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
151345
Product/Active constituent Name
Application Product Name
D-Max Plus INJECTION
Application Date
Application Number
151345
Application Product Name
D-Max Plus INJECTION
Application details
Product name:
D-Max Plus INJECTION
Product number:
96963
Applicant Name:
ABBEY LABORATORIES PTY LTD
Application purpose and description of use:
Registration of D-Max Plus INJECTION for Treatment and control of GI worms, cattle tick & sucking lice in cattle.
Reference details:
90001 - Dectomax V dual combination injection for cattle and sheep
Active constituents:
Active constituent name
95664 - Doramectin
Active constituent name
95484 - Doramectin
Active constituent name
82196 - LEVAMISOLE HYDROCHLORIDE
Active constituent name
82914 - Levamisole Hydrochloride
Active constituent name
84265 - Levamisole Hydrochloride
Description of data provided:
Data no
297071
Title
Product specifications
Study date
Dec 2025
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date
Application Date
Application No
Application Number
150763
Product/Active constituent Name
Application Product Name
Surefire Zinam 500 SC Fungicide
Application Date
Application Number
150763
Application Product Name
Surefire Zinam 500 SC Fungicide
Application details
Product name:
Surefire Zinam 500 SC Fungicide
Product number:
85676
Applicant Name:
PCT HOLDINGS PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to include additional uses in turf and update manufacturing sites.
Active constituents:
Active constituent name
68026 - FLUAZINAM
Description of data provided:
Data no
296304
Title
PCT Surefire Zinam Fungicide for control of turf diseases.
Study date
09/07/2025
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
296307
Title
PCT Surefire Zinam Fungicide for the control of various turf diseases and Algae
Study date
09/07/2025
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
296308
Title
Quali-Pro Compass Fungicide (82613/138194)
Study date
20/06/2023
Auth party contact address
-
Data no
296305
Title
PCT Surefire Zinam Fungicide for control of turf diseases.
Study date
12/08/2025
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
296306
Title
Evaluation of PCT Surefire Zinam Fungicide for Algae control in Turfgrass.
Study date
27/08/2024
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
296303
Title
Evaluation of PCT Surefire Zinam Fungicide for pythium plant disease control in Turfgrass.
Study date
27/08/2024
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
296309
Title
Part 8 Summary
Study date
October 2025
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Date
Application Date
Application No
Application Number
150541
Product/Active constituent Name
Application Product Name
Portela 2.5 mg Solution for Injection for Cats
Application Date
Application Number
150541
Application Product Name
Portela 2.5 mg Solution for Injection for Cats
Application details
Product name:
Portela 2.5 mg Solution for Injection for Cats
Product number:
96737
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 2.5 mg/mL relfovetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in cats in conjunction with the approval of the active ingredient relfovetmab.
Active constituents:
Active constituent name
96735 - Relfovetmab
Date
Application Date
Application No
Application Number
151070
Product/Active constituent Name
Application Product Name
IMTRADE MINDSET SC MITICIDE
Application Date
Application Number
151070
Application Product Name
IMTRADE MINDSET SC MITICIDE
Application details
Product name:
IMTRADE MINDSET SC MITICIDE
Product number:
96877
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 500g/L FENBUTATIN OXIDE + 60g/L HEXYTHIAZOX Suspension Concentrate product for the control of various species of mite pests in Pome and Stone Fruit, and Strawberries as per the Directions for Use table.
Reference details:
91789 - Sabakem Sabamite 560SC Miticide
Active constituents:
Active constituent name
91901 - fenbutatin oxide
Active constituent name
87449 - Hexythiazox
Description of data provided:
Data no
296694
Title
CoA - Fenbutatin Oxide Tech
Study date
02/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
296695
Title
CoA - Hexythiazox Technical
Study date
21/10/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
296693
Title
Holder's Declaration and Consent to access confidential information
Study date
28/10/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
151276
Product/Active constituent Name
Application Product Name
Redivom 1 mg/mL Solution for Injection for Dogs
Application Date
Application Number
151276
Application Product Name
Redivom 1 mg/mL Solution for Injection for Dogs
Application details
Product name:
Redivom 1 mg/mL Solution for Injection for Dogs
Product number:
92371
Applicant Name:
DECHRA REGULATORY B.V.
Application purpose and description of use:
Variation of product registration to introduce a new manufacturer.
Active constituents:
Active constituent name
92431 - Apomorphine hydrochloride hemihydrate
Description of data provided:
Data no
296639
Title
Certificate of GMP Compliance of a Manufacturer NZ/GMP/012/A/1/2023
Study date
16 September 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
296640
Title
Certificate of GMP Compliance of a Manufacturer
Study date
07/12/2023
Auth party contact address
-
Date
Application Date
Application No
Application Number
150539
Product/Active constituent Name
Application Product Name
Relfovetmab
Application Date
Application Number
150539
Application Product Name
Relfovetmab
Application details
Product name:
Relfovetmab
Product number:
96735
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 6.4 mg/mL relfovetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in cats in conjunction with the approval of the active ingredient relfovetmab.
Description of data provided:
Data no
294807
Title
module 3.2.S.4.1 - Annex 1 - Active Substance Specifications
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294784
Title
module 3.2.S.4.3 - Annex 13 - Method 1021.004 - Evaluation of new lot of reagents in xxx (CQ81W-US-21-234 protocol - F550 & F550-1)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294770
Title
module 3.2.S.4.2 - Annex 6 - Method GM099
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294776
Title
module 3.2.S.4.3 - Annex 5 - Method 1021.004 - Validation Report (BPP-QC-MVR-016-001)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294813
Title
module 3.2.S - GMP Certificate Site B
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294764
Title
module 3.2.S.4.2 - Analytical Procedures Drug Substance
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294787
Title
module 3.2.S.1 - General Information
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294793
Title
module 3.2.S.2.3.1 - Annex 1 - Upstream Raw Material Certificates of Analysis and TSE Declarations
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294804
Title
module 3.2.S.2.6 - Manufacturing Process Development
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294773
Title
module 3.2.S.4.3 - Annex 2 - Method 1021.054 - Validation Report (BPP-QC-MVR-026-001)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294767
Title
module 3.2.S.4.2 - Annex 3 - Method 1021.056
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294816
Title
module 3.2.S - Pharmacopoeial Monographs
Study date
2024
Auth party contact address
-
Data no
294790
Title
module 3.2.S.2.2 - Annex 1 - Regulatory Method of Manufacturing Active Substance - Relfovetmab FDS
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294810
Title
module 3.2.S.5 - Reference Standards or Materials
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294796
Title
module 3.2.S.2.3.1 - Annex 4 - Cell Boost 7a Technical Package
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294782
Title
module 3.2.S.4.3 - Annex 11 - Method 1021.004 - Analytical Method Transfer Report (19PR0088 & 19PR0088a-c)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294805
Title
module 3.2.S.3 - Characterisation
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294791
Title
module 3.2.S.2.2 - Annex 2 - Active Substance Manufacturing Flow Chart - Relfovetmab FDS
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294768
Title
module 3.2.S.4.2 - Annex 4 - Method 1021.055
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294811
Title
module 3.2.S.6 - Container Closure System
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294785
Title
module 3.2.S.4.3 - Annex 14 - Method GM099 - Validation Report (VM296 & VM415)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294799
Title
module 3.2.S.2.3.2 - Annex 2 - Protocol for Generation of WCB
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294779
Title
module 3.2.S.4.3 - Annex 8 - Method 1021.054 - Analytical Method Transfer Study (18PR0159)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294802
Title
module 3.2.S.2.5 - Process Validation
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294808
Title
module 3.2.S.4.4 - Batch Analyses Drug Substance
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294819
Title
Calculation of Protein Extinction Coefficients form Amino Acid Sequence Data
Study date
1989
Auth party contact address
-
Data no
294771
Title
module 3.2.S.4.3 - Validation of Analytical Procedures Drug Substance
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294765
Title
module 3.2.S.4.2 - Annex 1 - Method 1021.057
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294788
Title
module 3.2.S.2.1 - Manufacturer
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294803
Title
module 3.2.S.2.5 - Annex 1 - Report - Viral Clearance Validation
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294780
Title
module 3.2.S.4.3 - Annex 9 - Method 1021.056 - Analytical Method Transfer Report (19PR0087a)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294774
Title
module 3.2.S.4.3 - Annex 3 - Method 1021.056 - Validation Report (CH8MZ-US-18-101)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294820
Title
Characterisation of endogenous retrovirus in rodent cell lines used for production of biologicals
Study date
2003
Auth party contact address
-
Data no
294766
Title
module 3.2.S.4.2 - Annex 2 - Method 1021.054
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294797
Title
module 3.2.S.2.3.1 - Annex 5 - Cell Boost 7b Technical Package
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294777
Title
module 3.2.S.4.3 - Annex 6 - Method 1021.057 - Analytical Method Transfer Report (18PR0163 & MCD-40610)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294806
Title
module 3.2.S.4.1 - Specification Drug Substance
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294783
Title
module 3.2.S.4.3 - Annex 12 - Method 1021.004 - Evaluation of new lot of reagents in xxx (CQ81W-US-21-234 report)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294817
Title
module 3.2.S - Pharmacopoeial Test Methods
Study date
2024
Auth party contact address
-
Data no
294814
Title
module 3.2.S - GMP Certificate Site C
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294786
Title
module 3.2.S.4.3 - Annex 15 - Method 1021.004 - Qualification of xxx F550-1 (CHX9Z-US-25-491)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294794
Title
module 3.2.S.2.3.1 - Annex 2 - Downstream Raw Material Certificates of Analysis and TSE Declarations
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294800
Title
module 3.2.S.2.3.2 - Annex 3 - Vial Certificate of Compliance
Study date
2016
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294778
Title
module 3.2.S.4.3 - Annex 7 - Method 1021.057 - Equivalency Report (21PR0073)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294801
Title
module 3.2.S.2.4 - Control of Critical Steps
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294809
Title
module 3.2.S.4.5 - Drug Substance Specification Justification
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294818
Title
module 3.2.S - Day 180 Product Information
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294772
Title
module 3.2.S.4.3 - Annex 1 - Method 1021.057 - Validation Report (BPP-QC-MVR-015-001)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294815
Title
module 3.2.S - GMP Certificate Site D
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294789
Title
module 3.2.S.2.2 - Description of Manufacturing Process and Process Controls
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294795
Title
module 3.2.S.2.3.1 - Annex 3 - Chromatography Resin Certificates of Analysis
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294781
Title
module 3.2.S.4.3 - Annex 10 - Method 1021.055 - Analytical Method Transfer Study (18PR0178 & CQ81Z-US-23-284)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294821
Title
module 3.2.S.7 - Stability
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294775
Title
module 3.2.S.4.3 - Annex 4 - Method 1021.055 - Validation Report (BPP-QC-MVR-022-001)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294769
Title
module 3.2.S.4.2 - Annex 5 - Method 1021.004
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294792
Title
module 3.2.S.2.3.1 - Control of Materials
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294812
Title
module 3.2.S - GMP Certificate Site A
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294798
Title
module 3.2.S.2.3.2 - Annex 1 - MCB Report
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
150540
Product/Active constituent Name
Application Product Name
Portela 6.4 mg Solution for Injection for Cats
Application Date
Application Number
150540
Application Product Name
Portela 6.4 mg Solution for Injection for Cats
Application details
Product name:
Portela 6.4 mg Solution for Injection for Cats
Product number:
96736
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 6.4 mg/mL relfovetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in cats in conjunction with the approval of the active ingredient relfovetmab.
