMINARY ANALYSIS OF MECOPROP-P (MCPP-P) TECHNICAL GRADE ACTIVE INGREDIENT (TGAI)
Study date
April 25, 2014
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263947
Author
Gang Sun, Ph.D.
Title
POL YCHLORINATED DIBENZODIOXINS AND POL YC HLORINATED DIBENZOFURANS ANALYSIS OF MECOPROP-P (MCPP-P) TGAI
Study date
April 25, 2014
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263950
Author
Anon
Title
Doc
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263951
Author
anon
Title
The Statement of Batch Size of PaclobutrazolTechnical in 5-Batch Report
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263952
Author
Anon
Title
CoA
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
273746
Author
Anon
Title
Test QC results of Mecoprop-P Technical in the random samples produced in 2024
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263948
Author
Anon
Title
MANUFACTURE PROCESS OF MECOPROP-P Technical
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263945
Author
Shandong Rainbow International Co., Ltd.
Title
Chemistry &Manufacturing Dossier
Study date
14/12/2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263949
Author
Anon
Title
THE JUSTIFICATION OF IMPURITIES OF MECOPROP-P Technical
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date

Application Date

Application No

Application Number

142327
Product/Active constituent Name

Application Product Name

IMTRADE MOTTO RMR MITICIDE

Application details

Product name:

IMTRADE MOTTO RMR MITICIDE

Product number:

92373

Applicant Name:

IMTRADE AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to allow application by fixed-wing aircraft to Cotton only.

Active constituents:

Active constituent name
89349 - Etoxazole
Active constituent name
65954 - PIPERONYL BUTOXIDE

Description of data provided:

Data no
269524
Author
N/A
Title
Investigation into the Bio-equivalency of IMTRADE MOTTO? RMR? MITICIDE to that of PARAMITE SELECTIVE MITICIDE for the control of Mites in Cotton cv. Sicot 711RRF. One Trial - Forest Hill, QLD
Study date
27/03/2023
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
269525
Author
N/A
Title
Field Trial Protocol - Investigation into the efficacy of Imtrade Motto RMR Miticide for the control of mites in cotton as an aerial application
Study date
26/03/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
263940
Author
N/A
Title
Imtrade MOTTO?? RMR?? Miticide - RLP_V1 MARKED COPY 14/12/2023
Study date
14/12/2023
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
263938
Author
APVMA
Title
Environmental Technical Report App 135307 Imtrade MOTTO RMR Miticide
Study date
04/09/2023
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
263939
Author
N/A
Title
Further Assessment of Imtrade Motto RMR Miticide
Study date
14/12/2023
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date

Application Date

Application No

Application Number

142298
Product/Active constituent Name

Application Product Name

CHLORANTRANILIPROLE

Application details

Product name:

CHLORANTRANILIPROLE

Active name:

CHLORANTRANILIPROLE

Applicant Name:

GHARDA AUSTRALIA PTY. LTD.

Application purpose and description of use:

Approval of Chlorantraniliprole for use in agricultural chemical products.

Description of data provided:

Data no
263741
Author
S.K.CHANDORKAR
Title
SPECTRAL DATA OF CHLORANTRANILIPROLE ACTIVE INGREDIENT
Study date
23/06/2023
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
263742
Author
S.K.CHANDORKAR
Title
Chlorantraniliprole spectral data NMR,MS,IR,UV
Study date
23/06/2023
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
263743
Author
DR.K.N.SINGH
Title
DECLARATION OF COMPOSITION OF CHLORANTRANILIPROLE TECHNICAL
Study date
27/11/2023
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
263745
Author
S.K.CHANDORKAR
Title
ANALYSIS AND CERTIFICATION OF LIMITS FOR CHLORANTRANILIPROLE TECHNICAL STUDY NO.2303
Study date
23/06/2023
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
263744
Author
DR.K.N.SINGH
Title
SPECIFICATION OF CHLORANTRANILIPROLE TECHNICAL
Study date
27/11/2023
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
263747
Author
DR.K.N.SINGH
Title
MANUFACTURING SECTION CHLORANTRANILIPROLE TECHNICAL 95% MIN
Study date
27/11/2023
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
263748
Author
DR.K.N.SINGH
Title
QUALITY CONTROL DURING MANUFACTURING OF CHLORANTRANILIPROLE TECHNICAL
Study date
27/11/2023
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
263749
Author
DR.K.N.SINGH
Title
IMPURITY PROFILE OF CHLORANTRANILIPROLE TECHNICAL
Study date
27/11/2023
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
263750
Author
GHARDA CHEMICALS LIMITED
Title
MATERIAL SAFETY DATA SHEET OF CHLORANTRANILIPROLE TECHNICAL
Study date
22/11/2023
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
276474
Author
K Parameshwar
Title
Annexure 1 - Melting Point report ( GLP)
Study date
08/06/2025
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
276475
Author
Gharda
Title
Annexure 2 - Melting Point report of commercial scale batches
Study date
30/12/2024
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
276476
Author
Gharda
Title
Annexure 3 - Five Batch Analysis Report
Study date
05/08/2024
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
263746
Author
S.K.CHANDORKAR
Title
VALIDATION OF ANALYTICAL METHODS FOR ESTIMATION OF PURITY, RELATED IMPURITIES AND SOLVENT CONTENT IN CHLORANTRANILIPROLE TECHNICAL
Study date
12/06/2023
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
276477
Author
Gharda
Title
Annexure 4 - Manufacturing process - commercial scale production batches
Study date
8/8/2024
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
276478
Author
Gharda
Title
Annexure 5 - Analytical Methods from 5-BA of commercial scale batches
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
276479
Author
Gharda
Title
s159 Response to APVMA Queries on Chlorantraniliprole Technical
Study date
8/8/2024
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Data no
263751
Author
DR.K.N.SINGH
Title
EXECUTIVE SUMMARY-CHLORANTRANILIPROLE TECHNICAL
Study date
27/11/2023
Authorising party
Applicant
Auth party contact address
Suite 214 29-31 Lexington Drive Norwest Australia
Date

Application Date

Application No

Application Number

141950
Product/Active constituent Name

Application Product Name

IMAZAPIC

Application details

Product name:

IMAZAPIC

Active name:

IMAZAPIC

Applicant Name:

Jiangsu Flag Chemical Industry Co Ltd

Application purpose and description of use:

Approval of IMAZAPIC for use in agricultural chemical products.

Description of data provided:

Data no
262090
Author
Anon
Title
One-Batch Analysis (Validation)
Study date
2023
Authorising party
Applicant
Auth party contact address
No. 309 Changfenghe Road Nanjing Chemical Industrial Park NANJING China
Data no
278662
Author
Anon
Title
Test report of 3 new batches
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
No. 309 Changfenghe Road Nanjing Chemical Industrial Park NANJING China
Data no
262087
Author
Anon
Title
Five-batch report Imazapic TC
Study date
2023
Authorising party
Applicant
Auth party contact address
No. 309 Changfenghe Road Nanjing Chemical Industrial Park NANJING China
Data no
262091
Author
Anon
Title
One-Batch Analysis (Confidential Attachment)
Study date
2023
Authorising party
Applicant
Auth party contact address
No. 309 Changfenghe Road Nanjing Chemical Industrial Park NANJING China
Data no
262088
Author
Anon
Title
Manufacturing process
Study date
2023
Authorising party
Applicant
Auth party contact address
No. 309 Changfenghe Road Nanjing Chemical Industrial Park NANJING China
Data no
262089
Author
Anon
Title
Declaration of Composition
Study date
2023
Authorising party
Applicant
Auth party contact address
No. 309 Changfenghe Road Nanjing Chemical Industrial Park NANJING China
Data no
278663
Author
Anon
Title
COA for 3 new batches
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
No. 309 Changfenghe Road Nanjing Chemical Industrial Park NANJING China
Data no
262092
Author
Anon
Title
COA
Study date
2023
Authorising party
Applicant
Auth party contact address
No. 309 Changfenghe Road Nanjing Chemical Industrial Park NANJING China
Data no
262093
Author
Anon
Title
SDS
Study date
2023
Authorising party
Applicant
Auth party contact address
No. 309 Changfenghe Road Nanjing Chemical Industrial Park NANJING China
Data no
262086
Author
Anon
Title
Chemistry Dossier
Study date
2023
Authorising party
Applicant
Auth party contact address
No. 309 Changfenghe Road Nanjing Chemical Industrial Park NANJING China
Date

Application Date

Application No

Application Number

142296
Product/Active constituent Name

Application Product Name

Cerecarb Plus Herbicide

Application details

Product name:

Cerecarb Plus Herbicide

Product number:

94387

Applicant Name:

Shandong Rainbow International Co Ltd

Application purpose and description of use:

Registration of a 800 g/L PROSULFOCARB, 120 g/L S-METOLACHLOR in Emulsifiable Concentrate (EC) formulation for the control of Annual Ryegrass (Lolium rigidum) and other grass and broadleaf weeds in Barley, Chickpeas, Faba Beans, Field Peas, Lentils, Lupins, Potatoes, Triticale and Wheat.

