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
151673
Product/Active constituent Name
Application Product Name
That's It. Insect Repel
Application Date
Application Number
151673
Application Product Name
That's It. Insect Repel
Application details
Product name:
That's It. Insect Repel
Product number:
97062
Applicant Name:
M100 Ltd
Application purpose and description of use:
Registration of a topical insect repellent balm containing citrepel 75 at 200 g/kg for use as a personal insect repellent in humans.
Active constituents:
Active constituent name
85558 - Extract of lemon eucalyptus/acid modified oil of lemon eucalyptus
Description of data provided:
Data no
300670
Title
R&D Accelerated Stability Testing Summary - Insect Repellent Balm
Study date
01/12/25
Auth party contact address
151 Karahaki Rd WAVERLY New Zealand
Data no
300667
Title
Efficacy Study - Report 433 Protection time of Citrepel 75 against aedes aegypti
Study date
23/05/2016
Auth party contact address
151 Karahaki Rd WAVERLY New Zealand
Data no
300668
Title
Preservative Efficacy Test 5% Citrepel?? 75 Emulsion
Study date
03/12/2015
Auth party contact address
151 Karahaki Rd WAVERLY New Zealand
Data no
300671
Title
Product Label - That's It Insect Repellent Balm
Study date
2026
Auth party contact address
151 Karahaki Rd WAVERLY New Zealand
Data no
300666
Title
Citrepel?? 75 Safety Data Sheet
Study date
07/09/21
Auth party contact address
151 Karahaki Rd WAVERLY New Zealand
Data no
300669
Title
Formulation - Insect Repellent Balm
Study date
27/11/24
Auth party contact address
151 Karahaki Rd WAVERLY New Zealand
Date
Application Date
Application No
Application Number
151906
Product/Active constituent Name
Application Product Name
Omkar Azoxystrobin 250 SC Fungicide
Application Date
Application Number
151906
Application Product Name
Omkar Azoxystrobin 250 SC Fungicide
Application details
Product name:
Omkar Azoxystrobin 250 SC Fungicide
Applicant Name:
OMKAR AGRI GLOBAL PVT. LTD
Application purpose and description of use:
Registration of a 250 g/l azoxystrobin suspension concentrate product for the control of various diseases of Grapes, Potatoes, Tomatoes, Cucurbits, Avocados, Mangoes, Passionfruit and Poppies, as per the Directions for Use..
Date
Application Date
Application No
Application Number
151266
Product/Active constituent Name
Application Product Name
Izenivetmab
Application Date
Application Number
151266
Application Product Name
Izenivetmab
Application details
Product name:
Izenivetmab
Product number:
96925
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 0.5 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application Date
Application No
Application Number
151268
Product/Active constituent Name
Application Product Name
Lenivia 1 mg Solution for Injection for Dogs
Application Date
Application Number
151268
Application Product Name
Lenivia 1 mg Solution for Injection for Dogs
Application details
Product name:
Lenivia 1 mg Solution for Injection for Dogs
Product number:
96927
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 1 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application Date
Application No
Application Number
151269
Product/Active constituent Name
Application Product Name
Lenivia 1.5 mg Solution for Injection for Dogs
Application Date
Application Number
151269
Application Product Name
Lenivia 1.5 mg Solution for Injection for Dogs
Application details
Product name:
Lenivia 1.5 mg Solution for Injection for Dogs
Product number:
96928
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 1.5 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application Date
Application No
Application Number
151270
Product/Active constituent Name
Application Product Name
Lenivia 2 mg Solution for Injection for Dogs
Application Date
Application Number
151270
Application Product Name
Lenivia 2 mg Solution for Injection for Dogs
Application details
Product name:
Lenivia 2 mg Solution for Injection for Dogs
Product number:
96929
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 2 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application Date
Application No
Application Number
151271
Product/Active constituent Name
Application Product Name
Lenivia 3 mg Solution for Injection for Dogs
Application Date
Application Number
151271
Application Product Name
Lenivia 3 mg Solution for Injection for Dogs
Application details
Product name:
Lenivia 3 mg Solution for Injection for Dogs
Product number:
96930
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 3 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application Date
Application No
Application Number
151880
Product/Active constituent Name
Application Product Name
Spacraft Multi Spa Sanitiser
Application Date
Application Number
151880
Application Product Name
Spacraft Multi Spa Sanitiser
Application details
Product name:
Spacraft Multi Spa Sanitiser
Product number:
97105
Applicant Name:
SPA-CRAFT PTY LTD
Application purpose and description of use:
Registration of a 530g/kg chlorine (Cl), present as sodium dichloroisocynaurate and 150g/kg sodium bromide granular formulation product for control of bacteria and algae in spas.
Date
Application Date
Application No
Application Number
151881
Product/Active constituent Name
Application Product Name
Spacraft Spa Sanitiser
Application Date
Application Number
151881
Application Product Name
Spacraft Spa Sanitiser
Application details
Product name:
Spacraft Spa Sanitiser
Product number:
97106
Applicant Name:
SPA-CRAFT PTY LTD
Application purpose and description of use:
Registration of a 504g/kg chlorine (Cl), present as sodium dichlorisocyanurate, granular formulation product for the control of bacteria and algae in spas.
Date
Application Date
Application No
Application Number
151265
Product/Active constituent Name
Application Product Name
Izenivetmab
Application Date
Application Number
151265
Application Product Name
Izenivetmab
Application details
Product name:
Izenivetmab
Product number:
96924
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 0.5 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Description of data provided:
Data no
298689
Title
module 3.2.S.4.3 - Annex 5 - Method 1061.055 - Validation Report (S-QCB-PROT-AMV-016-02-R01)
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298666
Title
module 3.2.S.2.3.2 - Starting Materials
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298720
Title
Protein deamidation
Study date
2002
Auth party contact address
-
Data no
298697
Title
module 3.2.S.4.5 - Drug Substance Specification Justification
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298660
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
298706
Title
module 3.2.S - Flowchart of Manufacturers
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298680
Title
module 3.2.S.4.2 - Annex 4 - Method 1061.055
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298674
Title
module 3.2.S.3 - Characterisation
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298686
Title
module 3.2.S.4.3 - Annex 2 - Method 1061.054 - Validation Report (MVD-GMP-QCB-FG-830002590-AMVR-0011)
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298723
Title
Antibacterial polyphenols from olive oil mill waste waters
Study date
1995
Auth party contact address
-
Data no
298717
Title
Characterisation of endogenous retrovirus in rodent cell lines used for production of biologicals
Study date
2003
Auth party contact address
-
Data no
298709
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
298663
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
298700
Title
module 3.2.S.7.1 - Stability Summary and Conclusions
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298657
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
298703
Title
module 3.2.S.7.4 - Supportive Stability Data
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298677
Title
module 3.2.S.4.2 - Annex 1 - Method 1061.057
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298683
Title
module 3.2.S.4.2 - Annex 7 - Method GM099
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298695
Title
module 3.2.S.4.3 - Annex 11 - Method GM099 - Validation Report (VM296)
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298672
Title
module 3.2.S.2.5 - Annex 1 - Report - Viral Clearance Validation
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298718
Title
Calculation of Protein Extinction Coefficients form Amino Acid Sequence Data
Study date
1989
Auth party contact address
-
Data no
298712
Title
module 3.2.S - GMP Certificate Site F
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298701
Title
module 3.2.S.7.2 - Post-Approval Stability Protocol
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298655
Title
module 3.2.S.1 - General Information
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298658
Title
module 3.2.S.2.2 - Annex 1 - Regulatory Method of Manufacturing Active Substance - Izenivetmab FDS
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298704
Title
module 3.2.S.7.4 - Annex 1 - Stability Summary Report
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298721
Title
Fragmentation of monoclonal antibodies
Study date
2011
Auth party contact address
-
Data no
298678
Title
module 3.2.S.4.2 - Annex 2 - Method 1061.054
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298684
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
298692
Title
module 3.2.S.4.3 - Annex 8 - Method 1061.004 - Qualification Report (C667Z-US-22-515)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298715
Title
module 3.2.S - ICH Q11
Study date
2012
Auth party contact address
-
Data no
298669
Title
module 3.2.S.2.3.2 - Annex 3 - Genetic Stability Assessment
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298698
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
298661
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
298675
Title
module 3.2.S.4.1 - Specification Drug Substance
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298681
Title
module 3.2.S.4.2 - Annex 5 - Method 1061.004
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298716
Title
module 3.2.S - Pharmacopoeial Test Methods
Study date
2024
Auth party contact address
-
Data no
298670
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
298693
Title
module 3.2.S.4.3 - Annex 9 - Method 1061.004 - Evaluation Protocol
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298710
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
298664
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
298699
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
298676
Title
module 3.2.S.4.2 - Analytical Procedures Drug Substance
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298713
Title
module 3.2.S - Pharmacopoeial Monographs
Study date
2024
Auth party contact address
-
Data no
298719
Title
Scale-down model qualification of ambr 250 high-throughput mini bioreactor system for two commercial-scale mAb processes
Study date
2019
Auth party contact address
-
Data no
298690
Title
module 3.2.S.4.3 - Annex 6 - Method 1061.004 - Validation Report (MVD-GMP-QCB-FG-830002590-AMVR-0001)
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298696
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
298667
Title
module 3.2.S.2.3.2 - Annex 1 - MCB Report
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298707
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
298656
Title
module 3.2.S.2.1 - Manufacturer
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298673
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
298687
Title
module 3.2.S.4.3 - Annex 3 - Method 1061.056 - Validation Report (CH6MZ-US-19-279)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298679
Title
module 3.2.S.4.2 - Annex 3 - Method 1061.056
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298714
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
298691
Title
module 3.2.S.4.3 - Annex 7 - Method 1061.004 - Comparability Report (CH6MW-US-21-395)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298668
Title
module 3.2.S.2.3.2 - Annex 2 - Protocol for Generation of WCB
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298662
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
298708
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
298688
Title
module 3.2.S.4.3 - Annex 4 - Method 1061.056 - Analytical Method Transfer Report (MVD-GMP-QCB-FG-830002590-AMTR-0001)
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298682
Title
module 3.2.S.4.2 - Annex 6 - Method 1061.005
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298665
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
298671
Title
module 3.2.S.2.5 - Process Validation
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298694
Title
module 3.2.S.4.3 - Annex 10 - Method 1061.005 - Validation Report (S-QCB-PROT-AMV-022-01-R01)
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298711
Title
module 3.2.S - GMP Certificate Site E
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298659
Title
module 3.2.S.2.2 - Annex 2 - Active Substance Manufacturing Flow Chart - Izenivetmab FDS
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298702
Title
module 3.2.S.7.3 - Primary Stability Data