Active constituents:
Active constituent name
96735 - Relfovetmab
Description of data provided:
Data no
295016
Title
Pharmacokinetics of Nerve Growth Factor (NGF) Following Different Routes of Administration to Adult Rats
Study date
1994
Auth party contact address
-
Data no
294922
Title
One Hundred Years of Rita
Study date
2009
Auth party contact address
-
Data no
295039
Title
C7X4Z-US-23-389 - Structural report obtained by X-ray crystallography of ZTS-00075623 Fab in co-complex with canine NGF
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295254
Title
The female response to seminal fluid
Study date
2020
Auth party contact address
-
Data no
294899
Title
Part 3a4 - Other requirements
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295062
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 1
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295231
Title
Selective growth stimulating effects of mouse sarcoma on the sensory and sympathetic nervous system of the chick embryo
Study date
1951
Auth party contact address
-
Data no
294876
Title
module 3.2.P.8.2 - Post Approval Stability Commitment
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295085
Title
eLabel - Portela 6.4 mg solution for injection for cats
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295208
Title
Editorial - considering older cats
Study date
2006
Auth party contact address
-
Data no
294853
Title
module 3.2.P.3.5 - Annex 8 - Leachable report VAL-AM-009464-LR
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295108
Title
Monograph for ingredient X - pol
Study date
2009
Auth party contact address
-
Data no
295179
Title
Mice lacking nerve growth factor display perinatal loss of sensory and sympathetic neurons yet develop basal forebrain cholinergic neurons
Study date
1994
Auth party contact address
-
Data no
294830
Title
module 3.2.P.5.3 - Annex 5 - 1021.056 Method Transfer Doc. No. VM387
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295225
Title
Clinical applications of NGF in ocular diseases
Study date
2011
Auth party contact address
-
Data no
295202
Title
Abnormally short serum half-lives of IgG in beta2-microglobin-deficient mice
Study date
1996
Auth party contact address
-
Data no
295325
Title
C481R-US-22-268 - Pharmacokinetics study of anti-NGF mAbs and their respective NGF complexes in healthy adult cats
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295022
Title
First-in-human randomized clinical trials of the safety and efficacy of tanezumab for treatment of chronic knee osteoarthritis pain or acute bunionectomy pain
Study date
2018
Auth party contact address
-
Data no
295271
Title
VICH GL 44 - Target Animal Safety For Veterinary Live and Inactivated Vaccines
Study date
2008
Auth party contact address
-
Data no
294916
Title
C782Z-US-18-128 - Validation of an electrochemiluminescence assay for the detection of anti-ZTS-00084768 antibodies in feline serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294976
Title
Pain Intensity and Trajectory following intra-articular injection of mono-iodoacetate in experimental osteoarthritis: a meta-analysis of in vivo studies
Study date
2023
Auth party contact address
-
Data no
295308
Title
C491W-US-23-191 - Characterisation of total NGF after ZTS-00084768 and human NGF administration in wild type mice
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295317
Title
C360R-US-21-421 - Method development for electrophysiological detection of sensory function alteration following heat, tactile and electrical stimuli in dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294962
Title
Frunevetmab, a felinized anti-nerve growth factor monoclonal antibody, for the treatment of pain from osteoarthritis in cats
Study date
2021
Auth party contact address
-
Data no
295262
Title
Effect of molecular weight on the lymphatic absorption of water-soluble compounds following subcutaneous administration
Study date
1990
Auth party contact address
-
Data no
294824
Title
module 3.2.P.5.2 - Annex 2 - GM104 Test Method
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295162
Title
Nerve growth factor signaling and its contribution to pain
Study date
2020
Auth party contact address
-
Data no
295168
Title
Developmental toxicity assessment of tanezumab, an anti-nerve growth factor antibody, in cynomolgus monkeys (Macaca fascicularis)
Study date
2015
Auth party contact address
-
Data no
294970
Title
NGF/TrkA Signaling as a Therapeutic Target for Pain
Study date
2016
Auth party contact address
-
Data no
295068
Title
C386R-US-20-193 - Safety evaluation of two doses of ZTS-00084768 in laboratory cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294870
Title
Effect of Protein and Solution Properties on the Donnan Effect During the Ultrafiltration of Proteins
Study date
2011
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295116
Title
US FDA DailyMed Database - product Vy
Study date
2025
Auth party contact address
-
Data no
295214
Title
Mutations in the TRKA/NGF receptor gene in patients with congenital insensitivity to pain with anhidrosis
Study date
1996
Auth party contact address
-
Data no
295099
Title
Portela - xxx application
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295265
Title
Genotoxicity assessment of peptide/protein-related biotherapeutics: points to consider before testing
Study date
2016
Auth party contact address
-
Data no
295242
Title
Sequential protein and peptide immunoaffinity capture for mass spectrometry-based quantification of total human beta-nerve growth factor
Study date
2013
Auth party contact address
-
Data no
294887
Title
P.4.B Appendix 1 Skin finding review
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295148
Title
Certificate of Analysis - ZTS-00084768 drug substance - BN K0719RK09
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295122
Title
IgG placetal transfer in healthy and pathological pregnancies
Study date
2012
Auth party contact address
-
Data no
295171
Title
Refinement and initial validation of a multidimensional composite scale for use in assessing acute postoperative pain in cats
Study date
2011
Auth party contact address
-
Data no
294930
Title
Safety and efficacy of subcutaneous tanezumab in patients with knee or hip osteoarthritis
Study date
2018
Auth party contact address
-
Data no
294936
Title
Permeability of the endothelial barrier - identifying and reconciling controversies
Study date
2021
Auth party contact address
-
Data no
294836
Title
module 3.2.P.5.4 - Annex 2 - Pilot Batch Certificates of Analysis
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294979
Title
Owner-perceived signs and veterinary diagnosis in 50 cases of feline osteoarthritis
Study date
2012
Auth party contact address
-
Data no
295056
Title
C481W-US-18-094 - Pharmacokinetics of a pH 7 formulation of anti-NGF monoclonal antibody ZTS-00084768 in cats
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294956
Title
Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice
Study date
2007
Auth party contact address
-
Data no
295005
Title
The female response to seminal fluid
Study date
2020
Auth party contact address
-
Data no
295079
Title
Module 1 - Application overview
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295128
Title
Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip
Study date
2019
Auth party contact address
-
Data no
294856
Title
module 3.2.P.4.1 - Annex 1 - Excipients Certificates of Analysis
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295199
Title
Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice
Study date
2007
Auth party contact address
-
Data no
295248
Title
Evaluation of the effects of hospital visit stress on physiologic parameters in the cat
Study date
2011
Auth party contact address
-
Data no
294985
Title
Evaluation of a therapeutic diet for feline degenerative joint disease
Study date
2010
Auth party contact address
-
Data no
295234
Title
Antibody Pharmacokinetics and Pharmacodynamics
Study date
2004
Auth party contact address
-
Data no
294950
Title
Guideline on immunogenicity assessment of therapeutic proteins
Study date
2017
Auth party contact address
-
Data no
294999
Title
Lymphatic Transport of Proteins After Subcutaneous Administration
Study date
2000
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295036
Title
Portela - EU D181 responses - Aug 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294942
Title
Recommendations for Systemic Statisitcal Comutation of Immunogenicity Cut Points
Study date
2017
Auth party contact address
-
Data no
295185
Title
Guideline for immunogenicity assessment of therapeutic proteins
Study date
2017
Auth party contact address
-
Data no
295191
Title
Osteoarthritis in cats - more common than you think
Study date
2008
Auth party contact address
-
Data no
295285
Title
Portela - EU D121 response - appendix 100-2 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295291
Title
C883C-XC-18-078 - Dose determination of ZTS-00084768 for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients in Europe
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295334
Title
C182W-CA-17-064 - Study of biological agents in cats with naturally-occurring osteoarthritis - principal investigator report - bioanalytical, pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294893
Title
C181C-XC-19-168 - Efficacy and safety of ZTS-00084768 administration every three months for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295142
Title
Part 4b - Clinical
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294993
Title
Analgesic efficacy of an oral transmucosal spray formulation of meloxicam alone or in combination with tramadol in cats with naturally occurring osteoarthritis
Study date
2016
Auth party contact address
-
Data no
295042
Title
C6X0Z-US-23-376 - In vitro assessment of feline anti-nerve growth factor (NGF) mAbs in spontaneous firing rat primary DRG neurons
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294850
Title
module 3.2.P.3.5 - Annex 5 - Validation report VAL-AM-009464-BR2
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295182
Title
A review of current animal models of osteoarthritis pain
Study date
2011
Auth party contact address
-
Data no
294873
Title
Portela - EU D181 responses - Aug 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295088
Title
Data List 3 - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295205
Title
Chapter 12 - Domestic cats as laboratory animals
Study date
2002
Auth party contact address
-
Data no
294827
Title
module 3.2.P.5.3 - Annex 2 - Sterility Test Validation Doc. No. VM391
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295159
Title
Nerve growth factor in the synovial fluid of patients with chronic arthritis
Study date
1992
Auth party contact address
-
Data no
295274
Title
Pharmacokinetics and immunogenicity of frunevetmab in osteoarthritic cats following intravenous and subcutaneous administration
Study date
2021
Auth party contact address
-
Data no
295297
Title
C7X4Z-US-23-380 - Electron microscopy study for cantine b-NGF + antibody ABT-406
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295328
Title
C481W-US-16-049 - Low dose pharmacokinetics of anti-NGF monoclonal antibodies ZTS-00084768 and ZTS-00511205 in cats
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295228
Title
Cross-sectional study of the prevalence of radiographic degenerative joint disease in domesticated cats
Study date
2010
Auth party contact address
-
Data no
295251
Title
Hematopoietic cells as site of first-pass catabolism after subcutaneous dosing and contributors to systemic clearance of a monoclonal antibody in mice
Study date
2018
Auth party contact address
-
Data no
295105
Title
Monograph for ingredient X - dis
Study date
2020
Auth party contact address
-
Data no
294867
Title
GMP Certificate Site F
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294879
Title
module 3.2.P.8.3 - Annex 2 - Clinical batch stability report
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295211
Title
NGF/TrkA signaling as a therapeutic target for pain
Study date
2016
Auth party contact address
-
Data no
294973
Title
Nerve growth factor concentrations in the synovial fluid for healthy dogs and dogs with secondary arthritis
Study date
2011
Auth party contact address
-
Data no
295059
Title
Part 3a3 - Toxicology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295222
Title
Laboratory safety evaluation of bedinvetmab, a canine anti-nerve growth factor monoclonal antibody, in dogs
Study date
2021
Auth party contact address
-
Data no
295305
Title
C491W-US-22-180 - Pharmacokinetics of ZTS-00525973, ZTS-00084768, ZTS-00521310 and ZTS-00521427 in mice
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294913
Title
CTX0Z-US-20-185 - Generation of a GS vector encoding the feline anti-NGF antibody, ZTS-00084768
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295013
Title
Biodistribution mechanisms of therapeutic monoclonal antibodies in health and disease
Study date
2010
Auth party contact address
-
Data no
295019
Title
Guideline on good clinical practices
Study date
2009
Auth party contact address
-
Data no
295268
Title
Clinical magnetic resonance-enabled characterization of mono-iodoacetate-induced osteoarthritis in a large animal species
Study date
2018
Auth party contact address
-
Data no
295119
Title
US FDA Inactive Ingredients Database - ingredient X - pol
Study date
2025
Auth party contact address
-
Data no
295065
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 4
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295311
Title
C667Z-US-20-388 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibodies ZTS-00508841 (xxx) against canine/human/rat/mouse NGF, canine/human neurotrophins and canine/human/rat FcRns
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295314
Title
C762Z-US-20-323 - Validation of an electrochemiluminescence method for the quantitation of ZTS-00075623 in canine serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294919
Title
C782W-US-17-061 - Assay procedure for the quantitative determination of ZTS-00084768 in feline serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295165
Title
A study of owner observed behavioural and lifestyle changes in cats with musculoskeletal disease before and after analgesic therapy
Study date
2009
Auth party contact address
-
Data no
294933
Title
Refinement and initial validation of a multidimensional composite scale for use in assessing acute post operative pain in cats
Study date
2011
Auth party contact address
-
Data no
294910
Title
C782Z-US-18-127 - Validation of a GYROS method for the quantification of ZTS-00084768 in feline serum
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295076
Title
Chapter 22 - Disposition of biological therapeutics - monoclonal antibodies, proteins and peptides
Study date
2012
Auth party contact address
-
Data no
295145
Title
C486Z-US-18-125 - Validation of a competitive ligand binding electrochemiluminescence assay for the detection of neutralizing anti-ZTS-00084768 antibodies in feline serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294839
Title
module 3.2.P.1 - Description and Composition of the Drug Product
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294859
Title
module 3.2.P.5.5 - Characterisation of Impurities Drug Product
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295025
Title
Lymphatic transport and catabolism of therapeutic proteins after subcutaneous administration to rats and dogs
Study date
2012
Auth party contact address
-
Data no
295102
Title
Module 3.2 - OHS Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294953
Title
Guidance for Industry - Immunogenicity assessment for therapeutic protein products
Study date
2014
Auth party contact address
-
Data no
294959
Title
Abnormally short serum half-lives of IgG in beta2-microglobin-deficient mice
Study date
1996
Auth party contact address
-
Data no
295002
Title
Mechanistic determinants of biotherapeutics absoption following SC administration
Study date
2012
Auth party contact address
-
Data no
295125
Title
Monograph for ingredient X - suc
Study date
2020
Auth party contact address
-
Data no
294982
Title
Ca2plus transmembrane fluxes and nerve growth factor action on a clonal cell line of rat phaeochromocytoma
Study date
1980
Auth party contact address
-
Data no
295053
Title
C180W-CA-16-050 - Study of biological agents in cats with naturally-occurring osteoarthritis
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295151
Title
C782W-US-17-061 - Assay procedure for the quantitative determination of ZTS-00084768 in feline serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294833
Title
module 3.2.P.5.3 - Annex 8 - GM104 Method Validation
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294939
Title
High-affinity TrkA and p75 neurotrophin receptor complexes - a twisted affair
Study date
2022
Auth party contact address
-
Data no
295188
Title
Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs
Study date
2021
Auth party contact address
-
Data no
295033
Title
Portela - EU D121 responses - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295045
Title
C360R-US-21-420 - Mode of action comparative study with ZTS-00075623 and ZTS-00103182 in Beagle dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295082
Title
Application - Portela 2.5 mg solution for injection for cats
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294890
Title
C883C-XC-18-078 - Dose determination of ZTS-00084768 for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients in Europe - stats