Reference details:

61234 - BOXER GOLD HERBICIDE

Active constituents:

Active constituent name
83962 - Prosulfocarb
Active constituent name
69340 - S-METOLACHLOR

Description of data provided:

Data no
280127
Author
Shandong Rainbow International Co Ltd
Title
RAWS Updated
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
280138
Author
Shandong Rainbow International Co Ltd
Title
SDS of inert 1
Study date
August 2020
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
280139
Author
Shandong Rainbow International Co Ltd
Title
SDS of inert 2
Study date
September 2020
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
280140
Author
Shandong Rainbow International Co Ltd
Title
SDS of inert 3
Study date
May 2021
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
280141
Author
Shandong Rainbow International Co Ltd
Title
CoA of Prosulfocarb TC
Study date
September 2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263735
Author
-
Title
Analytical METHOD and VALIDATION report
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263730
Author
Yasser Sokeirik
Title
Chemistry Dossier
Study date
20/11/2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263731
Author
-
Title
RAWS
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263732
Author
-
Title
MANUFACTURE PROCESS OF Cerecarb Plus Herbicide
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263733
Author
Wang Youxin
Title
Accelerated Storage Stability Study on Prosulfocarb 800G/L + S-metolachlor 120G/L EC
Study date
October 5, 2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263734
Author
Wang Qingwei
Title
LOW TEMPERATURE STORAGE STABILITY TEST REPORT PROSULFOCARB 800G/L + S-METOLACHLOR 120G/L EC
Study date
OCT. , 2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263736
Author
Yasser Sokeirik & Geoff Cox
Title
Efficacy dossier
Study date
29/10/2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263737
Author
Caitlin Cavanagh
Title
Prosulfocarb and S-metolachlor Bioequivalence Wheat Longerenong, Victoria, 2023
Study date
23 October 2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263739
Author
Brett Bushell
Title
Prosulfocarb and S-metolachlor Bioequivalence Chickpea Yerong Creek, 2023
Study date
20 October 2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
273332
Author
Lauren Innes
Title
Prosulfocarb and S-metolachlor Bioequivalence Potato
Langhorne Creek, South Australia, 2023
Study date
28 March 2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263740
Author
-
Title
SDS and Label of Boxer Gold
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263738
Author
Adam Anfuso
Title
Prosulfocarb and S-metolachlor Bioequivalence Wheat Williams, WA, 2023
Study date
20 October 2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date

Application Date

Application No

Application Number

142215
Product/Active constituent Name

Application Product Name

Weed Busta

Application details

Product name:

Weed Busta

Product number:

94359

Applicant Name:

GROW CHOICE PTY LTD

Application purpose and description of use:

Registration of an undiluted liquid 16.8 g/L d-limonene to control small and young annual grass and broadleaf weeds in the home garden, and on paved areas and in potplants and suppress larger weeds in the home garden.

Reference details:

66480 - WEEDBEATER

Description of data provided:

Data no
263631
Author
Peter Wrigley
Title
FTIR Spectra
Study date
May 2023
Authorising party
Applicant
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
263632
Author
Peter Wrigley
Title
FTIR Spectra
Study date
May 2023
Authorising party
Applicant
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
263633
Author
Peter Wrigley
Title
FTIR Validation
Study date
May 2023
Authorising party
Applicant
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
278438
Author
anon
Title
Manufacturing Instructions Part 2
Study date
September 2024
Authorising party
Applicant
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
263624
Author
anon
Title
Specification of d-limonene
Study date
June 2022
Authorising party
Applicant
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
263625
Author
anon
Title
SDS d-limonene
Study date
June 2022
Authorising party
Applicant
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
263626
Author
anon
Title
SDS for inerts
Study date
June 2022
Authorising party
Applicant
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
263627
Author
anon
Title
Manufacturing Process manufacturing concentrate
Study date
May 2023
Authorising party
Applicant
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
263628
Author
anon
Title
Manufacturing Process EUP
Study date
May 2023
Authorising party
Applicant
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
263623
Author
anon
Title
Part 2 Chemistry and Manufacture
Study date
November 2023
Authorising party
Applicant
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
263629
Author
Allan Harvey Spencer
Title
16.8% d-limonene stability May 2023
Study date
May 2023
Authorising party
Applicant
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
263630
Author
Allan Harvey Spencer
Title
May 2023 Stability Testing
Study date
May 2023
Authorising party
Applicant
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Date

Application Date

Application No

Application Number

142289
Product/Active constituent Name

Application Product Name

Cyantraniliprole

Application details

Product name:

Cyantraniliprole

Active name:

Cyantraniliprole

Applicant Name:

ZHEJIANG XINAN CHEMICAL INDUSTRIAL GROUP CO., LTD

Application purpose and description of use:

Approval of cyantraniliprole active constituent for use in agricultural chemical products.

Description of data provided:

Data no
263701
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Qualitative and Quantitative Profile of Cyantraniliiprole Technical Wynca (Five Batch Analysis), Study # RF.14613.030.011.23_part1
Study date
2022
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
263702
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Qualitative and Quantitative Profile of Cyantraniliprole Technical Wynca (Five Batch Analysis), Study # 14613.030.011.23_part2
Study date
2023
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
274449
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
2024
Study date
2024
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
274450
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Summary response to S159 Notice
Study date
2024
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
263698
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Part 2 Chemistry and Manufacturing
Study date
2023
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
263703
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Cyantraniliprole Certificates of Analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
263704
Author
European Food Safety Authority (EFSA)
Title
Conclusion on the peer review of the pesticide risk assessment of the active substance cyantraniliprole
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
263705
Author
JMPR
Title
JMPR Cyantraniliprole (263)
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
275802
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Summary response to S159 Notice 2
Study date
2024
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
283719
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Cyantraniliprole Declaration of Composition
Study date
Feb2025
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
263700
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Cyantraniliprole Technical Declaration of Composition and Declaration of Manufacture
Study date
2023
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
263699
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Accelerated Storage Stability and Corrosion Characteristics of Cyantraniliprole Technical, Study # Report No.: RF. 14613.020.029.23
Study date
2023
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
274451
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Cyantraniliprole Declaration of Composition
Study date
2024
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
275803
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Cyantraniliprole Declaration of Composition
Study date
2024
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
282590
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Manufacturer's assurance statement
Study date
2025
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
282591
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Response letter persuant to S159 requirements
Study date
2025
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
283720
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Response letter pursuant to S159 requirements
Study date
Feb2025
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
283721
Author
Polish Department of Plant Breeding and Protection
Title
Letter confirming the equivalence of the technical material of the active substance cyantraniliprole.
Study date
28/01/2025
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
282588
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
In vitro Micronucleus study with Test Item Cyantraniliprole Technical
Study date
2024
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
282589
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Evaluation of the mutagenic potential of the test item Cyantraniliprole Technical by reverse mutation assay in Salmonella enterica serovar Typhimurium (Ames Test)
Study date
2024
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
283722
Author
Zhejiang Xinan Chemical Industrial Group Co., Ltd
Title
Technical justification for the use of OECD 487 - In vitro Mammalian Cell Micronucleus Test, as a tool for assessing chromosomal damage
Study date
19 Feb 2025
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Date

Application Date

Application No

Application Number

141983
Product/Active constituent Name

Application Product Name

FORTENZA Insecticide Seed Treatment

Application details

Product name:

FORTENZA Insecticide Seed Treatment

Product number:

94280

Applicant Name:

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 600 g/L cyantraniliprole FS formulation for use as a seed treatment in Maize, Sorghum and Sweetcorn seed for the early season control of Fall Armyworm.