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298705
Title
module 3.2.S.7.4 - Annex 2 - Freeze Thaw Report
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298722
Title
Detecting DNA double-stranded breaks in mammalian genomes by linear amplification-mediated high-throughput genome-wide translocation sequencing
Study date
2016
Auth party contact address
-
Data no
298685
Title
module 3.2.S.4.3 - Annex 1 - Method 1061.057 - Validation Report (S-QCB-PROT-AMV-017-01-R02)
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
151267
Product/Active constituent Name
Application Product Name
Lenivia 0.5 mg Solution for Injection for Dogs
Application Date
Application Number
151267
Application Product Name
Lenivia 0.5 mg Solution for Injection for Dogs
Application details
Product name:
Lenivia 0.5 mg Solution for Injection for Dogs
Product number:
96926
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 0.5 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Description of data provided:
Data no
298929
Title
The Transmission of Immunity from mother to young and the Catabolism of Immunoglobulins
Study date
1966
Auth party contact address
-
Data no
299261
Title
Stratification of antibody-positive subjects by antibody level reveals an impact of immunogenicity on pharmacokinetics
Study date
2013
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298906
Title
Part 3a4 - Other requirements
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299238
Title
Cyclooxygenase isozymes - the biology of prostaglandin synthesis and inhibition
Study date
2004
Auth party contact address
-
Data no
298883
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
299144
Title
Synovitis in dogs with stable stifle joints and incipient cranial cruciate ligament rupture: a cross-sectional study
Study date
2011
Auth party contact address
-
Data no
299215
Title
Contralateral cuciate survival in dogs with unilateral non-contact cranial cruciate ligament rupture
Study date
2011
Auth party contact address
-
Data no
298835
Title
module 3.2.P.5.3 - Annex 5 - 1061.056 Method Transfer Doc. No. VM378
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299167
Title
EMA scientific advice - NV-01
Study date
2014
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299092
Title
Lenivia PAA advice
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299115
Title
IgG placental transfer in healthy and pathological pregnancies
Study date
2012
Auth party contact address
-
Data no
299138
Title
Rita levi-montalcini - the discovery of nerve growth factor and modern neurobiology
Study date
2004
Auth party contact address
-
Data no
299307
Title
C461W-US-16-151 - Single dose pharmacokinetics of anti-NGF monoclonal antibody ZTS-00075623 in dogs
Study date
2017
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299161
Title
Chondroprotection by non-steroidal anti-inflammatory drugs
Study date
1989
Auth party contact address
-
Data no
299284
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
298852
Title
module 3.2.P.3.5 - Annex 4 - Validation report VAL-AM-014230-BR
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298912
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
299207
Title
Spontaneous dog osteoarthritis - a one medicine vision
Study date
2019
Auth party contact address
-
Data no
299244
Title
Disentangling the signaling complexity of nerve growth factor receptors by CRISPR/Cas9
Study date
2022
Auth party contact address
-
Data no
299301
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
298946
Title
Questions and answers on monoclonal antibodies for veterinary use
Study date
2017
Auth party contact address
-
Data no
298958
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
299290
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
299098
Title
Module 3.2 - OHS Overview - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299104
Title
The placenta, transfer of immunoglobulins, and safety assessment of biopharmaceuticals in pregnancy
Study date
2012
Auth party contact address
-
Data no
298998
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
299052
Title
C362R-US-16-156 - A 3-month exploratory safety study (once every 4 weeks) of ZTS-00075623 by subcutaneous injection in adult Beagle dogs
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298952
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
299198
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
299178
Title
Cardiac innervation and sudden cardiac death
Study date
2015
Auth party contact address
-
Data no
299035
Title
C461N-US-21-414 - Pharmacokinetic study of subcutaneous and intravenous administration of ZTS-00075623 in healthy dogs
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299084
Title
GMP Certificate Sites J, K, L, M, N
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299201
Title
Guidelines for safe and effective use of NSAIDs in dogs
Study date
2005
Auth party contact address
-
Data no
299250
Title
VICH GL 44 - Target Animal Safety For Veterinary Live and Inactivated Vaccines
Study date
2008
Auth party contact address
-
Data no
299058
Title
Fecal protease activity is associated with compositional alterations in the intestinal microbiota
Study date
2013
Auth party contact address
-
Data no
299227
Title
Evaluation of the safety of long-term, daily oral administration of grapiprant, a novel drug for treatment of osteoarthritic pain and inflammation, in healthy dogs
Study date
2015
Auth party contact address
-
Data no
298872
Title
GMP Certificate Site I
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298843
Title
module 3.2.P.2 - Pharmaceutical Development
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299009
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
299015
Title
Genotoxicity assessment of peptide/protein-related biotherapeutics: points to consider before testing
Study date
2016
Auth party contact address
-
Data no
298992
Title
Lymphatic Transport of Proteins After Subcutaneous Administration
Study date
2000
Auth party contact address
-
Data no
299158
Title
Evaluation of polysulfated glycosaminoglycan for the treatment of hip dysplasia in dogs
Study date
1994
Auth party contact address
-
Data no
298892
Title
Part 4B1 - Clinical Trials - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298966
Title
Immunotoxicity Studies for Human Pharmaceuticals, S8
Study date
2006
Auth party contact address
-
Data no
299064
Title
Module 4b - Scheduling Overview - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299135
Title
Part 4a4 - Target animal safety
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298866
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
298915
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
298935
Title
Anti-nerve growth factor in pain management: current evidence
Study date
2016
Auth party contact address
-
Data no
299184
Title
Mechanisms of drug toxicity and relevance to pharmaceutical development
Study date
2011
Auth party contact address
-
Data no
299029
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
299078
Title
Data List 2 - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298886
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
298972
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
299278
Title
C866C-XC-19-263 - Negative-controlled, multicentre field study investigating efficacy, safety and duration of effect of xxx of ZTS-00075623 for the treatment of pain associated with osteoarthritis in client-owned dogs - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299021
Title
Guideline on Target Animal Safety For Veterinary Live and Inactivated Vaccines
Study date
2008
Auth party contact address
-
Data no
299270
Title
Lenivia - EU D181 response - Aug 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299121
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
298978
Title
The T-cell-dependent antibody response assay in nonclinical studies of pharmaceuticals and chemicals: study design, data analysis, interpretation
Study date
2014
Auth party contact address
-
Data no
299221
Title
Chapter 18 - The stifle joint
Study date
2006
Auth party contact address
-
Data no
298829
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
299095
Title
Lenivia - xxx application
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299072
Title
eLabel - Lenivia 0.5 mg solution for injection for dogs
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299141
Title
Evaluation of the effects of tanezumab, a monoclonal antibody against nerve growth factor, on the sympathetic nervous system in adult cynomolgus monkeys (Macaca fascicularis): a stereologic, histomorphologic, and cardiofunctional assessment
Study date
2017
Auth party contact address
-
Data no
299118
Title
SDS for ingredient X - his
Study date
2024
Auth party contact address
-
Data no
299187
Title
Cranial cruciate ligament pathophysiology in dogs with cruciate disease: a review
Study date
2004
Auth party contact address
-
Data no
299258
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
299264
Title
5962C-85-08-365 - Comparative field safety and efficacy of Trocoxil (mavacoxib) in the treatment of pain and inflammation associated with degenerative joint disease in dogs
Study date
2010
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299164
Title
Breed, sex, and body weight as risk factors for rupture of the cranial cruciate ligament in young dogs
Study date
1999
Auth party contact address
-
Data no
299281
Title
C866C-XC-20-319 - Field study efficacy and safety of ZTS-00075623 administered every three months compared to placebo for the treatment of pain associated with osteoarthritis in client-owned dogs - amended contributing scientist report - pharmacokinetics and immunogenicity
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299287
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
299101
Title
Monograph for ingredient X - dis
Study date
2020
Auth party contact address
-
Data no
298863
Title
module 3.2.P.5.6 - Justification of Specification Drug Product
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299041
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
299195
Title
Serum nerve growth factor in horses with osteoarthritis-associated lameness
Study date
2023
Auth party contact address
-
Data no
299055
Title
Evaluation of clinical metrology instrument in dogs with osteoarthritis
Study date
2016
Auth party contact address
-
Data no
299304
Title
C762Z-US-20-325 - Validation of an xxx assay for the detection of neutralizing anti-ZTS-00075623 antibodies in canine serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298909
Title
C762Z-US-20-323 - Validation of an xxx method for the quantitation of ZTS-00075623 in canine serum
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298995
Title
Evaluation of the safety of long-term, daily oral administration of grapiprant, a novel drug for treatment of osteoarthritic pain and inflammation, in healthy dogs
Study date
2015
Auth party contact address
-
Data no
299241
Title
Caudal cruciate ligament damage in dogs with cranial cruciate ligament rupture
Study date
2010
Auth party contact address
-
Data no
298849
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
298855
Title
module 3.2.P.3.5 - Annex 7 - Extractable report VAL-AS-002790-ER1
Study date
2017
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298949
Title
Guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis
Study date
2010
Auth party contact address
-
Data no
298955
Title
Rapidly progressive osteoarthritis - a review of the clinical and radiologic presentation
Study date
2017
Auth party contact address
-
Data no
299293
Title
C491W-US-22-178 - Pharmacokinetics of canine monoclonal antibodies ZTS-00103289, ZTS-50000122, ZTS-00075623 and ABT406 in mice
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299049
Title
Part 4A4 - Pre-Clinical Trials - Tolerance in Target Animal Species - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299147
Title
NGF in early embryogenesis, differentiation, and pathology in the nervous and immune systems
Study date
2015
Auth party contact address
-
Data no
298903
Title
C863C-XC-17-176 - Negative-controlled, multicenter field study investigating efficacy and safety of xxx of ZTS-00075623 for the treatment of pain associated with osteoarthritis in client-owned dogs - statistics
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299001
Title
Pharmacokinetics of monoclonal antibodies
Study date
2017
Auth party contact address
-
Data no
299247
Title
Pharmacokinetics of nerve growth factor (NGF) following different routes of administration in rats
Study date
1994
Auth party contact address
-
Data no
298846
Title
module 3.2.P.3.3 - Description of Manufacturing Process and Process Controls
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299012
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
298869
Title
GMP Certificate Site G
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298918
Title
C762Z-US-20-324 - Validation of an xxx assay for the detection of anti-ZTS-00075623 antibodies in canine serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298895
Title