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295245
Title
Tanezumab - therapy targeting nerve growth factor in pain pathogenesis
Study date
2018
Auth party contact address
-
Data no
295282
Title
Stratification of antibody-positive subjects by antibody level reveals an impact of immunogenicity on pharmacokinetics
Study date
2013
Auth party contact address
-
Data no
295294
Title
C6X0Z-US-23-376 - In vitro assessment of feline anti-nerve growth factor (NGF) mAbs in spontaneous firing rat primary DRG neurons
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295331
Title
C180W-CA-16-050 - Study of biological agents in cats with naturally-occurring osteoarthritis
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294847
Title
module 3.2.P.3.5 - Annex 2 - Process Validation Report PV021
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295096
Title
Portela PAA advice
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294996
Title
Pain-related sensory innervation in monoiodoacetate-induced osteoarthritis in rat knees that gradually develops neuronal injury in addition to inflammatory pain
Study date
2011
Auth party contact address
-
Data no
294896
Title
C182W-US-16-048 - Comparing efficacy of the felinized anti-NGF monoclonal antibody ZTS-00084768 and ZTS-00511205 in the feline MIA model of osteoarthritis
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295139
Title
Part 3a4 - Other requirements
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295288
Title
C181C-US-17-065 - Field stafety and efficacy of ZTS-00084768 compared to placebo for the treatment of pain associated with osteoarthritis in cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295337
Title
Independent expert review and opinion on bone/cartilage findings in two repeat dose studies with ZTS-00084768 in male and female domestic short-haired cats
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294874
Title
Portela - commitment letter
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294945
Title
EMA scientific advice - NV-01-Mab osteoarthritis
Study date
2014
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295206
Title
Frunevetmab, a felinized anti-nerve growth factor monoclonal antibody, for the treatment of pain from osteoarthritis in cats
Study date
2021
Auth party contact address
-
Data no
295277
Title
Nerve growth factor - structure and function
Study date
2001
Auth party contact address
-
Data no
295229
Title
Evaluation of a therapeutic diet for feline degenerative joint disease
Study date
2010
Auth party contact address
-
Data no
294828
Title
module 3.2.P.5.3 - Annex 3 - 1021.058 Method Transfer Doc. No. VM390
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295160
Title
APVMA guidelines - Toxicology (Part 3)
Study date
2017
Auth party contact address
-
Data no
294851
Title
module 3.2.P.3.5 - Annex 6 - Compatibility report VAL-AM-009464-CR
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295183
Title
ICH S8 - Immunotoxicity studies for human pharmaceuticals
Study date
2006
Auth party contact address
-
Data no
295131
Title
Safety Data Sheet for Portela (relfovetmab injection), SDS No. AU 3398 v 01
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295154
Title
C782Z-US-20-232 - Method validation for the quantitation of ZTS-00084768 in cat serum by Turbo Ion Spray LC/MS/MS - revised report
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295323
Title
C481R-CA-18-102 - Absolute bioavailability and pharmacokinetics of ZTS-00084768 in cats with naturally occurring osteoarthritis - individual scientist report - pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295177
Title
High-affinity TrkA and p75 neurotrophin receptor complexes - a twisted affair
Study date
2022
Auth party contact address
-
Data no
295300
Title
C461W-US-21-463 - Exploratory pharmacokinetics study of anti-NGF mAbs and their respective complexes in healthy adult Beagle dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294868
Title
Pharmacopoeial Test Methods - Drug Product
Study date
2021
Auth party contact address
-
Data no
294928
Title
A study of owner observed behavioural and lifestyle changes in cats with musculoskeletal disease before and after analgesic therapy
Study date
2009
Auth party contact address
-
Data no
295223
Title
Animal models of osteoarthritis: classification, update, and measurement of outcomes
Study date
2016
Auth party contact address
-
Data no
295260
Title
ISFM and AAFP consensus guidelines - long-term use of NSAIDs in cats
Study date
2010
Auth party contact address
-
Data no
294914
Title
C481W-US-16-044 - Reagent generation of polyclonal antibodies to anti-NGF monoclonal antibodies ZTS-00084768, ZTS-00511205 and ZTS-00507082 in cats
Study date
2017
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294974
Title
Neurotrophic Factors and Nociceptor Sensitization
Study date
2009
Auth party contact address
-
Data no
295060
Title
Part 4A4 - Pre-Clinical Trials -Tolerance in Target Animal Species - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295269
Title
Somatosensory evoked potentials of the dog: recording techniques and normal values
Study date
1989
Auth party contact address
-
Data no
295306
Title
C491W-US-22-181 - Pharmacokinetics of ZTS-00084768 in human FcRn transgenic mouse model
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295114
Title
US FDA Inactive Ingredients Database - ingredient X - suc
Study date
2025
Auth party contact address
-
Data no
295120
Title
A physiologically-based pharmacokinetic model for the prediction of monoclonal antibody pharmacokinetics from in vitro data
Study date
2019
Auth party contact address
-
Data no
295014
Title
Disentangling the signaling complexity of nerve growth factor receptors by CRISPR/Cas9
Study date
2022
Auth party contact address
-
Data no
295020
Title
Guidance for Industry Target Animal Safety for Veterinary Pharmaceutical Products
Study date
2009
Auth party contact address
-
Data no
294822
Title
module 3.2.P.5.2 - Analytical Procedures Drug Product
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295166
Title
Safety and efficacy of subcutaneous tanezumab in patients with knee or hip osteoarthritis
Study date
2018
Auth party contact address
-
Data no
294968
Title
Perspectives on subcutaneous route of administration as an immunogenicity risk factor for therapeutic proteins
Study date
2017
Auth party contact address
-
Data no
295312
Title
C687Z-US-20-228 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibody NV-02 (xxx) against canine(feline)/human/rat/mouse NGFs, feline/human neurotrophins and feline/human/rat FcRns
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294862
Title
module 3.2.P.7 - Container Closure System
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295028
Title
Regulation of expression of mRNAs encoding the nerve growth factor receptors p75 and trkA in developing sensory neurons
Study date
1993
Auth party contact address
-
Data no
295289
Title
C181C-US-17-065 - Field stafety and efficacy of ZTS-00084768 compared to placebo for the treatment of pain associated with osteoarthritis in cats - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294885
Title
Part 4A3 Pre-Clinical Trials -Dose Determination-Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294934
Title
Anti-nerve growth factor in pain managment: current evidence
Study date
2016
Auth party contact address
-
Data no
294911
Title
C360R-US-21-421 - Method development for electrophysiological detection of sensory function alteration following heat, tactile and electrical stimuli in dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295097
Title
Portela Project Plan
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295146
Title
C782Z-US-18-111 - Quantification of an electrochemiluminescence assay for the detection of anti-ZTS-00084768 antibodies in feline serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295220
Title
Serum nerve growth factor in horses with osteoarthritis-associated lameness
Study date
2023
Auth party contact address
-
Data no
294954
Title
Immunogenicity testing of therapeutic protein products - developing and validating assays for anti-drug antibody detection
Study date
2019
Auth party contact address
-
Data no
295197
Title
Meniscal mineralization in domestic cats
Study date
2010
Auth party contact address
-
Data no
294977
Title
Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies
Study date
2010
Auth party contact address
-
Data no
294834
Title
module 3.2.P.5.4 - Batch Analyses Drug Product
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294905
Title
C7X4Z-US-23-379 - Electron microscopy study of ZTS-00075623: cytokine complex
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295077
Title
Chapter 11 - Physiologic IgG biodistribution, transport, and clearance - implications for monoclonal antibody products
Study date
2008
Auth party contact address
-
Data no
295054
Title
C180W-CA-16-050 - Study of biological agents in cats with naturally-occurring osteoarthritis - principal investigator report - bioanalytical, pharmacokinetics and immunogenicity
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295103
Title
Part 3a5 - User safety
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295034
Title
Portela - EU D121 response - appendix 100-1 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295283
Title
Portela - EU D121 responses - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294891
Title
C382R-US-17-051 - A 3-month exploratory safety study of ZTS-00084768 in adult laboratory cats
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294997
Title
Tanezumab: Therapy targeting nerve growth in pain pathogenesis
Study date
2018
Auth party contact address
-
Data no
295083
Title
Application - Portela 6.4 mg solution for injection for cats
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295246
Title
Pleiotropic activity of nerve growth factor in regulating cardiac functions and counteracting pathogenesis
Study date
2021
Auth party contact address
-
Data no
295332
Title
C180W-CA-16-050 - Study of biological agents in cats with naturally-occurring osteoarthritis - principal investigator report - bioanalytical, pharmacokinetics and immunogenicity
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295048
Title
C481R-US-22-268 - Pharmacokinetics study of anti-NGF mAbs and their respective NGF complexes in healthy adult cats
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294948
Title
EMA assessment report - Raylumis
Study date
2021
Auth party contact address
-
Data no
294842
Title
module 3.2.P.3.2 - Batch Formula
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294848
Title
module 3.2.P.3.5 - Annex 3 - Adsorption report VAL-AM-009464-AR
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295340
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 3
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294991
Title
NGF and Its Receptors in the Regulation of Inflammatory Response
Study date
2017
Auth party contact address
-
Data no
295240
Title
Beta-NGF and beta-NGF receptor upregulation in blood and synovial fluid in osteoarthritis
Study date
2017
Auth party contact address
-
Data no
295091
Title
GMP Certificate Site F
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295140
Title
Part 4a1 - Pharmacology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295040
Title
C687Z-US-22-272 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibody felinized ZTS-00084768 (xxx) against canine(feline)/human/rat/mouse NGFs, feline/human neurotrophins and feline/human/rat FcRns
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295111
Title
CVMP assessment report for Librela (EMEA/V/C/005180/0000)
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295063
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 2
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294825
Title
module 3.2.P.5.3 - Validation Analytical Procedures Drug Product
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295157
Title
Nerve growth factor biodelivery: a limiting step in moving toward extensive clinical application
Study date
2021
Auth party contact address
-
Data no
295134
Title
Module 3 - Health Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295203
Title
Development and validation of a new model of inflammation in the cat and selection of surrogate endpoints for testing anti-inflammatory drugs
Study date
2005
Auth party contact address
-
Data no
295280
Title
Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects
Study date
2010
Auth party contact address
-
Data no
294854
Title
module 3.2.P.3.5 - Annex 9 - Toxicology assessment RC-RSF
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295180
Title
Recommendations for systematic statistical computation of immunogenicity cut points
Study date
2017
Auth party contact address
-
Data no
295303
Title
C491W-US-15-026 - Pharmacokinetics of feline anti-NGF monoclonal antibodies ZTS-00084768 and ZTS-00507082 in rats
Study date
2017
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294831
Title
module 3.2.P.5.3 - Annex 6 - 1021.055 Method Transfer Doc. No. VM386
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295249
Title
Species-specific variation in glycosylation of IgG - evidence for the species-specific sialylation and branch-specific galactosylation and importance for engineering recombinant glycoprotein therapeutics
Study date
2000
Auth party contact address
-
Data no
295326
Title
C481W-US-15-028 - Pharmacokinetics of ZTS-00084768, an anti-NGF monoclonal antibody, in cats
Study date
2016
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295226
Title
Ca2plus transmembrane fluxes and nerve growth factor action on a clonal cell line of rat phaeochromocytoma
Study date
1980
Auth party contact address
-
Data no
295117
Title
US FDA DailyMed Database - product Cl
Study date
2025
Auth party contact address
-
Data no
295057
Title
C481W-US-15-030 - Pharmacokinetics and immunogenicity of speciated monoclonal antibodies in cats - principal investigator report - pharmacokinetics
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295071
Title
Module 7 - Environment Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295320
Title
C386R-US-20-193 - Safety evaluation of two doses of ZTS-00084768 in laboratory cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294925
Title
Rita levi-montalcini - the discovery of nerve growth factor and modern neurobiology
Study date
2004
Auth party contact address
-
Data no
295011
Title
ISFM and AAFP Consensus Guidelines Long-term use of NSAIDS in cats
Study date
2010
Auth party contact address
-
Data no
295257
Title
Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides - harmonized terminology and tactical recommendations
Study date
2014
Auth party contact address
-
Data no
294865
Title
module 3.2.P.7.2 - Annex 1 - Toxicology assessment - Extractables
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294871
Title
VICH GL 3 - Stability: Stability Testing of New Veterinary Drug Substances (Revision)
Study date
2007
Auth party contact address
-
Data no
294965
Title
Characterization of osteoarthritis in cats and meloxicam efficacy using objective chronic pain evaluation tools
Study date
2013
Auth party contact address
-
Data no
294971
Title
Preclinical safety evaluation of biotechnology-derived pharmaceuticals, S6(R1)
Study date
2011
Auth party contact address
-
Data no
295309
Title
C665Z-US-20-380 - In vitro functional potency of anti-nerve growth factor (NGF) mAbs
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294917
Title
Certificate of Analysis - ZTS-00084768 drug substance - BN K0719RK09
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295163
Title
Evaluation of the white-coat effects in cats
Study date
1999
Auth party contact address
-
Data no
295017
Title
Clinical magnetic resonance-enabled characterization of mono-iodoacetate-induced osteoarthritis in a large animal species
Study date
2018
Auth party contact address
-
Data no
295263
Title
Biodistribution mechanisms of therapeutic monoclonal antibodies in health and disease
Study date
2010
Auth party contact address
-
Data no
294957
Title
A fully caninised anti-NGF monoclonal antibody for pain relief in dogs
Study date
2013
Auth party contact address
-
Data no
295123
Title
Pain processing is faster that tactile processing in the human brain
Study date
2006
Auth party contact address
-
Data no
295194
Title
Guidance for Industry - Nonclinical evaluation of the immunotoxic potential of pharmaceuticals
Study date
2023
Auth party contact address
-
Data no
295051
Title
C181C-US-17-065 - Field stafety and efficacy of ZTS-00084768 compared to placebo for the treatment of pain associated with osteoarthritis in cats - stats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295100
Title
Portela - xxx responses to questions
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295217
Title
Cartilage stem/progenitor cells are activated in osteoarthritis via interleukin-1beta/nerve growth factor signaling
Study date
2015
Auth party contact address
-
Data no
295266
Title
Systems pharmacology of the NGF signalling through p75 and TrkA receptors
Study date
2014
Auth party contact address
-
Data no
295074
Title
Note for Guidance - Environmental risk assessment for immunological veterinary medicinal products
Study date
1997
Auth party contact address
-
Data no
295243
Title
Targeting the nerve growth factor (NGF) pathway in drug discovery. Potential applications to new therapies for chronic pain