Reference details:

66659 - CYANTRANILIPROLE
66684 - BENEVIA INSECTICIDE

Active constituents:

Active constituent name
69341 - CYANTRANILIPROLE

Description of data provided:

Data no
263268
Author
Sparrow K.
Title
Cyantraniliprole FS (600) A17960A - Analytical Method ST-18/1
Study date
28.06.2011
Data no
263269
Author
Das R.
Title
A17960A Validation of analytical method ST-18/1
Study date
24.05.2011
Data no
263270
Author
Khot S. B.
Title
A17960A ? Physical and Technical Properties of Batch SMU3HL020
Study date
27.2.2014
Data no
263271
Author
Abraham N.R.
Title
Cyantraniliprole- A17960A ? Chemical Characterization before Storage of Batch SMU3HL020
Study date
28.2.2014
Data no
263272
Author
Martin-Keusch C
Title
A17960A - Corrosion Testing of Metals of Batch SMU3HL020
Study date
26.2.2014
Data no
263273
Author
Jackson W.A.
Title
A17960A ? Safety Study
Study date
11.04.2011
Data no
263274
Author
T. Cohen Sat
Title
Part 2- Chemistry and Manufacture
Study date
12.2021
Data no
263275
Author
T. Cohen Sat
Title
A17960A ? FORTENZA FS ? Safety Data Sheets
Study date
21.12.2021
Data no
263276
Author
FMC Corporation
Title
CYANTRANILIPROLE TECH - CoA
Study date
1.2.2023
Data no
263277
Author
Kundel P.
Title
A17960A - Storage Stability and Shelf Life Statement (2 Weeks 54 ?C) in Packaging Made of
HDPE according to CIPAC MT 46.3
Study date
03.03.2014
Data no
263278
Author
Kundel P.
Title
A17960A - Storage Stability and Shelf Life Statement (3 Years 25 ?C) in Packaging Made of
HDPE
Study date
10.07.2017
Data no
263279
Author
English, P.
Title
Evaluation of seed dressing Fortenza 600FS compared with Cruiser 600FS for control of fall
armyworm (Spodoptera frugiperda) in maize.
Study date
27.08.2021
Data no
263280
Author
English, P.
Title
Evaluation of seed dressing Fortenza 600FS compared with Cruiser 600FS for control of fall
armyworm (Spodoptera frugiperda) in sweet corn
Study date
27.08.2021
Data no
263281
Author
Jalaludin, A.
Title
Efficacy and safety of Fortenza 600FS for the control of Fall Armyworm in corn.
Study date
17.05.2021
Data no
263282
Author
English, P.
Title
Evaluation of seed dressing Fortenza 600FS compared with Dermacor 625 FS and
Cruiser 600FS for control of fall armyworm (Spodoptera frugiperda) in maize. April-May
2021.
Study date
08.09.2021
Data no
263283
Author
Westerhuis, D.
Title
Efficacy and Safety of seed applied treatments for the control of Fall Armyworm (FAW)
and other early season soil and sucking pests of Maize.
Study date
16.08.2021
Data no
263284
Author
Jalaludin, A
Title
Efficacy and safety of Fortenza 600FS for the control of Fall Armyworm in Sweetcorn.
Study date
09.06.2021
Data no
263285
Author
English, P.
Title
Evaluation of seed dressing Fortenza 600FS compared with Dermacor 625 FS and
Cruiser 600FS for control of fall armyworm (Spodoptera frugiperda) in sweetcorn.
April-May 2021.
Study date
08.09.2021
Data no
263286
Author
Westerhuis, D.
Title
Efficacy and Safety of seed applied treatments for the control of Fall Armyworm (FAW)
and other early season soil and sucking pests of Sweet Corn.
Study date
26.08.21
Data no
263287
Author
Miles, M and Quade, A.
Title
Seed treatment evaluation ? Fortenza 600FS (cyantraniliprole, Syngenta) for control of
Fall Armyworm (Spodoptera frugiperda) in maize.
Study date
06.2021
Data no
263288
Author
English, P
Title
Evaluation of seed dressing Fortenza 600FS compared with Cruiser 600FS for control
of fall armyworm (Spodoptera frugiperda) in sorghum. November-December 2020.
Study date
27.08.21
Data no
263289
Author
Jalaludin, A.
Title
Efficacy and safety of Fortenza 600FS for the control of Fall Armyworm in Sorghum.
Study date
09.05.2021
Data no
263290
Author
English, P.
Title
Evaluation of seed dressing Fortenza 600FS compared with Cruiser 600FS and
Dermacor 625 FS for control of fall armyworm (Spodoptera frugiperda) in sorghum.
April-May 2021
Study date
03.09.2021
Data no
263291
Author
Westerhuis, D.
Title
Efficacy and Safety of seed applied treatments for the control of Fall Armyworm (FAW)
and other early season soil and sucking pests of Sorghum.
Study date
16.08.2021
Data no
263292
Author
Harvey, D.
Title
Efficacy and Safety of Seed Treatments for the control of Helicoverpa in Summer
Crops. Narrabri, NSW, 2020
Study date
06.08.2020
Data no
263293
Author
Heimoana, S.
Title
Syngenta Fortenza Seed Treatment Experiments 2020/21
Study date
03.09.2021
Data no
263294
Author
K. Mckee
Title
Part 8- Efficacy and Crop safety
Study date
18.10.2021
Data no
263295
Author
Kuhl R., Wydra V
Title
Cyantraniliprole FS (A17960A) - Acute toxicity to rainbow trout (Oncorhynchus mykiss) in a
96-hour static test
Study date
16.03.2011
Data no
263296
Author
Kuhl R., Wydra V
Title
Cyantraniliprole FS (A17960A) ? Acute Toxicity to Daphnia magna in a Static 48-hour
Immobilisation Test
Study date
20.06.2011
Data no
263297
Author
Kuhl R., Wydra V
Title
Cyantraniliprole FS (A17960A) - Toxicity to Pseudokirchneriella subcapitata in an Algal
Growth Inhibition Test
Study date
20.06.2011
Data no
263298
Author
Kling A
Title
Cyantraniliprole FS (A17960A) ? Acute Oral and Contact Toxicity to the Honeybee Apis
mellifera L. in the Laboratory
Study date
12.09.2011
Data no
263514
Author
Dittbrenner N.
Title
Cyantraniliprole FS (A17960B) - A Field Study to Evaluate Side Effects on Honeybees (Apis mellifera L.) in Winter Oil Seed Rape in Northern Germany.
Study date
02.07.2018
Data no
263515
Author
Dittbrenner N.
Title
Cyantraniliprole FS (A17960B) - A Field Study to Evaluate Side Effects on Honeybees (Apis mellifera L.) in Winter Oil Seed Rape in Alsace, France
Study date
29.06.2018
Data no
263517
Author
Kleebaum K.
Title
Cyantraniliprole (SYN545377) ? Repeated Exposure to the Honey Bee (Apis mellifera) Larvae under laboratory Conditions (until Adult Emergence up to Day 22).
Study date
08.01.2018
Data no
263518
Author
Dittbrenner N.
Title
Cyantraniliprole FS (A17960B) - A Field Study to Evaluate Side Effects on Honeybees (Apis mellifera L.) in Winter Oil Seed Rape in Southern Germany.
Study date
02.07.2018
Data no
263299
Author
Friedrich S
Title
Cyantraniliprole FS (A17960A) - Acute toxicity to the Earthworm Eisenia fetida Report
Number 11-10-48-033-S
Study date
13.05.2011
Data no
263300
Author
Schulz L
Title
Cyantraniliprole FS (A17960A) - Effects on the Activity of Soil Microflora (Nitrogen and
Carbon Transformation Tests)
Study date
16.06.2011
Data no
263301
Author
T. Cohen Sat
Title
Part 7.2 - Environmental Safety
Study date
09.2021
Data no
263302
Author
Hubbard PM, Beavers JB
Title
Cyantraniliprole SC (A17960A) ? An Acute Oral Toxicity Study with the Northern Bobwhite
Using a Sequential Testing Procedure
Study date
22.02.2011
Data no
263516
Author
Ruhland S.
Title
Cyantraniliprole (SYN545377) - Chronic toxicity to the honey bee Apis mellifera L. in a 10 day continuous laboratory feeding study
Study date
05.01.2018
Data no
263457
Author
Smart, C., Speldewinde, P.C.and Mills, H.R.
Title
Influence of habitat characteristics on the distribution of the water-rat (Hydromys chrysogaster) in the greater Perth region, Western Australia.
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
263458
Author
Speldewinde, P.C., Close, P., Weybury, M. and Comer, S.
Title
Habitat preference of the Australian water rat (Hydromys chrysogaster) in a coastal wetland and stream, Two Peoples Bay, south-western Australia.
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
263459
Author
Woollard, P., Vestjens, W.J.M. and Maclean, L.
Title
The ecology of the Eastern Water Rat Hydromys chrysogaster at Griffith, N.s.w.: Food and Feeding habitats.
Study date
1978
Authorising party
Public
Auth party contact address
-
Data no
263460
Author
Williams, G.A.
Title
Distribution and status of the Australian water-rat/Rakali (Hydromys chrysogatser) in
the Greater Act Region.
Study date
2019
Authorising party
Public
Auth party contact address
-
Data no
263461
Author
Speight, K.N., Kokkinn, M.J. and Breed, W.G.
Title
The gastrointestinal tract of theAustralian water rat (Hydromys chrysogaster) ? is morphological adaptations to a carnivorous diet.
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
263462
Author
Smith, G.C.
Title
Biology and habitat usage of sympatric populations of the fawn-footed Melomys (Melomys cervinipes) and the grassland Melomys (M. burtoni) (Rodentia: Muridae).