C866C-XC-20-319 - Field study efficacy and safety of ZTS-00075623 administered every three months compared to placebo for the treatment of pain associated with osteoarthritis in client-owned dogs - amended contributing scientist report - pharmacokinetics and immunogenicity
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299132
Title
Part 3a3 - Toxicology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299081
Title
GMP Certificate Site G
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299155
Title
High-affinity TrkA and p75 neurotrophin receptor complexes - a twisted affair
Study date
2022
Auth party contact address
-
Data no
299204
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
298938
Title
High-affinity TrkA and p75 neurotrophin receptor complexes - a twisted affair
Study date
2022
Auth party contact address
-
Data no
299181
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
298889
Title
Part 4A1 Efficacy Documentation - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299061
Title
Chapter 22 - Disposition of biological therapeutics - monoclonal antibodies, proteins and peptides
Study date
2012
Auth party contact address
-
Data no
298989
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
299038
Title
C360N-US-20-382 - A T-cell dependent immune response study in Beagle dogs treated with ZTS-00075623
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299112
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
299018
Title
Somatosensory evoked potentials of the dog: recording techniques and normal values
Study date
1989
Auth party contact address
-
Data no
299267
Title
Lenivia - EU D121 response - appendix 70-1 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298875
Title
Module 2 - Chemistry & Manufacture Overview - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298969
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
299218
Title
Etiopathogenesis of canine cruciate ligament disease: a scoping review
Study date
2023
Auth party contact address
-
Data no
299230
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
299032
Title
Lenivia - EU D121 responses - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298926
Title
Osteoarthritis, angiogenesis and inflammation
Study date
2005
Auth party contact address
-
Data no
298932
Title
Power of treatment success definitions when the Canine Brief Pain Inventory is used to evaluate carprofen treatment for the control of pain and inflammation in dogs with osteoarthritis
Study date
2013
Auth party contact address
-
Data no
299175
Title
Guidance for Industry - Nonclinical evaluation of the immunotoxic potential of pharmaceuticals
Study date
2023
Auth party contact address
-
Data no
298832
Title
module 3.2.P.5.3 - Annex 2 - Sterility Test Validation Doc. No. VM407
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298975
Title
Guidelines for safe and effective use of NSAIDs in dogs
Study date
2005
Auth party contact address
-
Data no
299224
Title
Prevalence of cranial cruciate ligament rupture in a population of dogs with lameness previously attributed to hip dysplasia: 369 cases (1994-2003)
Study date
2005
Auth party contact address
-
Data no
299075
Title
eLabel - Lenivia 2 mg solution for injection for dogs
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299124
Title
Needlestick injuries among female veterinarians: frequency, syringe contents and side-effects
Study date
1997
Auth party contact address
-
Data no
298858
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
299119
Title
Classifying Hazardous Chemicals - National Guide, June 2023
Study date
2023
Auth party contact address
-
Data no
299190
Title
Neurotrophin signaling is required for glucose-induced insulin secretion
Study date
2016
Auth party contact address
-
Data no
298881
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
299096
Title
Lenivia - xxx responses to questions
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299213
Title
2022 WSAVA guidelines for the recognition, assessment and treatment of pain
Study date
2023
Auth party contact address
-
Data no
299142
Title
Systematic review of surgical treatments for cranial cruciate ligament disease in dogs
Study date
2014
Auth party contact address
-
Data no
299282
Title
C866C-XC-20-319 - Field study efficacy and safety of ZTS-00075623 administered every three months compared to placebo for the treatment of pain associated with osteoarthritis in client-owned dogs - statistics
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299305
Title
C461N-US-21-414 - Pharmacokinetic study of subcutaneous and intravenous administration of ZTS-00075623 in healthy dogs
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299236
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
299259
Title
Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects
Study date
2010
Auth party contact address
-
Data no
298864
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
299196
Title
Neurotoxicity studies with a tropomyosin-related kinase A inhibitor, ASP7962, on the sympathetic and sensory nervous systems of rats
Study date
2021
Auth party contact address
-
Data no
299090
Title
GMP Certificate Site E
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298898
Title
C866C-XC-19-263 - Negative-controlled, multicentre field study investigating efficacy, safety and duration of effect of xxx of ZTS-00075623 for the treatment of pain associated with osteoarthritis in client-owned dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298910
Title
C762Z-US-20-392 - Method Validation for the quantitation of ZTS-00075623 in Dog Serum by xxx
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298996
Title
A prospective, randomized, masked, placebo-controlled multisite clinical study of grapiprant, an EP4 prostaglandin receptor antagonist (PRA), in dogs with osteoarthritis
Study date
2016
Auth party contact address
-
Data no
299242
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
299044
Title
C667Z-US-20-377 - Anti-NGF mAb inhibition 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
299056
Title
Module 7 - Environment Overview - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299253
Title
Lymphatic transport and catabolism of therapeutic proteins after subcutaneous administration to rats and dogs
Study date
2012
Auth party contact address
-
Data no
298950
Title
Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs
Study date
2021
Auth party contact address
-
Data no
298850
Title
module 3.2.P.3.5 - Annex 2 - Process Validation Report PV024
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299004
Title
Evaluation of genotoxicity testing of FDA approved large molecule therapeutics
Study date
2014
Auth party contact address
-
Data no
299299
Title
C360N-US-20-382 - A T-cell dependent immune response study in Beagle dogs treated with ZTS-00075623
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298904
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
299150
Title
Clinical assessments of increased sensory sensitivity in dogs with cranial cruciate ligament rupture
Study date
2012
Auth party contact address
-
Data no
299050
Title
Part 3c -Conclusions on safety
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299296
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
298870
Title
GMP Certificate Site H
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298941
Title
Multicenter randomized prospective clinical evaluation of meloxicam administered via transmucosal oral spray in client-owned dogs
Study date
2013
Auth party contact address
-
Data no
299107
Title
US FDA DailyMed Database - product xo
Study date
2025
Auth party contact address
-
Data no
299225
Title
Equine umbilical cord mesenchymal stem cells demonstrate safety and efficacy in the treatment of canine osteoarthritis - a randomized placebo-controlled trial
Study date
2022
Auth party contact address
-
Data no
299156
Title
Models of osteoarthritis - the good, the bad and the promising
Study date
2019
Auth party contact address
-
Data no
298847
Title
module 3.2.P.3.4 - Controls of Critical Steps and Intermediates
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299033
Title
Lenivia - EU D181 responses - Aug 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299133
Title
Part 3a4 - Other requirements
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299182
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
298913
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
298990
Title
An update on nonsteroidal anti-inflammatory drugs (NSAIDs) in small animals
Study date
2008
Auth party contact address
-
Data no
298841
Title
module 3.2.P.5.4 - Annex 2 - Clinical Batch Certificates of Analysis
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298890
Title
Part 4A2 Pre-Clinical Trials - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298964
Title
Neurotrophin signaling is required for glucose-induced insulin secretion
Study date
2016
Auth party contact address
-
Data no
299013
Title
Biodistribution mechanisms of therapeutic monoclonal antibodies in health and disease
Study date
2010
Auth party contact address
-
Data no
299113
Title
Monograph for ingredient X - tre
Study date
2017
Auth party contact address
-
Data no
299219
Title
An update on nonsteroidal anti-inflammatory drugs (NSAIDs) in small animals
Study date
2008
Auth party contact address
-
Data no
298984
Title
A prospective, randomized, double-blind, placebo-controlled multisite, parallel-group field study in dogs with osteoarthritis conducted in the United States of America evaluating bedinvetmab, a canine anti-nerve growth factor monoclonal antibody
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298921
Title
Nerve growth factor biodelivery: a limiting step in moving toward extensive clinical application
Study date
2021
Auth party contact address
-
Data no
298933
Title
Correction: Power of treatment success definitions when the Canine Brief Pain Inventory is used to evaluate carprofen treatment for the control of pain and inflammation in dogs with osteoarthritis
Study date
2014
Auth party contact address
-
Data no
298970
Title
Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies
Study date
2010
Auth party contact address
-
Data no
299027
Title
Strategies to determine assay format for the assessment of neutralizing antibody responses to biotherapeutics
Study date
2016
Auth party contact address
-
Data no
299276
Title
C863C-XC-17-176 - Negative-controlled, multicenter field study investigating efficacy and safety of xxx of ZTS-00075623 for the treatment of pain associated with osteoarthritis in client-owned dogs - statistics
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299127
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
299170
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
299176
Title
Rapidly progressive osteoarthritis - a review of the clinical and radiologic presentation
Study date
2017
Auth party contact address
-
Data no
298827
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
299076
Title
eLabel - Lenivia 3 mg solution for injection for dogs
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298878
Title
VICH GL 17 - Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products
Study date
2000
Auth party contact address
-
Data no
298927
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
298953
Title
Guidance for Industry - Immunogenicity assessment for therapeutic protein products
Study date
2014
Auth party contact address
-
Data no
299024
Title
Monoclonal Antibody Pharmacokinetics and Pharmacodynamics
Study date
2008
Auth party contact address
-
Data no
299285
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
298930
Title
Development and psychometric testing of an instrument designed to measure chronic pain in dogs with osteo arthritis
Study date
2007
Auth party contact address
-
Data no
299047
Title
C491W-US-22-178 - Pharmacokinetics of canine monoclonal antibodies ZTS-00103289, ZTS-50000122, ZTS-00075623 and ABT406 in mice
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299262
Title
Lenivia - EU D121 response - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298907
Title
3.2.s.1 General Information
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299070
Title
Application - Lenivia 2 mg solution for injection for dogs
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299239
Title
Cranial cruciate ligament rupture in dogs: review on biomechanics, etiopathogenetic factors and rehabilitation
Study date
2021
Auth party contact address
-
Data no
298884
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
299093
Title
Lenivia Project Plan
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299216
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
298861
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
299116
Title
Pain processing is faster than tactile processing in the human brain
Study date
2006
Auth party contact address
-
Data no
298838
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
299139
Title
APVMA guidelines - Toxicology (Part 3)
Study date
2017
Auth party contact address
-
Data no
299162
Title
Behavior of laboratory beagles towards humans: assessment in an encounter test and a simulation of experimental situations
Study date
2014
Auth party contact address
-
Data no
299233
Title
The female response to seminal fluid
Study date
2020
Auth party contact address
-
Data no
299210
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
299308
Title
C762Z-US-20-323 - Validation of an xxx method for the quantitation of ZTS-00075623 in canine serum
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298947
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
299053
Title
C366R-US-21-397 - A single xxx (xxx) dose subcutaneous injection safety evaluation study of xxx of ZTS-00075623 in Beagle dogs with a 14-day observation period
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299256
Title
Strategies to determine assay format for the assessment of neutralizing antibody responses to biotherapeutics
Study date
2016
Auth party contact address
-
Data no
298993
Title
Equine umbilical cord mesenchymal stem cells demonstrate safety and efficacy in the treatment of canine osteoarthritis - a randomized placebo-controlled trial
Study date
2022
Auth party contact address
-
Data no
299007
Title
Antibody biodistribution coefficients
Study date
2013
Auth party contact address
-
Data no
299302
Title
C461W-US-17-164 - Reagent generation of polyclonal antibodies to anti-NGF monoclonal antibody ZTS-00075623 in dogs
Study date
2017
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299193
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
299199
Title
Clinical applications of NGF in ocular diseases
Study date
2011
Auth party contact address
-
Data no
298901
Title
C863C-XC-17-176 - Negative-controlled, multicenter field study investigating efficacy and safety of xxx of ZTS-00075623 for the treatment of pain associated with osteoarthritis in client-owned dogs
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299245
Title
Genotoxicity assessment of peptide/protein-related biotherapeutics: points to consider before testing
Study date
2016
Auth party contact address
-
Data no
299099
Title
Part 3a5 - User safety
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299036
Title
C461W-US-16-151 - Single dose pharmacokinetics of anti-NGF monoclonal antibody ZTS-00075623 in dogs
Study date
2017
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299202
Title
A canine-specific anti-nerve growth factor antibody alleviates pain and improves mobility and function in dogs with degenerative joint disease-associated pain
Study date
2015
Auth party contact address
-
Data no
299273
Title
C366R-US-21-398 - A two xxx (xxx) dose subcutaneous injection safety evaluation study of ZTS-00075623 in Beagle dogs with a 14-day observation period
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299153
Title
Neurotrophins and their receptors - a convergence point for many signalling pathways
Study date
2003
Auth party contact address
-
Data no
299130
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
299179
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
298867
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
298944
Title
Behavior of laboratory beagles towards humans: assessment in an encounter test and a simulation of experimental situations
Study date
2014
Auth party contact address
-
Data no
299110
Title
US FDA Inactive Ingredients Database - ingredient X - met
Study date
2025
Auth party contact address
-
Data no
298844
Title
module 3.2.P.3.1 - Manufacturer(s)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298961
Title
Perspectives on subcutaneous route of administration as an immunogenicity risk factor for therapeutic proteins
Study date
2017
Auth party contact address
-
Data no
298967
Title
Randomised, double-blind, placebo controlled parallel group study of P54PF for the treatment of dogs with osteoarthritis
Study date
2003
Auth party contact address
-
Data no
299010
Title
Cyclooxygenase isozymes - the biology of prostaglandin synthesis and inhibition
Study date
2004
Auth party contact address
-
Data no
299016
Title
Systems pharmacology of the NGF signalling through p75 and TrkA receptors
Study date
2014
Auth party contact address
-
Data no
298987
Title
2022 WSAVA guidelines for the recognition, assessment and treatment of pain
Study date
2023
Auth party contact address
-
Data no
299159
Title
Recommendations for systematic statistical computation of immunogenicity cut points
Study date
2017
Auth party contact address
-
Data no
299087
Title
GMP Certificate Site B
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299136
Title
Part 4b - Clinical
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299030
Title
Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects
Study date
2010
Auth party contact address
-
Data no
299279
Title
C866C-XC-19-263 - Negative-controlled, multicentre field study investigating efficacy, safety and duration of effect of xxx of ZTS-00075623 for the treatment of pain associated with osteoarthritis in client-owned dogs - statistics
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298887
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
298924
Title
Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensu development at OMERACT III
Study date
1997
Auth party contact address
-
Data no
298981
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
299067
Title
Application - Lenivia 0.5 mg solution for injection for dogs
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299079
Title
Data List 3 - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299265
Title
Lenivia - EU D121 response - appendix 60-1 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298973
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
299073
Title
eLabel - Lenivia 1 mg solution for injection for dogs
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299173
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
299222
Title
Pleiotropic activity of nerve growth factor in regulating cardiac functions and counteracting pathogenesis
Study date
2021
Auth party contact address
-
Data no
299048
Title
C461R-US-22-503 - Pharmacokinetics study of two anti-NGF mAbs and their respective complexes in healthy adult beagle dogs
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299071
Title
Application - Lenivia 3 mg solution for injection for dogs
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298833
Title
module 3.2.P.5.3 - Annex 3 - 1061.057 Method Transfer Doc. No. VM405
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299094
Title
Application - Lenivia Import Permit
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299165
Title
Publication of registration studies for veterinary medicine in peer-reviewed academic journals
Study date
2024
Auth party contact address
-
Data no
298908
Title
C762Z-US-18-206 - Assay Procedure for the Quantitative Determination of ZTS-00075623 in Canine Serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299240
Title
Cutaneous lesions and clinical outcomes in five cats after frunevetmab injections
Study date
2023
Auth party contact address
-
Data no
298885
Title
module 3.2.P.8.3 - Annex 2 - Clinical batch stability report
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299211
Title
NGF and its receptors in the regulation of inflammatory response
Study date
2017
Auth party contact address
-
Data no
299288
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
298862
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
299188
Title
Morphology, histology and functional anatomy of the canine cranial cruciate ligament
Study date
1978
Auth party contact address
-
Data no
298839
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
299257
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
299234
Title
Concentrations in serum of IgG, IgM and IgA and their age-dependence in Beagle Dogs as determined by a newly developed enzyme-linked-immuno-sorbent-assay (ELISA)
Study date
1992
Auth party contact address
-
Data no
299042
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
299303
Title
C762Z-US-20-324 - Validation of an xxx assay for the detection of anti-ZTS-00075623 antibodies in canine serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298948
Title
EMA assessment report - Raylumis
Study date
2021
Auth party contact address
-
Data no
299102
Title
Monograph for ingredient X - pol
Study date
2009
Auth party contact address
-
Data no
299008
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
298956
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
299294
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
298856
Title
module 3.2.P.3.5 - Annex 8 - Supporting Letter for extractables VAL-AS-002790-SR
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299194
Title
Clinical pharmacokinetics of therapeutic monoclonal antibodies
Study date
2010
Auth party contact address
-
Data no
299002
Title
Efficacy and safety of enflicoxib for treatment of canine osteoarthritis: a 6-week randomised, controlled, blind, multicentre clinical trial
Study date
2022
Auth party contact address
-
Data no
299248
Title
Somatosensory evoked potentials of the dog: recording techniques and normal values
Study date
1989
Auth party contact address
-
Data no
298902
Title
C863C-XC-17-176 - Negative-controlled, multicenter field study investigating efficacy and safety of xxx of ZTS-00075623 for the treatment of pain associated with osteoarthritis in client-owned dogs - contributing scientist report - bioanalytical, pharmacokinetics and immunogenicity
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299148
Title
The Transmission of Immunity from mother to young and the Catabolism of Immunoglobulins
Study date
1966
Auth party contact address
-
Data no
299131
Title
Part 3a2 - Pharmacology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299297
Title
C667Z-US-22-520 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibody caninized ZTS-00075623 (ZTS-623) against canine/human/rat/mouse NGFs, canine/human neurotrophins and canine/human/rat FcRns
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299274
Title
C863C-XC-17-176 - Negative-controlled, multicenter field study investigating efficacy and safety of xxx of ZTS-00075623 for the treatment of pain associated with osteoarthritis in client-owned dogs
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298845
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
298919
Title
C762Z-US-20-325 - Validation of an xxx assay for the detection of neutralizing anti-ZTS-00075623 antibodies in canine serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299082
Title
GMP Certificate Site H
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298896
Title
C866C-XC-20-319 - Field study efficacy and safety of ZTS-00075623 administered every three months compared to placebo for the treatment of pain associated with osteoarthritis in client-owned dogs - statistics
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299105
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
299154
Title
Permeability of the endothelial barrier - identifying and reconciling controversies
Study date
2021
Auth party contact address
-
Data no
298962
Title
Validation of a client-based clinical metrology instrument for the evaluation of canine elbow osteoarthritis
Study date
2009
Auth party contact address
-
Data no
298968
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
299039
Title
C667Z-US-22-520 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibody caninized ZTS-00075623 (ZTS-623) against canine/human/rat/mouse NGFs, canine/human neurotrophins and canine/human/rat FcRns
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299205
Title
Antibody Pharmacokinetics and Pharmacodynamics
Study date
2004
Auth party contact address
-
Data no
299011
Title
Cutaneous lesions and clinical outcomes in five cats after frunevetmab injections
Study date
2023
Auth party contact address
-
Data no
299088
Title
GMP Certificate Site C
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298939
Title
Models of osteoarthritis - the good, the bad and the promising
Study date
2019
Auth party contact address
-
Data no
298988
Title
Accumulation of CD4plus CD25plus highCD127low regulatory T cells in osteoarthritis joints - analysis of frequency and phenotype in synovial membrane, synovial fluid and peripheral blood
Study date
2014
Auth party contact address
-
Data no
299062
Title
Chapter 11 - Physiologic IgG biodistribution, transport, and clearance - implications for monoclonal antibody products
Study date
2008
Auth party contact address
-
Data no
299111
Title
US FDA Inactive Ingredients Database - ingredient X - pol
Study date
2025
Auth party contact address
-
Data no
298876
Title
The Product Quality Research Institute (PQRI) leachables and extractables working group initiatives for parenteral and ophthalmic drug product (PODP)
Study date
2013
Auth party contact address
-
Data no
299125
Title
Safety Data Sheet for Lenivia (izenivetmab injection), SDS No. AU 3339 v 01
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299231
Title
Pharmacokinetics of monoclonal antibodies
Study date
2017
Auth party contact address
-
Data no
299268
Title
Lenivia - EU D121 response - statistics query rsc6q027 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299280
Title
C866C-XC-20-319 - Field study efficacy and safety of ZTS-00075623 administered every three months compared to placebo for the treatment of pain associated with osteoarthritis in client-owned dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298982
Title
Spontaneous dog osteoarthritis - a one medicine vision
Study date
2019
Auth party contact address
-
Data no
299019
Title
Guideline on good clinical practices
Study date
2009
Auth party contact address
-
Data no
299031
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
299068
Title
Application - Lenivia 1 mg solution for injection for dogs
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299217
Title
Acetabular bone destruction related to non-steroidal anti-inflammatory drugs
Study date
1985
Auth party contact address
-
Data no
298925
Title
Canine osteoarthritis and treatments: a review
Study date
2015
Auth party contact address
-
Data no
299174
Title
Guidance for Industry - Immunogenicity assessment for therapeutic protein products
Study date
2014
Auth party contact address
-
Data no
298976
Title
A canine-specific anti-nerve growth factor antibody alleviates pain and improves mobility and function in dogs with degenerative joint disease-associated pain
Study date
2015
Auth party contact address
-
Data no
299025
Title
Lymphatic transport and catabolism of therapeutic proteins after subcutaneous administration to rats and dogs
Study date
2012
Auth party contact address
-
Data no
299074
Title
eLabel - Lenivia 1.5 mg solution for injection for dogs
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298882
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
299214
Title
Accumulation of CD4plus CD25plus highCD127low regulatory T cells in osteoarthritis joints - analysis of frequency and phenotype in synovial membrane, synovial fluid and peripheral blood
Study date
2014
Auth party contact address
-
Data no
298905
Title
Part 3a3 - Toxicology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299237
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
298836
Title
module 3.2.P.5.3 - Annex 6 - 1021.055 Method Transfer Doc. No. VM380/VM416
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299168
Title
Guideline on immunogenicity assessment of therapeutic proteins
Study date
2017
Auth party contact address
-
Data no
298859
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
299191
Title
Preclinical safety evaluation of biotechnology-derived pharmaceuticals, S6(R1)
Study date
2011
Auth party contact address
-
Data no
299260
Title
Clinico-radiological diagnosis and grading of rapidly progressive osteoarthritis of the hip
Study date
2017
Auth party contact address
-
Data no
299185
Title
Perspectives on subcutaneous route of administration as an immunogenicity risk factor for therapeutic proteins
Study date
2017
Auth party contact address
-
Data no
298959
Title
2022 AAHA Pain management guidelines for dogs and cats
Study date
2022
Auth party contact address
-
Data no
299208
Title
A blinded, randomized, placebo-controlled, dose determination trial of lokivetmab (ZTS-00103289), a caninized, anti-canine IL-31 monoclonal antibody in client owned dogs with atopic dermatitis
Study date
2016
Auth party contact address
-
Data no
299291
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
298899
Title
C866C-XC-19-263 - Negative-controlled, multicentre field study investigating efficacy, safety and duration of effect of xxx of ZTS-00075623 for the treatment of pain associated with osteoarthritis in client-owned dogs - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299005
Title
The female response to seminal fluid
Study date
2020
Auth party contact address
-
Data no
299091
Title
GMP Certificate Site F
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299254
Title
Re: Re: Laboratory safety evaluation of bedinvetmab, a canine anti-nerve growth factor monoclonal antibody, in dogs
Study date
2024
Auth party contact address
-
Data no
298945
Title
EMA scientific advice - NV-01-Mab osteoarthritis
Study date
2014
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299045
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
299051
Title
C362N-US-19-307 - A safety evaluation of ZTS-00075623 in Beagle dogs
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299300
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
299145
Title
Osteoarthritis, angiogenesis and inflammation
Study date
2005
Auth party contact address
-
Data no
299151
Title
Lack of effectivenss of tramadol hydrochloride for the treatment of pain and joint dysfunction in dogs with chronic osteoarthritis
Study date
2018
Auth party contact address
-
Data no
298999
Title
A randomized clinical efficacy study targeting mPGES1 or EP4 in dogs with spontaneous osteoarthritis
Study date
2019
Auth party contact address
-
Data no
298853
Title
module 3.2.P.3.5 - Annex 5 - Validation report VAL-AM-014231-BR
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299197
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
298965
Title
Preclinical safety evaluation of biotechnology-derived pharmaceuticals, S6(R1)
Study date
2011
Auth party contact address
-
Data no
298893
Title
Part 4C - Conclusions on Efficacy - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298942
Title
Evaluation of polysulfated glycosaminoglycan for the treatment of hip dysplasia in dogs
Study date
1994
Auth party contact address
-
Data no
299059
Title
Note for Guidance - Environmental risk assessment for immunological veterinary medicinal products
Study date
1997
Auth party contact address
-
Data no
299108
Title
US FDA DailyMed Database - product av
Study date
2025
Auth party contact address
-
Data no
299177
Title
Meniscal injury in dogs with cranial cruciate ligament rupture
Study date
2010
Auth party contact address
-
Data no
299251
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
299228
Title
A prospective, randomized, masked, placebo-controlled multisite clinical study of grapiprant, an EP4 prostaglandin receptor antagonist (PRA), in dogs with osteoarthritis
Study date
2016
Auth party contact address
-
Data no
299134
Title
Part 4a1 - Pharmacology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298985
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
298991
Title
Investigation and management of canine osteoarthritis
Study date
2015
Auth party contact address
-
Data no
299157
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
298842
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
298916
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
299085
Title
GMP Certificate Site O
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298865
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
299220
Title
Investigation and management of canine osteoarthritis
Study date
2015
Auth party contact address
-
Data no
298936
Title
Neurotrophins and their receptors - a convergence point for many signalling pathways
Study date
2003
Auth party contact address
-
Data no
299065
Title
Module 1 - Application overview
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299114
Title
Choreographing immunity in the skin epithelial barrier
Study date
2019
Auth party contact address
-
Data no
298922
Title
Rita levi-montalcini - the discovery of nerve growth factor and modern neurobiology
Study date
2004
Auth party contact address
-
Data no
299277
Title
C866C-XC-19-263 - Negative-controlled, multicentre field study investigating efficacy, safety and duration of effect of xxx of ZTS-00075623 for the treatment of pain associated with osteoarthritis in client-owned dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298873
Title
GMP Certificate Sites J, K, L, M, N
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298879
Title
Lenivia - EU D181 responses - Aug 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299122
Title
Transfer of antibody via mother's milk
Study date
2003
Auth party contact address
-
Data no
299128
Title
Module 3 - Health Overview - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298979
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
299022
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
299028
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
298830
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
298928
Title
NGF in early embryogenesis, differentiation, and pathology in the nervous and immune systems
Study date
2015
Auth party contact address
-
Data no
299171
Title
Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs
Study date
2021
Auth party contact address
-
Data no
299271
Title
C362R-US-16-156 - A 3-month exploratory safety study (once every 4 weeks) of ZTS-00075623 by subcutaneous injection in adult Beagle dogs
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298977
Title
Measurement of chronic pain in companion animals: Discussions from the Pain in Animals Workshop (PAW) 2017
Study date
2019
Auth party contact address
-
Data no
299309
Title
C362N-US-19-307 - A safety evaluation of ZTS-00075623 in Beagle dogs
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298954
Title
Guidance for Industry - Nonclinical evaluation of the immunotoxic potential of pharmaceuticals
Study date
2023
Auth party contact address
-
Data no
299286
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
298860
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
298931
Title
Ability of the Canine Brief Pain Inventory to detect response to treatment in dogs with osteoarthritis
Study date
2008
Auth party contact address
-
Data no
299192
Title
Nerve growth factor concentrations in the synovial fluid from health dogs and dogs with secondary osteoarthritis
Study date
2011
Auth party contact address
-
Data no
299263
Title
Lenivia - EU D121 SPC - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299117
Title
Tear volume in normal eyes and keratoconjunctivitis sicca
Study date
1974
Auth party contact address
-
Data no
299140
Title
Nerve growth factor signaling and its contribution to pain
Study date
2020
Auth party contact address
-
Data no
298837
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
299163
Title
Contralateral cranial cruciate ligament rupture: incidence in 114 dogs
Study date
1993
Auth party contact address
-
Data no
299186
Title
Long-term health effects of neutering dogs: comparison of labrador retrievers with golden retrievers
Study date
2014
Auth party contact address
-
Data no
299209
Title
A prospective, randomized, double-blind, placebo controlled multisite, parallel-group field study in dogs with osteoarthritis conducted in the United States of America evaluating bedinvetmab, a canine anti-nerve growth factor monoclonal antibody
Study date
2023
Auth party contact address
-
Data no
298900
Title
C866C-XC-19-263 - Negative-controlled, multicentre field study investigating efficacy, safety and duration of effect of xxx of ZTS-00075623 for the treatment of pain associated with osteoarthritis in client-owned dogs - statistics
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299054
Title
C366R-US-21-398 - A two xxx (xxx) dose subcutaneous injection safety evaluation study of ZTS-00075623 in Beagle dogs with a 14-day observation period
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298960
Title
Mechanisms of drug toxicity and relevance to pharmaceutical development
Study date
2011
Auth party contact address
-
Data no
299255
Title
Estimate of the annual economic impact of treatment of cranial cruciate ligament injury in dogs in the United States
Study date
2005
Auth party contact address
-
Data no
299292
Title
C491W-US-21-145 - Pharmacokinetics of ZTS-00075623 and ABT406 in a canine FcRn/B2M transgenic mouse model
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298994
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
299006
Title
Concentrations in serum of IgG, IgM and IgA and their age-dependence in Beagle Dogs as determined by a newly developed enzyme-linked-immuno-sorbent-assay (ELISA)
Study date
1992
Auth party contact address
-
Data no
299146
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
299152
Title
Anti-nerve growth factor in pain management: current evidence
Study date
2016
Auth party contact address
-
Data no
299046
Title
C491W-US-21-145 - Pharmacokinetics of ZTS-00075623 and ABT406 in a canine FcRn/B2M transgenic mouse model
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299200
Title
Cranial cruciate disease: current status of diagnosis, surgery, and risk for disease
Study date
2003
Auth party contact address
-
Data no
298854
Title
module 3.2.P.3.5 - Annex 6 - Compatibility report VAL-AM-014231-CR
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299100
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
299000
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparision to the WOMAC in total knee replacement
Study date
2003
Auth party contact address
-
Data no
299246
Title
Systems pharmacology of the NGF signalling through p75 and TrkA receptors
Study date
2014
Auth party contact address
-
Data no
298894
Title
C866C-XC-20-319 - Field study efficacy and safety of ZTS-00075623 administered every three months compared to placebo for the treatment of pain associated with osteoarthritis in client-owned dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299060
Title
Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies
Study date
2010
Auth party contact address
-
Data no
298917
Title
C461W-US-17-164 - Reagent generation of polyclonal antibodies to anti-NGF monoclonal antibody ZTS-00075623 in dogs
Study date
2017
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298943
Title
Recommendations for Systemic Statistical Computation of Immunogenicity Cut Points
Study date
2017
Auth party contact address
-
Data no
299180
Title
Patellar luxation in 70 large breed dogs
Study date
2006
Auth party contact address
-
Data no
299129
Title
Module 3.1 - Toxicology Overview - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299203
Title
The T-cell-dependent antibody response assay in nonclinical studies of pharmaceuticals and chemicals: study design, data analysis, interpretation
Study date
2014
Auth party contact address
-
Data no
299252
Title
Monoclonal antibody pharmacokinetics and pharmacodynamics
Study date
2008
Auth party contact address
-
Data no
298986
Title
Beta-NGF and beta-NGF receptor upregulation in blood and synovial fluid in osteoarthritis
Study date
2017
Auth party contact address
-
Data no
299229
Title
Mechanistic determinants of biotherapeutics absoption following SC administration
Study date
2012
Auth party contact address
-
Data no
298868
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
298937
Title
Permeability of the endothelial barrier - identifying and reconciling controversies
Study date
2021
Auth party contact address
-
Data no
299109
Title
US FDA DailyMed Database - product cl
Study date
2025
Auth party contact address
-
Data no
299037
Title
C461W-US-14-083 - Pharmacokinetics of ZTS-00075623, an anti-NGF monoclonal antibody, in dogs
Study date
2014
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299086
Title
GMP Certificate Site A
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299160
Title
Do NSAIDs affect the progression of osteoarthritis?
Study date
2002
Auth party contact address
-
Data no
298888
Title
Module 8 - Efficacy & Safety Overview - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299066
Title
Cover letter - Lenivia registration application
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298923
Title
Nerve growth factor signaling and its contribution to pain
Study date
2020
Auth party contact address
-
Data no
299017
Title
Pharmacokinetics of Nerve Growth Factor (NGF) Following Different Routes of Administration to Adult Rats
Study date
1994
Auth party contact address
-
Data no
299266
Title
Lenivia - EU D121 response - appendix 67-1 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299080
Title
Data List 4 - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298974
Title
Clinical applications of NGF in ocular diseases
Study date
2011
Auth party contact address
-
Data no
298980
Title
Antibody Pharmacokinetics and Pharmacodynamics
Study date
2004
Auth party contact address
-
Data no
299223
Title
Lymphatic transport of proteins after subcutaneous administration
Study date
2000
Auth party contact address
-
Data no
298831
Title
module 3.2.P.5.3 - Annex 1 - Endotoxin Test Validation Doc. No. VM408
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298874
Title
GMP Certificate Site O
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298880
Title
Lenivia - commitment letter
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299023
Title
Evaluation of construct and criterion validity for te'Liverpool Osteoarthritis in Dogs" (LOAD) clinical metrology instrument and comparison to two other instruments
Study date
2013
Auth party contact address
-
Data no
299272
Title
C366R-US-21-397 - A single xxx (xxx) dose subcutaneous injection safety evaluation study of xxx of ZTS-00075623 in Beagle dogs with a 14-day observation period
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299123
Title
WHO food additives series 46 - Ingredient X
Study date
2001
Auth party contact address
-
Data no
299172
Title
EMA assessment report - Raylumis
Study date
2021
Auth party contact address
-
Data no
299143
Title
Canine osteoarthritis and treatments: a review
Study date
2015
Auth party contact address
-
Data no
299120
Title
Monograph for ingredient X - lme
Study date
2009
Auth party contact address
-
Data no
298857
Title
module 3.2.P.3.5 - Annex 9 - Leachable report VAL-AM-014231-LR
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299189
Title
Association of rapidly destructive osteoarthritis of the hip with intra-articular steroid injections
Study date
2018
Auth party contact address
-
Data no
298834
Title
module 3.2.P.5.3 - Annex 4 - 1061.054 Method Transfer Doc. No. VM377
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299166
Title
ICH S8 - Immunotoxicity studies for human pharmaceuticals
Study date
2006
Auth party contact address
-
Data no
299235
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
299306
Title
C461W-US-14-083 - Pharmacokinetics of ZTS-00075623, an anti-NGF monoclonal antibody, in dogs
Study date
2014
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299212
Title
Beta-NGF and beta-NGF receptor upregulation in blood and synovial fluid in osteoarthritis
Study date
2017
Auth party contact address
-
Data no
298840
Title
module 3.2.P.5.4 - Annex 1 - Registration Batch Certificates of Analysis
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299283
Title
C866C-XC-20-319 - Field study efficacy and safety of ZTS-00075623 administered every three months compared to placebo for the treatment of pain associated with osteoarthritis in client-owned dogs - statistics queries
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299137
Title
Nerve growth factor biodelivery: a limiting step in moving toward extensive clinical application
Study date
2021
Auth party contact address
-
Data no
299149
Title
Tanezumab does not cause sympathetic nervous system dysfunction in clinical osteoarthritis studies (P3.303)
Study date
2015
Auth party contact address
-
Data no
298911
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
299089
Title
GMP Certificate Site D
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299243
Title
Biodistribution mechanisms of therapeutic monoclonal antibodies in health and disease
Study date
2010
Auth party contact address
-
Data no
299103
Title
Subcutaneous bioavailability of therapeutic antibodies as a function of FcRn binding affinity in mice
Study date
2012
Auth party contact address
-
Data no
298957
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
299043
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
299289
Title
C461R-US-22-503 - Pharmacokinetics study of two anti-NGF mAbs and their respective complexes in healthy adult beagle dogs
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298897
Title
C866C-XC-20-319 - Field study efficacy and safety of ZTS-00075623 administered every three months compared to placebo for the treatment of pain associated with osteoarthritis in client-owned dogs - statistics queries
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298997
Title
Mechanistic determinants of biotherapeutics absoption following SC administration
Study date
2012
Auth party contact address
-
Data no
299003
Title
Enflicoxib for canine osteoarthritis: A randomized, blind, multicentre, non-inferiority clinical trial compared to mavacoxib
Study date
2022
Auth party contact address
-
Data no
298851
Title
module 3.2.P.3.5 - Annex 3 - Adsorption report VAL-AM-014230-AR
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299097
Title
Module 4a - Metabolism & Kinetics Overview - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298951
Title
Guideline on immunogenicity assessment of therapeutic proteins
Study date
2017
Auth party contact address
-
Data no
299295
Title
C667Z-US-20-377 - Anti-NGF mAb inhibition 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
299226
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
299083
Title
GMP Certificate Site I
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299249
Title
VICH GL 43 - Target Animal Safety for Veterinary Pharmaceutical Products
Study date
2008
Auth party contact address
-
Data no
299298
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
298848
Title
module 3.2.P.3.5 - Process Validation and/or Evaluation
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299106
Title
US FDA Inactive Ingredients Database - ingredient X - his
Study date
2025
Auth party contact address
-
Data no
299275
Title
C863C-XC-17-176 - Negative-controlled, multicenter field study investigating efficacy and safety of xxx of ZTS-00075623 for the treatment of pain associated with osteoarthritis in client-owned dogs - contributing scientist report - bioanalytical, pharmacokinetics and immunogenicity
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298871
Title
Pharmacopoeial Test Methods - Drug Product
Study date
2021
Auth party contact address
-
Data no
298920
Title
module 3.2.P.5.4 - Annex 2 - Clinical Batch Certificates of Analysis
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298891
Title
Part 4A3 Pre-Clinical Trials - Dose Determination - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299057
Title
Part 3a6 - Environmental Risk Assessment
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299063
Title
VICH GL 6 - Guideline on environmental impact assessment (EIAS) for veterinary medicinal products - Phase 1
Study date
2000
Auth party contact address
-
Data no
299034
Title
Part 3a2 - Pharmacology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299040
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
299206
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
298940
Title
A prospective, randomized, blinded, placebo-controlled multisite clinical study of bedinvetmab, a conine monoclonal antibody targeting nerve growth factor, in dogs with osteoarthritis
Study date
2021
Auth party contact address
-
Data no
299014
Title
Disentangling the signaling complexity of nerve growth factor receptors by CRISPR/Cas9
Study date
2022
Auth party contact address
-
Data no
299183
Title
2022 AAHA Pain management guidelines for dogs and cats
Study date
2022
Auth party contact address
-
Data no
298914
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
298963
Title
Psychometric testing of the Helsinki chronic pain index by completion of a questionnaire in Finnish by owners of dogs with chronic signs of pain caused by osteoarthritis
Study date
2009
Auth party contact address
-
Data no
298971
Title
Serum nerve growth factor in horses with osteoarthritis-associated lameness
Study date
2023
Auth party contact address
-
Data no
298983
Title
A blinded, randomized, placebo-controlled, dose determination trial of lokivetmab (ZTS-00103289), a caninized, anti-canine IL-31 monoclonal antibody in client owned dogs with atopic dermatitis
Study date
2016
Auth party contact address
-
Data no
299232
Title
Evaluation of genotoxicity testing of FDA approved large molecule therapeutics
Study date
2014
Auth party contact address
-
Data no
299077
Title
Data List 1 - Lenivia
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299126
Title
C762Z-US-20-368 - Construction and validation of a mechanistic pharmacokinetic (PK) model for projections of in vivo ZTS-623 concentrations in human upon accidental exposure
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298934
Title
Lack of effectivenss of tramadol hydrochloride for the treatment of pain and joint dysfunction in dogs with chronic osteoarthritis
Study date
2018
Auth party contact address
-
Data no
299020
Title
Guidance for Industry Target Animal Safety for Veterinary Pharmaceutical Products
Study date
2009
Auth party contact address
-
Data no
299069
Title
Application - Lenivia 1.5 mg solution for injection for dogs
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
299169
Title
Questions and answers on monoclonal antibodies for veterinary use
Study date
2017
Auth party contact address
-
Data no
299026
Title
Linguistic validation of the Canine Brief Pain Inventroy (CBPI) for global use
Study date
2021
Auth party contact address
-
Data no
299269
Title
Lenivia - EU D121 response - statistics query rsc6q030 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298828
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
298877
Title
VICH GL 3 - Stability: Stability Testing of New Veterinary Drug Substances (Revision)
Study date
2007
Auth party contact address
-
Date
Application Date
Application No
Application Number
151406
Product/Active constituent Name
Application Product Name
Ant & Roach Dusting Powder
Application Date
Application Number
151406
Application Product Name
Ant & Roach Dusting Powder
Application details
Product name:
Ant & Roach Dusting Powder
Product number:
96980
Applicant Name:
Lifeguard Sciences (Pty) Ltd
Application purpose and description of use:
The following data summary has been compiled in support of the application for the registration of Ant & Roach Dusting Powder, a formulated insecticidal product containing Permethrin (5 g/kg) and Piperonyl Butoxide (40 g/kg) as active constituents. This product is intended for the control of fleas, cockroaches, and ants and is designed for application in agricultural, industrial, commercial, and residential settings.
Reference details:
66574 - BIN BUDDY BERRY INSECTICIDE
Active constituents:
Active constituent name
56092 - PIPERONYL BUTOXIDE
Active constituent name
89258 - Permethrin
Description of data provided:
Data no
300226
Title
Safety Data Sheet_ Ant and Roach Dusting Powder
Study date
12 November 2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300223
Title
Formulator and Formulation Plant Details
Study date
2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300217
Title
Safety Data Sheet_Aerisol 200 (Silicon dioxide)
Study date
14 March 2022
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300220
Title
Efficacy trial report
Study date
24 February 2005
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300214
Title
Manufacturer's site declaration
Study date
10 October 2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300221
Title
Trial efficacy summary
Study date
05 November 2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300215
Title
Safety Data Sheet_Permethrin
Study date
01 September 2021
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300212
Title
Raw Data
Study date
29 October 2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300224
Title
Analytical Methods & Validation Data
Study date
2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300218
Title
Safety Data Sheet_Sericil and Sericil GS
Study date
March 2015
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300213
Title
Piperonyl Butoxide - Declaration of manufacturing and supply
Study date
18 September 2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300219
Title
Certificate of Analysis_Ant & Roach Dusting Powder
Study date
24 April 2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300227
Title
Packaging Specs for 100g
Study date
2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300216
Title
Safety Data Sheet_Piperonyl Butoxide
Study date
02 February 2022
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300211
Title
anon
Study date
29 October 2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300228
Title
Formulation Process and Quality Control
Study date
2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300225
Title
Globally Harmonised System Classification Rational
Study date
12 November 2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
300222
Title
anon
Study date
2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Date
Application Date
Application No
Application Number
151706
Product/Active constituent Name
Application Product Name
RIFAWAY Fire Ant Bait HG
Application Date
Application Number
151706
Application Product Name
RIFAWAY Fire Ant Bait HG
Application details
Product name:
RIFAWAY Fire Ant Bait HG
Product number:
97077
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 0.5 g/kg indoxacarb (Ready-to-use-bait) product for the control of Fire Ants around buildings,
gardens, grazing areas, lawns and public areas.
Reference details:
66532 - ADVION FIRE ANT BAIT
94840 - Rifaway Fire Ant Bait
Active constituents:
Active constituent name
66198 - INDOXACARB
Active constituent name
51669 - INDOXACARB AND ITS R-ENANTIOMER (DPX-MP062) MANUFACTURING CONCENTRATE
Description of data provided:
Data no
301022
Title
Technical Argument ??? Control of red imported fire ant - Home Garden use
Study date
23 Jan 2026
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301023
Title
Advion Fire Ant Bait Permit
Study date
15 Mar 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
152206
Product/Active constituent Name
Application Product Name
Rifaway Fire Ant Bait
Application Date
Application Number
152206
Application Product Name
Rifaway Fire Ant Bait
Application details
Product name:
Rifaway Fire Ant Bait
Product number:
94840
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration to register an alternative formulation of RIFAWAY Fire Ant Bait (A20380A)
Active constituents:
Active constituent name
51669 - INDOXACARB AND ITS R-ENANTIOMER (DPX-MP062) MANUFACTURING CONCENTRATE
Description of data provided:
Data no
301640
Title
Validation of Analytical Method SF-1031/1
Study date
15 October 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301634
Title
EXPLOSIVE PROPERTIES
Study date
30 August 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301637
Title
Accelerated storage stability, 2 weeks at 54-C
Study date
23 October 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301631
Title
Part 2 - Chemistry and Manufacture
Study date
24 February 2026
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301638
Title
Accelerated storage stability, 2 weeks at 54-C - Amendment
Study date
27 November 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301632
Title
SELF-IGNITION BEHAVIOUR FOR SOLIDS
Study date
20 August 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301635
Title
FLAMMABILITY N.1
Study date
11 June 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301633
Title
Bulk density and flowability
Study date
08 April 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
302145
Title
Certificate of Analysis
Study date
16 June 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301641
Title
Safety Data Sheets
Study date
24 February 2026
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301636
Title
OXIDISING PROPERTIES OF SOLIDS 0.1
Study date
11 June 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301639
Title
Determination of NOA445432 in A20380A by HPLC - Analytical Method SF 1031/1
Study date
23 August 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
152198
Product/Active constituent Name
Application Product Name
ADVION FIRE ANT BAIT
Application Date
Application Number
152198
Application Product Name
ADVION FIRE ANT BAIT
Application details
Product name:
ADVION FIRE ANT BAIT
Product number:
66532
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration to replace the formulation of ADVION Fire Ant Bait.
Active constituents:
Active constituent name
66198 - INDOXACARB
Description of data provided:
Data no
301614
Title
Safety Data Sheets
Study date
23 February 2026
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301611
Title
A20380A - Accelerated Storage stability, 2 weeks at 540C in Packaging made of HDPE - Amendment-1
Study date
27 November 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301606
Title
A20380A - EXPLOSIVE PROPERTIES
Study date
30 August 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301612
Title
NOA445432 RB (0.045) - Determination of NOA445432 in A20380A by HPLC - Analytical Method SF 1031/1
Study date
23 August 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301609
Title
Certificate of Analysis - A20380A - ADVION FIRE ANT BAIT RB (0.043%)
Study date
14 January 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301603
Title
Part 2 - Chemistry and Manufacture
Study date
23 February 2026
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301610
Title
A20380A - Accelerated Storage stability, 2 weeks at 540C in Packaging made of HDPE
Study date
23 October 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301604
Title
A20380A - SELF-IGNITION BEHAVIOUR SOLIDS
Study date
20 August 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301613
Title
A20380A - Validation of Analytical Method
Study date
15 October 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301607
Title
A20380A - FLAMMABILITY N.1
Study date
11 June 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301608
Title
A20380A - OXIDATION PROPERTIES OF SOLIDS O.1
Study date
11 June 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301605
Title
A20380A - Bulk density and Flowability
Study date
08 April 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
302123
Title
Certificate of Analysis
Study date
16 June 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
151963
Product/Active constituent Name
Application Product Name
Headway Amoxiclav 500 mg Tablets
Application Date
Application Number
151963
Application Product Name
Headway Amoxiclav 500 mg Tablets
Application details
Product name:
Headway Amoxiclav 500 mg Tablets
Applicant Name:
HEADWAY INVESTMENTS PTY LTD
Application purpose and description of use:
Registration of a Amoxiclav 500 mg Tablet product for use in Calves and dogs for bacterial infections.
Date
Application Date
Application No
Application Number
151413
Product/Active constituent Name
Application Product Name
APPEAR II Turf Fungicide
Application Date
Application Number
151413
Application Product Name
APPEAR II Turf Fungicide
Application details
Product name:
APPEAR II Turf Fungicide
Product number:
96981
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 335 g/L phosphorous acid present as the mono-di-potassium phosphite in a soluble liquid formulation product for the prevention and control of diseases caused by Pythium spp. in turf.
Reference details:
87962 - Kenso Agcare Ken-Fos 600 Systemic Fungicide
48147 - M-DKP FOLI-R-FOS 400 FUNGICIDE
54430 - AGRI-FOS 600 SYSTEMIC FUNGICIDE
Description of data provided:
Data no
300257
Title
Appear Xtra: Storage Stability Study
Study date
2 May 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300240
Title
Appear II -Part 8 ??? Efficacy and Crop Safety
Study date
9 Dec 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300280
Title
STAMINA: ACUTE TOXICITY TO THE APHID PARASITOID, APHIDIUS RHOPALOSIPHI (HYMENOPTERA, BRACONIDAE) DE STEFANI- PEREZ IN THE LABORATORY
Study date
2001
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300246
Title
Equivalency of Two Fungicide formulations for Pythium Control and Colour
Study date
16 Nov 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300266
Title
Potassium phosphite: Reverse Mutation Assay "Ames Test" Using Salmonella Typhimurium and Escherichia Coli
Study date
18 Oct 1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300260
Title
Vital Green 3: Acute Oral Toxicity Up and Down Procedure in Rats
Study date
11 Oct 2010
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300237
Title
Conclusion on the peer review of the pesticide risk assessment of the active substance potassium phosphonates
Study date
12 June 2013
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300277
Title
POTASSIUM PHOSPHONATES TK: A STUDY ON THE TOXICITY TO FRESHWATER GREEN ALGAE (RAPHIDOCELIS SUBCAPITATA)
Study date
2022
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300269
Title
POTASSIUM PHOSPHITE: AN ACUTE ORAL TOXICITY STUDY WITH THE NORTHERN BOBWHITE
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300243
Title
Demonstrate the efficacy of Appear fungicide to prevent various forms of Pythium spp. in turf and compare to the industry standard phosphonate fungicides.
Study date
28 Aug 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300263
Title
Potassium phosphite: Acute Dermal Irritation Test in the Rabbit
Study date
4 Mar 1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300249
Title
Efficacy of two fungicide formulations for Pythium spp. control and colour.
Study date
5 July 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300238
Title
Ecological Risk Assessment in support of the registration of Vita Green XTRA (EPA 42519-GO) containing 49.41% mono and di potassium salts of phosphorus acid as its active ingredient
Study date
22 Feb 2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300278
Title
POTASSIUM PHOSPHITE: AN ACUTE ORAL TOXICITY STUDY WITH THE HONEY BEE
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300244
Title
Demonstrate the efficacy of Appear fungicide to prevent various forms of Pythium spp. in turf and compare to the industry standard phosphonate fungicides.
Study date
28 Aug 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300252
Title
Manufacturing procedure for Vital Green Xtra
Study date
Jul 2025
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300264
Title
Vital Green 3: Primary Eye Irritation Study in Rabbits
Study date
11 Oct 2010
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300281
Title
ACUTE TOXICITY OF POTASSIUM PHOSPHITE(LBG-01F34) ON EARTHWORMS, EISENIA FETIDA USING AN ARTIFICIAL SOIL TEST
Study date
2006
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300258
Title
Declaration concerning physical chemistry properties of safety items
Study date
2 May 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300235
Title
Final Human Health Risk Assessment in support of the registration of Vita Green XTRA (EPA 42519-GO) containing 49.41% mono and di potassium salts of phosphorus acid (potassium phosphite) as its active ingredient (A.I.)
Study date
1 Mar 2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300275
Title
POTASSIUM PHOSPHITE: A TOXICITY TEST TO DETERMINE THE EFFECTS OF THE TEST SUBSTANCE ON VEGETATIVE VIGOR OF SIX SPECIES OF PLANTS
Study date
2008
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300241
Title
Demonstrate the efficacy of Appear fungicide to prevent various forms of Pythium spp. in turf and compare to the industry standard phosphonate fungicides.
Study date
25 Aug 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300261
Title
POTASSIUM PHOSPHITE: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT
Study date
4 Mar 1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300255
Title
Potassium phosphite technical specifications
Study date
Jul 2025
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300259
Title
Appear II - Part 3 ??? Toxicology
Study date
Dec 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300236
Title
Science Review in Support of the Registration of Potassium Phosphite Technical (EPA File 42519-GA), Containing 99% Mono- & di- Potassium Salts of Phosphorous. Review Product Chemistry, Acute Toxicity, and Non-Target Organisms Studies.
Study date
7 Oct 2011
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300276
Title
TESTING OF TOXIC EFFECTS OF STAMINA ON THE SINGLE CELL GREEN ALGA DESMODESMUS SUBSPICATUS
Study date
2001
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300270
Title
POTASSIUM PHOSPHITE: A DIETARY LC50 STUDY WITH THE NORTHERN BOBWHITE
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300250
Title
Evaluate the efficacy of A14658D on Pythium in CEU and SEU - PT (GEP)
Study date
08 March 2017
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300256
Title
Potassium phosphite specifications CoA
Study date
Jul 2025
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300239
Title
Ecological Toxicity Review for Potassium Salts of Phosphorus Acid
Study date
28 March 1997
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300273
Title
POTASSIUM PHOSPHITE: A 48-HOUR FLOWTHROUGH ACUTE TOXICITY TEST WITH THE CALDOCERAN (DAPHINA MAGNA)
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300279
Title
POTASSIUM PHOSPHITE: AN ACUTE CONTACT TOXICITY STUDY WITH THE HONEY BEE
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300247
Title
Equivalency of Two Fungicide formulations for Pythium Control and Colour
Study date
16 Nov 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300267
Title
Appear II - Part 6 ??? Occupational Health and Safety
Study date
16 Dec 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300253
Title
Vital Green Xtra - formulation composition
Study date
Jul 2025
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300234
Title
Vital Green Extra: Acute Toxicology Summary
Study date
2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300282
Title
EFFECTS OF POTASSIUM PHOSPHONATES TK ON THE REPRODUCTION OF THE EARTHWORM EISENIA ANDREI IN ARTIFICIAL SOIL
Study date
2022
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300274
Title
ASSESSMENT OF TOXIC EFFECTS OF POTASSIUM PHOSPHITE ON DAPHNIA MAGNA USING THE 21 DAY REPRODUCTION TEST
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300248
Title
Equivalency of Two Fungicide formulations for Pythium Control and Colour
Study date
2 Dec 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300268
Title
Appear II - Part 7.2 ????????Environmental Toxicology
Study date
Dec 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300242
Title
Demonstrate the efficacy of Appear fungicide to prevent various forms of Pythium spp. in turf and compare to the industry standard phosphonate fungicides.
Study date
24 Aug 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300262
Title
Potassium phosphite: Acute Inhalation Toxicity (Nose Only) Study in the Rat
Study date
3 Nov1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300254
Title
List of SDS
Study date
Jul 2025
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300245
Title
Demonstrate the crop safety on a variety of warm and cool season turf with Appear fungicide.
Study date
27 Aug 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
300271
Title
POTASSIUM PHOSPHITE: A DIETARY LC50 STUDY WITH THE MALLARD
Study date
1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300265
Title
Potassium phosphite: Magnusson & Kligman Maximization Study in the Guinea Pig
Study date
4 Mar 1999
Auth party contact address
Address: 27 Hamered St., Tel Aviv 6812509, Israel. Contact: Ora David (Regulatory Affairs Manager). Email: Ora@luxembourg.co.il
Data no
300251
Title
Appear II - Part 2 Chemistry and Manufacture
Study date
Dec 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
151690
Product/Active constituent Name
Application Product Name
Titan Titanium Herbicide
Application Date
Application Number
151690
Application Product Name
Titan Titanium Herbicide
Application details
Product name:
Titan Titanium Herbicide
Product number:
92218
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of label approval to add a new use for the control of a range of weeds with over-the-top application into XtendFlex cotton.
Reference details:
81975 - ROUNDUP READY PL HERBICIDE
81975 - Roundup Ready PL Herbicide With Plantshield Technology
Active constituents:
Active constituent name
62532 - GLYPHOSATE
Description of data provided:
Data no
300695
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
7.1.2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300701
Title
Trial ??? Titan Titanium Bioequivalence in XtendFlex Cotton
Study date
April 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300698
Title
Titan Titanium Herbicide Efficacy and Crop Safety Module 8.2
Study date
23.1.2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300693
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
16.9.2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300699
Title
Bioequivalence of Titan Titanium 570 with Roundup Ready PL with Plantshield for Weed Control and Crop Safety in XtendFlex Cotton
Study date
28.9.2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300696
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
3.12.2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300702
Title
Titan Titanium Herbicide draft label
Study date
January 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300697
Title
Titan Titanium Herbicide draft label
Study date
January 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300694
Title
To Determine the Residues of Glyphosate in XtendFlex
Study date
13.9.2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300692
Title
Titan Titanium Herbicide Residues Module 5.4
Study date
23.1.2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300700
Title
Bioequivalence of Titan Titanium 570 with Roundup Ready PL with Plantshield for Crop Safety in XtendFlex Cotton.
Study date
14.10.2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
151868
Product/Active constituent Name
Application Product Name
Genfarm Pyrox 850 WG Herbicide
Application Date
Application Number
151868
Application Product Name
Genfarm Pyrox 850 WG Herbicide
Application details
Product name:
Genfarm Pyrox 850 WG Herbicide
Product number:
91310
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Variation of product registration to adda 850 g/kg pyroxasulfone WG formulation for the pre-emergence control of annual ryegrass, barley grass, annual phalaris, silver grass and toad rush and suppression of certain grass weeds in wheat (not durum wheat), triticale and certain winter legume crops.
Reference details:
91741 - WINGER 850 WG HERBICIDE
Active constituents:
Active constituent name
90545 - Pyroxasulfone
Active constituent name
64067 - PYROXASULFONE
Active constituent name
80051 - Pyroxasulfone
Active constituent name
80847 - Pyroxasulfone
Description of data provided:
Data no
301481
Title
Supporting documentation
Study date
Feb-2026
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
301482
Title
CCI access
Study date
Feb-2026
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
150306
Product/Active constituent Name
Application Product Name
Sedator Injection
Application Date
Application Number
150306
Application Product Name
Sedator Injection
Application details
Product name:
Sedator Injection
Product number:
82623
Applicant Name:
RANDLAB AUSTRALIA PTY LTD
Application purpose and description of use:
Item 12 Appplication for the inclusion of overseas manufacturer in addition to the currently approved manufacturers in Australia.
Active constituents:
Active constituent name
83583 - Detomidine Hydrochloride
Active constituent name
83583 - Detomidine Hydrochloride
Description of data provided:
Data no
292126
Title
Certificate of GMP Manufacturer
Study date
17/02/2025
Auth party contact address
71 Milperra Road Revesby Australia
Data no
292127
Title
Finished Product Specification
Study date
03/11/2020
Auth party contact address
71 Milperra Road Revesby Australia