Study date
2016
Auth party contact address
-
Data no
294888
Title
C883C-XC-18-078 - Dose determination of ZTS-00084768 for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients in Europe
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295031
Title
Clinico-radiological diagnosis and grading of rapidly progressive osteoarthritis of the hip
Study date
2017
Auth party contact address
-
Data no
295008
Title
Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides - harmonized terminology and tactical recommendations
Study date
2014
Auth party contact address
-
Data no
295174
Title
Permeability of the endothelial barrier - identifying and reconciling controversies
Study date
2021
Auth party contact address
-
Data no
294908
Title
C667Z-US-20-388 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibodies ZTS-00508841 (xxx) against canine/human/rat/mouse NGF, canine/human neurotrophins and canine/human/rat FcRns
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295080
Title
Module 4b - Scheduling Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294882
Title
module 3.2.P.8.3 - Annex 5 - Registration batch stability report
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294931
Title
Osteoarthritis, angiogenesis and inflammation
Study date
2005
Auth party contact address
-
Data no
294980
Title
Animal models of osteoarthritis: classification, update, and measurement of outcomes
Study date
2016
Auth party contact address
-
Data no
294951
Title
Anti-nerve growth factor monoclonal antibodies for the control of pain in dogs and cats
Study date
2018
Auth party contact address
-
Data no
295200
Title
A fully caninised anti-NGF monoclonal antibody for pain relief in dogs
Study date
2013
Auth party contact address
-
Data no
295094
Title
module 3.2.S - GMP Certificate Site C
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294902
Title
C6X0Z-US-23-401 - In vitro functional and transcriptomic assessment of canine anti-nerve growth factor (NGF) mAbs in spontaneous firing rat primary DRG neurons
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294988
Title
Antibody Pharmacokinetics and Pharmacodynamics
Study date
2004
Auth party contact address
-
Data no
295000
Title
Evaluation of the effects of hospital visit stress on physiologic parameters in the cat
Study date
2011
Auth party contact address
-
Data no
295329
Title
C481W-US-17-066 - Pharmacokinetics of two formulations of anti-NGF monoclonal antibodies ZTS-00084768 in cats
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294937
Title
Prevalence of radiographic signs of degenerative joint disease in a hospital population of cats
Study date
2005
Auth party contact address
-
Data no
295343
Title
C181C-XC-19-168 - Efficacy and safety of ZTS-00084768 administration every three months for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295037
Title
Part 3a4 - Formulation description relfovetmab
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295286
Title
Portela - EU D181 responses - Aug 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295292
Title
C883C-XC-18-078 - Dose determination of ZTS-00084768 for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients in Europe - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295137
Title
Part 3a2 - Pharmacology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295143
Title
Part 4b - Clinical - appendix 1
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295186
Title
Questions and answers on monoclonal antibodies for veterinary use
Study date
2017
Auth party contact address
-
Data no
294994
Title
Sequential protein and peptide immunoaffinity capture for mass spectrometry-based quantification of total human beta-nerve growth factor
Study date
2013
Auth party contact address
-
Data no
295237
Title
WSAVA guidelines for recognition, assessment and treatment of pain
Study date
2014
Auth party contact address
-
Data no
294845
Title
module 3.2.P.3.5 - Process Validation and/or Evaluation
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294894
Title
C181C-XC-19-168 - Efficacy and safety of ZTS-00084768 administration every three months for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295135
Title
Module 3.1 - Toxicology Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294897
Title
Module 8 - Efficacy & Safety Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295112
Title
US FDA Inactive Ingredients Database - ingredient X - sod
Study date
2025
Auth party contact address
-
Data no
294849
Title
module 3.2.P.3.5 - Annex 4 - Validation report VAL-AM-009464-BR1
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295181
Title
Chemical arthrodesis of the distal tarsal joints using sodium monoiodoacetate in 104 horses
Study date
2004
Auth party contact address
-
Data no
294826
Title
module 3.2.P.5.3 - Annex 1 - Endotoxin Test Validation Doc. No. VM392
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295158
Title
Rita levi-montalcini - the discovery of nerve growth factor and modern neurobiology
Study date
2004
Auth party contact address
-
Data no
295298
Title
C7X4Z-US-23-389 - Structural report obtained by X-ray crystallography of ZTS-00075623 Fab in co-complex with canine NGF
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295304
Title
C491W-US-21-144 - Pharmacokinetics of ZTS-00084768 and ZTS-00521632 in a feline FcRn/B2M transgenic mouse model
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295321
Title
C182W-US-15-025 - Effects of the felinized anti-NGF monoclonal antibody ZTS-00084768 (5 mg/kg, SC) in feline MIA model of osteoarthritis
Study date
2016
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295327
Title
C481W-US-15-030 - Pharmacokinetics and immunogenicity of speciated monoclonal antibodies in cats - principal investigator report - pharmacokinetics
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295252
Title
Pharmacokinetics of monoclonal antibodies
Study date
2017
Auth party contact address
-
Data no
295275
Title
Monoclonal antibody pharmacokinetics and pharmacodynamics
Study date
2008
Auth party contact address
-
Data no
294880
Title
module 3.2.P.8.3 - Annex 3 - Freeze thaw stability report
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295058
Title
C461W-US-22-466 - Pharmacokinetics study of canine NGF in healthy adult Beagle dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295212
Title
Neurotrophin signaling is required for glucose-induced insulin secretion
Study date
2016
Auth party contact address
-
Data no
295106
Title
Monograph for ingredient X - sod
Study date
2020
Auth party contact address
-
Data no
295118
Title
US FDA Inactive Ingredients Database - ingredient X - lme
Study date
2025
Auth party contact address
-
Data no
294926
Title
Nerve growth factor signaling and its contribution to pain
Study date
2020
Auth party contact address
-
Data no
295012
Title
Effect of Molecular weight on the Lymphatic Absorption of Water-Soluble Compounds Following Subcutaneous Administration
Study date
1990
Auth party contact address
-
Data no
295258
Title
Neurotrophins and neurotrophin antagonists as potential therapeutics
Study date
1995
Auth party contact address
-
Data no
295072
Title
Part 3a6 - Environmental Risk Assessment
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294966
Title
Evoked Temporal Summation in Cats to Highlight Central Sensitization related to Osteoarthritis-associated Chronic Pain: A Preliminary Study
Study date
2014
Auth party contact address
-
Data no
294972
Title
Mutations in the TRKA/NGF receptor gene in patients with congenital insensitivity to pain with anhidrosis
Study date
1996
Auth party contact address
-
Data no
294866
Title
GMP Certificate Site E
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295315
Title
Technical Memo - Qantitative analysis of reports NIS424.R004 and NIS424.R002
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294920
Title
C782Z-US-18-110 - Qualification of a GYROS method for the quantification of ZTS-00084768 in feline serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295264
Title
Disentangling the signaling complexity of nerve growth factor receptors by CRISPR/Cas9
Study date
2022
Auth party contact address
-
Data no
295066
Title
C380N-US-17-074 - ZTS-00084768: A 70-day T-cell dependent immune response study in cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295052
Title
C481R-CA-18-102 - Absolute bioavailability and pharmacokinetics of ZTS-00084768 in cats with naturally occurring osteoarthritis - individual scientist report - pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295218
Title
Pain intensity and trajectory following intra-articular injection of mono-iodoacetate in experimental osteoarthritis: a meta-analysis of in vivo studies
Study date
2023
Auth party contact address
-
Data no
294909
Title
C782Z-US-20-232 - Method validation for the quantitation of ZTS-00084768 in cat serum by Turbo Ion Spray LC/MS/MS - revised report
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295075
Title
Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies
Study date
2010
Auth party contact address
-
Data no
294840
Title
module 3.2.P.2 - Pharmaceutical Development
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295169
Title
NGF in early embryogenesis, differentiation, and pathology in the nervous and immune systems
Study date
2015
Auth party contact address
-
Data no
295195
Title
Rapidly progressive osteoarthritis - a review of the clinical and radiologic presentation
Study date
2017
Auth party contact address
-
Data no
295244
Title
Pain-related sensory innervation in monoiodoacetate-induced osteoarthritis in rat knees that gradually develops neuronal injury in addition to inflammatory pain
Study date
2011
Auth party contact address
-
Data no
294883
Title
Part 4A1 Efficacy Documentation
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294960
Title
Development and validation of a new model of inflammation in the cat and selection of surrogate endpoints for testing anti-inflammatory drugs
Study date
2005
Auth party contact address
-
Data no
295126
Title
Classifying Hazardous Chemicals - National Guide, June 2023
Study date
2023
Auth party contact address
-
Data no
294860
Title
module 3.2.P.5.6 - Justification of Specification Drug Product
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294983
Title
Evaluation of Functional Outcome After BFX Total Hip Replacement Using a Pressure Sensitive Walkway
Study date
2010
Auth party contact address
-
Data no
295026
Title
Nerve growth factor: structure and function
Study date
2001
Auth party contact address
-
Data no
295032
Title
Stratification of Antibody-Positive Subjects by antibody Level Reveals an Impact of Immunognicity on Pharmacokinetics
Study date
2013
Auth party contact address
-
Data no
294932
Title
The Transmission of Immunity from mother to young and the Catabolism of Immunoglobulins
Study date
1966
Auth party contact address
-
Data no
295003
Title
Hematopoietic cells as site of first-pass catabolism after subcutaneous dosing and contributors to systemic clearance of a monoclonal antibody in mice
Study date
2018
Auth party contact address
-
Data no
295175
Title
Feline osteoarthritis - a prospective study of 28 cases
Study date
2006
Auth party contact address
-
Data no
295152
Title
C782Z-US-18-110 - Qualification of a GYROS method for the quantification of ZTS-00084768 in feline serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295046
Title
C6X0Z-US-23-401 - In vitro functional and transcriptomic assessment of canine anti-nerve growth factor (NGF) mAbs in spontaneous firing rat primary DRG neurons
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295295
Title
C6X0Z-US-23-401 - In vitro functional and transcriptomic assessment of canine anti-nerve growth factor (NGF) mAbs in spontaneous firing rat primary DRG neurons
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294903
Title
C182W-CA-17-064 - Study of biological agents in cats with naturally-occurring osteoarthritis
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294940
Title
Models of osteoarthritis - the good, the bad and the promising
Study date
2019
Auth party contact address
-
Data no
294952
Title
Osteoarthritis in cats: More common than you think
Study date
2008
Auth party contact address
-
Data no
295095
Title
module 3.2.S - GMP Certificate Site D
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295344
Title
C181C-XC-19-168 - Efficacy and safety of ZTS-00084768 administration every three months for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients - stats
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295281
Title
Clinico-radiological diagnosis and grading of rapidly progressive osteoarthritis of the hip
Study date
2017
Auth party contact address
-
Data no
294889
Title
C883C-XC-18-078 - Dose determination of ZTS-00084768 for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients in Europe - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295138
Title
Part 3a3 - Toxicology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294989
Title
Antagonism of Nerve Growth Factor-TrkA Signaling and the Relief of Pain
Study date
2011
Auth party contact address
-
Data no
294995
Title
Targeting the Nerve Growth Factor (NGF) Pathway in Drug Discovery. Potential Applications to New Therapies for Chronic Pain
Study date
2017
Auth party contact address
-
Data no
294846
Title
module 3.2.P.3.5 - Annex 1 - Process Validation Report PV011
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295089
Title
Data List 4 - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295338
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 1
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295189
Title
EMA assessment report - Raylumis
Study date
2021
Auth party contact address
-
Data no
295238
Title
Familial insensitivity to pain (HSAN V) and a mutation in the NGFB gene. A neurophysiological and pathological study
Study date
2004
Auth party contact address
-
Data no
294969
Title
Determination of salivary and serum immunoglobulin concentrations in the cat
Study date
1998
Auth party contact address
-
Data no
295301
Title
C461W-US-22-466 - Pharmacokinetics study of canine NGF in healthy adult Beagle dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294946
Title
Questions and answers on monoclonal antibodies for veterinary use
Study date
2017
Auth party contact address
-
Data no
295278
Title
Regulation of expression of mRNAs encoding the nerve growth factor receptors p75 and trkA in developing sensory neurons
Study date
1993
Auth party contact address
-
Data no
294923
Title
Nerve growth factor biodelivery: a limiting step in moving toward extensive clinical application
Study date
2021
Auth party contact address
-
Data no
295086
Title
Data List 1 - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295255
Title
Antibody biodistribution coefficients. Inferring tissue concentrations of monoclonal antibodies based on the plasma concentrations in several preclinical species and human
Study date
2013
Auth party contact address
-
Data no
294900
Title
3.2.s.1 General Information
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295109
Title
Subcutaneous bioavailability of therapeutic antibodies as a function of FcRn binding affinity in mice
Study date
2012
Auth party contact address
-
Data no
295232
Title
Nerve growth factor and nociception
Study date
1993
Auth party contact address
-
Data no
294877
Title
module 3.2.P.8.3 - Primary and Supportive Stability Data
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295132
Title
C782Z-US-21-251 - Construction and validation of a mechanistic pharmacokinetic (PK) model for projections of in vivo relfovetmab concentrations in human upon accidental exposure
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294829
Title
module 3.2.P.5.3 - Annex 4 - 1021.054 Method Transfer Doc. No. VM385
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295155
Title
Heart rate and heart rate variability of healthy cats in home and hospital environments
Study date
2005
Auth party contact address
-
Data no
295178
Title
Models of osteoarthritis - the good, the bad and the promising
Study date
2019
Auth party contact address
-
Data no
295201
Title
In vitro and in vivo characterization of a fully felinized therapeutic anti-nerve growth factor monoclonal antibody for the treatment of pain in cats
Study date
2016
Auth party contact address
-
Data no
295324
Title
C481R-CA-20-213 - Absolute bioavailability and pharmacokinetics of ZTS-00084768 in cats with naturally occurring osteoarthritis - amended individual scientist report - pharmacokinetics and immunogenicity
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294963
Title
Mechanisms of drug toxicity and relevance to pharmaceutical development
Study date
2011
Auth party contact address
-
Data no
295224
Title
Nerve growth factor inhibition with tanezumab influences weight-bearing and subsequent cartilage damage in the rat medial meniscal tear model
Study date
2016
Auth party contact address
-
Data no
295307
Title
C491W-US-23-185 - Pharmacokinetics of ZTS-00084768 in feline FcRn transgenic mouse model
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295069
Title
Expert opinion on ECG result comparisons across two target animal safety studies with ZTS-00084768
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295272
Title
Association of mineralisations in the stifle joint of domestic cats with degenerative joint disease and cranial cruciate ligament pathology
Study date
2017