Study date
1985
Authorising party
Public
Auth party contact address
-
Data no
263463
Author
Begg, R., Walsh, B., Woerle, F. and King, S.
Title
Ecology of Melomys burtoni, the grassland Melomys (Rodentia: Muridae) at Cobourg Peninsula, N.T.
Study date
1983
Authorising party
Public
Auth party contact address
-
Data no
263464
Author
Dyer, B.C., Clarke, A.R., Fuller, S.J.
Title
Population dynamics, diet and pest status of the grassland melomys (Melomys burtoni) in northern Queensland sugar cane crops.
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
263465
Author
Dyer, B.C.
Title
The biology of the grassland Melomys (Melomys burtoni) (Rodentia: Muridae) in far north Queensland sugarcane crops.
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
263466
Author
Liedloff, A.C., Wilson, J.C. and Engeman, R.M.
Title
The effect of wildfire on population dynamics for two native small mammal species in a coastal heathland in Queensland, Australia.
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
263467
Author
Macaranga, S. and Macaranga, O.
Title
Habitat of Melomys cervinipes (Rodentia: Muridae) on Carlisle Island, Central Queensland.
Study date
1989
Authorising party
Public
Auth party contact address
-
Data no
263468
Author
Rader, R. and Krockenberger, A.
Title
Three-dimensional use of space by a tropical rainforest rodent, Melomys cervinipes, and its implications for foraging and home-range size.
Study date
2006
Authorising party
Public
Auth party contact address
-
Data no
263469
Author
Callaway, W.A., Turner, A.A., Croshaw, O.B., Ferguson, J.A., Julson, Y.J-N., Volp, T.M., Kerr, S.E. and Rymer, T.L.
Title
Melomys cervinipes (Rodentia: Muridae).
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
263470
Author
Fuller, S. and Dyer, B.
Title
An integrated pest management strategy for climbing rat in the far-north
Queensland sugarcane production system.
Study date
2008
Authorising party
Public
Auth party contact address
-
Data no
263471
Author
Doherty, T.S., Davis, R.A.. and van Etten, E.J.B.
Title
A game of cat-and-mouse: microhabitat influences rodent foraging in recently burnt not long unburnt shrublands.
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
263472
Author
Haering, R. and Fox, B.J.
Title
Habitat utilization patterns of symatric populations of Pseudomys gracilicaudatus and Rattus lutreolus in coastal heathland: A multivariate analysis.
Study date
1995
Authorising party
Public
Auth party contact address
-
Data no
263473
Author
Kutt, A.s. and Gordon, I.J.
Title
Variation in terrestrial mammal abundance on pastoral and conservation land tenures in north-eastern Australian tropical savannas.
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
263474
Author
Luo, J., Fox, B.J. and Jefferys, E.
Title
Diet of the Eastern Chestnut mouse (pseudomys gracilicaudatus). I.
Composition, Diversity and Individual Variation.
Study date
1994
Authorising party
Public
Auth party contact address
-
Data no
263475
Author
Luo, J. and Fox, B.J.
Title
Diet of the Eastern Chestnut Mouse(Pseudomys gracilicaudatus). II. Seasonal
and successional patterns.
Study date
1994
Authorising party
Public
Auth party contact address
-
Data no
263476
Author
Ford, F. and Johnson, C.
Title
Eroding abodes and vanished bridges: historical biogeography of the substrate specialist pebble-mound mice (Pseudomys).
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
263477
Author
Bennett, A.F.
Title
Microhabitat use by the long-nosed potoroo, Potorous tridactylus, and other small mammals in remnant forest vegetation, south-western Victoria.
Study date
1993
Authorising party
Public
Auth party contact address
-
Data no
263478
Author
Cheal, D.C.
Title
The diets and dietary preferences of Rattus fuscipes and Rattus lutreolus at Walkerville in Victoria.
Study date
1987
Authorising party
Public
Auth party contact address
-
Data no
263479
Author
Carron, P.L., Happold, D.C.D. and Bubela, T.M.
Title
Diet of two sympatric subalpine rodents, Mastacomys fuscus and Rattus fuscipes.
Study date
1990
Authorising party
Public
Auth party contact address
-
Data no
263480
Author
Tory, M.K., May, T.W., Keane, P.J.and Bennett, F.
Title
Mycophagy in small mammals: A comparison of the occurrence and diet of hypogeal fungi in the diet of the long-nosed potorooPotorous tridactylus and the bush rat Rattus fuscipes from southwestern Victoria, Australia.
Study date
1997
Authorising party
Public
Auth party contact address
-
Data no
263481
Author
Braithwaite, R.W. and Griffiths, A.D.
Title
The paradox of Rattus tunneyi: Endangerment of a native pest.
Study date
1996
Authorising party
Public
Auth party contact address
-
Data no
263482
Author
O`Neill, S., Short, J. and Calver, M.
Title
The distribution, habitat preference and population dynamics of the pale field-rat (Rattus tunneyi) at Edel Land, Shark Bay, western Australia: the role of refuges and refugia in population persistence.
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
263483
Author
McIlwee, A.P. and Johnson, C.N.
Title
The contribution of fungus to the diets of three mycophagous marsuopials in Eucalypt forests, revealed by stable isotope analysis.
Study date
1998
Authorising party
Public
Auth party contact address
-
Data no
263484
Author
Standaloft, I. and Kirkpatrick, J.B.
Title
Identifying important environmental variables in the niche partitioning of two keystone ecosystem engineers (Bettongia gaimardi and Potorous tridactylus) in Tasmania.
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
263485
Author
Mason, R.J.
Title
Habitat use and population size of the long-nosed potoroo, Potorous tridactylus (Marsupialia: Potoroidae) in a coastal reserve, North-Eastern New South Wales.
Study date
1998
Authorising party
Public
Auth party contact address
-
Data no
263486
Author
Norton, M.A., French, K. and Claridge, A.W.
Title
Habitat associations of the long-nosed potoroo (Potorous tridactylus) at multiple spatial scales.
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
263487
Author
Seebeck, J
Title
Potorous tridactylus (Kerr) (Marsupialia: Macropodidae): its distribution, status and habitat preferences in Victoria.
Study date
1981
Authorising party
Public
Auth party contact address
-
Data no
263488
Author
Bennett, A.F. and Baxter, B.J.
Title
Diet of the long-nosed potoroo, Potorous-tridactylus (Marsupialia, Potoroidae), in Southwestern Victoria.
Study date
1989
Authorising party
Public
Auth party contact address
-
Data no
263489
Author
Claridge, A.W., Tanton, M.T. and Cunningham, R.B.
Title
Hypogeal fungi in the diet of the long-nosed potoroo (Potorous tridactylus) in mixed-species and regrowth eucalypt forest stands in south-eastern Australia.
Study date
1993
Authorising party
Public
Auth party contact address
-
Data no
263490
Author
Gott, M.
Title
Ecology of the northern brown bandicoot, Isoodon macrourus: reproduction and resource use
in a heathland population.
Study date
1996
Authorising party
Public
Auth party contact address
-
Data no
263491
Author
FitzGibbon, S.I.
Title
Reproductive ecology of the northern brown bandicoot (Isoodon macrourus) in habitat fragments of urban Brisbane
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
263492
Author
MacGregor, C.I., Blanchard, W., Stein, J.and Lindenmayer, D.
Title
Factors influencing the occurrence of the Southern Long-nosed bandicoot (Peramales nasuta Geoffroy) during a population irruption and decline.
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
263493
Author
Scott, L.K., Hume, I.D. and Dickman, C.R.
Title
Ecology and population biology of long-nosed bandicoots (Perameles nasuta) at North Head, Sydney Harbour National park.
Study date
1999
Authorising party
Public
Auth party contact address
-
Data no
263494
Author
Chambers, L.K., and Dickman, C.R.
Title
Habitat selection of the long-nosed bandicoot, Perameles nasuta (Mammalia, Peramelidae), in a patchy urban environment.
Study date
2002
Authorising party
Public
Auth party contact address
-
Data no
263495
Author
Thums, M., Klaassen, M. and Hume, I.D.
Title
Seasonal changes in the diet of the long-nosed bandicoot (Perameles nasuta) assess by analysis of faecal scats and of stable isotopes in blood.
Study date