Auth party contact address
-
Data no
295009
Title
Neurotrophins and neurotrophin antagonists as potential therapeutics
Study date
1995
Auth party contact address
-
Data no
295023
Title
Pharmacokinetics and immunogenicity of frunevetmab in osteoarthritic cats following intravenous and subcutaneous administration
Study date
2021
Auth party contact address
-
Data no
295318
Title
C380N-US-17-074 - ZTS-00084768: A 70-day T-cell dependent immune response study in cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295209
Title
Perspectives on subcutaneous route of administration as an immunogenicity risk factor for therapeutic proteins
Study date
2017
Auth party contact address
-
Data no
295215
Title
Nerve growth factor concentrations in the synovial fluid from healthy dogs and dogs with secondary osteoarthritis
Study date
2011
Auth party contact address
-
Data no
294823
Title
module 3.2.P.5.2 - Annex 1 - GM103 Test Method
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295161
Title
Utility of a human FcRn transgenic mouse model in drug discovery for early assessment and prediction of human pharmacokinetics of monoclonal antibodies
Study date
2016
Auth party contact address
-
Data no
295015
Title
Systems pharmacology of the NGF signalling through p75 and TrkA receptors
Study date
2014
Auth party contact address
-
Data no
295261
Title
Cutaneous lesions and clinical outcomes in five cats after frunevetmab injections
Study date
2023
Auth party contact address
-
Data no
294869
Title
Module 2 - Chemistry & Manufacture Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295115
Title
US FDA DailyMed Database - product No
Study date
2025
Auth party contact address
-
Data no
294886
Title
Part 4B1 - Clinical Trials - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295241
Title
2022 WSAVA guidelines for the recognition, assessment and treatment of pain
Study date
2023
Auth party contact address
-
Data no
294837
Title
module 3.2.P.5.4 - Annex 3 - Supporting Batch Certificates of Analysis
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295098
Title
Application - Portela Import Permit
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295172
Title
Anti-nerve growth factor in pain management - current evidence
Study date
2016
Auth party contact address
-
Data no
294863
Title
module 3.2.P.7.2 - Annex 1 - Extractables and Leachables Study Report - Container / Closure
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294912
Title
C360R-CA-21-426 - Effects of anti-NGF monoclonal antibodies on nerve growth factor (NGF)-induced sensitization using nerve conduction testing in dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295049
Title
C181C-US-17-065 - Field stafety and efficacy of ZTS-00084768 compared to placebo for the treatment of pain associated with osteoarthritis in cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295055
Title
C481W-US-15-028 - Pharmacokinetics of ZTS-00084768, an anti-NGF monoclonal antibody, in cats
Study date
2016
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295221
Title
Owner-perceived signs and veterinary diagnosis in 50 cases of feline osteoarthritis
Study date
2012
Auth party contact address
-
Data no
295149
Title
CTX0Z-US-20-185 - Generation of a GS vector encoding the feline anti-NGF antibody, ZTS-00084768
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295198
Title
Cardiac innervation and sudden cardiac death
Study date
2015
Auth party contact address
-
Data no
294929
Title
Osteoarthritis in the cat - 1. how common is it and how easy to recognise
Study date
2012
Auth party contact address
-
Data no
295006
Title
Antibody biodistribution coefficients
Study date
2013
Auth party contact address
-
Data no
294857
Title
module 3.2.P.4.5 - Annex 1 - BSE/TSE statements
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294906
Title
Technical Memo - Qantitative analysis of reports NIS424.R004 and NIS424.R002
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295029
Title
Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development
Study date
2017
Auth party contact address
-
Data no
295078
Title
VICH GL 6 - Guideline on environmental impact assessment (EIAS) for veterinary medicinal products - Phase 1
Study date
2008
Auth party contact address
-
Data no
295129
Title
Transfer of antibody via mother's milk
Study date
2003
Auth party contact address
-
Data no
295141
Title
Part 4a4 - Target animal safety
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295235
Title
Antagonism of nerve growth factor-TrkA signaling and relief of pain
Study date
2011
Auth party contact address
-
Data no
295284
Title
Portela - EU D121 response - appendix 100-1 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295341
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 4
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294949
Title
Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs
Study date
2014
Auth party contact address
-
Data no
294986
Title
Nerve growth factor and nociception
Study date
1993
Auth party contact address
-
Data no
295035
Title
Portela - EU D121 response - appendix 100-2 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295043
Title
C481W-US-16-049 - Low dose pharmacokinetics of anti-NGF monoclonal antibodies ZTS-00084768 and ZTS-00511205 in cats
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295192
Title
Guidance for Industry - Immunogenicity assessment for therapeutic protein products
Study date
2014
Auth party contact address
-
Data no
294843
Title
module 3.2.P.3.3 - Description of Manufacturing Process and Process Controls
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295092
Title
module 3.2.S - GMP Certificate Site A
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295335
Title
C382N-US-17-069 - A 6-month study of ZTS-00084768 by subcutaneous injection in adult domestic cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294943
Title
Chemical arthrodesis of the distal tarsal joints using sodium monoiodoacetate in 104 horses
Study date
2004
Auth party contact address
-
Data no
294992
Title
Beta-NGF and beta-NGF receptor upregulation in blood and synovial fluid in osteoarthritis
Study date
2017
Auth party contact address
-
Data no
295064
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 3
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295087
Title
Data List 2 - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295302
Title
C491R-US-24-205 - Pharmacokinetics of ZTS-00084768 in human FcRn transgenic mouse model
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294947
Title
CVMP assessment report for Solensia
Study date
2021
Auth party contact address
-
Data no
295110
Title
The placenta, transfer of immunoglobulins, and safety assessment of biopharmaceuticals in pregnancy
Study date
2012
Auth party contact address
-
Data no
295279
Title
Recommendations for the assessment and management of pre-existing drug-reactive antibodies during biotherapeutic development
Study date
2017
Auth party contact address
-
Data no
294924
Title
Nerve Growth Factor in the Synovial Fluid of Patients with Chronic Arthritis
Study date
1992
Auth party contact address
-
Data no
295133
Title
Zoetis Safety Assessment - assessment of human exposure cases received following use of Librela or Solensia
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295256
Title
A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
Study date
2007
Auth party contact address
-
Data no
294901
Title
C687Z-US-20-228 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibody NV-02 (xxx) against canine(feline)/human/rat/mouse NGFs, feline/human neurotrophins and feline/human/rat FcRns
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295156
Title
One hundred years of Rita
Study date
2009
Auth party contact address
-
Data no
295227
Title
Kinetic evaluation of normal walking and jumping in cats, using a pressure-sensitive walkway
Study date
2007
Auth party contact address
-
Data no
294878
Title
module 3.2.P.8.3 - Annex 1 - VICH Real time stability Report
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295204
Title
Theoretical analysis of antibody targeting of tumor spheroids - importance of dosage for penetration and affinity for retention
Study date
2003
Auth party contact address
-
Data no
294855
Title
module 3.2.P.4 - Control of Excipients
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295273
Title
First-in-human randomized clinical trials of the safety and efficacy of tanezumab for treatment of chronic knee osteoarthritis pain or acute bunionectomy pain
Study date
2018
Auth party contact address
-
Data no
294832
Title
module 3.2.P.5.3 - Annex 7 - GM103 Method Validation
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295250
Title
Mechanistic determinants of biotherapeutics absoption following SC administration
Study date
2012
Auth party contact address
-
Data no
295070
Title
Independent expert review and opinion on bone/cartilage findings in two repeat dose studies with ZTS-00084768 in male and female domestic short-haired cats
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295319
Title
C386R-US-20-192 - Safety evaluation of a single 5X dose of three batches of ZTS-00084768 in cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294964
Title
Evaluation of Osteoarthritis in Cats: Novel Information from a Pilot Study
Study date
2012
Auth party contact address
-
Data no
295024
Title
Monoclonal Antibody Pharmacokinetics and Pharmacodynamics
Study date
2008
Auth party contact address
-
Data no
295010
Title
Zoetis Safety Assessment - assessment of human exposure cases received following use of Librela or Solensia
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295310
Title
C667Z-US-20-377 - Anti-NGF mAb inhibitiion of NGF induced matrix metalloproteinase production in PC-12 cells
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294872
Title
VICH GL 17 - Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products
Study date
2000
Auth party contact address
-
Data no
295210
Title
Determination of salivary and serum immunoglobulin concentrations in the cat
Study date
1998
Auth party contact address
-
Data no
295216
Title
Chapter 2 - Neurotrophic factors and nociceptor sensitization
Study date
2009
Auth party contact address
-
Data no
295018
Title
Somatosensory evoked potentials of the dog: recording techniques and normal values
Study date
1989
Auth party contact address
-
Data no
294918
Title
C486Z-US-18-125 - Validation of a competitive ligand binding electrochemiluminescence assay for the detection of neutralizing anti-ZTS-00084768 antibodies in feline serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295164
Title
Osteoarthritis in the cat - 1. how common is it and how easy to recognise
Study date
2012
Auth party contact address
-
Data no
294981
Title
Nerve growth factor inhibition with tanezumab influences weight-bearing and subsequent cartilage damage in the rat medial meniscal tear model
Study date
2016
Auth party contact address
-
Data no
294958
Title
In vitro and in vivo characterisation of a fully felinized therapeutic anti-nerve growth factor monoclonal antibody for the treatment of pain in cats
Study date
2016
Auth party contact address
-
Data no
295124
Title
Tear volume in normal eyes and keratoconjunctivitis sicca
Study date
1974
Auth party contact address
-
Data no
294864
Title
module 3.2.P.7.2 - Annex 1 - Primary packaging specifications and Certificates of Analysis
Study date
2016
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295193
Title
Guidance for Industry - Immunogenicity testing of therapeutic protein products - developing and validating assays for anti-drug antibody detection
Study date
2019
Auth party contact address
-
Data no
295267
Title
Pharmacokinetics of nerve growth factor (NGF) following different routes of administration to adult rats
Study date
1994
Auth party contact address
-
Data no
294838
Title
module 3.2.S - Flowchart of Manufacturers
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294907
Title
C461W-US-21-463 - Exploratory pharmacokinetics study of anti-NGF mAbs and their respective complexes in healthy adult Beagle dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295073
Title
Fecal protease activity is associated with compositional alterations in the intestinal microbiota
Study date
2013
Auth party contact address
-
Data no
295150
Title
Part 3a4 - Formulation description relfovetmab
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295001
Title
Species-specific variation in glycosylation of IgG: evidence for the species-specific sialylation and branch-specific galactosylation and importance for engineering recombinant glycoprotein therapeutics
Study date
2000
Auth party contact address
-
Data no
295007
Title
A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
Study date
2007
Auth party contact address
-
Data no
295050
Title
C181C-US-17-065 - Field stafety and efficacy of ZTS-00084768 compared to placebo for the treatment of pain associated with osteoarthritis in cats - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295173
Title
Neurotrophins and their receptors - a convergence point for many signalling pathways
Study date
2003
Auth party contact address
-
Data no
294858
Title
module 3.2.P.5.1 - Specification Drug Product
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295030
Title
Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects
Study date
2010
Auth party contact address
-
Data no
295101
Title
Module 4a - Metabolism & Kinetics Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294881
Title
module 3.2.P.8.3 - Annex 4 - Photostability report
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294987
Title
Regulation of TrkA and ChAT expression in developing rat basal forebrain: evidence that both exogenous and endogenous NGF regulate differentiation of cholinergic neurons
Study date
1995
Auth party contact address
-
Data no
295236
Title
Anti-NGF monoclonal antibody muMab 911 does not deplete neurons in the superior cervical ganglia of young or old adult rats
Study date
2016
Auth party contact address
-
Data no
295081
Title
Cover letter - Portela registration application
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295093
Title
module 3.2.S - GMP Certificate Site B
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295130
Title
Needlestick injuries among femal veterinarians - frequency, syringe contents and side-effects
Study date
1997
Auth party contact address
-
Data no
294938
Title
Feline osteoarthritis: a prospective study of 28 cats
Study date
2006
Auth party contact address
-
Data no
295293
Title
C883C-XC-18-078 - Dose determination of ZTS-00084768 for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients in Europe - stats
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295330
Title
C481W-US-18-094 - Pharmacokinetics of a pH 7 formulation of anti-NGF monoclonal antibody ZTS-00084768 in cats
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295342
Title
C181C-XC-19-168 - Efficacy and safety of ZTS-00084768 administration every three months for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294895
Title
C181C-XC-19-168 - Efficacy and safety of ZTS-00084768 administration every three months for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients - stats
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295144
Title
C481W-US-16-044 - Reagent generation of polyclonal antibodies to anti-NGF monoclonal antibodies ZTS-00084768, ZTS-00511205 and ZTS-00507082 in cats
Study date
2017
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295038
Title
Part 3a2 - Pharmacology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295044
Title
C481W-US-17-066 - Pharmacokinetics of two formulations of anti-NGF monoclonal antibodies ZTS-00084768 in cats
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294944
Title
A review of current animal models of osteoarthritis pain
Study date
2011
Auth party contact address
-
Data no
295187
Title
CVMP assessment report for Solensia (EMEA/V/C/005179/0000)
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294844
Title
module 3.2.P.3.4 - Controls of Critical Steps and Intermediates
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295287
Title
C382R-US-17-051 - A 3-month exploratory safety study of ZTS-00084768 in adult laboratory cats
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295336
Title
Expert opinion on ECG result comparisons across two target animal safety studies with ZTS-00084768
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294898
Title
Part 3a1 - Precise identification of the product and of its active substance(s)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295230
Title
Relationship of orthopedic examination, goniometric measurements, and radiographic signs of degenerative joint disease in cats
Study date
2012
Auth party contact address
-
Data no
294921
Title
Heart rate and heart rate variability of healthy cats in home and hospital environments
Study date
2005
Auth party contact address
-
Data no
295136
Title
Part 3a1 - Precise identification of the product and of its active substance(s)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295253
Title
Evaluation of genotoxicity testing of FDA approved large molecule therapeutics
Study date
2014
Auth party contact address
-
Data no
294852
Title
module 3.2.P.3.5 - Annex 7 - Extractable report VAL-AS-002790-ER1
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295184
Title
EMA scientific advice - NV-01
Study date
2014