2005
Authorising party
Public
Auth party contact address
-
Data no
263496
Author
Dexter, N., Hudson, M., Carter, T. and MacGregor, C.
Title
Habitat-dependent population regulation in an irrupting population of long-nosed bandicoots (Peramles nasuta).
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
263497
Author
Guppy, M. and Guppy, S.
Title
The long-nosed bandicoot (Perameles nasuta) as a nest-predator.
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
263498
Author
Vernes, K.
Title
Seasonal truffle consumption by long-noosed bandicoots(Perameles nasuta) in a mixed rainforest-open forest community in north-eastern New South Wales.
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
263499
Author
Blakey A. , Kragten S.
Title
Cyantraniliprole - Higher Tier Mammalian Risk Assessment for Maize and Sorghum Seed Treatment
Study date
17.03.2023
Data no
263500
Author
Barber, I., Tarrant, K. A. & Thompson, H. M.
Title
Exposure of small mammals, in particular the wood mouse Apodemus sylvaticus, to pesticide seed treatments
Study date
2003
Data no
263501
Author
Barfknecht R
Title
Generic Field Monitoring of Mammals on freshly drilled summer cereals in Hunsruck, Germany.
Study date
2008
Data no
263502
Author
Barnett J.
Title
DPX-HGW86 Technical: Oral (Diet) Two-Generation (One Litter per Generation) Reproduction Toxicity Study in Rats.
Study date
2011
Data no
263503
Author
Br?hl, C. A., Guckenmus, B., Ebeling, M. & Barfknecht, R.
Title
Exposure reduction of seed treatments through dehusking behaviour of the wood mouse (Apodemus sylvaticus).
Study date
2011
Data no
263504
Author
DEFRA
Title
Dehusking of seed by small mammals - default values for use in risk assessment.
Study date
2010
Data no
263505
Author
European Food Safety Authority
Title
Guidance Document on Risk Assessment for Birds and Mammals
Study date
2009
Data no
263506
Author
F?lling O & Miersch C
Title
Generic Field Study on PT of Wood Mice in freshly drilled Spring Cereal Fields (Germany).
Study date
2016
Data no
263507
Author
Gersdorf, E.
Title
Translation : Wood mice and birds destroy coated beet seed.
Study date
1971
Data no
263508
Author
Murfitt R,
Title
Review of effect of lower bodyweight upon wild mammal population dynamics.
Study date
2008
Data no
263509
Author
Pelz, H.-J.
Title
Translation: The wood mouse, Apodemus sylvaticus L., on arable land: population dynamics, seed damage and defense options.
Study date
1979
Data no
263510
Author
Quellmalz, A., Grimm, T.,
Title
Generic field study on PT of wood mice in freshly drilled maize fields in Central Europe.
Study date
2020
Data no
263511
Author
Tew, T. E., Todd, I. A. & Macdonald, D. W.
Title
Arable habitat use by wood mice (Apodemus sylvaticus). 2. Microhabitat.
Study date
2000
Data no
263512
Author
Wang, M. and Guckland, A.
Title
Effects of body weight reduction on survival and reproduction in small farmland mammals.
Study date
2019
Data no
263513
Author
Westerman, P., Hofman, A., Vet, L. & Van der Werf, W.
Title
Relative importance of vertebrates and invertebrates in epigeaic weed seed predation in organic cereal fields.
Study date
2003
Data no
262059
Author
Dall, D.
Title
ENVIRONMENTAL TECHNICAL REPORT (Revised)
Study date
10.08.2023
Data no
262060
Author
Knight, J.
Title
ENVIRONMENTAL TECHNICAL REPORT
Study date
14.08.2022
Data no
262061
Author
APVMA
Title
STUDY SUMMARIES
Study date
14.08.2022
Data no
262062
Author
Deller, J.
Title
RESIDUES AND TRADE EVALUATION REPORT
Study date
04.2023
Data no
262063
Author
Dr. Tattersall, D.
Title
HUMAN HEALTH RISK ASSESSMENT
Study date
11.05.2023
Data no
262064
Author
Dorr, G.
Title
Efficacy and safety technical Report
Study date
15.11.2022
Data no
263303
Author
T. Cohen Sat
Title
Part 6 -OHS
Study date
05.2020
Data no
263304
Author
Office of Chemical Safety
Title
Health Risk Assessment Technical Report: Cyantraniliprole and Thiamethoxam. A16901B Turf Insecticide.
Study date
04.02.2013
Data no
263305
Author
Cohen Sat. T
Title
A17960A Safety Data Sheets Cyantraniliprole 600 g/LFS
Study date
20.12.2021
Data no
263306
Author
Noakes J.
Title
Cyantraniliprole FS (A17960B) -In vitro absorption through dermatomed human skin using
[14C] -Cyantraniliprole.
Study date
05.03.2014
Data no
263307
Author
Rosenheck L.A., Schuster, L. and Selman, F.B.
Title
Worker Exposure to Apron Flowable While Treating Seed Commercially.
Study date
15.03.1993
Data no
263308
Author
Pengelly S.
Title
Determination of Cyantraniliprole Residues in Sweet Corn Foliage, Ears and Stubble following
a seed applied application of A17960A. Australia 2021
Study date
10.12.2021
Data no
263309
Author
Pengelly S.
Title
Determination of cyantraniliprole residues in maize foliage, seed and stubble following seed
applied application of A17960A. Australia 2021
Study date
10.12.2021
Data no
263310
Author
De G?is Marconi F.E.Z.
Title
A17690 - Magnitude of Residues of Cyantraniliprole in Ears of Corn and Dried Corn Grains -
Brazil, 2012-13
Study date
26.08.2013
Data no
263311
Author
Andrews G.
Title
Cyantraniliprole- Residue study, following seed treatment, on Maize in the United Kingdom
and Northern France in 2014
Study date
23.01.2015
Data no
263312
Author
Andrews G.
Title
Cyantraniliprole- Residue study, following seed treatment on Maize in Southern France in
2014
Study date
01.04.2015
Data no
263313
Author
Mayer T. J.
Title
Cyantraniliprole FS and WG (A17960B and A16971B) - Magnitude of the Residues in or on
Field and Pop Corn Resulting from Seed Treatment Only and from Seed Treatment +Foliar
Applications USA 2011
Study date
11.7.2013
Data no
263314
Author
McDonald J. T.
Title
Cyantraniliprole (A17960B and A16971B)-Magnitude of the Residues in or on Sweet Corn
following Seed Treatment or Seed Treatment +Foliar Applications USA 2011
Study date
25.02.2014
Data no
263315
Author
Pengelly S.
Title
Determination of Cyantraniliprole residues in sorghum foliage, seed and stubble following a
seed applied application of A17960A. Australia 2021
Study date
02.12.2021
Data no
263316
Author
Ward C. Vance, C.
Title
DPX-HGW86: magnitude of residues of Cyantraniliprole (DPX-HGW86) and metabolites in
edible tissues and milk of lactating dairy cows following dosing with Cyantraniliprole. Report
amendment 1.
Study date
06.04.2011
Data no
263317
Author
Roberts S., Ward C
Title
Magnitude of residues of cyantraniliprole (DPX-HGW86) and metabolites in edible tissues and
eggs of poultry following dosing with cyantraniliprole
Study date
19.08.2010
Data no
263318
Author
McClory J., Stevens-Shreve S., Henze R.
Title
Analytical method for the determination of DPX-HGW86 and metabolites in crops using LC/
MS/MS Revision No. 1. DuPont Crop Protection
Study date
16.10.2017
Data no
263319
Author
T. Cohen Sat
Title
Part 5A-Residues
Study date
12.2021
Data no
263320
Author
Zelen?k V.
Title
Cyantraniliprole FS (A17960A) - Acute Dermal Toxicity Study in Rats
Study date
06.05.2011
Data no
263321
Author
Zelen?k V.
Title
Cyantraniliprole FS (A17960A) - Acute Eye Irritation Study in Rabbits Final Report
Amendment 2
Study date
06.11.2017
Data no
263322
Author
Nagy K.
Title
Cyantraniliprole FS (A17960A) - Acute Inhalation Toxicity Study (Nose-Only) in the Rat. Final
Report Amendment 2.
Study date
16.06.2011
Data no
263323
Author
Buda, I.
Title
Cyantraniliprole FS (A17960A) ? Acute Oral Toxicity Study in the Rat (Up and Down
Procedure)
Study date
13.04.2011
Data no
263324
Author
Zelen?k V.
Title
Cyantraniliprole FS (A17960A) - Primary Skin Irritation Study in Rabbits
Study date
27.04.2011
Data no
263325
Author
T?r?k-Bath? M.
Title
Cyantraniliprole (A17960A) - Skin Sensitization in Guinea Pigs by the Buehler Method (9
Induction)
Study date
07.04.2011
Data no
263326
Author
Thomazotti Claro F.
Title
Cyantraniliprole FS (AI7960A) - Mammalian Erythrocyte Micronucleus Test ?Final Report
Study date
02.09.2011
Data no
263327
Author
T. Cohen Sat
Title
Part 3 -Toxicology
Study date
04.2020
Data no
263328
Author
Syngenta Australia Pty Ltd
Title
Toxicological Database ? Cyantraniliprole
Study date
12.2021
Data no
262058
Author
Dr. Kragten S.
Title
FORTENZA - Higher tier mammalian risk assessment maize & sorghum seed treatment Australia Supplementary and Supporting Information
Study date
27.10.2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

142091
Product/Active constituent Name

Application Product Name

MORTEIN KILL & PROTECT COCKROACH BAITS

Application details

Product name:

MORTEIN KILL & PROTECT COCKROACH BAITS

Product number:

61000

Applicant Name:

RB (HYGIENE HOME) AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to extend the duration of protection claim to 6 months.

Active constituents:

Active constituent name
51669 - INDOXACARB AND ITS R-ENANTIOMER (DPX-MP062) MANUFACTURING CONCENTRATE

Description of data provided:

Data no
262445
Author
S Phani
Title
Efficacy Substantiation Report
Study date
14.11.2023
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
262446
Author
Pest Research Consultants
Title
Arena Study to Determine the Efficacy of Fresh and 6-month Aged Mortein Cockroach Baits Against the German & American Cockroach
Study date
31.01.2023
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
262444
Author
Department of Agriculture, Fisheries & Forestry
Title
Biosecurity import permit
Study date
2023
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Date

Application Date

Application No

Application Number

142092
Product/Active constituent Name

Application Product Name

MORTEIN POWERGARD THE EXPERT'S COCKROACH BAITS

Application details

Product name:

MORTEIN POWERGARD THE EXPERT'S COCKROACH BAITS

Product number:

68731

Applicant Name:

RB (HYGIENE HOME) AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to extend the duration of protection claim to 6 months.

Active constituents:

Active constituent name
51669 - INDOXACARB AND ITS R-ENANTIOMER (DPX-MP062) MANUFACTURING CONCENTRATE

Description of data provided:

Data no
262450
Author
S Phani
Title
Efficacy Substantiation Report
Study date
14.11.2023
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
262451
Author
Pest Research Consultants
Title
Arena Study to Determine the Efficacy of Fresh and 6-month Aged Mortein Cockroach Baits Against the German & American Cockroach
Study date
31.01.2023
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
277641
Author
B Pendleton
Title
s159 response - producy efficacy
Study date
28.06.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
277642
Author
V Djohan
Title
Efficacy Substantiation Report
Study date
25.06.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
277643
Author
Insect Research Laboratory
Title
Arena Study to Determine the Efficacy of Fresh and 12-Month Aged Mortein Cockroach Baits Against the
German & American Cockroach
Study date
29.04.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
262449
Author
Department of Agriculture, Fisheries & Forestry
Title
Biosecurity import permit
Study date
2023
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Date

Application Date

Application No

Application Number

141781
Product/Active constituent Name

Application Product Name

NOBIVAC CANINE ORAL Bb LIVE VACCINE

Application details

Product name:

NOBIVAC CANINE ORAL Bb LIVE VACCINE

Product number:

87083

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Variation of product registration to vary sites of manufacture and update label.

Active constituents:

Active constituent name
89980 - Bordetella Bronchiseptica (Live), Strain B-C2

Description of data provided:

Data no
261053
Author
Anon.
Title
App 2.35 WS 2307302 QC
Study date
6 April 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261054
Author
Anon.
Title
App 2.36 PS 2307303 QC
Study date
19 April 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261055
Author
Anon.
Title
App 2.37 Ag. B2313115
Study date
22 Aug 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261056
Author
Anon.
Title
App 2.38 Ag. B2313113
Study date
17 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261057
Author
Anon.
Title
App 2.39 Ag. B2313114
Study date
14 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261066
Author
2023
Title
App 2.48 Ag. B2313115
Study date
21 July
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261067
Author
Anon.
Title
App 2.49 Ag. B2313113
Study date
16 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261103
Author
Anon.
Title
App 2.85 Ag. B2313114
Study date
14 September 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261099
Author
Anon.
Title
App 2.81 Seed Lineage
Study date
23 November 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261072
Author
Anon.
Title
App 2.54 BP1031 WS PS
Study date
2 February 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261073
Author
Anon.
Title
App 2.55 BP1035 Ag.
Study date
21 September 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261051
Author
Anon.
Title
App 2.33 WS 2307302 mfr.
Study date
2 May 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261052
Author
Anon.
Title
App 2.34 PS 2307303 mfr.
Study date
2 May 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261122
Author
Anon.
Title
App 2.104 BP1037
Study date
26 January 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261117
Author
Anon.
Title
App 2.99 Ag. Eng. B2311702
Study date
9 May 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261058
Author
Anon.
Title
App 2.40 SP-BGO-23-004-02
Study date
1 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261059
Author
Anon.
Title
App 2.41 SP-BGO-23-022-01
Study date
1 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261060
Author
Anon.
Title
App 2.42 SR-BGO-23-004-01 14D
Study date
22 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261061
Author
Anon.
Title
App 2.43 SR-BGO-23-022-01 14D
Study date
7 September 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261049
Author
Anon.
Title
App 2.31 VAL-2022-0078-01
Study date
15 November 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261050
Author
Anon.
Title
App 2.32 VAL-2019-0026-01
Study date
22 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261045
Author
Anon.
Title
App 2.27 VAL-2023-0048
Study date
1 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261046
Author
Anon.
Title
App 2.28 VAL-2023-0050-01
Study date
9 October 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261047
Author
Anon.
Title
App 2.29 VAL-2023-0024-01
Study date
4 April 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261048
Author
Anon.
Title
App 2.30 VAL-2023-0047-01
Study date
15 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261069
Author
Anon.
Title
App 2.51 FPU B2313106 QC
Study date
25 September 2033
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261070
Author
Anon.
Title
App 2.52 FPU B2313107 QC
Study date
13 September 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261071
Author
Anon.
Title
App 2.53 FPU B2313108 QC
Study date
7 September 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277369
Author
APVMA
Title
GMP 6241_Eurofins ams Girraween APVMA_26June2022
Study date
26 June 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261116
Author
Anon.
Title
App 2.98 Dil. Rep. CoA
Study date
October 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277356
Author
Intervet Australia Pty Limited
Title
Process Flow Chart - Diluent
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277370
Author
Intervet Australia Pty Limited
Title
VAL-2013-0149 Moisture content validation report
Study date
11 October 2013
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277371
Author
Intervet Australia Pty Limited
Title
VAL-2015-0012 gram stain report
Study date
6 March 2015
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277372
Author
Intervet Australia Pty Limited
Title
RND COA 3 ML vial_Gerresheimer
Study date
September 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277373
Author
Intervet Australia Pty Limited
Title
RND COA- ALU CAP RED_Datwyler
Study date
October 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
281079
Author
Intervet Australia Pty Limited
Title
s159 Applicant Response- 20Nov2024
Study date
Nov 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261118
Author
Anon.
Title
App 2.100 FPU Eng. B2313001
Study date
23 May 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261095
Author
Anon.
Title
App 2.77 B2256021
Study date
29 September 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261096
Author
Anon.
Title
App 2.78 MP0174.05
Study date
5 September 2019
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261098
Author
Anon.
Title
App 2.80 B2312660
Study date
3 March 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261115
Author
Anon.
Title
GMP 7
Study date
26 February 2018
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277358
Author
Intervet Australia Pty Limited
Title
BP0301 2M Hydrochloric Acid
Study date
21 February 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277359
Author
Intervet Australia Pty Limited
Title
BP0300 2M Sodium Hydroxide
Study date
2 December 2021
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277360
Author
Intervet Australia Pty Limited
Title
BP0821 KC buffer
Study date
23 November 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277361
Author
Intervet Australia Pty Limited
Title
SP0135-25 Bacterial Purity Test Procedure
Study date
July 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277362
Author
Intervet Australia Pty Limited
Title
N0352-05 Operation of Cole Parmer Spectrophotometer
Study date
18 Feb 2014
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277363
Author
Intervet Australia Pty Limited
Title
N0525-18 Microbial sample preparation and tracking instructions
Study date
July 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277364
Author
Intervet Australia Pty Limited
Title
SP0346-15 Determination of potency of B.bronchiseptica in Ag and FP
Study date
July 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277365
Author
Intervet Australia Pty Limited
Title
SP0523-04 Bacterial Cell Count - Thoma Chamber Method
Study date
June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277366
Author
Intervet Australia Pty Limited
Title
N0682-09 Moisture Analyzer OI
Study date
April 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277367
Author
Intervet Australia Pty Limited
Title
SP0134-11 Procedure for Gram Staining
Study date
18 Feb 2014
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277368
Author
Intervet Australia Pty Limited
Title
TSB Seed media BPR
Study date
10 February 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261123
Author
Anon.
Title
App 2.105 VS16479 Dil-V spec
Study date
November 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261124
Author
Anon.
Title
App 2.106 B2309503
Study date
21 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261125
Author
Anon.
Title
App 2.107 B2314511
Study date
23 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261126
Author
Anon.
Title
App 2.108 B2309503
Study date
28 April 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261127
Author
Anon.
Title
App 2.109 B2314511
Study date
23 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261128
Author
Anon.
Title
App 2.110 BP1032 Sol.Mfr.
Study date
2 February 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261129
Author
Anon.
Title
App 2.111 B2303312
Study date
23 February 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261130
Author
Anon.
Title
App 2.112 B2303312
Study date
23 February 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261131
Author
Anon.
Title
App 2.113 B2305416
Study date
3 april 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261132
Author
Anon.
Title
App 2.114 B2313813
Study date
7 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261133
Author
Anon.
Title
App 2.115 B2313817
Study date
7 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261134
Author
Anon.
Title
App 2.116 B2315218
Study date
7 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261135
Author
Anon.
Title
App 2.117 MP0011
Study date
9 March 2016
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261136
Author
Anon.
Title
App 2.118 BP1034
Study date
22 March 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261137
Author
Anon.
Title
App 2.119 CoA
Study date
28 December 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261138
Author
Anon.
Title
App 2.120 CoA
Study date
18 May 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261139
Author
Anon.
Title
App 2.121 CoA
Study date
19 January 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261140
Author
Anon.
Title
App 2.122 CoA
Study date
23 January 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261141
Author
Anon.
Title
App 2.123 CoA
Study date
31 May 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261142
Author
Anon.
Title
App 2.124 CoA
Study date
12 May 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262934
Author
Anon.
Title
GMP 1
Study date
28 Feb 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262935
Author
Anon.
Title
GMP 2
Study date
25 March 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261068
Author
USDA, Anon.
Title
App 2.50 USDA OOP 1081.02
Study date
5 March 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261100
Author
Anon.
Title
App 2.82 BP0367.10
Study date
29 March 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261101
Author
Anon.
Title
App 2.83 Vial CoA
Study date
14 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261102
Author
Anon.
Title
App 2.84 stopper CoA
Study date
24 Feb 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261104
Author
Anon.
Title
App 2.86 B0000663514
Study date
22 October 2021
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261105
Author
Anon.
Title
App 2.87 CoA K53179736
Study date
27 September 2021
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261106
Author
Anon.
Title
App 2.88 MP0587
Study date
21 December 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261107
Author
Anon.
Title
App 2.89 B1703373
Study date
9 February 2021
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261108
Author
Anon.
Title
App 2.90 B2216611
Study date
9 November 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261109
Author
Anon.
Title
App 2.91 B000720415
Study date
17 August 2021
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261110
Author
Anon.
Title
App 2.92 CoA B.F2220086
Study date
14 April 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261111
Author
Anon.
Title
App 2.93 CoA D009J7GL99
Study date
3 July 2020
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261112
Author
Anon.
Title
App 2.94 MP0008-02 Spec
Study date
21 December 2015
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261113
Author
Anon.
Title
App 2.95 CoA B. K45338463
Study date
23 June 2014
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261074
Author
Anon.
Title
App 2.56 BP1030 Bulk
Study date
5 April 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261075
Author
Anon.
Title
App 2.57 BP0986-Oral Bb Fill Cap FD
Study date
12 January 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261076
Author
Anon.
Title
GMP 4
Study date
30 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261077
Author
Anon.
Title
GMP 5
Study date
18 April 2018
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261078
Author
Anon.
Title
App 2.60 MP0145-02
Study date
14 March 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261079
Author
Anon.
Title
App 2.61 MP0029-02
Study date
16 February 2017
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261080
Author
Anon.
Title
App 2.62 MP0192-02
Study date
30 September 2016
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261081
Author
Anon.
Title
App 2.63 MP0126-02
Study date
1 August 2019
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261082
Author
Anon.
Title
App 2.64 MP0141-04
Study date
27 September 2020
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261083
Author
Anon.
Title
App 2.65 MP0148-02
Study date
29 March 2017
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261084
Author
Anon.
Title
App 2.66 MP0586
Study date
2 March 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261085
Author
Anon.
Title
App 2.67 MP0573-01
Study date
15 August 2019
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261086
Author
Anon.
Title
App 2.68 MP0143-03
Study date
5 December 2019
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261087
Author
Anon.
Title
App 2.69 MP0091-03
Study date
9 March 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261088
Author
Anon.
Title
App 2.70 IP0006856727
Study date
3 March 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261089
Author
Anon.
Title
App 2.71 CoA B0001893098
Study date
4 April 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261090
Author
Anon.
Title
App 2.72 MP0058-03
Study date
9 March 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261091
Author
Anon.
Title
App 2.73 IP0005427360
Study date
2 August 2021
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261092
Author
Anon.
Title
App 2.74 CoA B0000689770
Study date
11 July 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261093
Author
Anon.
Title
App 2.75 MP0051-02
Study date
5 December 2019
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261062
Author
Anon.
Title
App 2.44 Mfr. B2313106
Study date
8 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261063
Author
Anon.
Title
App 2.45 Mfr. B2313107
Study date
15 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261064
Author
Anon.
Title
App 2.46 Mfr. B2313108
Study date
30 Aug 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261065
Author
Anon.
Title
App 2.47 Antifoam rationale
Study date
14 April 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261018
Author
Anon.
Title
S0808-4 Part 2 Dossier
Study date
October 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261019
Author
Anon.
Title
App 2.1 87083_137783 PAA
Study date
23 November 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261020
Author
Anon.
Title
App 2.2 PAA Written Assistance 87083_137783
Study date
22 February 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261021
Author
Anon.
Title
App 2.3 VAL-2022-0080-01
Study date
November 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261022
Author
Anon.
Title
GMP 3
Study date
4 March 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261023
Author
Anon.
Title
App 2.5 VAL-2023-0066-01
Study date
12 October 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261024
Author
Anon.
Title
App 2.6 MP0215
Study date
14 March 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261025
Author
Anon.
Title
App 2.7 MP0224
Study date
6 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261026
Author
Anon.
Title
App 2.8 MP0588
Study date
4 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261027
Author
Anon.
Title
App 2.9 MUC-09Q673_401196
Study date
10 November 2020
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261028
Author
Anon.
Title
App 2.10 MUC-31Q611_025124
Study date
10 November 2020
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261029
Author
Anon.
Title
App 2.11 BTS-2023-0012-01
Study date
27 April 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261030
Author
Anon.
Title
App 2.12 BTS-2023-0024-01
Study date
6 September 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261031
Author
Anon.
Title
App 2.13 VAL-2023-0001-01
Study date
16 February 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261032
Author
Anon.
Title
App 2.14 VAL-2023-0035-01
Study date
16 May 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261033
Author
Anon.
Title
App 2.15 VAL-2023-0032-01
Study date
13 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261034
Author
Anon.
Title
App 2.16 VAL-2023-0059-01
Study date
11 October 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261035
Author
Anon.
Title
App 2.17 VAL-2023-0027-01
Study date
5 May 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261036
Author
Anon.
Title
App 2.18 VAL-2023-0041-01
Study date
19 July 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261037
Author
Anon.
Title
App 2.19 BTS-2023-0011-01
Study date
19 May 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261038
Author
Anon.
Title
App 2.20 BTS-2023-0022-01
Study date
31 July 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261039
Author
Anon.
Title
App 2.21 VAL-2023-0026-01
Study date
22 May 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261040
Author
Anon.
Title
App 2.22 VAL-2023-0040-01
Study date
14 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261041
Author
Anon.
Title
App 2.23 BTS-2023-0010-01
Study date
6 April 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261042
Author
Anon.
Title
App 2.24 BTS-2023-0017-02
Study date
28 September 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261043
Author
Anon.
Title
App 2.25 BTS-2023-0018-01
Study date
13 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261044
Author
Anon.
Title
App 2.26 BTS-2023-0034-01
Study date
6 September 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261094
Author
Anon.
Title
App 2.76 2021_075
Study date
7 September 2021
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261114
Author
Anon.
Title
GMP 6
Study date
11 October 2018
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261097
Author
Anon.
Title
App 2.79 2020/088
Study date
22 October 2020
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
277357
Author
Intervet Australia Pty Limited
Title
SP0104-31 Operation, Monitoring & Maintenance of the Purified Water System
Study date
August 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261119
Author
Anon.
Title
App 2.101 SP-BGO-23-006-01
Study date
13 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261120
Author
Anon.
Title
App 2.102 SP-BGO-23-008-01
Study date
13 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
261121
Author
Anon.
Title
App 2.103 SP-BGO-23-007-01
Study date
13 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262936
Author
Anon.
Title
DN3. eLabel DC14-44024397 23Oct23
Study date
23 October 2023
Date