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294875
Title
module 3.2.P.8.1 - Stability Summary and Conclusions
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295207
Title
Mechanisms of drug toxicity and relevance to pharmaceutical development
Study date
2011
Auth party contact address
-
Data no
295322
Title
C182W-US-16-048 - Comparing efficacy of the felinized anti-NGF monoclonal antibody ZTS-00084768 and ZTS-00511205 in the feline MIA model of osteoarthritis
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295276
Title
Lymphatic transport and catabolism of therapeutic proteins after subcutaneous administration to rats and dogs
Study date
2012
Auth party contact address
-
Data no
295299
Title
C360R-US-21-420 - Mode of action comparative study with ZTS-00075623 and ZTS-00103182 in Beagle dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294975
Title
Cartilage stem/progenitor cells are activated in osteoarthritis via interleukin-1beta/nerve growth factor signaling
Study date
2015
Auth party contact address
-
Data no
295153
Title
C782Z-US-18-127 - Validation of a GYROS method for the quantification of ZTS-00084768 in feline serum
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294915
Title
C782Z-US-18-111 - Quantification of an electrochemiluminescence assay for the detection of anti-ZTS-00084768 antibodies in feline serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294927
Title
Evaluation of the White-Coat Effect in Cats
Study date
1999
Auth party contact address
-
Data no
295259
Title
Zoetis Safety Assessment - assessment of human exposure cases received following use of Librela or Solensia
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295021
Title
Guideline on Target Animal Safety For Veterinary Live and Inactivated Vaccines
Study date
2008
Auth party contact address
-
Data no
295107
Title
Monograph for ingredient X - ace
Study date
2020
Auth party contact address
-
Data no
295270
Title
VICH GL 43 - Target Animal Safety for Veterinary Pharmaceutical Products
Study date
2008
Auth party contact address
-
Data no
294961
Title
Theoretical analysis of antibody targeting of tumor spheroids - importance of dosage for penetration and affinity for retention
Study date
2003
Auth party contact address
-
Data no
295061
Title
Part 3c -Conclusions on safety
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295067
Title
C386R-US-20-192 - Safety evaluation of a single 5X dose of three batches of ZTS-00084768 in cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295316
Title
C360R-CA-21-426 - Effects of anti-NGF monoclonal antibodies on nerve growth factor (NGF)-induced sensitization using nerve conduction testing in dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295167
Title
Osteoarthritis, angiogenesis and inflammation
Study date
2005
Auth party contact address
-
Data no
295113
Title
US FDA Inactive Ingredients Database - ingredient X - ace
Study date
2025
Auth party contact address
-
Data no
294967
Title
Considering older cats
Study date
2006
Auth party contact address
-
Data no
295213
Title
Preclinical safety evaluation of biotechnology-derived pharmaceuticals, S6(R1)
Study date
2011
Auth party contact address
-
Data no
295147
Title
C782Z-US-18-128 - Validation of an electrochemiluminescence assay for the detection of anti-ZTS-00084768 antibodies in feline serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295313
Title
C687Z-US-22-272 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibody felinized ZTS-00084768 (xxx) against canine(feline)/human/rat/mouse NGFs, feline/human neurotrophins and feline/human/rat FcRns
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295290
Title
C181C-US-17-065 - Field stafety and efficacy of ZTS-00084768 compared to placebo for the treatment of pain associated with osteoarthritis in cats - stats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294861
Title
module 3.2.P.6 - Reference Standards or Materials
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294935
Title
Neurotrophins and their receptors - a convergence point for many signalling pathways
Study date
2003
Auth party contact address
-
Data no
295196
Title
Feline idiopathic cystitis
Study date
2015
Auth party contact address
-
Data no
295121
Title
Choreographing immunity in the skin epithelial barrier
Study date
2019
Auth party contact address
-
Data no
295170
Title
The Transmission of Immunity from mother to young and the catabolism of immunoglobulins
Study date
1966
Auth party contact address
-
Data no
295219
Title
Clinical pharmacokinetics of therapeutic monoclonal antibodies
Study date
2010
Auth party contact address
-
Data no
294978
Title
Serum nerve growth factor in horses with osteoarthritis-associated lameness
Study date
2023
Auth party contact address
-
Data no
294984
Title
Cross-sectional study of the prevalence of radiographic degenerative joint disease in domesticated cats
Study date
2010
Auth party contact address
-
Data no
294835
Title
module 3.2.P.5.4 - Annex 1 - Registration Batch Certificates of Analysis
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294884
Title
Part 4A2 Pre-Clinical Trials - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295027
Title
Guidelines for Recognition, Assessment and Treatment of Pain
Study date
2014
Auth party contact address
-
Data no
295104
Title
FcRn, but not Fc gamma Rs, drives maternal-fetal transplacental transport of human IgG antibodies
Study date
2020
Auth party contact address
-
Data no
294955
Title
Rapidly progressive osteoarthritis - a review of the clinical and radiologic presentation
Study date
2017
Auth party contact address
-
Data no
295004
Title
Pharmacokinetics of monoclonal antibodies
Study date
2017
Auth party contact address
-
Data no
295127
Title
Monograph for ingredient X - lme
Study date
2009
Auth party contact address
-
Data no
295176
Title
Prevalence of radiographic signs of degenerative joint disease in a hospital population of cats
Study date
2005
Auth party contact address
-
Data no
294892
Title
C382N-US-17-069 - A 6-month study of ZTS-00084768 by subcutaneous injection in adult domestic cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294904
Title
C182W-CA-17-064 - Study of biological agents in cats with naturally-occurring osteoarthritis - principal investigator report - bioanalytical, pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295247
Title
Lymphatic transport of proteins after subcutaneous administration
Study date
2000
Auth party contact address
-
Data no
295296
Title
C7X4Z-US-23-379 - Electron microscopy study of ZTS-00075623: cytokine complex
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294998
Title
Pleiotropic activity of nerve growth factor in regulating cardiac functions and counteracting pathogenesis
Study date
2021
Auth party contact address
-
Data no
295047
Title
C481R-CA-20-213 - Absolute bioavailability and pharmacokinetics of ZTS-00084768 in cats with naturally occurring osteoarthritis - amended individual scientist report - pharmacokinetics and immunogenicity
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295084
Title
eLabel - Portela 2.5 mg solution for injection for cats
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294990
Title
Familial insensitivity to pain (HSAN V) and a mutation in the NGFB gene. A neurophysiological and pathological study
Study date
2004
Auth party contact address
-
Data no
295233
Title
Regulation of TrkA and ChAT expression in developing rat basal forebrain: evidence that both exogenous and endogenous NGF regulate differentiation of cholinergic neurons
Study date
1995
Auth party contact address
-
Data no
295239
Title
NGF and its receptors in the regulation of inflammatory response
Study date
2017
Auth party contact address
-
Data no
294841
Title
module 3.2.P.3.1 - Manufacturer(s)
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295333
Title
C182W-CA-17-064 - Study of biological agents in cats with naturally-occurring osteoarthritis
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295339
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 2
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294941
Title
Mice lacking nerve growth factor display perinatal loss of sensory and sympathetic neurons yet develop basal forebrain cholinergic neurons
Study date
1994
Auth party contact address
-
Data no
295190
Title
Anti-nerve growth factor monoclonal antibodies for the control of pain in dogs and cats
Study date
2018
Auth party contact address
-
Data no
295041
Title
C665Z-US-20-380 - In vitro functional potency of anti-nerve growth factor (NGF) mAbs
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295090
Title
GMP Certificate Site E
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
151002
Product/Active constituent Name
Application Product Name
EMECALM INJECTION
Application Date
Application Number
151002
Application Product Name
EMECALM INJECTION
Application details
Product name:
EMECALM INJECTION
Product number:
93494
Applicant Name:
VETPHARM LABORATORIES IP PTY LTD
Application purpose and description of use:
Variation of product registration to vary relevant particulars.
Active constituents:
Active constituent name
93496 - Maropitant citrate
Description of data provided:
Data no
295784
Title
Product specifications
Study date
2025
Auth party contact address
7/20 St Johns Avenue GORDON Australia
Date
Application Date
Application No
Application Number
151236
Product/Active constituent Name
Application Product Name
Owtbac Spinobeat Pour-On for Sheep
Application Date
Application Number
151236
Application Product Name
Owtbac Spinobeat Pour-On for Sheep
Application details
Product name:
Owtbac Spinobeat Pour-On for Sheep
Product number:
95339
Applicant Name:
THE UNITED ANIMAL HEALTHCARE (INNER MONGOLIA) CO., LTD.
Application purpose and description of use:
Variation of product registration to include the additional manufacturing site The United Animal Healthcare (Inner Mongolia) Co., Ltd.
Active constituents:
Active constituent name
89208 - SPINOSAD
Description of data provided:
Data no
296467
Title
GMP certificate
Study date
11/2025
Auth party contact address
South Section No.1 Fuyuan South Road Bayannaoer Economy & Technology Park Inner Mongolia China
Date
Application Date
Application No
Application Number
150721
Product/Active constituent Name
Application Product Name
TriSulfa-Sol Antimicrobial Soluble Powder
Application Date
Application Number
150721
Application Product Name
TriSulfa-Sol Antimicrobial Soluble Powder
Application details
Product name:
TriSulfa-Sol Antimicrobial Soluble Powder
Product number:
95687
Applicant Name:
DOX-AL AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to vary relevant particulars.
Reference details:
37126 - KEYMIX SULPHATRIM ORAL SULPHADIAZINE AND TRIMETHOPRIM MEDICATION
Active constituents:
Active constituent name
93949 - SULFADIAZINE
Active constituent name
93883 - TRIMETHOPRIM
Date
Application Date
Application No
Application Number
150989
Product/Active constituent Name
Application Product Name
Apparent Superhero 850 WG Herbicide
Application Date
Application Number
150989
Application Product Name
Apparent Superhero 850 WG Herbicide
Application details
Product name:
Apparent Superhero 850 WG Herbicide
Product number:
92848
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration to add an alternate formulation to registration details.
Reference details:
94284 - Locsufon Herbicide
94284 - ProRox 850 Dry Herbicide
Active constituents:
Active constituent name
64067 - PYROXASULFONE
Description of data provided:
Data no
297122
Title
RE: Access to limits on use of information and confidential information (CCI)
Study date
December 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
150990
Product/Active constituent Name
Application Product Name
Titan Besuto 850 WG Herbicide
Application Date
Application Number
150990
Application Product Name
Titan Besuto 850 WG Herbicide
Application details
Product name:
Titan Besuto 850 WG Herbicide
Product number:
90874
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration to add an alternate formulation/ formulation site to registration details
Reference details:
94284 - Locsufon Herbicide
94284 - ProRox 850 Dry Herbicide
Active constituents:
Active constituent name
90545 - Pyroxasulfone
Active constituent name
64067 - PYROXASULFONE
Active constituent name
80051 - Pyroxasulfone
Active constituent name
80847 - Pyroxasulfone
Description of data provided:
Data no
297137
Title
RE: Access to limits on use of information and confidential information (CCI)
Study date
December 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
151294
Product/Active constituent Name
Application Product Name
NOBIVAC CANINE ORAL Bb LIVE VACCINE
Application Date
Application Number
151294
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 remove non-standard conditions on Stability
Active constituents:
Active constituent name
89980 - Bordetella Bronchiseptica (Live), Strain B-C2
Description of data provided:
Data no
296834
Title
Stability report 24 months Nobivac Canine Oral Bb
Study date
December 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
150459
Product/Active constituent Name
Application Product Name
Terrad'or Herbicide
Application Date
Application Number
150459
Application Product Name
Terrad'or Herbicide
Application details
Product name:
Terrad'or Herbicide
Product number:
88074
Applicant Name:
FarmHannong Co.,Ltd.
Application purpose and description of use:
Variation of product registration and label approval to to extend the directions for use to include use in grapevines, fruit orchard crops and tree nut plantations.
Active constituents:
Active constituent name
86287 - Tiafenacil
Description of data provided:
Data no
296699
Title
Magnitude of the Residue of DCC-3825 70% WG in/on Citrus and Processed Fractions, Crop Group 10-10
Study date
14 September 2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296722
Title
To evaluate the crop safety and efficacy of Terrad???or when applied under pear trees during dormancy. One Field Trial, Echunga, South Australia, 2023.??
Study date
2024
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296745
Title
16-US-H-2-BSF601 IB 6002/Efficacy/Permanent Crops- Grape??
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296822
Title
PSM-21-06-08 Stone Fruit Tolerance to High Rates of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296728
Title
Crop Safety and Efficacy of Terrad???or Applied Under Plum Trees, one field trial, Katunga, Victoria??
Study date
2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296751
Title
LR22108-01 - Tree Nut Tolerance to Multiple Applications of DCC-3825. 2022USA3825_TRN_01_02_4361????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296785
Title
16-US-H-2-PF601. Crop Safety of Terrad????????or Herbicide in Pome Fruit.????
Study date
2016
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296791
Title
PMF_01_03 4337_Apple. Crop Safety of Terrad????????or Herbicide in Pome Fruit????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296739
Title
Comparison of 2 rates of Terrad???or for the control of weeds and crop safety applied as a directed spray in ratoon cane prior to out-of-hand stage??
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296808
Title
CTFTOL2 704. Citrus Tolerance to Multiple Applications of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296802
Title
2021NAM3825CTFTOL2. Citrus Tolerance to High Rates of DCC-3825.????
Study date
2016
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296765
Title
Optimizing weed and sucker control in hazelnut orchards????with tiafenacil????
Study date
2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296708
Title
Appendix 7.2 88074-138235 ETR
Study date
07/03/2024
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296814
Title
CTFTOL2 633. Citrus Tolerance to High Rates of DCC-3825????
Study date
2020
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296771
Title
Draft Label
Study date
2025
Auth party contact address
-
Data no
296748
Title
2022USA3825_STF_02_02 Stone Fruit Tolerance to High Rates of DCC-3825
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296794
Title
PMF_01_06 4419 4440. Pome Fruit (Apple) Tolerance to High Rates of DC-3825 ???????? CRC ???????? 2022.????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296725
Title
Crop safety and efficacy of Terrad???or applied under Citrus (Mandarin)??
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296702
Title
Magnitude and Decline of the Residues of Tiafenacil and its Metabolites in or on Cherry, Peach, and Plum Agricultural Commodities as the Representative Crops of the Stone Fruits Crop Group (CG12-09) Following Three Applications of DCC-3825 70%WG Herbicide ??? 2021
Study date
31/10/2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296742
Title
NUL3373 Herbicide for total weed control under grapevines??
Study date
2018
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296731
Title
Crop Safety and efficacy of Terrad???or applied under Stone fruit (cherries). Echunga, South Australia, 2022??
Study date
2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296788
Title
PMFTOL2 723_Apple. Pome Fruit Tolerance to Multiple Applications of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296711
Title
Terrad???or HERBICIDE EFFICACY ??? NEW WEED AND TANK MIX CLAIMS FOR HORTICULTURAL USES
Study date
September 2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296805
Title
CTFTOL2 664. Citrus Tolerance to Multiple Applications of DCC-3825????