Application Date

Application No

Application Number

142005
Product/Active constituent Name

Application Product Name

PREVEMETIC INJECTION

Application details

Product name:

PREVEMETIC INJECTION

Product number:

94287

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

Approval of Active Maropitant Citrate and product Prevemetic Injection to prevent and treat acute vomiting in Dogs and Cats

Reference details:

61840 - CERENIA INJECTABLE SOLUTION

Description of data provided:

Data no
262124
Author
Abbey Laboratories Pty Ltd
Title
Prevemetic Injection product specifications
Study date
Nov23
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
273673
Author
Abbey Laboratories Pty Ltd
Title
Prevemetic Injection Product Inj V3JUN24
Study date
June 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
273672
Author
Abbey Laboratories Pty Ltd
Title
Abbey chem letter V2
Study date
June 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date

Application Date

Application No

Application Number

142006
Product/Active constituent Name

Application Product Name

Maropitant Citrate

Application details

Product name:

Maropitant Citrate

Active name:

Maropitant Citrate

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

New source of active constituent

Description of data provided:

Data no
275547
Author
Not Identified
Title
Impurities
Study date
May 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
275548
Author
Not Identified
Title
Validation Report for Related Substances
Study date
May 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
275550
Author
Not Identified
Title
Validation Report for Assay
Study date
May 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
275551
Author
Not Identified
Title
Validation Report for Optical Isomer
Study date
May 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
263407
Author
Not identified
Title
Maropitant CoAs
Study date
July 2023
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
275545
Author
Not Identified
Title
Description of Manufacturing Process and Process Controls
Study date
May 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
275546
Author
Not I dentified
Title
Controls of Critical Steps and Intermediates
Study date
May 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
262954
Author
Abbey Laboratories Pty Ltd
Title
Maropitant Citrate Dossier
Study date
NOV23
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
275549
Author
Not Identified
Title
Responses to deficiency
Study date
May 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date

Application Date

Application No

Application Number

142029
Product/Active constituent Name

Application Product Name

CaniPRBC - Canine Packed Red Blood Cells

Application details

Product name:

CaniPRBC - Canine Packed Red Blood Cells

Product number:

81359

Applicant Name:

PLASVACC PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to include an additional pack size of 175mL, and to update the release specifications.

Reference details:

81359 - CaniPRBC - Canine Packed Red Blood Cells

Active constituents:

Active constituent name
83189 - CANINE ERYTHROCYTES

Description of data provided:

Data no
281456
Author
Shield, K. & Von Kistowski, S.
Title
Upper PCV Limit
Study date
5 Dec 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
281459
Author
Shield, K. & Hamilton, M.
Title
Formulation Details
Study date
5 Dec 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262255
Author
Rathbone, D. & Shield, K.
Title
Work Instructions
Study date
8 Nov 2023
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262256
Author
Shield, K.
Title
Records
Study date
8 Nov 2023
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262254
Author
Shield, K.
Title
Batch Record
Study date
8 Nov 2023
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
281454
Author
Shield, K.
Title
Final Product Specifications
Study date
5 Dec 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
281453
Author
Shield, K.
Title
IPC
Study date
5 Dec 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
271651
Author
Shield, K. & Hamilton, M.
Title
Chemistry & Manufacture
Study date
2 April 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262249
Author
Shield, K. & Hamilton, M.
Title
Chemistry & Manufacture
Study date
8 Nov 2023
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262252
Author
Shield, K
Title
Master Formula Instructions
Study date
8 Nov 2023
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262253
Author
Not identified
Title
Certifications for Product Packaging
Study date
8 Nov 2023
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262250
Author
APVMA
Title
GMP Licences for Manufacturer
Study date
8 Nov 2023
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262251
Author
Shield, K.
Title
Donor Specification
Study date
May 2023
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262258
Author
Shield, K.
Title
Document Master List
Study date
8 Nov 2023
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262259
Author
Sharma, R. R. & Marwaha, Neelam
Title
Leucoreduced Blood Components: Advantages and Strategies for its Implementation in Developing Countires
Study date
2010
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262260
Author
Campbell-Lee, Sally A., and Ness, Paul M.
Title
Chapter 18: Packed Red Blood Cells and Related Products
Study date
2007
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262261
Author
Wardrop, K.J., and Young, E. Wilson
Title
An in vitro Evaluation of Storage Media for the Preservation of Canine Packed Red Blood Cells
Study date
1994
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262262
Author
Makroo, R.N., et al.
Title
Evaluation of the Red Cell Haemolysis in Packed Red Cells during Processing and Storage
Study date
2011
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262263
Author
Rutan, Jennifer
Title
Blood Transfusions in Anemic Pets
Study date
2007
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262264
Author
Hunter, Tammy, Llera, Ryan amd Ward, Ernest
Title
Anemia in Dogs
Study date
2023
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
271652
Author
Anon
Title
GMP Licences for Manufacturer
Study date
2 Apr 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
271653
Author
Shield, K.
Title
GMP Licence Information
Study date
2 Apr 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
271654
Author
Shield, K.
Title
Application Response Letter
Study date
2 Apr 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
271655
Author
Anon
Title
Certification for raw material
Study date
2 Apr 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
271656
Author
Anon
Title
Specification for Product Packaging
Study date
2 Apr 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
271657
Author
Anon
Title
Certification for Product Packaging
Study date
2 Apr 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
262257
Author
Von Kistowski, S.
Title
Stability Data
Study date
2023
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
281455
Author
Shield, K. & Von Kistowski, S.
Title
Stability Data
Study date
July 2023
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
281458
Author
Shield, K.
Title
Executive Summary
Study date
5 Dec 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia
Data no
281457
Author
Shield, K.
Title
Plasvacc 142029 Response Nov 24
Study date
5 Dec 2024
Authorising party
Applicant
Auth party contact address
RIGBY 6066 CUNNINGHAM HIGHWAY KALBAR Australia