Study date
2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296782
Title
2022USA3825_BSF_01_04 Crop Safety of Terrad????????or Herbicide in Grapes????????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296705
Title
Residue Trial of Tiafenacil 5% SC in Crop (Chestnut)
Study date
28/12/217
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296754
Title
LR22108-01 - Tree Nut Tolerance to Multiple Applications of DCC-3825. 2022USA3825_TRN_05_01 4365????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296719
Title
Efficacy of Terrad???or 700 WG for control of various weeds in pears cv. Packham. White Beach, Tasmania, 2022??
Study date
2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296762
Title
To determine the crop safety of Tiafenacil 5% SC when applied to Mandarin orange inter-row application.????
Study date
2016
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296768
Title
Consent For Use of Confidential Commercial Information and Access to Information with Limits on Use
Study date
9 September 2025
Auth party contact address
-
Data no
296811
Title
CTFTOL2 702. Citrus Tolerance to Multiple Applications of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296820
Title
2022USA3825_STF_03_02. Stone Fruit Tolerance to Multiple Applications of DCC-3825????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296697
Title
Consent For Use of Confidential Commercial Information and Access to Information with Limits on Use
Study date
9 September 2025
Auth party contact address
-
Data no
296703
Title
Magnitude of the Residue of DCC-3825 70% WG in/on Tree Nuts, Crop Group 14-12
Study date
06/10/2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296797
Title
PMFTOL2 724. Pome Fruit Tolerance to Multiple Applications of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296726
Title
To evaluate Terrad???or for the control of various weed species in lemon cv. Eureka. Wallaville / Queensland / 2023??
Study date
2024
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296789
Title
PMF_01_02 4334_Apple. Pome Fruit Tolerance to Multiple Applications of DCC-3825????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296743
Title
14-US-H-2-BSF602. IB 6002/Efficacy/Permanent Crops- Grape??
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296737
Title
Efficacy of Terrad???or applied to broadleaf weeds during a fallow period.??
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296783
Title
2022USA3825_PMF_01_06. Performance of Post Herbicides on Red and Black Raspberry for Cane Growth and Weed Control.????
Study date
2016
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296734
Title
Efficacy of NUL3373 and glufosinate co-mix on annual ryegrass
Study date
2018
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296757
Title
DCC-3825 for weed control in tree nuts: Almond. Crop Safety data only. 2024NAM3285_TRN_EFF_ALMOND 5635 H????
Study date
2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296806
Title
CTFTOL2 698. Citrus Tolerance to High Rates of DCC-3825.????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296706
Title
Part 7: Environment
Study date
20/08/2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296720
Title
Crop Safety and efficacy of Terrad???or applied under Pome fruit (apples)
Study date
2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296714
Title
Crop Safety and efficacy of Terrad???or applied under grape vines????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296763
Title
To determine the crop safety of Tiafenacil 5% SC when applied to Mandarin orange inter-row application.????
Study date
2016
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296700
Title
Magnitude of tiafenacil residues and its metabolites in citrus fruits after application of product DCC-3825 70%WG (EXP-3825 70% WG)
Study date
16/02/2018
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296723
Title
Crop safety and efficacy of Terrad???or applied under citrus (Orange). Mypolonga, South Australia, 2022??
Study date
2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296746
Title
PSM-21-06-07 Eff. Evaluation of DCC-3825 Efficacy in Stone Fruit????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296817
Title
2021NAM3825 CTFTOL2. Crop Safety of Terrad????????or Herbicide in Citrus????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296769
Title
Consent For Use of Confidential Commercial Information and Access to Information with Limits on Use
Study date
9 September 2025
Auth party contact address
-
Data no
296823
Title
PSM-21-06-09 Stone Fruit Tolerance to Multiple Applications of DCC-3825????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296800
Title
PMF_02_03 4340_Pear. Crop Safety of Terrad????????or Herbicide in Pome Fruit????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296777
Title
BSF44.OR. POST (DIRECTED) BURNDOWN WEED CONTROL WITH APPLICATIONS OF TIAFENACIL IN GRAPES????
Study date
2018
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296786
Title
PMFTOL2 605_Apple. Pome Fruit Tolerance to High Rates of DCC-3825
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296740
Title
Terrad???or as a Directed Spray for Control of Weeds in Sugarcane??
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296760
Title
To determine the crop safety of Tiafenacil 5% SC when applied to Kiwifruit inter-row application.????
Study date
2017
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296780
Title
2021NAM3825BSFEFF. Evaluation of DCC-3825 for Sucker Management in Grapes.????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296803
Title
2021NAM3825CTFTOL2. Citrus Tolerance to Multiple Applications of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296717
Title
Nufarm, Crop safety and efficacy of Terrad???or applied under vines, Cowaramup, Western Australia 2022??
Study date
2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296766
Title
Tiafenacil. Petition for the Establishment of Pennanent Tolerances and Registration for Use on Grapes, Com, Cotton, Soybeans, And Wheat. Summary of Analytical Chemistry and Residue Data.
Study date
2020
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296809
Title
CTFTOL2 649.???? Citrus Tolerance to High Rates of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296795
Title
15-US-H-2-PF601_Pear. Crop Safety of Terrad????????or Herbicide in Pome Fruit????
Study date
2015
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296818
Title
2022NAM3825_STF_TOL2_4329. Stone Fruit Tolerance to Multiple Applications of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296749
Title
DCC-3825/Efficacy/Permanent Crops - Trees. 15-US-H-2-TN601????
Study date
2015
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296701
Title
Magnitude and Decline of the Residues of Tiafenacil and Tolpyralate in or on Apple and Pear Raw Agricultural and Processed Commodities as the Representative Crops of the Pome Fruit Crop Group (CG11-09) Following Three Applications of DCC-3825 70%WG and Tolpyralate 400 SC Herbicide ??? 2021
Study date
31/10/2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296824
Title
2020NAM3825 TRNEFT. Evaluation of DCC-3825 efficacy and crop safety to tree nut crops
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296741
Title
Crop safety of Terrad???or when applied as a broadcast application over 2-3 leaf sugarcane.??
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296778
Title
2018US63825BSF45. Crop Safety of Terrad????????or Herbicide in Grapes????????
Study date
2018
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296732
Title
Crop Safety and efficacy of Terrad???or applied under Tree Nuts (Macadamia)
Study date
2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296712
Title
CROP SAFETY Terrad???or Orchard and Vineyard Safety
Study date
September 2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296781
Title
2022USA3825_BSF_01_01 Evaluation of DCC-3825 for Sucker Management????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296804
Title
CTFTOL2 648. Citrus Tolerance to High Rates of DCC-3825.????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296718
Title
Crop Safety and efficacy of Terrad???or applied under grape vines????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296755
Title
LR22108-01 - Tree Nut Tolerance to Multiple Applications of DCC-3825. 2022USA3825_TRN_05_02 4366????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296761
Title
To determine the crop safety of Tiafenacil 5% SC when applied to Yuzu inter-row application.????
Study date
2017
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296812
Title
CTFTOL2 726. Citrus Tolerance to High Rates of DCC-3825
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296721
Title
Comparison of Terrad???or 700 WG + CanDo 500 EC, CRUCIAL?? 600 SL -+/- Terrad???or + CanDo and CRUCIAL +/- Nail 600 EC + CanDo on wild oats grass (Avena spp.) ryegrass (Lolium rigidum) marshmallow (Malva parviflora) and milk thistle (Sonchus oleraceus) and assessment of crop safety in apples cv. Royal Gala. Stanthorpe, Qld, 2022-23??
Study date
2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296798
Title
PMF_02_01 4338_Pear.Crop Safety of Terrad????????or Herbicide in Pome Fruit????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296698
Title
Residues and Trade
Study date
28/09/2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296821
Title
2022USA3825_STF_03_04 Stone Fruit Tolerance to High Rates of DCC-3825????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296752
Title
LR22108-01 - Tree Nut Tolerance to Multiple Applications of DCC-3825. 2022USA3825_TRN_03_01 4363.????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296775
Title
16-US-H-2-BSF602. DCC-3825 / Permanent Crops????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296729
Title
Evaluation of Terrad???or 700 WG for crop safety and the control of grass and broadleaved weeds in peaches cv. April Snow. Perth Hills, Western Australia, 2023??
Study date
2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296792
Title
PMF_01_03 4333_Apple. Pome Fruit Tolerance to Multiple Applications of DCC-3825????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296738
Title
Comparison of 2 rates of Terrad???or for the control of weeds and crop safety applied as a broadcast spray in plant cane applied at 3???4 leaf stage??
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296735
Title
Efficacy of NUL3373 and glufosinate co-mix on annual ryegrass??
Study date
2018
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296784
Title
14-US-H-2-PF602. IB 6002/Efficacy/Tree Fruit????
Study date
2014
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296758
Title
To determine crop safety of Tiafenacil 5%SC when applied to Chestnut inter-row application????
Study date
2017
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296801
Title
CTFEFT 00342. Evaluation of DCC-3825 efficacy and crop safety to citrus crops????
Study date
2014
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296709
Title
Appendix 7.3 List of endpoints-tank mix partners
Study date
2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296715
Title
Evaluation of Terrad'or 700 WG with or without Biffo 200 SL or CRUCIAL?? 600 SL for the post emergence control of weeds under table grapes cv. Crimson Seedless. Caversham, Western Australia, 2021??
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296815
Title
CTFTOL2 647. Citrus Tolerance to High Rates of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296764
Title
Evaluation of weed control efficacy and crop safety of the PPO-inhibiting herbicide tiafenacil in California orchard cropping systems????
Study date
2024
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296724
Title
Evaluation of Terrad???or 700 WDG for crop safety and post-emergence weed control under established lemon trees cv. Eureka. Perth Hills, Western Australia, 2023??
Study date
2024
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296747
Title
2022USA3825_STF_02_01 Stone Fruit Tolerance to Multiple Applications of DCC-3825????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296770
Title
Consent For Use of Confidential Commercial Information and Access to Information with Limits on Use
Study date
9 September 2025
Auth party contact address
-
Data no
296793
Title
PMF_01_03 4336_Apple. Crop Safety of Terrad????????or Herbicide in Pome Fruit????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296776
Title
2018US63825BSF43.RR. Crop Safety of Terrad????????or Herbicide in Grapes????????
Study date
2018
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296799
Title
PMF_02_02 4339_Pear. Crop Safety of Terrad????????or Herbicide in Pome Fruit????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296730
Title
Efficacy of Terrad???or 700 WG for control of various winter annual weeds and grass weeds in sweet cherries cv. Simone. Spreyton, Tasmania. 2022??
Study date
2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296787
Title
PMFTOL2 606_Apple. Pome Fruit Tolerance to Multiple Applications of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296736
Title
Efficacy of Terrad???or applied to broadleaf and grass weeds during a fallow period.????
Study date
2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296759
Title
To determine the crop safety of Tiafenacil 5% SC when applied to Chinese Jujube inter-row application.????
Study date
2017
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296753
Title
LR22108-01 - Tree Nut Tolerance to Multiple Applications of DCC-3825. 2022USA3825_TRN_04_01 4364????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296767
Title
Tiafenacil.Petition to Support Proposed Uses on Barley (Subgroup15- 22B), CitrusFruit (Group10-10), Sweet Corn (Subgroup15-22D), Pulses, Dry Shelled Beans except Soybean (Subgroup6-22E), Pulses, DryShelledPeas (Subgroup6-22F), GrainSorghumMillet (Subgroup15-22E), PomeFruit (Group11-10), Rapeseed (Subgroup 20A), StoneFruit (Group12-12), Peanut Tree Nuts (Group14-12).Summary Analytical Chem Res Data
Study date
2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296810
Title
CTFTOL2 700 Citrus Tolerance to High Rates of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296816
Title
CTFTOL2 665. Citrus Tolerance to Multiple Applications of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296710
Title
Appendix 7.4 88074_144818 - PAA Written Assistance
Study date
24/03/2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296716
Title
Crop Safety and efficacy of Terrad???or applied under grape vines????
Study date
2 Feb 2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296819
Title
2022CAN3825_STF_03_03. Stone Fruit Tolerance to High Rates of DCC-3825????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296796
Title
15-US-H-2-PF603_Pear. DCC-3825/Efficacy/Permanent Crops.????
Study date
2015
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296727
Title
Crop safety and efficacy of Terrad???or applied under apricot trees in season, one field trial, Invergordon, Victoria??
Study date
2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296704
Title
Magnitude and Decline of the Residues of Tiafenacil and its Metabolites in/on Grape Raw Agricultural and Processed Commodities Following a Single Directed Application of DCC-3825 70WG Herbicide (2015)
Study date
06/11/2017
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296750
Title
LR22108-01 - Tree Nut Tolerance to Multiple Applications of DCC-3825. 2022USA3825_TRN_01_01_4360????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296790
Title
PMF_01_03 4335_Apple. Pome Fruit Tolerance to Multiple Applications of DCC-3825????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296696
Title
Executive Summary
Study date
Oct 2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296779
Title
2021NAM3825 BSF/EFF Crop Safety of Terrad????????or Herbicide in Grapes????????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296744
Title
14-US-H-2-BSF603. IB 6002/Efficacy/Permanent Crops- Grape??
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296733
Title
Efficacy of co-mix of NUL3373 and glufosinate of annual ryegrass.??
Study date
2018
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296807
Title
CTFTOL2 701. Citrus Tolerance to Multiple Applications of DCC-3825????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296813
Title
2022USA3825_CTFEFT 338. Crop Safety of Terrad????????or Herbicide in Citrus????
Study date
2022
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296707
Title
Appendix 7.1 88074-120214 ETR
Study date
13/10/2020
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296756
Title
DCC-3825 for weed control in tree nuts: Pistachio. Crop Safety data only. 2024NAM3285_TRN_EFF_PISTACHIO, 4829.????
Study date
2024
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
296713
Title
Crop Safety and efficacy of Terrad???or applied under grape vines????
Study date
2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Date
Application Date
Application No
Application Number
150629
Product/Active constituent Name
Application Product Name
Rapid Strike Ratsak Reusable Rodent Bait Station with Dual Active Wax Blocks
Application Date
Application Number
150629
Application Product Name
Rapid Strike Ratsak Reusable Rodent Bait Station with Dual Active Wax Blocks
Application details
Product name:
Rapid Strike Ratsak Reusable Rodent Bait Station with Dual Active Wax Blocks
Product number:
96767
Applicant Name:
ZAPI S.P.A
Application purpose and description of use:
Registration of a 0.025 g/kg bromadiolone and 0.025 g/kg difenacoum ready to use block bait product for control of rats and mice in indoor and outdoor household situations.
Reference details:
69994 - MUSKIL DUAL ACTIVE RODENTICIDE BLOCKS WITH FLUO-NP TECHNOLOGY
84831 - RATSAK RAPID STRIKE DUAL ACTIVE WAXBLOCKS
Active constituents:
Active constituent name
67881 - DIFENACOUM
Active constituent name
67898 - BROMADIOLONE
Description of data provided:
Data no
295657
Title
Calculation supporting the label claims
Study date
13/10/2025
Auth party contact address
VIA TERZA STRADA 12 35026 CONSELVE (PADOVA) Italy
Data no
295655
Title
Certificate of analysis
Study date
17/10/2023
Auth party contact address
VIA TERZA STRADA 12 35026 CONSELVE (PADOVA) Italy
Data no
295653
Title
Permit to import conditionally non-prohibited goods
Study date
21/07/2025
Auth party contact address
VIA TERZA STRADA 12 35026 CONSELVE (PADOVA) Italy
Data no
295656
Title
Certificate of analysis
Study date
15/10/2024
Auth party contact address
VIA TERZA STRADA 12 35026 CONSELVE (PADOVA) Italy
Data no
295654
Title
Safety Data Sheet
Study date
21/02/2023
Auth party contact address
VIA TERZA STRADA 12 35026 CONSELVE (PADOVA) Italy
Date
Application Date
Application No
Application Number
150824
Product/Active constituent Name
Application Product Name
PROTHIOCONAZOLE
Application Date
Application Number
150824
Application Product Name
PROTHIOCONAZOLE
Application details
Product name:
PROTHIOCONAZOLE
Active name:
PROTHIOCONAZOLE
Applicant Name:
HEXTAR CHEMICALS PTY LTD
Application purpose and description of use:
Approval of PROTHIOCONAZOLE for use in agricultural chemical products.
Description of data provided:
Data no
297100
Title
Dossier for approval of a new active constituent Prothioconazole
Study date
05.11.2025
Auth party contact address
15 ORBISON CRT ENDEAVOUR HILLS Australia
Data no
297106
Title
4191: Confidential Attachment
Study date
24.06.2025
Auth party contact address
Report sponsor and sister company of the manufacturer
Data no
297103
Title
4190: Confidential Attachment (Part I to Part IV)
Study date
26.06.2025
Auth party contact address
Report sponsor and sister company of the manufacturer
Data no
297112
Title
Safety Data Sheet Prothioconazole TC
Study date
28.10.2025
Auth party contact address
Manufacturer of active constituent
Data no
297101
Title
Letter of Authorization for Chemistry and Manufacture Data Submission
Study date
24.09.2025
Auth party contact address
Report sponsor and sister company of the manufacturer
Data no
297109
Title
Manufacturing Process of Prothioconazole Technical
Study date
28.10.2025
Auth party contact address
Manufacturer of active constituent
Data no
297104
Title
4190: Confidential Attachment (Part V, Appendices)
Study date
26.06.2025
Auth party contact address
Report sponsor and sister company of the manufacturer
Data no
297110
Title
Declaration of Composition (DoC)
Study date
28.10.2025
Auth party contact address
Manufacturer of active constituent
Data no
297107
Title
4192: Study on the Physico-Chemical Properties of Prothioconazole Technical ??? Appearance, Relative density, Volatility, Dissociation constant, Flammability, Surface tension, UV/vis, Explosive properties, Oxidizing properties, Corrosiveness, pH, Hydrolysis, Stability of packaging, Accelerated storage stability
Study date
26.06.2025
Auth party contact address
Report sponsor and sister company of the manufacturer
Data no
297102
Title
4190: Final Report ??? Analysis of Five Representative Production Batches of Prothioconazole Technical Grade Active Ingredient (TGAI) to Identify and Quantify Prothioconazole and its Associate Impurities
Study date
26.06.2025
Auth party contact address
Report sponsor and sister company of the manufacturer
Data no
297108
Title
4193: Study on the Physico-Chemical Properties of Prothioconazole Technical ??? Melting point, Solubility, Partition coefficient, Vapour pressure
Study date
26.06.2025
Auth party contact address
Report sponsor and sister company of the manufacturer
Data no
297111
Title
Analytical Method of Prothioconazole Active Ingredient
Study date
28.10.2025
Auth party contact address
Manufacturer of active constituent
Data no
297105
Title
4191: Final Report - Determination of Solvent Impurity in Five Representative Production Batches of Prothioconazole Technical
Study date
24.06.2025
Auth party contact address
Report sponsor and sister company of the manufacturer
Date
Application Date
Application No
Application Number
150995
Product/Active constituent Name
Application Product Name
Decco IMZ S-75 Fungicide
Application Date
Application Number
150995
Application Product Name
Decco IMZ S-75 Fungicide
Application details
Product name:
Decco IMZ S-75 Fungicide
Product number:
96867
Applicant Name:
DECCO US POST-HARVEST INC.
Application purpose and description of use:
Registration of a 75 g/L SL soluble concentrate product for control of post-harvest diseases in citrus.
Reference details:
62247 - IMAZACURE 750 SG FUNGICIDE
50077 - DECCOZIL EC FUNGICIDE
85892 - FUNGAFLOR 750 WSP JANSSEN FUNGICIDE WATER SOLUBLE POWDER
Active constituents:
Active constituent name
90045 - Imazalil
Description of data provided:
Data no
296645
Title
Physico-chemical tests on AGF/3-01 (Imazalil 75 g/L SL)
Study date
27/05/2013
Data no
296659
Title
To determine the efficacy and possible phytotoxicity of Decco Imazalil 75 SL applied in dip system for the control of green mould Penicillium digitatum
Study date
10/11/2020
Data no
296665
Title
Deccozil EC Fungicide (50077)
Study date
2015
Auth party contact address
-
Data no
296656
Title
Part 3 Summary
Study date
October 2025
Data no
296648
Title
Chemical stability and physico-chemical tests after a storage procedure for 24 months at 20 ?? 2??C on AGF/3-01 (Imazalil 75 g/L SL)
Study date
31/03/2015
Data no
296642
Title
Test Report
Study date
29/11/2023
Data no
296662
Title
Deccozil SL - 7.5
Study date
2025
Data no
296651
Title
Part 2 Summary
Study date
October 2025
Data no
296643
Title
Safety data sheet
Study date
15/05/2025
Data no
296657
Title
Efficacy evaluation of the product AGF/3-01, on the main fungi that cause decay in postharvest of citrus fruits.
Study date
06/05/2013
Data no
296663
Title
Imazacure 750 SG Fungicide (62247)
Study date
2010
Auth party contact address
-
Data no
296654
Title
Assessment of sensitising properties on albino guinea pigs
Study date
21/06/2013
Data no
296660
Title
To determine the efficacy and possible phytotoxicity of Decco Imazalil 75 SL applied in dip system for the control of green mould Penicillium digitatum
Study date
10/11/2020
Data no
296649
Title
Validation of an analytical method for the determination of imazalil content in AGF/3-01 (Imazalil 75 g/L SL)
Study date
05/07/2013
Data no
296655
Title
Toxicological data base
Study date
October 2025
Data no
296652
Title
Evaluation of Acute Oral Toxicity in rats ??? acute toxic class method
Study date
21/06/2013
Data no
296646
Title
Physico-chemical tests and analyses before and after an accelerated storage procedure for 14 days at 54 ?? 2??C on AGF/3-01 (Imazalil 75 g/L SL)
Study date
27/08/2013
Data no
296658
Title
To determine the efficacy and possible phytotoxicity of Decco Imazalil 75 SL applied in dip system for the control of green mould Penicillium digitatum
Study date
10/11/2020
Data no
296666
Title
Part 8 Summary
Study date
October 2025
Data no
296653
Title
Evaluation of Acute Dermal toxicity in rats
Study date
21/06/2013
Data no
296647
Title
Annex to analysis report: 20-12-4041-0
Study date
15/02/2021
Data no
296641
Title
Certificate of analysis
Study date
03/05/2025
Data no
296661
Title
To determine the efficacy and possible phytotoxicity of Decco Imazalil 75 SL applied in dip system for the control of green mould Penicillium digitatum
Study date
10/11/2020
Data no
296650
Title
Decco IMZ S-7.5 Safety Data Sheet
Study date
30/08/2023
Data no
296644
Title
Manufacturing of an imazalil sulfate formulation
Study date
September 2025
Data no
296664
Title
Imazacure 750 SG
Study date
2011
Auth party contact address
-
Date
Application Date
Application No
Application Number
151285
Product/Active constituent Name
Application Product Name
Terrad'or Herbicide
Application Date
Application Number
151285
Application Product Name
Terrad'or Herbicide
Application details
Product name:
Terrad'or Herbicide
Product number:
88074
Applicant Name:
FarmHannong Co.,Ltd.
Application purpose and description of use:
Variation of product registration and label approval to remove the current grazing restraint for fallow situations and establish a grazing withholding period of 7 days for fallow.
Active constituents:
Active constituent name
86287 - Tiafenacil
Description of data provided:
Data no
297091
Title
Magnitude and Decline of the Residues of Tiafenacil and its Metabolites in/on Wheat Raw Agricultural and Processed Commodities Following One Pre-plant or Pre-emergence Application of DCC-3825 70WG Herbicide (2015)
Study date
6 Nov 2017
Data no
297094
Title
DCC-3825 residues applied preharvest to lentils
Study date
13 Dec 2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
297086
Title
RESIDUES AND TRADE EVALUATION REPORT
Study date
November 2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
297097
Title
Freezer Storage Stability of Tiafenacil and Metabolites in Grape, Raisin, Grape Juice, Soybean Seed, Wheat Forage, Wheat Straw and Wheat Grain
Study date
11 Dec 2018
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
297092
Title
GLP residues of Terrad'or 700 WG applied at IBS and preharvest in pulses
Study date
23 Oct 2024
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
297089
Title
TERRAD???OR 700 WG (DCC-3825) GLP DETERMINATION OF RESIDUES OF TIAFENACIL AND ITS METABOLITES IN WHEAT - 2021
Study date
09 Feb 2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
297095
Title
DCC-3825 residues applied preharvest to field peas
Study date
17 May 2021
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
297087
Title
Magnitude of Residue of DCC-3825 and Metabolites in Bovine Tissues and Milk- A Livestock Feeding Study
Study date
4 Sep 2024
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
297090
Title
Tiafenacil residues in wheat
Study date
8 Jul 2020
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
297096
Title
Method Validation for the Determination of DCC-3825 and Metabolites in Bovine Tissues and Milk
Study date
24 Sep 2024
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
297093
Title
TERRAD???OR 700 WG (DCC-3825) GLP DETERMINATION OF RESIDUES OF TIAFENACIL AND ITS METABOLITES IN PULSES - 2021
Study date
9 Feb 2023
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
297085
Title
Executive Summary
Study date
04 Dec 2025
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Data no
297088
Title
GLP residues of Terrad'or 700 WG applied at IBS and preharvest in wheat
Study date
24.10.2024
Auth party contact address
5-6F FKI Tower 24, Yeoui-daero Yeongdeungpo-gu Korea, South
Date
Application Date
Application No
Application Number
150786
Product/Active constituent Name
Application Product Name
AMGROW BIN-DIE PROFESSIONAL SELECTIVE HERBICIDE
Application Date
Application Number
150786
Application Product Name
AMGROW BIN-DIE PROFESSIONAL SELECTIVE HERBICIDE
Application details
Product name:
AMGROW BIN-DIE PROFESSIONAL SELECTIVE HERBICIDE
Product number:
66082
Applicant Name:
AUSTRALIAN AGRIBUSINESS (HOLDINGS) PTY LTD
Application purpose and description of use:
Variation of product label approval to update the Directions for use to show a rate of 5 L in 200 - 500 L water/ha
or 50 mL in 2–5 L water per 100m2
Reference details:
66082 - AMGROW BIN-DIE PROFESSIONAL SELECTIVE HERBICIDE
66082 - JOLT SELECTIVE HERBICIDE
Active constituents:
Active constituent name
53379 - CLOPYRALID
Active constituent name
57937 - DIFLUFENICAN
Active constituent name
55950 - MCPA
Date
Application Date
Application No
Application Number
150829
Product/Active constituent Name
Application Product Name
CONQUEST SNOOKER 240 EC SELECTIVE HERBICIDE
Application Date
Application Number
150829
Application Product Name
CONQUEST SNOOKER 240 EC SELECTIVE HERBICIDE
Application details
Product name:
CONQUEST SNOOKER 240 EC SELECTIVE HERBICIDE
Product number:
62567
Applicant Name:
CONQUEST CROP PROTECTION PTY LTD
Application purpose and description of use:
Variation to the pack size
Reference details:
67006 - APPARENT CLODINAFOP 240 EC HERBICIDE
67565 - OPAL CLODINAFOP 240 EC SELECTIVE HERBICIDE
68172 - ACP CLODINAFOP 240 EC SELECTIVE HERBICIDE
89228 - NAADCO Clodinafop 240 Herbicide
93764 - Point Clodinafop 240 EC Herbicide
Active constituents:
Active constituent name
60740 - CLODINAFOP-PROPARGYL
Active constituent name
60031 - CLOQUINTOCET-MEXYL
Description of data provided:
Data no
297098
Title
(01) - Application Overview
Study date
Nov 25
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
297099
Title
(02) - Label with Comments
Study date
Nov 25
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia