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
151081
Product/Active constituent Name
Application Product Name
Yosky Glufosinate-P 200 SL Herbicide
Application Date
Application Number
151081
Application Product Name
Yosky Glufosinate-P 200 SL Herbicide
Application details
Product name:
Yosky Glufosinate-P 200 SL Herbicide
Product number:
96884
Applicant Name:
YONGNONG BIOSCIENCES CO., LTD
Application purpose and description of use:
This application is for the approval of a new active constituent, a new manufacturing concentrate, and a new agricultural product, containing a new active constituent Glufosinate-P-ammonium.
Description of data provided:
Data no
295941
Title
Study of Acute Oral Toxicity in Rats (Rattus norvegicus) with the Test Item Glufosinate-P 200 g/L SL
Study date
19/Oct/2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296012
Title
DETERMINATION OF MELTING POINT OF GLUFOSINATE-P AMMONIUM TC
Study date
09 November 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295918
Title
Determination of Explodability of Glufosinate-P 200 g/L SL
Study date
09/May/2022
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296035
Title
GROWTH INHIBITION TEST OF GLUFOSINATE-P AMMONIUM TC ON duckweed, Lemna gibba
Study date
17 July 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296058
Title
[14C] Glufosinate-P, Ammonium Salt: Assessment Of Ready Biodegradability By Co2 Evolution (Modified Sturm) Test
Study date
02/09/2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296081
Title
EVALUATION STUDY OF THE BIOLOGICAL EFFECTIVENESS OF THE HERBICIDE YOSTAR PRO (glufosinate-P) FOR THE CONTROL OF BROAD AND NARROW LEAF WEEDS IN AVOCADO CROP (Persea americana)
Study date
SEPTEMBER 05, 2022
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296064
Title
Toxicity of Glufosinate-P 200 g/L SL to alga Pseudokirchneriella subcapitata
Study date
November 06, 2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296087
Title
AGRONOMIC EFFICACY REPORT OF THE HERBICIDE Glufosinate-P 200 SL YONON FOR WEED CONTROL IN PRE-PLANTING DESICCATION OF SOYBEAN
Study date
2022
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295912
Title
Physical State, Appearance, Color, and Odor of Glufosinate-P 200 g/L SL
Study date
13/Nov/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296041
Title
CHRONIC ORAL TOXICITY STUDY OF GLUFOSINATE-P AMMONIUM TC ON HONEYBEE Apis mellifera
Study date
13 August 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295958
Title
Glufosinate-P. US EPA Human Health Risk Assessment for New Active Ingredient Isomer.
Study date
17 Apr 2024
Auth party contact address
-
Data no
295995
Title
Magnitude of the residue Glufosinate-P ammonium and of the metabolites Glufosinate-N-Acetyl and 3-MPPA in soybean seeds after application of product Glufosinate-p 200g/L SL
Study date
Mar 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295949
Title
In vitro Dermal Irritation study with Test Item Glufosinate-P 200 g/L SL in Reconstructed Human Epidermis (SkinEthicTM RHE)
Study date
16/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296004
Title
Glufosinate-P 200 g/L SL on Soil Microorganisms: Nitrogen Transformation Test_amendmend 2
Study date
26/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296052
Title
TERRESTRIAL PLANT TEST: SEEDLING EMERGENCE AND SEEDLING GROWTH TEST OF GLUFOSINATE-P 280 g/L SL ON PLANTS
Study date
21 February 2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296024
Title
Volatility results
Study date
17/01/2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296018
Title
DETERMINATION OF FLAMMABILITY OF GLUFOSINATE-P AMMONIUM TC
Study date
02 January 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295969
Title
Oral toxicity test of 3-methyl-phosphinico-propionic acid in rats
Study date
2024-02-20
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295981
Title
Transgenic plants containing the phosphinothricin-N-acetyltransferase gene metabolize the herbicide L-phosphinothricin (glufosinate) differently from untransformed plants
Study date
1991
Auth party contact address
-
Data no
296067
Title
TECHNICAL REPORT OF EFFICACY AND AGRONOMIC PRACTICABILITY_Soybean
Study date
Feb 2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296032
Title
ACUTE TOXICITY STUDY OF GLUFOSINATE-P AMMONIUM TC ON FISH, Oncorhynchus mykiss (RAINBOW TROUT)
Study date
27 May 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295932
Title
Determination the recovery of Glufosinate-P 200g/L SL
Study date
26 August 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295975
Title
Bacterial Reverse Mutation test of 2-(hydroxy(methyl)phosphoryl)acetic acid
Study date
2024-02-21
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296075
Title
Distribution and metabolism of D/L-, L- and D-glufosinate in transgenic, glufosinate- tolerant crops of maize (Zea mays L ssp mays) and oilseed rape (Brassica napus L var napus)
Study date
2004
Auth party contact address
-
Data no
296084
Title
EFFICACY AND AGRONOMIC FEASIBILITY_Itaara/RS 2_Soybean pre-planting
Study date
August 13, 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295938
Title
REPRODUCTION / DEVELOPMENTAL TOXICITY SCREENING TEST ???????? REVIEW OF STUDY OUTCOME
Study date
21 Aug 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296015
Title
DETERMINATION OF PARTITION COEFFICIENT OF GLUFOSINATE-P AMMONIUM TC
Study date
11 November 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295961
Title
Toxicokinetics Test of Glufosinate-p 90% TC
Study date
2024-03-03
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295992
Title
Enantioselective degradation and chiral stability of glufosinate in soil and water samples and the formation of 3-methylphosphinicopropionic acid and N-acety Glufosinate-P ammonium metabolites
Study date
Sep 2019
Auth party contact address
-
Data no
296061
Title
US EPA Draft Environmental assessment on Glufosinate-P and Glufosinate-P Ammonium
Study date
2025
Auth party contact address
-
Data no
295915
Title
Viscosity of Glufosinate-P 200 g/L SL
Study date
13/Nov/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296038
Title
Study of Acute Oral Toxicity in Rats (Rattus norvegicus) with the Test Item Glufosinate-P 200 g/L SL,
Study date
October 19, 2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296055
Title
Acute toxicity of Glufosinate-P ammonium TC to the earthworm Eisenia andrei
Study date
19/Jun/2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296044
Title
GLUFOSINATE-p AMMONIUM TC: A 96-HOUR STATIC ACUTE TOXICITY TEST WITH THE SALTWATER MYSID (Americamysis bahia)
Study date
February 19, 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295955
Title
90% Glufosinate-p technical acute neurotoxicity in rats
Study date
2024-02-25
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295998
Title
Conclusion regarding the peer review of the pesticide risk assessment of the active substance glufosinate
Study date
2005
Auth party contact address
-
Data no
295952
Title
Evaluation of the mutagenic potential of the test item Glufosinate-P 200 g/L SL by reverse mutation assay in Salmonella enterica serovar Typhimurium (Ames Test)
Study date
28/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296001
Title
Acute contact toxicity of Glufosinate-P 200 g/L SL to honeybee Apis mellifera (africanized)
Study date
19/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295929
Title
Amendment number three: Stability Report ??? Formulated Product
Study date
05/Feb/2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295935
Title
Assessment of GLUTAMINE SYNTHETASE INHIBITION STUDY
Study date
4 Oct 2022
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296078
Title
EFFICACY AND AGRONOMIC FEASIBILITY_Formosa 1_Soybean pre-planting
Study date
August 20, 2024.
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295972
Title
3-methyl-phosphinico-propionic acid in vitro mammalian cell gene mutation test
Study date
2024-01-28
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295984
Title
AEROBIC TRANSFORMATION OF [14C] GLUFOSINATE-P AMMONIUM IN FOUR SOILS
Study date
15/11/2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295921
Title
Persistent Foaming of Glufosinate-P 200 g/L SL
Study date
20/May/2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296021
Title
HYDROLYSIS OF GLUFOSINATE-P AMMONIUM TC IN STERILE AQUEOUS BUFFER SOLUTIONS OF pH 4, 7 AND 9
Study date
06 February 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295978
Title
Comparison chromatography on glufosinate ammonium racemic and chromatography on Glufosinate-P ammonium alone
Study date
2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296033
Title
ACUTE IMMOBILISATION TEST OF GLUFOSINATE-P AMMONIUM TC ON Daphnia magna
Study date
12 August 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296039
Title
ACUTE ORAL TOXICITY STUDY OF GLUFOSINATE-P AMMONIUM TC ON HONEYBEES, Apis mellifera
Study date
29 December 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296010
Title
DETERMINATION OF PHYSICAL STATE, COLOR AND ODOR OF GLUFOSINATE-P AMMONIUM TC
Study date
02 January 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296016
Title
PAA Written response
Study date
2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295916
Title
Determination of the Surface Tension in Water of Glufosinate-P 200 g/L SL
Study date
13/Nov/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295987
Title
US EPA work plan
Study date
June 2023
Auth party contact address
-
Data no
295964
Title
ACUTE ORAL TOXICITY STUDY OF Glufosinate-N-acetyl IN SPRAGUE DAWLEY RATS
Study date
2024-02-20
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296062
Title
EU Draft Environmental Assessment Report
Study date
2025
Auth party contact address
-
Data no
295947
Title
Acute Eye Irritation/Corrosion in Rabbits (Oryctolagus cuniculus) with the Test Item Glufosinate-P 200 g/L SL
Study date
22/Nov/2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295910
Title
Executive summary
Study date
2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295993
Title
New Zealand ACVM Deviation Request
Study date
30 October 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296056
Title
[3,4-14C] GLUFOSINATE-P AMMONIUM SALT: BATCH EQUILIBRIUM (ADSORPTION / DESORPTION) IN FOUR SOILS
Study date
15/11/2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295956
Title
Two-generation reproductive toxicity test of 90% Glufosinate-p in rats
Study date
2024-03-01
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295999
Title
Part 7 Environment
Study date
24 Oct 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296050
Title
Acute Toxicity study of Glufosinate-P ammonium 20% SL in Trichogramma Ostriniae
Study date
2020-12-21
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295953
Title
In vitro Micronucleus study with Test Item Glufosinate-P 200 g/L SL in CHO-K1 Cells
Study date
07/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295930
Title
Purity of Glufosinate-P 200 g/L SL and analytical method validation for active ingredient content Glufosinate-P-ammonium
Study date
23/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296030
Title
Glufosinate-P Ammonium TC: An Acute Oral Toxicity Study with the Northern Bobwhite
Study date
June 20, 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295924
Title
CERTIFICATE OF ANALYSIS
Study date
November 30, 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295936
Title
NTERIM STUDY REPORT Dose Range Finding Study Prenatal Developmental in NZ White Rabbits
Study date
17 July 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296079
Title
EFFICACY AND AGRONOMIC FEASIBILITY_Formosa 2_Soybean pre-planting
Study date
May 20, 2025.
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295973
Title
Subchronic oral toxicity test of 3-methyl-phosphinico-propionic acid in rats
Study date
2024-02-20
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296073
Title
Summary of 3 public journals on glufosinate isomer transformation
Study date
2025
Auth party contact address
-
Data no
296036
Title
ALGA GROWTH INHIBITION TEST OF GLUFOSINATE-P AMMONIUM TC ON Pseudokirchneriella subcapitata
Study date
25 May 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296059
Title
ACUTE ORAL TOXICITY STUDY OF GLUFOSINATE-P AMMONIUM TC IN SPRAGUE DAWLEY RATS
Study date
30 December 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296082
Title
EFFICACY AND AGRONOMIC FEASIBILITY_Conchal/SP 2_Soybean pre-planting
Study date
August 14, 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295944
Title
Amendment n???? 01 to the Acute Inhalation Toxicity Test with Glufosinate-P 200 g/L SL in Rats
Study date
16/Dec/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295967
Title
N-acetyl-glufosinate in vitro mammalian cell gene mutation test
Study date
2024-02-21
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295913
Title
Determination of the density of Glufosinate-P 200 g/L SL
Study date
13/Nov/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295990
Title
Pre-application Assistance Brief
Study date
6 August 2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296013
Title
DETERMINATION OF WATER SOLUBILITY OF GLUFOSINATE-P AMMONIUM TC
Study date
09 November 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296053
Title
TERRESTRIAL PLANT TEST: VEGETATIVE VIGOUR TEST OF GLUFOSINATE-P 280 g/L SL ON PLANTS
Study date
04 March 2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296090
Title
EVALUATION STUDY OF THE BIOLOGICAL EFFECTIVENESS OF THE HERBICIDE YOSTAR PRO (glufosinate-P) FOR THE CONTROL OF BROAD AND NARROW LEAF WEEDS IN CORN CROPS (Zea mays)
Study date
July 08,2022
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295996
Title
Part 6 OH&S
Study date
30 Oct 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296007
Title
Effects of Glufosinate-P 200 g/L SL on Soil Microorganisms: Carbon Transformation Test_amandment 2
Study date
29/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295950
Title
In vitro Dermal Corrosion study with Test Item Glufosinate-P 200 g/L SL in Reconstructed Human Epidermis (SkinEthicTM RHE)
Study date
19/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296047
Title
EFFECT OF GLUFOSINATE-P AMMONIUM TC ON HONEYBEES, Apis mellifera, LARVAL TOXICITY TEST- REPEATED EXPOSURE
Study date
08 February 2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296070
Title
GLUFOSINATE BIOEQUIVALENCE IN AN IN-CROP SITUATION WHEN APPLIED USING A BOOM ONE FIELD TRIAL, WALLAVILLE, QLD, AUSTRALIA, 2024
Study date
13 June 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295933
Title
Part 3 Toxicology and Part 4 Metabolism
Study date
Mar 2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295970
Title
3-methyl-phosphinico-propionic acid bacterial reverse mutation test
Study date
2024-02-01
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296019
Title
DETERMINATION OF pH OF GLUFOSINATE-P AMMONIUM TC
Study date
02 January 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296027
Title
Conclusion regarding the peer review of the pesticide risk assessment of the active substance glufosinate
Study date
14 March 2005
Auth party contact address
-
Data no
296076
Title
Transgenic plants containing the phosphinothricin-N-acetyltransferase gene metabolize the herbicide L-phosphinothricin (glufosinate) differently from untransformed plants
Study date
1991
Auth party contact address
-
Data no
295927
Title
Amendment number one: Stability Report ??? Formulated Product
Study date
01/Oct/2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295976
Title
In vitro mammalian cells Chromosome Aberration test of 2-(hydroxy(methyl)phosphoryl)acetic acid
Study date
2024-02-21
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295962
Title
In vitro mammalian cells Gene mutation test of 2- (hydroxy(methyl)phosphoryl)acetic acid
Study date
2024-02-21
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295968
Title
Subchronic Oral Toxicity Test Of GLUFOSINATE-N-ACETYL
Study date
2024-02-20
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295985
Title
Waiver Request for Crop Metabolism Studies: Glufosinate-P Ammonium
Study date
April 8, 2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295991
Title
APVMA Written Assistance
Study date
6 August 2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296014
Title
DETERMINATION OF SOLUBILITY OF GLUFOSINATE-P AMMONIUM TC IN ORGANIC SOLVENTS
Study date
09 November 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296085
Title
EVALUATION STUDY OF THE BIOLOGICAL EFFECTIVENESS OF THE HERBICIDE YOSTAR PRO (glufosinate-P) FOR THE CONTROL OF BROAD AND NARROW LEAF WEEDS IN BANANO CROPS (Musa paradisiaca)
Study date
SEPTEMBER 05, 2022
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295939
Title
Comparison of actions of DL-Glufosinate to L-Glufosinate free acid on in vitro Assays for Network Formation, Network Function, and Neurite Outgrowth
Study date
November 9, 2020
Auth party contact address
-
Data no
296054
Title
Earthworm Eisenia andrei Reproduction Test to Glufosinate-P ammonium TC
Study date
20/May/2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296008
Title
Acute toxicity of Glufosinate-P 200 g/L SL to the earthworm Eisenia foetida (Savigny 1826)
Study date
19/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296091
Title
AGRONOMIC EFFICACY REPORT OF Glufosinate -P 200 SL YONON IN PRE- HARVEST DESICCATION OF SOYBEANS DURING THE 2022 OFF-SEASON
Study date
2022
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295945
Title
EYE IRRITATION/CORROSION POTENTIAL IN VITRO FOR SHORT EXPOSURE TIME (STE) Glufosinate-P 200 g/L SL
Study date
29 Apr. 2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296045
Title
AEROBIC TRANSFORMATION OF [14C] GLUFOSINATE-P AMMONIUM IN FOUR SOILS
Study date
15/11/2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296002
Title
Effects of Glufosinate-P 200 g/L SL on Soil Microorganisms: Nitrogen Transformation Test
Study date
26/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295951
Title
Amendment n???? 01 to In vitro Dermal Corrosion study with Test Item Glufosinate-P 200 g/L SL in Reconstructed Human Epidermis (SkinEthicTM RHE)
Study date
06/Dec/2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296048
Title
Initial risk assessment provided by the rapporteur Member State Sweden for the existing active substance GLUFOSINATE
Study date
Jan 2004
Auth party contact address
-
Data no
296071
Title
GLUFOSINATE BIOEQUIVALENCE IN AN IN-CROP SITUATION WHEN APPLIED USING A HANDGUN ONE FIELD TRIAL, BUNDABERG, QUEENSLAND, AUSTRALIA, 2024
Study date
13 June 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295971
Title
3-methyl-phosphinico-propionic acid in vitro mammalian cell chromosome aberration test
Study date
2024-01-28
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296065
Title
Acute oral toxicity of Glufosinate-P 200 g/L SL to honeybee Apis mellifera (africanized)
Study date
October 21, 2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296077
Title
Yosky Glufosinate-P 200 SL Deviation outcome letter_Efficacy
Study date
17 May 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295922
Title
Miscibility in water and organic solvents of Glufosinate-P 200 g/L SL
Study date
13/Nov/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295979
Title
A comparative investigation of the metabolism of the herbicide glufosinate in cell cultures of transgenic glufosinate-resistant and non-transgenic oilseed rape (Brassica napus) and corn (Zea mays)
Study date
2002
Auth party contact address
-
Data no
296022
Title
DETERMINATION OF DISSOCIATION CONSTANT OF GLUFOSINATE-P AMMONIUM TC
Study date
15 January 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296028
Title
DIRECT PHOTOLYSIS OF GLUFOSINATE-P AMMONIUM TC (Tier I)
Study date
13/03/2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295928
Title
Amendment number two: Stability Report ??? Formulated Product
Study date
28/Dec/2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295965
Title
N-acetyl-Glufosinate bacterial reverse mutation test
Study date
2024-02-21
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295942
Title
Acute Dermal Toxicity in Rats (Rattus norvegicus) with the Test Item Glufosinate-P 200 g/L SL
Study date
09/Nov/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295919
Title
Oxidation/reduction: Chemical Incompatibility of Glufosinate-P 200 g/L SL
Study date
02/May/2022
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296034
Title
Daphnia magna REPRODUCTION TEST WITH GLUFOSINATE-P AMMONIUM TC
Study date
2 August 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296011
Title
DETERMINATION OF VAPOUR PRESSURE OF GLUFOSINATE-P AMMONIUM TC
Study date
09 November 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296088
Title
Evaluation of the control efficacy of different doses of the herbicide Glufosinate ???????? P 200 SL YONON for post- emergence weed control in soybean crops
Study date
2022
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295988
Title
MRL of Agricultural Chemical:GLUFOSINATE
Study date
2025
Auth party contact address
-
Data no
295959
Title
Integration of toxicodynamic and toxicokinetic new approach methods into a weight-of-evidence analysis for pesticide developmental neurotoxicity assessment: A case-study with DL- and L-glufosinate
Study date
6 April 2022
Auth party contact address
-
Data no
296042
Title
GLUFOSINATE-P AMMONIUM TC EFFECT ON NITROGEN TRANSFORMATION ACTIVITY OF SOIL MICROORGANISMS
Study date
18 March 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295911
Title
Manufacturing process ??? Formulated Product
Study date
2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295948
Title
Study of Opacity and Permeability in Bovine Cornea with the Test Item Glufosinate-P 200 g/L SL
Study date
18/Dec/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296005
Title
Effects of Glufosinate-P 200 g/L SL on Soil Microorganisms: Carbon Transformation Test
Study date
29/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295994
Title
DV860-01 - Yosky Glufosinate-P 200 SL Outcome letter
Study date
17 May 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296051
Title
Acute contact toxicity of Glufosinate-p ammonium 20% SL in enemy (Ladybug)
Study date
2020-12-22
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295931
Title
Additional stability report ??? formulated product
Study date
2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295982
Title
Magnitude of the Residues of Glufosinate-ammonium, Glufosinate-P-ammonium, and Metabolites in or on Field Corn Raw Agricultural Commodities Following Foliar Applications of Glufosinate-P 280 g/L SL - 2023
Study date
December 4, 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296031
Title
AVIAN ACUTE ORAL TOXICITY STUDY OF GLUFOSINATE-P AMMONIUM TC ON MALLARD DUCK ???????? Anas platyrhynchos
Study date
29 December 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296068
Title
GLUFOSINATE BIOEQUIVALENCE IN A NON-CROP SITUATION WHEN APPLIED USING A BOOM, ONE FIELD TRIAL, MOOLBOOLAMAN, QLD, AUSTRALIA, 2024
Study date
13 June 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295925
Title
Accelerated Storage Stability and Corrosion Characteristics of Glufosinate-P 200 g/L SL
Study date
27/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296025
Title
DETERMINATION OF EXPLOSIVE PROPERTIES OF GLUFOSINATE-P AMMONIUM TC
Study date
02 January 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296074
Title
A comparative investigation of the metabolism of the herbicide glufosinate in cell cultures of transgenic glufosinate-resistant and non-transgenic oilseed rape (Brassica napus) and corn (Zea mays)
Study date
2002
Auth party contact address
-
Data no
295989
Title
Pesticide MRLs in Agricultural Commodities
Study date
2019
Auth party contact address
-
Data no
296060
Title
Acute toxicity of Glufosinate-P 200 g/L SL to fish Danio rerio
Study date
November 6, 2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295966
Title
N-acetyl-glufosinate in vitro chromosome aberration test in mammalian cells
Study date
2024-02-21
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296083
Title
EFFICACY AND AGRONOMIC FEASIBILITY_Itaara/RS 1_Soybean pre-planting
Study date
2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295943
Title
Acute Inhalation Toxicity Test with Glufosinate-P 200 g/L SL in Rats (Rattus norvegicus)
Study date
23/Nov/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295920
Title
Corrosiveness of Glufosinate-P 200 g/L SL
Study date
12/Nov/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295937
Title
AMENDMENT TO STUDY REPORT to Interim Study Report - Dose Range Finding Study
Study date
24 Apr 2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295914
Title
Determination of the pH value of an aqueous solution of Glufosinate-P 200 g/L SL
Study date
13/Nov/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296037
Title
ACUTE CONTACT TOXICITY STUDY OF GLUFOSINATE-P AMMONIUM TC ON HONEYBEES, Apis Mellifera
Study date
29 December 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295960
Title
Waiver Request for Toxicokinetics Study (Absorption, Distribution, Metabolism And Excretion) in Mammals: Glufosinate-P Ammonium
Study date
April 15, 2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296089
Title
TECHNICAL REPORT OF EFFICACY AND AGRONOMIC PRACTICABILITY_Brazil
Study date
10 October 2023
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296006
Title
Effects of Glufosinate-P 200 g/L SL on Soil Microorganisms: Carbon Transformation Test_amandment 1
Study date
29/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296043
Title
GLUFOSINATE-P AMMONIUM TC EFFECT ON CARBON TRANSFORMATION ACTIVITY OF SOIL MICROORGANISMS
Study date
14 March 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295997
Title
Non-active ingredients SDS
Study date
2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295977
Title
Part 5 Residue
Study date
29 Oct 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295983
Title
Magnitude of the Residues of Glufosinate-ammonium, Glufosinate-P-ammonium, and Metabolites in or on Field Corn Raw Agricultural Commodities Following Foliar Applications of Glufosinate-P 280 g/L SL - 2023
Study date
December 4, 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295934
Title
2022_Yongnong PAA2-132269 - Written Assistance
Study date
Jan 2022
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296020
Title
DETERMINATION OF OXIDATION / REDUCTION (CHEMICAL INCOMPATIBILITY) OF GLUFOSINATE-P AMMONIUM TC
Study date
05 January 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296069
Title
GLUFOSINATE BIOEQUIVALENCE IN A NON-CROP SITUATION WHEN APPLIED USING A HANDGUN ONE FIELD TRIAL, WALLAVILLE, QUEENSLAND, AUSTRALIA, 2024
Study date
13 June 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296026
Title
DETERMINATION OF UV-VIS ABSORPTION SPECTRA OF GLUFOSINATE-P AMMONIUM TC
Study date
02 January 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295926
Title
Letter confirming sample size and container material ??? stability study
Study date
1 April 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295917
Title
Flash point of Glufosinate-P 200 g/L SL
Study date
13/Nov/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295986
Title
Glufosinate-P ammonium TC: Bridging Residue Data Developed on Racemic Glufosinate Ammonium to L-Glufosinate Ammonium
Study date
28 September 2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296057
Title
[3,4-14C] Glufosinate-P, Ammonium Salt: Leaching In Soil Columns
Study date
18/09/2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296063
Title
Acute toxicity of Glufosinate-P 200 g/L SL to Daphnia magna
Study date
October 30, 2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296009
Title
Acute toxicity of Glufosinate-P 200 g/L SL to the earthworm Eisenia foetida (Savigny 1826)_amandment 1
Study date
19/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296040
Title
EFFECT OF GLUFOSINATE-P AMMONIUM TC ON HONEYBEES, Apis mellifera, LARVAL TOXICITY TEST - SINGLE EXPOSURE
Study date
10 August 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295940
Title
New Approach Methodologies for Developmental Neurotoxicity Hazard.
Study date
February 14, 2023
Auth party contact address
-
Data no
295963
Title
Subchronic Oral Toxicity Test Of 2- (hydroxy (methyl) phosphoryl) Acetic Acid In Rats
Study date
February 20, 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296086
Title
EVALUATION STUDY OF THE BIOLOGICAL EFFECTIVENESS OF THE HERBICIDE YOSTAR PRO (glufosinate-P) FOR CONTROL OF BROAD AND NARROW LEAF WEEDS IN LEMON CROPS (Citrus aurantifolia)
Study date
SEPTEMBER 05, 2022
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295946
Title
Amendment n???? 01 to EYE IRRITATION/CORROSION POTENTIAL IN VITRO FOR SHORT EXPOSURE TIME (STE) Glufosinate-P 200 g/L SL
Study date
24 Sep. 2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295957
Title
Combined Chronic Toxicity And Carcinogenicity Test Of Glufosinate-P 90% Tc In Rats
Study date
2024-03-03
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296003
Title
Effects of Glufosinate-P 200 g/L SL on Soil Microorganisms: Nitrogen Transformation Test_amendmend 1
Study date
26/Oct/2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296046
Title
FISH, EARLY-LIFE STAGE TOXICITY TEST OF GLUFOSINATE-P-AMMONIUM TC ON ZEBRAFISH, Danio rerio
Study date
23 November 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296000
Title
Pre-application Assistance Brief
Study date
6 August 2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296049
Title
Avian Acute Oral Toxicity Test with Glufosinate-P 200 g/L SL in Japanese Quail (Coturnix coturnix japonica)
Study date
November 11, 2020
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296072
Title
Chromatograms of glufosinate-p ammonium
Study date
2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295954
Title
Subacute Dermal Toxicity Test Of Glufosinate-P 90% Tc In Rats
Study date
2024-02-25
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296066
Title
Part 8 Efficacy and crop safety
Study date
Nov 2025
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295923
Title
Determination of Active Content in Formulated Product
Study date
25 August 2021
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296017
Title
DETERMINATION OF DENSITY OF GLUFOSINATE-P AMMONIUM TC
Study date
02 January 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296029
Title
DIRECT PHOTOLYSIS OF GLUFOSINATE-P AMMONIUM TC (Tier ii)
Study date
13/08/2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
296080
Title
EFFICACY AND AGRONOMIC FEASIBILITY_Conchal/SP 1_Soybean pre-planting
Study date
August 14, 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295974
Title
Acute Oral Toxicity Test Of 2-(hydroxy(methyl)phosphoryl)acetic Acid In Rats
Study date
February 20, 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Data no
295980
Title
Distribution and metabolism of D/L-, L- and D-glufosinate in transgenic, glufosinate- tolerant crops of maize (Zea mays L ssp mays) and oilseed rape (Brassica napus L var napus)???????
Study date
2002
Auth party contact address
-
Data no
296023
Title
DETERMINATION OF SURFACE TENSION OF GLUFOSINATE-P AMMONIUM TC
Study date
02 January 2024
Auth party contact address
NO.3, Weiqi Rd (East) Hangzhou Gulf Economy and Technology Development Zone Shangyu China
Date
Application Date
Application No
Application Number
151147
Product/Active constituent Name
Application Product Name
PROTECH BRONCHI-SHIELD III BORDETELLA BRONCHISEPTICA, CANINE ADENOVIRUS TYPE 2 AND PARAINFLUENZA VACCINE
Application Date
Application Number
151147
Application Product Name
PROTECH BRONCHI-SHIELD III BORDETELLA BRONCHISEPTICA, CANINE ADENOVIRUS TYPE 2 AND PARAINFLUENZA VACCINE
Application details
Product name:
PROTECH BRONCHI-SHIELD III BORDETELLA BRONCHISEPTICA, CANINE ADENOVIRUS TYPE 2 AND PARAINFLUENZA VACCINE
Product number:
51824
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of product registration to remove non-standard conditions applied to the product.
Active constituents:
Active constituent name
83716 - CANINE ADENOVIRUS TYPE 2
Active constituent name
83719 - CANINE PARAINFLUENZA VIRUS
Active constituent name
83715 - BORDETELLA BRONCHISEPTICA
Description of data provided:
Data no
306707
Title
Outline of Production 12X1.21
Study date
13/12/2023
Data no
306708
Title
351-PRC-001479 titration and identity of CPI in seed, harvest and final product
Study date
01/03/2019
Data no
306709
Title
Titration and Identity of CAV in seed, harvest and final product
Study date
28/03/2019
Data no
306710
Title
Transfer of Assay methods for potency of canine parainfluenza and canine adenovirus type 2 in Protech Bronchi-Shield
Study date
28/09/2017
Data no
296204
Title
batch 5267019
Study date
19/01/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296198
Title
Batch 5267024 part 2
Study date
25/06/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296210
Title
CAV3183THV QC test report
Study date
03/09/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296201
Title
Batch 5267026 - part 1
Study date
07/01/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
306712
Title
Protech Bronchi-Shield III s159 response
Study date
22/06/2026
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296207
Title
Antigen stability
Study date
01/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296202
Title
Batch 5267026 - part 2
Study date
07/01/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296205
Title
diluent batch 10H67S
Study date
19/05/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296199
Title
Batch 5267024 part 3
Study date
25/06/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
306711
Title
Veterinary medicines technical report final: chemistry/manufacturing
Study date
07/08/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296208
Title
PAA 139907 -written advice
Study date
04/07/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296200
Title
diluent batch 10J45S
Study date
10/02/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296197
Title
Batch 5267024 part 1
Study date
25/06/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296211
Title
import permit
Study date
27/08/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296206
Title
Stability report Protech Bronchi-Shield III
Study date
30/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296212
Title
Executive summary Protech Bronchi-Shield III
Study date
24/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296203
Title
diluent batch 10K34S
Study date
11/11/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
306706
Title
permit PER93792
Study date
03/12/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296209
Title
CAV3183THV batch report
Study date
03/09/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
151214
Product/Active constituent Name
Application Product Name
PROTECH MULTI C4 CANINE DISTEMPER, ADENOVIRUS, PARAINFLUENZA & PARVOVIRUS LIVE VACCINE
Application Date
Application Number
151214
Application Product Name
PROTECH MULTI C4 CANINE DISTEMPER, ADENOVIRUS, PARAINFLUENZA & PARVOVIRUS LIVE VACCINE
Application details
Product name:
PROTECH MULTI C4 CANINE DISTEMPER, ADENOVIRUS, PARAINFLUENZA & PARVOVIRUS LIVE VACCINE
Product number:
59731
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of product registration to remove non-standard conditions applied to the registration.
Active constituents:
Active constituent name
54990 - CANINE PARAINFLUENZA TYPE 2
Active constituent name
54985 - CANINE DISTEMPER VIRUS
Active constituent name
57265 - HEPATITIS CANINE = CANINE ADENOVIRUS
Active constituent name
57473 - PARVOVIRUS - LIVE
Active constituent name
83690 - CANINE PARVOVIRUS
Active constituent name
83717 - CANINE ADENOVIRUS TYPE 2
Active constituent name
83718 - CANINE DISTEMPER VIRUS
Active constituent name
83719 - CANINE PARAINFLUENZA VIRUS
Active constituent name
54990 - CANINE PARAINFLUENZA TYPE 2
Active constituent name
54985 - CANINE DISTEMPER VIRUS
Active constituent name
57265 - HEPATITIS CANINE = CANINE ADENOVIRUS
Active constituent name
57473 - PARVOVIRUS - LIVE
Description of data provided:
Data no
306784
Title
Special Outline 3156 Canine distemper titration
Study date
29/03/2019
Data no
306785
Title
Special Outline 3157 - Titration of canine parvovirus
Study date
17/04/2019
Data no
306786
Title
Special Outline 3158 Canine adenovirus titration
Study date
11/04/2019
Data no
306787
Title
Special Outline 3160 Canine parainfluenza modifed live virus potency test
Study date
17/04/2019
Data no
306788
Title
351-PRC-001490 titration and identity of CDV in seed, harvest and final product
Study date
17/07/2019
Data no
306789
Title
351-PRC-001480 Titration and Identity of CAV in seed, harvest and final product
Study date
11/11/2019
Data no
306790
Title
351-PRC-001485 Titration and identity of CPV in seed, harvest and final product
Study date
04/11/2019
Data no
306791
Title
351-PRC-001479 Titration and identity of CPI in seed, harvest and final product
Study date
31/10/2019
Data no
296290
Title
Batch 5260009
Study date
14/06/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296296
Title
CAV3183THV 002 batch record
Study date
03/09/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296293
Title
Stability report
Study date
28/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
306792
Title
Veterinary medicines technical report 124274
Study date
05/03/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
306793
Title
Product Multi C4 response to s159 notice
Study date
25/06/2026
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296291
Title
Batch 5260010
Study date
21/08/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296299
Title
Executive summary Duramune C4
Study date
26/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296294
Title
Antigen stability
Study date
01/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296297
Title
CDV3166THV specification
Study date
22/09/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296298
Title
import permit
Study date
12/11/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296292
Title
Batch 5260012
Study date
25/03/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
306783
Title
Outline of Production 13D1.23
Study date
18/10/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296295
Title
PAA 139907
Study date
04/07/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
151360
Product/Active constituent Name
Application Product Name
Glufosinate-P-ammonium manufacturing concentrate
Application Date
Application Number
151360
Application Product Name
Glufosinate-P-ammonium manufacturing concentrate
Application details
Product name:
Glufosinate-P-ammonium manufacturing concentrate
Product number:
96971
Applicant Name:
YONGNONG BIOSCIENCES CO., LTD
Application purpose and description of use:
This application is for the approval of a new active constituent, a new manufacturing concentrate, and a new agricultural product, containing a new active constituent Glufosinate-P-ammonium.
Date
Application Date
Application No
Application Number
151441
Product/Active constituent Name
Application Product Name
Fluazuron
Application Date
Application Number
151441
Application Product Name
Fluazuron
Application details
Product name:
Fluazuron
Active name:
Fluazuron
Applicant Name:
B.J. BLUE PTY LTD
Application purpose and description of use:
Approval of fluazuron for use in veterinary chemical products.
Description of data provided:
Data no
298740
Title
Fluazuron DMF Part III
Study date
2025
Auth party contact address
Unit 10 2-8 Daniel Street WETHERILL PARK Australia
Data no
298741
Title
Fluazuron Certificates of analysis
Study date
2025
Auth party contact address
Unit 10 2-8 Daniel Street WETHERILL PARK Australia
Data no
298738
Title
Fluazuron DMF Part I
Study date
2025
Auth party contact address
Unit 10 2-8 Daniel Street WETHERILL PARK Australia
Data no
298739
Title
Fluazuron DMF Part II
Study date
2025
Auth party contact address
Unit 10 2-8 Daniel Street WETHERILL PARK Australia
Date
Application Date
Application No
Application Number
150739
Product/Active constituent Name
Application Product Name
Mortein Powergard Flying Insect Killer
Application Date
Application Number
150739
Application Product Name
Mortein Powergard Flying Insect Killer
Application details
Product name:
Mortein Powergard Flying Insect Killer
Product number:
96809
Applicant Name:
VEH AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 0.8 g/kg transfluthrin, 0.7 g/kg permethrin, 0.5 g/kg imiprothrin aerosol product to kill flying insects in domestic applications.
Reference details:
86370 - Hovex Vaporgard Multi Insect Killer
61609 - MORTEIN KABOOM! ALL INSECT KILLER HOUSEHOLD PROTECTION
91308 - Mortein Powergard Multi Insect Killer
Active constituents:
Active constituent name
47544 - TRANSFLUTHRIN
Active constituent name
89258 - Permethrin
Active constituent name
50876 - IMIPROTHRIN MANUFACTURING CONCENTRATE
Description of data provided:
Data no
296273
Title
Peet-Grady Chamber Study to Determine the Knockdown and Kill of Six Aerosol Formulations Against Culex quinquefasciatus
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296281
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Five Aerosol Formulations Against the Silverfish
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296284
Title
Aerosol Spray Test Against German Cockroaches (Knockdown Test)
Study date
22.04.2008
Auth party contact address
680 George Street Sydney Australia
Data no
296270
Title
Health Module documents
Study date
16.09.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296285
Title
Aerosol Spray Test Against American Cockroaches (Knockdown Test)
Study date
22.04.2008
Auth party contact address
680 George Street Sydney Australia
Data no
296279
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Five Aerosol Formulations Against a Black Ant
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296282
Title
Laboratory study to Determine the Direct Spray Knockdown & Kill of Two Aerosol formulations Against the Paper Wasp
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296268
Title
Stability Report ??? Accelerated (2 weeks)
Study date
20.05.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296276
Title
Aerosol Spray Test against the American Cockroach (Knockdown Test) Results and Report (One Second Spray)
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296283
Title
Laboratory study to Determine the Residual Knockdown & Mortality of Aerosol formulation DJS-1060a against Musca domestica ??? WHO protocol
Study date
25.09.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296277
Title
Aerosol Spray Test against the German Cockroach (Knockdown Test) Results and Report
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296271
Title
Efficacy Summary
Study date
10.09.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296274
Title
Laboratory Study to determine the Direct Spray Knockdown & Kill of Five Aerosol Formulations Against the Mosquito
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296280
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Five Aerosol Formulations Against a Brown Ant
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296275
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Five Aerosol Formulations Against the House Fly
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296269
Title
Quantification of Transfluthrin, Imiporthrin and Permethrin in water-based formulations via High-Performance Liquid Chromatography with Ultra-Biolet Detector (HPLC-UV)
Study date
14.11.2024
Auth party contact address
680 George Street Sydney Australia
Data no
296278
Title
Laboratory study to Determine the Direct Spray Knockdown & Kill of Three Aerosol Formulations against Spiders ??? one Second Spray
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296272
Title
Peet-Grady Chamber Study to Determine the Knockdown and Kill of Seven Aerosol Formulations Against Musca domestica
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Date
Application Date
Application No
Application Number
150963
Product/Active constituent Name
Application Product Name
Spirotetramat
Application Date
Application Number
150963
Application Product Name
Spirotetramat
Application details
Product name:
Spirotetramat
Active name:
Spirotetramat
Applicant Name:
ALBAUGH AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of a new source of spirotetramat for use in agricultural chemical products.
Description of data provided:
Data no
297120
Title
Confidential attachment_Analysis reports
Study date
2023
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
297117
Title
Appendix 2.2. Attachment 1. Preliminary Analysis and Enforcement Analytical Method of Spirotetramat TC
Study date
2023
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
297121
Title
Appendix 2.6. Declaration of Composition
Study date
2025
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
297118
Title
Appendix 2.3. Attachment 2. Preliminary Analysis and Enforcement Analytical Method of Spirotetramat TC
Study date
2023
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
297115
Title
2 Chemistry dossier
Study date
2025
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
297116
Title
Appendix 2.1. Preliminary Analysis and Validation of Analytical Methods of Spirotetramat TC.
Study date
2023
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
297119
Title
Appendix 2.4. Spirotetramat manufacturing process and impurities formation description.
Study date
2025
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
151129
Product/Active constituent Name
Application Product Name
PROTECH C3
Application Date
Application Number
151129
Application Product Name
PROTECH C3
Application details
Product name:
PROTECH C3
Product number:
51487
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of product registration to remove non-standard conditions applied to the registration.
Active constituents:
Active constituent name
83690 - CANINE PARVOVIRUS
Active constituent name
83717 - CANINE ADENOVIRUS TYPE 2
Active constituent name
83718 - CANINE DISTEMPER VIRUS
Description of data provided:
Data no
296138
Title
QC test report CVD3166TC 001
Study date
22/01/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296141
Title
Executive summary Protech C3
Study date
20/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296133
Title
Batch 4964015
Study date
01/08/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
306713
Title
specifications CDV3166TC
Study date
22/09/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296136
Title
Stability report
Study date
28/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296139
Title
QC test report CPV3184THV 001
Study date
28/11/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296137
Title
Batch report CAV3203THV 012
Study date
12/08/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296140
Title
QC test report CAV3203THV 002
Study date
07/03/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296134
Title
batch 4964016A
Study date
10/10/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296135
Title
batch 4964019
Study date
29/05/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
306714
Title
Executive summary s159 response
Study date
08/05/2026
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
151191
Product/Active constituent Name
Application Product Name
4 Farmers Impulse Penetrant
Application Date
Application Number
151191
Application Product Name
4 Farmers Impulse Penetrant
Application details
Product name:
4 Farmers Impulse Penetrant
Product number:
96895
Applicant Name:
4 FARMERS AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a 1000g/L polyether modified polysiloxane adjuvant for agricultural use in Australia. The product is intended to be used as a tank mix adjuvant to improve the spreading, wetting, and penetration of agricultural chemical products on target crops. This application seeks registration based on a reference product, Nufarm Pulse, which is an already registered polyether modified polysiloxane adjuvant. The proposed product is functionally equivalent to the reference product, providing similar efficacy and safety profiles under equivalent use conditions.
Reference details:
57279 - Nufarm Pulse Adjuvant
Active constituents:
Active constituent name
87364 - Wynspread Organosilicone Penetrant
Description of data provided:
Data no
296854
Title
4Farmers Impulse Penetrant-Stability Data
Study date
22/08/2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296853
Title
Certificate of Analysis--Polyether modified Polysiloxane
Study date
11/11/2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Date
Application Date
Application No
Application Number
151241
Product/Active constituent Name
Application Product Name
PROTECH C4
Application Date
Application Number
151241
Application Product Name
PROTECH C4
Application details
Product name:
PROTECH C4
Product number:
51486
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of product registration to remove non-standard conditions applied to the registration.
Active constituents:
Active constituent name
83690 - CANINE PARVOVIRUS
Active constituent name
83717 - CANINE ADENOVIRUS TYPE 2
Active constituent name
83718 - CANINE DISTEMPER VIRUS
Active constituent name
83719 - CANINE PARAINFLUENZA VIRUS
Description of data provided:
Data no
306715
Title
Specifications CDV3166TC
Study date
22/09/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296542
Title
Batch 5257037-pool
Study date
28/10/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296545
Title
Batch 257039A
Study date
21/05/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296540
Title
Batch 5257037A
Study date
28/10/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296551
Title
Executive summary Protech C4
Study date
27/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
306716
Title
Protech C4 response to s159
Study date
08/05/2026
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296548
Title
CDV3166TC001
Study date
22/01/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296549
Title
CPV3184THV001
Study date
28/11/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296543
Title
Batch 5257038A
Study date
27/01/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296546
Title
Stability report
Study date
28/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296544
Title
Batch 5257038B
Study date
27/01/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296547
Title
CAV3203THV 012
Study date
21/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296541
Title
Batch 5257037B
Study date
28/10/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296550
Title
CAV3203THV002
Study date
07/03/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
151305
Product/Active constituent Name
Application Product Name
Closantel Base
Application Date
Application Number
151305
Application Product Name
Closantel Base
Application details
Product name:
Closantel Base
Active name:
Closantel Base
Applicant Name:
AARAMBH LIFE SCIENCE
Application purpose and description of use:
Approval of a new manufacture source of closantel for use in veterinary chemical products.
Description of data provided:
Data no
296857
Title
Certificates of analysis
Study date
01/10/2025
Auth party contact address
Unit No. 1, Bldg No. 3 Manish Compound Anjur Phata, Rehnal Village Bhiwandi India
Data no
296856
Title
Drug Master File - Closantel
Study date
2025
Auth party contact address
Unit No. 1, Bldg No. 3 Manish Compound Anjur Phata, Rehnal Village Bhiwandi India
Date
Application Date
Application No
Application Number
151130
Product/Active constituent Name
Application Product Name
PROTECH PI2
Application Date
Application Number
151130
Application Product Name
PROTECH PI2
Application details
Product name:
PROTECH PI2
Product number:
60808
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of the conditions of product registration to remove non-standard conditions imposed on the product.
Active constituents:
Active constituent name
55559 - CANINE PARAINFLUENZA VIRUS
Active constituent name
83719 - CANINE PARAINFLUENZA VIRUS
Description of data provided:
Data no
307213
Title
351-QCD-SP-0556
Study date
17/06/2019
Data no
307214
Title
TRS-QCD-17/007R transfer of assay methods for potency
Study date
28/09/2017
Data no
307217
Title
Outline of Production 1421.U1
Study date
07/03/2024
Data no
307218
Title
Special Outline 3160
Study date
17/04/2019
Data no
307219
Title
351-PRC-001479 titration and identity of CPI
Study date
31/10/2019
Data no
307216
Title
s159 response
Study date
12/06/2026
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296144
Title
batch records 5264015
Study date
21/08/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296147
Title
import permit
Study date
12/11/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296142
Title
Stability Study report
Study date
28/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296145
Title
Antigen stability
Study date
01/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296148
Title
Executive summary Protech PI2
Study date
20/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296146
Title
PAA 139907 written advice
Study date
04/07/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
307215
Title
Protech PI2 60808/124170 chemistry report
Study date
10/02/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296143
Title
batch records 5264014
Study date
14/06/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
150763
Product/Active constituent Name
Application Product Name
Surefire Zinam 500 SC Fungicide
Application Date
Application Number
150763
Application Product Name
Surefire Zinam 500 SC Fungicide
Application details
Product name:
Surefire Zinam 500 SC Fungicide
Product number:
85676
Applicant Name:
PCT HOLDINGS PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to include additional uses in turf and update manufacturing sites.
Active constituents:
Active constituent name
68026 - FLUAZINAM
Description of data provided:
Data no
296304
Title
PCT Surefire Zinam Fungicide for control of turf diseases.
Study date
09/07/2025
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
296307
Title
PCT Surefire Zinam Fungicide for the control of various turf diseases and Algae
Study date
09/07/2025
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
296308
Title
Quali-Pro Compass Fungicide (82613/138194)
Study date
20/06/2023
Auth party contact address
-
Data no
296305
Title
PCT Surefire Zinam Fungicide for control of turf diseases.
Study date
12/08/2025
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
296306
Title
Evaluation of PCT Surefire Zinam Fungicide for Algae control in Turfgrass.
Study date
27/08/2024
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
296303
Title
Evaluation of PCT Surefire Zinam Fungicide for pythium plant disease control in Turfgrass.
Study date
27/08/2024
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
296309
Title
Part 8 Summary
Study date
October 2025
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Date
Application Date
Application No
Application Number
151309
Product/Active constituent Name
Application Product Name
Tulathromycin
Application Date
Application Number
151309
Application Product Name
Tulathromycin
Application details
Product name:
Tulathromycin
Active name:
Tulathromycin
Applicant Name:
CEVA ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Approval of tulathromycin for use in veterinary chemical products.
Description of data provided:
Data no
296877
Title
Certificate of Analysis
Study date
Oct 2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
296878
Title
Declaration letter
Study date
Feb 2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Date
Application Date
Application No
Application Number
151345
Product/Active constituent Name
Application Product Name
D-Max Plus INJECTION
Application Date
Application Number
151345
Application Product Name
D-Max Plus INJECTION
Application details
Product name:
D-Max Plus INJECTION
Product number:
96963
Applicant Name:
ABBEY LABORATORIES PTY LTD
Application purpose and description of use:
Registration of D-Max Plus INJECTION for Treatment and control of GI worms, cattle tick & sucking lice in cattle.
Reference details:
90001 - Dectomax V dual combination injection for cattle and sheep
Active constituents:
Active constituent name
95664 - Doramectin
Active constituent name
95484 - Doramectin
Active constituent name
82196 - LEVAMISOLE HYDROCHLORIDE
Active constituent name
82914 - Levamisole Hydrochloride
Active constituent name
84265 - Levamisole Hydrochloride
Description of data provided:
Data no
297071
Title
Product specifications
Study date
Dec 2025
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date
Application Date
Application No
Application Number
151276
Product/Active constituent Name
Application Product Name
Redivom 1 mg/mL Solution for Injection for Dogs
Application Date
Application Number
151276
Application Product Name
Redivom 1 mg/mL Solution for Injection for Dogs
Application details
Product name:
Redivom 1 mg/mL Solution for Injection for Dogs
Product number:
92371
Applicant Name:
DECHRA REGULATORY B.V.
Application purpose and description of use:
Variation of product registration to introduce a new manufacturer.
Description of data provided:
Data no
307515
Title
Validation Report Manufacturing Process RAP VP R1177-2
Study date
March 2023
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Date
Application Date
Application No
Application Number
150721
Product/Active constituent Name
Application Product Name
TriSulfa-Sol Antimicrobial Soluble Powder
Application Date
Application Number
150721
Application Product Name
TriSulfa-Sol Antimicrobial Soluble Powder
Application details
Product name:
TriSulfa-Sol Antimicrobial Soluble Powder
Product number:
95687
Applicant Name:
DOX-AL AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to vary relevant particulars.
Reference details:
37126 - KEYMIX SULPHATRIM ORAL SULPHADIAZINE AND TRIMETHOPRIM MEDICATION
Date
Application Date
Application No
Application Number
150539
Product/Active constituent Name
Application Product Name
Relfovetmab
Application Date
Application Number
150539
Application Product Name
Relfovetmab
Application details
Product name:
Relfovetmab
Product number:
96735
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 6.4 mg/mL relfovetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in cats in conjunction with the approval of the active ingredient relfovetmab.
Description of data provided:
Data no
294807
Title
module 3.2.S.4.1 - Annex 1 - Active Substance Specifications
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294784
Title
module 3.2.S.4.3 - Annex 13 - Method 1021.004 - Evaluation of new lot of reagents in xxx (CQ81W-US-21-234 protocol - F550 & F550-1)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294770
Title
module 3.2.S.4.2 - Annex 6 - Method GM099
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294776
Title
module 3.2.S.4.3 - Annex 5 - Method 1021.004 - Validation Report (BPP-QC-MVR-016-001)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294813
Title
module 3.2.S - GMP Certificate Site B
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294764
Title
module 3.2.S.4.2 - Analytical Procedures Drug Substance
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294787
Title
module 3.2.S.1 - General Information
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294793
Title
module 3.2.S.2.3.1 - Annex 1 - Upstream Raw Material Certificates of Analysis and TSE Declarations
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294804
Title
module 3.2.S.2.6 - Manufacturing Process Development
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294773
Title
module 3.2.S.4.3 - Annex 2 - Method 1021.054 - Validation Report (BPP-QC-MVR-026-001)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294767
Title
module 3.2.S.4.2 - Annex 3 - Method 1021.056
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294816
Title
module 3.2.S - Pharmacopoeial Monographs
Study date
2024
Auth party contact address
-
Data no
294790
Title
module 3.2.S.2.2 - Annex 1 - Regulatory Method of Manufacturing Active Substance - Relfovetmab FDS
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294810
Title
module 3.2.S.5 - Reference Standards or Materials
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294796
Title
module 3.2.S.2.3.1 - Annex 4 - Cell Boost 7a Technical Package
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294782
Title
module 3.2.S.4.3 - Annex 11 - Method 1021.004 - Analytical Method Transfer Report (19PR0088 & 19PR0088a-c)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294805
Title
module 3.2.S.3 - Characterisation
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294791
Title
module 3.2.S.2.2 - Annex 2 - Active Substance Manufacturing Flow Chart - Relfovetmab FDS
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294768
Title
module 3.2.S.4.2 - Annex 4 - Method 1021.055
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294811
Title
module 3.2.S.6 - Container Closure System
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294785
Title
module 3.2.S.4.3 - Annex 14 - Method GM099 - Validation Report (VM296 & VM415)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294799
Title
module 3.2.S.2.3.2 - Annex 2 - Protocol for Generation of WCB
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294779
Title
module 3.2.S.4.3 - Annex 8 - Method 1021.054 - Analytical Method Transfer Study (18PR0159)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294802
Title
module 3.2.S.2.5 - Process Validation
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294808
Title
module 3.2.S.4.4 - Batch Analyses Drug Substance
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294819
Title
Calculation of Protein Extinction Coefficients form Amino Acid Sequence Data
Study date
1989
Auth party contact address
-
Data no
294771
Title
module 3.2.S.4.3 - Validation of Analytical Procedures Drug Substance
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294765
Title
module 3.2.S.4.2 - Annex 1 - Method 1021.057
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294788
Title
module 3.2.S.2.1 - Manufacturer
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294803
Title
module 3.2.S.2.5 - Annex 1 - Report - Viral Clearance Validation
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294780
Title
module 3.2.S.4.3 - Annex 9 - Method 1021.056 - Analytical Method Transfer Report (19PR0087a)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294774
Title
module 3.2.S.4.3 - Annex 3 - Method 1021.056 - Validation Report (CH8MZ-US-18-101)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294820
Title
Characterisation of endogenous retrovirus in rodent cell lines used for production of biologicals
Study date
2003
Auth party contact address
-
Data no
294766
Title
module 3.2.S.4.2 - Annex 2 - Method 1021.054
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294797
Title
module 3.2.S.2.3.1 - Annex 5 - Cell Boost 7b Technical Package
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294777
Title
module 3.2.S.4.3 - Annex 6 - Method 1021.057 - Analytical Method Transfer Report (18PR0163 & MCD-40610)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294806
Title
module 3.2.S.4.1 - Specification Drug Substance
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294783
Title
module 3.2.S.4.3 - Annex 12 - Method 1021.004 - Evaluation of new lot of reagents in xxx (CQ81W-US-21-234 report)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294817
Title
module 3.2.S - Pharmacopoeial Test Methods
Study date
2024
Auth party contact address
-
Data no
294814
Title
module 3.2.S - GMP Certificate Site C
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294786
Title
module 3.2.S.4.3 - Annex 15 - Method 1021.004 - Qualification of xxx F550-1 (CHX9Z-US-25-491)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294794
Title
module 3.2.S.2.3.1 - Annex 2 - Downstream Raw Material Certificates of Analysis and TSE Declarations
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294800
Title
module 3.2.S.2.3.2 - Annex 3 - Vial Certificate of Compliance
Study date
2016
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294778
Title
module 3.2.S.4.3 - Annex 7 - Method 1021.057 - Equivalency Report (21PR0073)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294801
Title
module 3.2.S.2.4 - Control of Critical Steps
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294809
Title
module 3.2.S.4.5 - Drug Substance Specification Justification
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294818
Title
module 3.2.S - Day 180 Product Information
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294772
Title
module 3.2.S.4.3 - Annex 1 - Method 1021.057 - Validation Report (BPP-QC-MVR-015-001)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294815
Title
module 3.2.S - GMP Certificate Site D
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294789
Title
module 3.2.S.2.2 - Description of Manufacturing Process and Process Controls
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294795
Title
module 3.2.S.2.3.1 - Annex 3 - Chromatography Resin Certificates of Analysis
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294781
Title
module 3.2.S.4.3 - Annex 10 - Method 1021.055 - Analytical Method Transfer Study (18PR0178 & CQ81Z-US-23-284)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294821
Title
module 3.2.S.7 - Stability
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294775
Title
module 3.2.S.4.3 - Annex 4 - Method 1021.055 - Validation Report (BPP-QC-MVR-022-001)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294769
Title
module 3.2.S.4.2 - Annex 5 - Method 1021.004
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294792
Title
module 3.2.S.2.3.1 - Control of Materials
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294812
Title
module 3.2.S - GMP Certificate Site A
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294798
Title
module 3.2.S.2.3.2 - Annex 1 - MCB Report
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
150540
Product/Active constituent Name
Application Product Name
Portela 6.4 mg Solution for Injection for Cats
Application Date
Application Number
150540
Application Product Name
Portela 6.4 mg Solution for Injection for Cats
Application details
Product name:
Portela 6.4 mg Solution for Injection for Cats
Product number:
96736
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 6.4 mg/mL relfovetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in cats in conjunction with the approval of the active ingredient relfovetmab.
Active constituents:
Active constituent name
96735 - Relfovetmab
Description of data provided:
Data no
295016
Title
Pharmacokinetics of Nerve Growth Factor (NGF) Following Different Routes of Administration to Adult Rats
Study date
1994
Auth party contact address
-
Data no
294922
Title
One Hundred Years of Rita
Study date
2009
Auth party contact address
-
Data no
295039
Title
C7X4Z-US-23-389 - Structural report obtained by X-ray crystallography of ZTS-00075623 Fab in co-complex with canine NGF
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295254
Title
The female response to seminal fluid
Study date
2020
Auth party contact address
-
Data no
294899
Title
Part 3a4 - Other requirements
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295062
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 1
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295231
Title
Selective growth stimulating effects of mouse sarcoma on the sensory and sympathetic nervous system of the chick embryo
Study date
1951
Auth party contact address
-
Data no
294876
Title
module 3.2.P.8.2 - Post Approval Stability Commitment
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295085
Title
eLabel - Portela 6.4 mg solution for injection for cats
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295208
Title
Editorial - considering older cats
Study date
2006
Auth party contact address
-
Data no
294853
Title
module 3.2.P.3.5 - Annex 8 - Leachable report VAL-AM-009464-LR
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295108
Title
Monograph for ingredient X - pol
Study date
2009
Auth party contact address
-
Data no
295179
Title
Mice lacking nerve growth factor display perinatal loss of sensory and sympathetic neurons yet develop basal forebrain cholinergic neurons
Study date
1994
Auth party contact address
-
Data no
294830
Title
module 3.2.P.5.3 - Annex 5 - 1021.056 Method Transfer Doc. No. VM387
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295225
Title
Clinical applications of NGF in ocular diseases
Study date
2011
Auth party contact address
-
Data no
295202
Title
Abnormally short serum half-lives of IgG in beta2-microglobin-deficient mice
Study date
1996
Auth party contact address
-
Data no
295325
Title
C481R-US-22-268 - Pharmacokinetics study of anti-NGF mAbs and their respective NGF complexes in healthy adult cats
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295022
Title
First-in-human randomized clinical trials of the safety and efficacy of tanezumab for treatment of chronic knee osteoarthritis pain or acute bunionectomy pain
Study date
2018
Auth party contact address
-
Data no
295271
Title
VICH GL 44 - Target Animal Safety For Veterinary Live and Inactivated Vaccines
Study date
2008
Auth party contact address
-
Data no
294916
Title
C782Z-US-18-128 - Validation of an electrochemiluminescence assay for the detection of anti-ZTS-00084768 antibodies in feline serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294976
Title
Pain Intensity and Trajectory following intra-articular injection of mono-iodoacetate in experimental osteoarthritis: a meta-analysis of in vivo studies
Study date
2023
Auth party contact address
-
Data no
295308
Title
C491W-US-23-191 - Characterisation of total NGF after ZTS-00084768 and human NGF administration in wild type mice
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295317
Title
C360R-US-21-421 - Method development for electrophysiological detection of sensory function alteration following heat, tactile and electrical stimuli in dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294962
Title
Frunevetmab, a felinized anti-nerve growth factor monoclonal antibody, for the treatment of pain from osteoarthritis in cats
Study date
2021
Auth party contact address
-
Data no
295262
Title
Effect of molecular weight on the lymphatic absorption of water-soluble compounds following subcutaneous administration
Study date
1990
Auth party contact address
-
Data no
294824
Title
module 3.2.P.5.2 - Annex 2 - GM104 Test Method
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295162
Title
Nerve growth factor signaling and its contribution to pain
Study date
2020
Auth party contact address
-
Data no
295168
Title
Developmental toxicity assessment of tanezumab, an anti-nerve growth factor antibody, in cynomolgus monkeys (Macaca fascicularis)
Study date
2015
Auth party contact address
-
Data no
294970
Title
NGF/TrkA Signaling as a Therapeutic Target for Pain
Study date
2016
Auth party contact address
-
Data no
295068
Title
C386R-US-20-193 - Safety evaluation of two doses of ZTS-00084768 in laboratory cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294870
Title
Effect of Protein and Solution Properties on the Donnan Effect During the Ultrafiltration of Proteins
Study date
2011
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295116
Title
US FDA DailyMed Database - product Vy
Study date
2025
Auth party contact address
-
Data no
295214
Title
Mutations in the TRKA/NGF receptor gene in patients with congenital insensitivity to pain with anhidrosis
Study date
1996
Auth party contact address
-
Data no
295099
Title
Portela - xxx application
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295265
Title
Genotoxicity assessment of peptide/protein-related biotherapeutics: points to consider before testing
Study date
2016
Auth party contact address
-
Data no
295242
Title
Sequential protein and peptide immunoaffinity capture for mass spectrometry-based quantification of total human beta-nerve growth factor
Study date
2013
Auth party contact address
-
Data no
294887
Title
P.4.B Appendix 1 Skin finding review
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295148
Title
Certificate of Analysis - ZTS-00084768 drug substance - BN K0719RK09
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295122
Title
IgG placetal transfer in healthy and pathological pregnancies
Study date
2012
Auth party contact address
-
Data no
295171
Title
Refinement and initial validation of a multidimensional composite scale for use in assessing acute postoperative pain in cats
Study date
2011
Auth party contact address
-
Data no
294930
Title
Safety and efficacy of subcutaneous tanezumab in patients with knee or hip osteoarthritis
Study date
2018
Auth party contact address
-
Data no
294936
Title
Permeability of the endothelial barrier - identifying and reconciling controversies
Study date
2021
Auth party contact address
-
Data no
294836
Title
module 3.2.P.5.4 - Annex 2 - Pilot Batch Certificates of Analysis
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294979
Title
Owner-perceived signs and veterinary diagnosis in 50 cases of feline osteoarthritis
Study date
2012
Auth party contact address
-
Data no
295056
Title
C481W-US-18-094 - Pharmacokinetics of a pH 7 formulation of anti-NGF monoclonal antibody ZTS-00084768 in cats
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294956
Title
Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice
Study date
2007
Auth party contact address
-
Data no
295005
Title
The female response to seminal fluid
Study date
2020
Auth party contact address
-
Data no
295079
Title
Module 1 - Application overview
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295128
Title
Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip
Study date
2019
Auth party contact address
-
Data no
294856
Title
module 3.2.P.4.1 - Annex 1 - Excipients Certificates of Analysis
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295199
Title
Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice
Study date
2007
Auth party contact address
-
Data no
295248
Title
Evaluation of the effects of hospital visit stress on physiologic parameters in the cat
Study date
2011
Auth party contact address
-
Data no
294985
Title
Evaluation of a therapeutic diet for feline degenerative joint disease
Study date
2010
Auth party contact address
-
Data no
295234
Title
Antibody Pharmacokinetics and Pharmacodynamics
Study date
2004
Auth party contact address
-
Data no
294950
Title
Guideline on immunogenicity assessment of therapeutic proteins
Study date
2017
Auth party contact address
-
Data no
294999
Title
Lymphatic Transport of Proteins After Subcutaneous Administration
Study date
2000
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295036
Title
Portela - EU D181 responses - Aug 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294942
Title
Recommendations for Systemic Statisitcal Comutation of Immunogenicity Cut Points
Study date
2017
Auth party contact address
-
Data no
295185
Title
Guideline for immunogenicity assessment of therapeutic proteins
Study date
2017
Auth party contact address
-
Data no
295191
Title
Osteoarthritis in cats - more common than you think
Study date
2008
Auth party contact address
-
Data no
295285
Title
Portela - EU D121 response - appendix 100-2 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295291
Title
C883C-XC-18-078 - Dose determination of ZTS-00084768 for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients in Europe
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295334
Title
C182W-CA-17-064 - Study of biological agents in cats with naturally-occurring osteoarthritis - principal investigator report - bioanalytical, pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294893
Title
C181C-XC-19-168 - Efficacy and safety of ZTS-00084768 administration every three months for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295142
Title
Part 4b - Clinical
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294993
Title
Analgesic efficacy of an oral transmucosal spray formulation of meloxicam alone or in combination with tramadol in cats with naturally occurring osteoarthritis
Study date
2016
Auth party contact address
-
Data no
295042
Title
C6X0Z-US-23-376 - In vitro assessment of feline anti-nerve growth factor (NGF) mAbs in spontaneous firing rat primary DRG neurons
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294850
Title
module 3.2.P.3.5 - Annex 5 - Validation report VAL-AM-009464-BR2
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295182
Title
A review of current animal models of osteoarthritis pain
Study date
2011
Auth party contact address
-
Data no
294873
Title
Portela - EU D181 responses - Aug 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295088
Title
Data List 3 - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295205
Title
Chapter 12 - Domestic cats as laboratory animals
Study date
2002
Auth party contact address
-
Data no
294827
Title
module 3.2.P.5.3 - Annex 2 - Sterility Test Validation Doc. No. VM391
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295159
Title
Nerve growth factor in the synovial fluid of patients with chronic arthritis
Study date
1992
Auth party contact address
-
Data no
295274
Title
Pharmacokinetics and immunogenicity of frunevetmab in osteoarthritic cats following intravenous and subcutaneous administration
Study date
2021
Auth party contact address
-
Data no
295297
Title
C7X4Z-US-23-380 - Electron microscopy study for cantine b-NGF + antibody ABT-406
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295328
Title
C481W-US-16-049 - Low dose pharmacokinetics of anti-NGF monoclonal antibodies ZTS-00084768 and ZTS-00511205 in cats
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295228
Title
Cross-sectional study of the prevalence of radiographic degenerative joint disease in domesticated cats
Study date
2010
Auth party contact address
-
Data no
295251
Title
Hematopoietic cells as site of first-pass catabolism after subcutaneous dosing and contributors to systemic clearance of a monoclonal antibody in mice
Study date
2018
Auth party contact address
-
Data no
295105
Title
Monograph for ingredient X - dis
Study date
2020
Auth party contact address
-
Data no
294867
Title
GMP Certificate Site F
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294879
Title
module 3.2.P.8.3 - Annex 2 - Clinical batch stability report
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295211
Title
NGF/TrkA signaling as a therapeutic target for pain
Study date
2016
Auth party contact address
-
Data no
294973
Title
Nerve growth factor concentrations in the synovial fluid for healthy dogs and dogs with secondary arthritis
Study date
2011
Auth party contact address
-
Data no
295059
Title
Part 3a3 - Toxicology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295222
Title
Laboratory safety evaluation of bedinvetmab, a canine anti-nerve growth factor monoclonal antibody, in dogs
Study date
2021
Auth party contact address
-
Data no
295305
Title
C491W-US-22-180 - Pharmacokinetics of ZTS-00525973, ZTS-00084768, ZTS-00521310 and ZTS-00521427 in mice
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294913
Title
CTX0Z-US-20-185 - Generation of a GS vector encoding the feline anti-NGF antibody, ZTS-00084768
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295013
Title
Biodistribution mechanisms of therapeutic monoclonal antibodies in health and disease
Study date
2010
Auth party contact address
-
Data no
295019
Title
Guideline on good clinical practices
Study date
2009
Auth party contact address
-
Data no
295268
Title
Clinical magnetic resonance-enabled characterization of mono-iodoacetate-induced osteoarthritis in a large animal species
Study date
2018
Auth party contact address
-
Data no
295119
Title
US FDA Inactive Ingredients Database - ingredient X - pol
Study date
2025
Auth party contact address
-
Data no
295065
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 4
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295311
Title
C667Z-US-20-388 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibodies ZTS-00508841 (xxx) against canine/human/rat/mouse NGF, canine/human neurotrophins and canine/human/rat FcRns
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295314
Title
C762Z-US-20-323 - Validation of an electrochemiluminescence method for the quantitation of ZTS-00075623 in canine serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294919
Title
C782W-US-17-061 - Assay procedure for the quantitative determination of ZTS-00084768 in feline serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295165
Title
A study of owner observed behavioural and lifestyle changes in cats with musculoskeletal disease before and after analgesic therapy
Study date
2009
Auth party contact address
-
Data no
294933
Title
Refinement and initial validation of a multidimensional composite scale for use in assessing acute post operative pain in cats
Study date
2011
Auth party contact address
-
Data no
294910
Title
C782Z-US-18-127 - Validation of a GYROS method for the quantification of ZTS-00084768 in feline serum
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295076
Title
Chapter 22 - Disposition of biological therapeutics - monoclonal antibodies, proteins and peptides
Study date
2012
Auth party contact address
-
Data no
295145
Title
C486Z-US-18-125 - Validation of a competitive ligand binding electrochemiluminescence assay for the detection of neutralizing anti-ZTS-00084768 antibodies in feline serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294839
Title
module 3.2.P.1 - Description and Composition of the Drug Product
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294859
Title
module 3.2.P.5.5 - Characterisation of Impurities Drug Product
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295025
Title
Lymphatic transport and catabolism of therapeutic proteins after subcutaneous administration to rats and dogs
Study date
2012
Auth party contact address
-
Data no
295102
Title
Module 3.2 - OHS Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294953
Title
Guidance for Industry - Immunogenicity assessment for therapeutic protein products
Study date
2014
Auth party contact address
-
Data no
294959
Title
Abnormally short serum half-lives of IgG in beta2-microglobin-deficient mice
Study date
1996
Auth party contact address
-
Data no
295002
Title
Mechanistic determinants of biotherapeutics absoption following SC administration
Study date
2012
Auth party contact address
-
Data no
295125
Title
Monograph for ingredient X - suc
Study date
2020
Auth party contact address
-
Data no
294982
Title
Ca2plus transmembrane fluxes and nerve growth factor action on a clonal cell line of rat phaeochromocytoma
Study date
1980
Auth party contact address
-
Data no
295053
Title
C180W-CA-16-050 - Study of biological agents in cats with naturally-occurring osteoarthritis
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295151
Title
C782W-US-17-061 - Assay procedure for the quantitative determination of ZTS-00084768 in feline serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294833
Title
module 3.2.P.5.3 - Annex 8 - GM104 Method Validation
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294939
Title
High-affinity TrkA and p75 neurotrophin receptor complexes - a twisted affair
Study date
2022
Auth party contact address
-
Data no
295188
Title
Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs
Study date
2021
Auth party contact address
-
Data no
295033
Title
Portela - EU D121 responses - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295045
Title
C360R-US-21-420 - Mode of action comparative study with ZTS-00075623 and ZTS-00103182 in Beagle dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295082
Title
Application - Portela 2.5 mg solution for injection for cats
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294890
Title
C883C-XC-18-078 - Dose determination of ZTS-00084768 for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients in Europe - stats
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295245
Title
Tanezumab - therapy targeting nerve growth factor in pain pathogenesis
Study date
2018
Auth party contact address
-
Data no
295282
Title
Stratification of antibody-positive subjects by antibody level reveals an impact of immunogenicity on pharmacokinetics
Study date
2013
Auth party contact address
-
Data no
295294
Title
C6X0Z-US-23-376 - In vitro assessment of feline anti-nerve growth factor (NGF) mAbs in spontaneous firing rat primary DRG neurons
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295331
Title
C180W-CA-16-050 - Study of biological agents in cats with naturally-occurring osteoarthritis
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294847
Title
module 3.2.P.3.5 - Annex 2 - Process Validation Report PV021
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295096
Title
Portela PAA advice
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294996
Title
Pain-related sensory innervation in monoiodoacetate-induced osteoarthritis in rat knees that gradually develops neuronal injury in addition to inflammatory pain
Study date
2011
Auth party contact address
-
Data no
294896
Title
C182W-US-16-048 - Comparing efficacy of the felinized anti-NGF monoclonal antibody ZTS-00084768 and ZTS-00511205 in the feline MIA model of osteoarthritis
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295139
Title
Part 3a4 - Other requirements
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295288
Title
C181C-US-17-065 - Field stafety and efficacy of ZTS-00084768 compared to placebo for the treatment of pain associated with osteoarthritis in cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295337
Title
Independent expert review and opinion on bone/cartilage findings in two repeat dose studies with ZTS-00084768 in male and female domestic short-haired cats
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294874
Title
Portela - commitment letter
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294945
Title
EMA scientific advice - NV-01-Mab osteoarthritis
Study date
2014
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295206
Title
Frunevetmab, a felinized anti-nerve growth factor monoclonal antibody, for the treatment of pain from osteoarthritis in cats
Study date
2021
Auth party contact address
-
Data no
295277
Title
Nerve growth factor - structure and function
Study date
2001
Auth party contact address
-
Data no
295229
Title
Evaluation of a therapeutic diet for feline degenerative joint disease
Study date
2010
Auth party contact address
-
Data no
294828
Title
module 3.2.P.5.3 - Annex 3 - 1021.058 Method Transfer Doc. No. VM390
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295160
Title
APVMA guidelines - Toxicology (Part 3)
Study date
2017
Auth party contact address
-
Data no
294851
Title
module 3.2.P.3.5 - Annex 6 - Compatibility report VAL-AM-009464-CR
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295183
Title
ICH S8 - Immunotoxicity studies for human pharmaceuticals
Study date
2006
Auth party contact address
-
Data no
295131
Title
Safety Data Sheet for Portela (relfovetmab injection), SDS No. AU 3398 v 01
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295154
Title
C782Z-US-20-232 - Method validation for the quantitation of ZTS-00084768 in cat serum by Turbo Ion Spray LC/MS/MS - revised report
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295323
Title
C481R-CA-18-102 - Absolute bioavailability and pharmacokinetics of ZTS-00084768 in cats with naturally occurring osteoarthritis - individual scientist report - pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295177
Title
High-affinity TrkA and p75 neurotrophin receptor complexes - a twisted affair
Study date
2022
Auth party contact address
-
Data no
295300
Title
C461W-US-21-463 - Exploratory pharmacokinetics study of anti-NGF mAbs and their respective complexes in healthy adult Beagle dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294868
Title
Pharmacopoeial Test Methods - Drug Product
Study date
2021
Auth party contact address
-
Data no
294928
Title
A study of owner observed behavioural and lifestyle changes in cats with musculoskeletal disease before and after analgesic therapy
Study date
2009
Auth party contact address
-
Data no
295223
Title
Animal models of osteoarthritis: classification, update, and measurement of outcomes
Study date
2016
Auth party contact address
-
Data no
295260
Title
ISFM and AAFP consensus guidelines - long-term use of NSAIDs in cats
Study date
2010
Auth party contact address
-
Data no
294914
Title
C481W-US-16-044 - Reagent generation of polyclonal antibodies to anti-NGF monoclonal antibodies ZTS-00084768, ZTS-00511205 and ZTS-00507082 in cats
Study date
2017
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294974
Title
Neurotrophic Factors and Nociceptor Sensitization
Study date
2009
Auth party contact address
-
Data no
295060
Title
Part 4A4 - Pre-Clinical Trials -Tolerance in Target Animal Species - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295269
Title
Somatosensory evoked potentials of the dog: recording techniques and normal values
Study date
1989
Auth party contact address
-
Data no
295306
Title
C491W-US-22-181 - Pharmacokinetics of ZTS-00084768 in human FcRn transgenic mouse model
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295114
Title
US FDA Inactive Ingredients Database - ingredient X - suc
Study date
2025
Auth party contact address
-
Data no
295120
Title
A physiologically-based pharmacokinetic model for the prediction of monoclonal antibody pharmacokinetics from in vitro data
Study date
2019
Auth party contact address
-
Data no
295014
Title
Disentangling the signaling complexity of nerve growth factor receptors by CRISPR/Cas9
Study date
2022
Auth party contact address
-
Data no
295020
Title
Guidance for Industry Target Animal Safety for Veterinary Pharmaceutical Products
Study date
2009
Auth party contact address
-
Data no
294822
Title
module 3.2.P.5.2 - Analytical Procedures Drug Product
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295166
Title
Safety and efficacy of subcutaneous tanezumab in patients with knee or hip osteoarthritis
Study date
2018
Auth party contact address
-
Data no
294968
Title
Perspectives on subcutaneous route of administration as an immunogenicity risk factor for therapeutic proteins
Study date
2017
Auth party contact address
-
Data no
295312
Title
C687Z-US-20-228 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibody NV-02 (xxx) against canine(feline)/human/rat/mouse NGFs, feline/human neurotrophins and feline/human/rat FcRns
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294862
Title
module 3.2.P.7 - Container Closure System
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295028
Title
Regulation of expression of mRNAs encoding the nerve growth factor receptors p75 and trkA in developing sensory neurons
Study date
1993
Auth party contact address
-
Data no
295289
Title
C181C-US-17-065 - Field stafety and efficacy of ZTS-00084768 compared to placebo for the treatment of pain associated with osteoarthritis in cats - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294885
Title
Part 4A3 Pre-Clinical Trials -Dose Determination-Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294934
Title
Anti-nerve growth factor in pain managment: current evidence
Study date
2016
Auth party contact address
-
Data no
294911
Title
C360R-US-21-421 - Method development for electrophysiological detection of sensory function alteration following heat, tactile and electrical stimuli in dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295097
Title
Portela Project Plan
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295146
Title
C782Z-US-18-111 - Quantification of an electrochemiluminescence assay for the detection of anti-ZTS-00084768 antibodies in feline serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295220
Title
Serum nerve growth factor in horses with osteoarthritis-associated lameness
Study date
2023
Auth party contact address
-
Data no
294954
Title
Immunogenicity testing of therapeutic protein products - developing and validating assays for anti-drug antibody detection
Study date
2019
Auth party contact address
-
Data no
295197
Title
Meniscal mineralization in domestic cats
Study date
2010
Auth party contact address
-
Data no
294977
Title
Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies
Study date
2010
Auth party contact address
-
Data no
294834
Title
module 3.2.P.5.4 - Batch Analyses Drug Product
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294905
Title
C7X4Z-US-23-379 - Electron microscopy study of ZTS-00075623: cytokine complex
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295077
Title
Chapter 11 - Physiologic IgG biodistribution, transport, and clearance - implications for monoclonal antibody products
Study date
2008
Auth party contact address
-
Data no
295054
Title
C180W-CA-16-050 - Study of biological agents in cats with naturally-occurring osteoarthritis - principal investigator report - bioanalytical, pharmacokinetics and immunogenicity
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295103
Title
Part 3a5 - User safety
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295034
Title
Portela - EU D121 response - appendix 100-1 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295283
Title
Portela - EU D121 responses - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294891
Title
C382R-US-17-051 - A 3-month exploratory safety study of ZTS-00084768 in adult laboratory cats
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294997
Title
Tanezumab: Therapy targeting nerve growth in pain pathogenesis
Study date
2018
Auth party contact address
-
Data no
295083
Title
Application - Portela 6.4 mg solution for injection for cats
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295246
Title
Pleiotropic activity of nerve growth factor in regulating cardiac functions and counteracting pathogenesis
Study date
2021
Auth party contact address
-
Data no
295332
Title
C180W-CA-16-050 - Study of biological agents in cats with naturally-occurring osteoarthritis - principal investigator report - bioanalytical, pharmacokinetics and immunogenicity
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295048
Title
C481R-US-22-268 - Pharmacokinetics study of anti-NGF mAbs and their respective NGF complexes in healthy adult cats
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294948
Title
EMA assessment report - Raylumis
Study date
2021
Auth party contact address
-
Data no
294842
Title
module 3.2.P.3.2 - Batch Formula
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294848
Title
module 3.2.P.3.5 - Annex 3 - Adsorption report VAL-AM-009464-AR
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295340
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 3
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294991
Title
NGF and Its Receptors in the Regulation of Inflammatory Response
Study date
2017
Auth party contact address
-
Data no
295240
Title
Beta-NGF and beta-NGF receptor upregulation in blood and synovial fluid in osteoarthritis
Study date
2017
Auth party contact address
-
Data no
295091
Title
GMP Certificate Site F
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295140
Title
Part 4a1 - Pharmacology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295040
Title
C687Z-US-22-272 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibody felinized ZTS-00084768 (xxx) against canine(feline)/human/rat/mouse NGFs, feline/human neurotrophins and feline/human/rat FcRns
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295111
Title
CVMP assessment report for Librela (EMEA/V/C/005180/0000)
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295063
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 2
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294825
Title
module 3.2.P.5.3 - Validation Analytical Procedures Drug Product
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295157
Title
Nerve growth factor biodelivery: a limiting step in moving toward extensive clinical application
Study date
2021
Auth party contact address
-
Data no
295134
Title
Module 3 - Health Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295203
Title
Development and validation of a new model of inflammation in the cat and selection of surrogate endpoints for testing anti-inflammatory drugs
Study date
2005
Auth party contact address
-
Data no
295280
Title
Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects
Study date
2010
Auth party contact address
-
Data no
294854
Title
module 3.2.P.3.5 - Annex 9 - Toxicology assessment RC-RSF
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295180
Title
Recommendations for systematic statistical computation of immunogenicity cut points
Study date
2017
Auth party contact address
-
Data no
295303
Title
C491W-US-15-026 - Pharmacokinetics of feline anti-NGF monoclonal antibodies ZTS-00084768 and ZTS-00507082 in rats
Study date
2017
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294831
Title
module 3.2.P.5.3 - Annex 6 - 1021.055 Method Transfer Doc. No. VM386
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295249
Title
Species-specific variation in glycosylation of IgG - evidence for the species-specific sialylation and branch-specific galactosylation and importance for engineering recombinant glycoprotein therapeutics
Study date
2000
Auth party contact address
-
Data no
295326
Title
C481W-US-15-028 - Pharmacokinetics of ZTS-00084768, an anti-NGF monoclonal antibody, in cats
Study date
2016
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295226
Title
Ca2plus transmembrane fluxes and nerve growth factor action on a clonal cell line of rat phaeochromocytoma
Study date
1980
Auth party contact address
-
Data no
295117
Title
US FDA DailyMed Database - product Cl
Study date
2025
Auth party contact address
-
Data no
295057
Title
C481W-US-15-030 - Pharmacokinetics and immunogenicity of speciated monoclonal antibodies in cats - principal investigator report - pharmacokinetics
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295071
Title
Module 7 - Environment Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295320
Title
C386R-US-20-193 - Safety evaluation of two doses of ZTS-00084768 in laboratory cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294925
Title
Rita levi-montalcini - the discovery of nerve growth factor and modern neurobiology
Study date
2004
Auth party contact address
-
Data no
295011
Title
ISFM and AAFP Consensus Guidelines Long-term use of NSAIDS in cats
Study date
2010
Auth party contact address
-
Data no
295257
Title
Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides - harmonized terminology and tactical recommendations
Study date
2014
Auth party contact address
-
Data no
294865
Title
module 3.2.P.7.2 - Annex 1 - Toxicology assessment - Extractables
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294871
Title
VICH GL 3 - Stability: Stability Testing of New Veterinary Drug Substances (Revision)
Study date
2007
Auth party contact address
-
Data no
294965
Title
Characterization of osteoarthritis in cats and meloxicam efficacy using objective chronic pain evaluation tools
Study date
2013
Auth party contact address
-
Data no
294971
Title
Preclinical safety evaluation of biotechnology-derived pharmaceuticals, S6(R1)
Study date
2011
Auth party contact address
-
Data no
295309
Title
C665Z-US-20-380 - In vitro functional potency of anti-nerve growth factor (NGF) mAbs
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294917
Title
Certificate of Analysis - ZTS-00084768 drug substance - BN K0719RK09
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295163
Title
Evaluation of the white-coat effects in cats
Study date
1999
Auth party contact address
-
Data no
295017
Title
Clinical magnetic resonance-enabled characterization of mono-iodoacetate-induced osteoarthritis in a large animal species
Study date
2018
Auth party contact address
-
Data no
295263
Title
Biodistribution mechanisms of therapeutic monoclonal antibodies in health and disease
Study date
2010
Auth party contact address
-
Data no
294957
Title
A fully caninised anti-NGF monoclonal antibody for pain relief in dogs
Study date
2013
Auth party contact address
-
Data no
295123
Title
Pain processing is faster that tactile processing in the human brain
Study date
2006
Auth party contact address
-
Data no
295194
Title
Guidance for Industry - Nonclinical evaluation of the immunotoxic potential of pharmaceuticals
Study date
2023
Auth party contact address
-
Data no
295051
Title
C181C-US-17-065 - Field stafety and efficacy of ZTS-00084768 compared to placebo for the treatment of pain associated with osteoarthritis in cats - stats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295100
Title
Portela - xxx responses to questions
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295217
Title
Cartilage stem/progenitor cells are activated in osteoarthritis via interleukin-1beta/nerve growth factor signaling
Study date
2015
Auth party contact address
-
Data no
295266
Title
Systems pharmacology of the NGF signalling through p75 and TrkA receptors
Study date
2014
Auth party contact address
-
Data no
295074
Title
Note for Guidance - Environmental risk assessment for immunological veterinary medicinal products
Study date
1997
Auth party contact address
-
Data no
295243
Title
Targeting the nerve growth factor (NGF) pathway in drug discovery. Potential applications to new therapies for chronic pain
Study date
2016
Auth party contact address
-
Data no
294888
Title
C883C-XC-18-078 - Dose determination of ZTS-00084768 for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients in Europe
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295031
Title
Clinico-radiological diagnosis and grading of rapidly progressive osteoarthritis of the hip
Study date
2017
Auth party contact address
-
Data no
295008
Title
Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides - harmonized terminology and tactical recommendations
Study date
2014
Auth party contact address
-
Data no
295174
Title
Permeability of the endothelial barrier - identifying and reconciling controversies
Study date
2021
Auth party contact address
-
Data no
294908
Title
C667Z-US-20-388 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibodies ZTS-00508841 (xxx) against canine/human/rat/mouse NGF, canine/human neurotrophins and canine/human/rat FcRns
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295080
Title
Module 4b - Scheduling Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294882
Title
module 3.2.P.8.3 - Annex 5 - Registration batch stability report
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294931
Title
Osteoarthritis, angiogenesis and inflammation
Study date
2005
Auth party contact address
-
Data no
294980
Title
Animal models of osteoarthritis: classification, update, and measurement of outcomes
Study date
2016
Auth party contact address
-
Data no
294951
Title
Anti-nerve growth factor monoclonal antibodies for the control of pain in dogs and cats
Study date
2018
Auth party contact address
-
Data no
295200
Title
A fully caninised anti-NGF monoclonal antibody for pain relief in dogs
Study date
2013
Auth party contact address
-
Data no
295094
Title
module 3.2.S - GMP Certificate Site C
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294902
Title
C6X0Z-US-23-401 - In vitro functional and transcriptomic assessment of canine anti-nerve growth factor (NGF) mAbs in spontaneous firing rat primary DRG neurons
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294988
Title
Antibody Pharmacokinetics and Pharmacodynamics
Study date
2004
Auth party contact address
-
Data no
295000
Title
Evaluation of the effects of hospital visit stress on physiologic parameters in the cat
Study date
2011
Auth party contact address
-
Data no
295329
Title
C481W-US-17-066 - Pharmacokinetics of two formulations of anti-NGF monoclonal antibodies ZTS-00084768 in cats
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294937
Title
Prevalence of radiographic signs of degenerative joint disease in a hospital population of cats
Study date
2005
Auth party contact address
-
Data no
295343
Title
C181C-XC-19-168 - Efficacy and safety of ZTS-00084768 administration every three months for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295037
Title
Part 3a4 - Formulation description relfovetmab
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295286
Title
Portela - EU D181 responses - Aug 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295292
Title
C883C-XC-18-078 - Dose determination of ZTS-00084768 for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients in Europe - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295137
Title
Part 3a2 - Pharmacology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295143
Title
Part 4b - Clinical - appendix 1
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295186
Title
Questions and answers on monoclonal antibodies for veterinary use
Study date
2017
Auth party contact address
-
Data no
294994
Title
Sequential protein and peptide immunoaffinity capture for mass spectrometry-based quantification of total human beta-nerve growth factor
Study date
2013
Auth party contact address
-
Data no
295237
Title
WSAVA guidelines for recognition, assessment and treatment of pain
Study date
2014
Auth party contact address
-
Data no
294845
Title
module 3.2.P.3.5 - Process Validation and/or Evaluation
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294894
Title
C181C-XC-19-168 - Efficacy and safety of ZTS-00084768 administration every three months for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295135
Title
Module 3.1 - Toxicology Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294897
Title
Module 8 - Efficacy & Safety Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295112
Title
US FDA Inactive Ingredients Database - ingredient X - sod
Study date
2025
Auth party contact address
-
Data no
294849
Title
module 3.2.P.3.5 - Annex 4 - Validation report VAL-AM-009464-BR1
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295181
Title
Chemical arthrodesis of the distal tarsal joints using sodium monoiodoacetate in 104 horses
Study date
2004
Auth party contact address
-
Data no
294826
Title
module 3.2.P.5.3 - Annex 1 - Endotoxin Test Validation Doc. No. VM392
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295158
Title
Rita levi-montalcini - the discovery of nerve growth factor and modern neurobiology
Study date
2004
Auth party contact address
-
Data no
295298
Title
C7X4Z-US-23-389 - Structural report obtained by X-ray crystallography of ZTS-00075623 Fab in co-complex with canine NGF
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295304
Title
C491W-US-21-144 - Pharmacokinetics of ZTS-00084768 and ZTS-00521632 in a feline FcRn/B2M transgenic mouse model
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295321
Title
C182W-US-15-025 - Effects of the felinized anti-NGF monoclonal antibody ZTS-00084768 (5 mg/kg, SC) in feline MIA model of osteoarthritis
Study date
2016
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295327
Title
C481W-US-15-030 - Pharmacokinetics and immunogenicity of speciated monoclonal antibodies in cats - principal investigator report - pharmacokinetics
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295252
Title
Pharmacokinetics of monoclonal antibodies
Study date
2017
Auth party contact address
-
Data no
295275
Title
Monoclonal antibody pharmacokinetics and pharmacodynamics
Study date
2008
Auth party contact address
-
Data no
294880
Title
module 3.2.P.8.3 - Annex 3 - Freeze thaw stability report
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295058
Title
C461W-US-22-466 - Pharmacokinetics study of canine NGF in healthy adult Beagle dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295212
Title
Neurotrophin signaling is required for glucose-induced insulin secretion
Study date
2016
Auth party contact address
-
Data no
295106
Title
Monograph for ingredient X - sod
Study date
2020
Auth party contact address
-
Data no
295118
Title
US FDA Inactive Ingredients Database - ingredient X - lme
Study date
2025
Auth party contact address
-
Data no
294926
Title
Nerve growth factor signaling and its contribution to pain
Study date
2020
Auth party contact address
-
Data no
295012
Title
Effect of Molecular weight on the Lymphatic Absorption of Water-Soluble Compounds Following Subcutaneous Administration
Study date
1990
Auth party contact address
-
Data no
295258
Title
Neurotrophins and neurotrophin antagonists as potential therapeutics
Study date
1995
Auth party contact address
-
Data no
295072
Title
Part 3a6 - Environmental Risk Assessment
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294966
Title
Evoked Temporal Summation in Cats to Highlight Central Sensitization related to Osteoarthritis-associated Chronic Pain: A Preliminary Study
Study date
2014
Auth party contact address
-
Data no
294972
Title
Mutations in the TRKA/NGF receptor gene in patients with congenital insensitivity to pain with anhidrosis
Study date
1996
Auth party contact address
-
Data no
294866
Title
GMP Certificate Site E
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295315
Title
Technical Memo - Qantitative analysis of reports NIS424.R004 and NIS424.R002
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294920
Title
C782Z-US-18-110 - Qualification of a GYROS method for the quantification of ZTS-00084768 in feline serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295264
Title
Disentangling the signaling complexity of nerve growth factor receptors by CRISPR/Cas9
Study date
2022
Auth party contact address
-
Data no
295066
Title
C380N-US-17-074 - ZTS-00084768: A 70-day T-cell dependent immune response study in cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295052
Title
C481R-CA-18-102 - Absolute bioavailability and pharmacokinetics of ZTS-00084768 in cats with naturally occurring osteoarthritis - individual scientist report - pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295218
Title
Pain intensity and trajectory following intra-articular injection of mono-iodoacetate in experimental osteoarthritis: a meta-analysis of in vivo studies
Study date
2023
Auth party contact address
-
Data no
294909
Title
C782Z-US-20-232 - Method validation for the quantitation of ZTS-00084768 in cat serum by Turbo Ion Spray LC/MS/MS - revised report
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295075
Title
Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies
Study date
2010
Auth party contact address
-
Data no
294840
Title
module 3.2.P.2 - Pharmaceutical Development
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295169
Title
NGF in early embryogenesis, differentiation, and pathology in the nervous and immune systems
Study date
2015
Auth party contact address
-
Data no
295195
Title
Rapidly progressive osteoarthritis - a review of the clinical and radiologic presentation
Study date
2017
Auth party contact address
-
Data no
295244
Title
Pain-related sensory innervation in monoiodoacetate-induced osteoarthritis in rat knees that gradually develops neuronal injury in addition to inflammatory pain
Study date
2011
Auth party contact address
-
Data no
294883
Title
Part 4A1 Efficacy Documentation
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294960
Title
Development and validation of a new model of inflammation in the cat and selection of surrogate endpoints for testing anti-inflammatory drugs
Study date
2005
Auth party contact address
-
Data no
295126
Title
Classifying Hazardous Chemicals - National Guide, June 2023
Study date
2023
Auth party contact address
-
Data no
294860
Title
module 3.2.P.5.6 - Justification of Specification Drug Product
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294983
Title
Evaluation of Functional Outcome After BFX Total Hip Replacement Using a Pressure Sensitive Walkway
Study date
2010
Auth party contact address
-
Data no
295026
Title
Nerve growth factor: structure and function
Study date
2001
Auth party contact address
-
Data no
295032
Title
Stratification of Antibody-Positive Subjects by antibody Level Reveals an Impact of Immunognicity on Pharmacokinetics
Study date
2013
Auth party contact address
-
Data no
294932
Title
The Transmission of Immunity from mother to young and the Catabolism of Immunoglobulins
Study date
1966
Auth party contact address
-
Data no
295003
Title
Hematopoietic cells as site of first-pass catabolism after subcutaneous dosing and contributors to systemic clearance of a monoclonal antibody in mice
Study date
2018
Auth party contact address
-
Data no
295175
Title
Feline osteoarthritis - a prospective study of 28 cases
Study date
2006
Auth party contact address
-
Data no
295152
Title
C782Z-US-18-110 - Qualification of a GYROS method for the quantification of ZTS-00084768 in feline serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295046
Title
C6X0Z-US-23-401 - In vitro functional and transcriptomic assessment of canine anti-nerve growth factor (NGF) mAbs in spontaneous firing rat primary DRG neurons
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295295
Title
C6X0Z-US-23-401 - In vitro functional and transcriptomic assessment of canine anti-nerve growth factor (NGF) mAbs in spontaneous firing rat primary DRG neurons
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294903
Title
C182W-CA-17-064 - Study of biological agents in cats with naturally-occurring osteoarthritis
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294940
Title
Models of osteoarthritis - the good, the bad and the promising
Study date
2019
Auth party contact address
-
Data no
294952
Title
Osteoarthritis in cats: More common than you think
Study date
2008
Auth party contact address
-
Data no
295095
Title
module 3.2.S - GMP Certificate Site D
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295344
Title
C181C-XC-19-168 - Efficacy and safety of ZTS-00084768 administration every three months for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients - stats
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295281
Title
Clinico-radiological diagnosis and grading of rapidly progressive osteoarthritis of the hip
Study date
2017
Auth party contact address
-
Data no
294889
Title
C883C-XC-18-078 - Dose determination of ZTS-00084768 for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients in Europe - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295138
Title
Part 3a3 - Toxicology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294989
Title
Antagonism of Nerve Growth Factor-TrkA Signaling and the Relief of Pain
Study date
2011
Auth party contact address
-
Data no
294995
Title
Targeting the Nerve Growth Factor (NGF) Pathway in Drug Discovery. Potential Applications to New Therapies for Chronic Pain
Study date
2017
Auth party contact address
-
Data no
294846
Title
module 3.2.P.3.5 - Annex 1 - Process Validation Report PV011
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295089
Title
Data List 4 - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295338
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 1
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295189
Title
EMA assessment report - Raylumis
Study date
2021
Auth party contact address
-
Data no
295238
Title
Familial insensitivity to pain (HSAN V) and a mutation in the NGFB gene. A neurophysiological and pathological study
Study date
2004
Auth party contact address
-
Data no
294969
Title
Determination of salivary and serum immunoglobulin concentrations in the cat
Study date
1998
Auth party contact address
-
Data no
295301
Title
C461W-US-22-466 - Pharmacokinetics study of canine NGF in healthy adult Beagle dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294946
Title
Questions and answers on monoclonal antibodies for veterinary use
Study date
2017
Auth party contact address
-
Data no
295278
Title
Regulation of expression of mRNAs encoding the nerve growth factor receptors p75 and trkA in developing sensory neurons
Study date
1993
Auth party contact address
-
Data no
294923
Title
Nerve growth factor biodelivery: a limiting step in moving toward extensive clinical application
Study date
2021
Auth party contact address
-
Data no
295086
Title
Data List 1 - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295255
Title
Antibody biodistribution coefficients. Inferring tissue concentrations of monoclonal antibodies based on the plasma concentrations in several preclinical species and human
Study date
2013
Auth party contact address
-
Data no
294900
Title
3.2.s.1 General Information
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295109
Title
Subcutaneous bioavailability of therapeutic antibodies as a function of FcRn binding affinity in mice
Study date
2012
Auth party contact address
-
Data no
295232
Title
Nerve growth factor and nociception
Study date
1993
Auth party contact address
-
Data no
294877
Title
module 3.2.P.8.3 - Primary and Supportive Stability Data
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295132
Title
C782Z-US-21-251 - Construction and validation of a mechanistic pharmacokinetic (PK) model for projections of in vivo relfovetmab concentrations in human upon accidental exposure
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294829
Title
module 3.2.P.5.3 - Annex 4 - 1021.054 Method Transfer Doc. No. VM385
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295155
Title
Heart rate and heart rate variability of healthy cats in home and hospital environments
Study date
2005
Auth party contact address
-
Data no
295178
Title
Models of osteoarthritis - the good, the bad and the promising
Study date
2019
Auth party contact address
-
Data no
295201
Title
In vitro and in vivo characterization of a fully felinized therapeutic anti-nerve growth factor monoclonal antibody for the treatment of pain in cats
Study date
2016
Auth party contact address
-
Data no
295324
Title
C481R-CA-20-213 - Absolute bioavailability and pharmacokinetics of ZTS-00084768 in cats with naturally occurring osteoarthritis - amended individual scientist report - pharmacokinetics and immunogenicity
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294963
Title
Mechanisms of drug toxicity and relevance to pharmaceutical development
Study date
2011
Auth party contact address
-
Data no
295224
Title
Nerve growth factor inhibition with tanezumab influences weight-bearing and subsequent cartilage damage in the rat medial meniscal tear model
Study date
2016
Auth party contact address
-
Data no
295307
Title
C491W-US-23-185 - Pharmacokinetics of ZTS-00084768 in feline FcRn transgenic mouse model
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295069
Title
Expert opinion on ECG result comparisons across two target animal safety studies with ZTS-00084768
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295272
Title
Association of mineralisations in the stifle joint of domestic cats with degenerative joint disease and cranial cruciate ligament pathology
Study date
2017
Auth party contact address
-
Data no
295009
Title
Neurotrophins and neurotrophin antagonists as potential therapeutics
Study date
1995
Auth party contact address
-
Data no
295023
Title
Pharmacokinetics and immunogenicity of frunevetmab in osteoarthritic cats following intravenous and subcutaneous administration
Study date
2021
Auth party contact address
-
Data no
295318
Title
C380N-US-17-074 - ZTS-00084768: A 70-day T-cell dependent immune response study in cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295209
Title
Perspectives on subcutaneous route of administration as an immunogenicity risk factor for therapeutic proteins
Study date
2017
Auth party contact address
-
Data no
295215
Title
Nerve growth factor concentrations in the synovial fluid from healthy dogs and dogs with secondary osteoarthritis
Study date
2011
Auth party contact address
-
Data no
294823
Title
module 3.2.P.5.2 - Annex 1 - GM103 Test Method
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295161
Title
Utility of a human FcRn transgenic mouse model in drug discovery for early assessment and prediction of human pharmacokinetics of monoclonal antibodies
Study date
2016
Auth party contact address
-
Data no
295015
Title
Systems pharmacology of the NGF signalling through p75 and TrkA receptors
Study date
2014
Auth party contact address
-
Data no
295261
Title
Cutaneous lesions and clinical outcomes in five cats after frunevetmab injections
Study date
2023
Auth party contact address
-
Data no
294869
Title
Module 2 - Chemistry & Manufacture Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295115
Title
US FDA DailyMed Database - product No
Study date
2025
Auth party contact address
-
Data no
294886
Title
Part 4B1 - Clinical Trials - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295241
Title
2022 WSAVA guidelines for the recognition, assessment and treatment of pain
Study date
2023
Auth party contact address
-
Data no
294837
Title
module 3.2.P.5.4 - Annex 3 - Supporting Batch Certificates of Analysis
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295098
Title
Application - Portela Import Permit
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295172
Title
Anti-nerve growth factor in pain management - current evidence
Study date
2016
Auth party contact address
-
Data no
294863
Title
module 3.2.P.7.2 - Annex 1 - Extractables and Leachables Study Report - Container / Closure
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294912
Title
C360R-CA-21-426 - Effects of anti-NGF monoclonal antibodies on nerve growth factor (NGF)-induced sensitization using nerve conduction testing in dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295049
Title
C181C-US-17-065 - Field stafety and efficacy of ZTS-00084768 compared to placebo for the treatment of pain associated with osteoarthritis in cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295055
Title
C481W-US-15-028 - Pharmacokinetics of ZTS-00084768, an anti-NGF monoclonal antibody, in cats
Study date
2016
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295221
Title
Owner-perceived signs and veterinary diagnosis in 50 cases of feline osteoarthritis
Study date
2012
Auth party contact address
-
Data no
295149
Title
CTX0Z-US-20-185 - Generation of a GS vector encoding the feline anti-NGF antibody, ZTS-00084768
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295198
Title
Cardiac innervation and sudden cardiac death
Study date
2015
Auth party contact address
-
Data no
294929
Title
Osteoarthritis in the cat - 1. how common is it and how easy to recognise
Study date
2012
Auth party contact address
-
Data no
295006
Title
Antibody biodistribution coefficients
Study date
2013
Auth party contact address
-
Data no
294857
Title
module 3.2.P.4.5 - Annex 1 - BSE/TSE statements
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294906
Title
Technical Memo - Qantitative analysis of reports NIS424.R004 and NIS424.R002
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295029
Title
Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development
Study date
2017
Auth party contact address
-
Data no
295078
Title
VICH GL 6 - Guideline on environmental impact assessment (EIAS) for veterinary medicinal products - Phase 1
Study date
2008
Auth party contact address
-
Data no
295129
Title
Transfer of antibody via mother's milk
Study date
2003
Auth party contact address
-
Data no
295141
Title
Part 4a4 - Target animal safety
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295235
Title
Antagonism of nerve growth factor-TrkA signaling and relief of pain
Study date
2011
Auth party contact address
-
Data no
295284
Title
Portela - EU D121 response - appendix 100-1 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295341
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 4
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294949
Title
Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs
Study date
2014
Auth party contact address
-
Data no
294986
Title
Nerve growth factor and nociception
Study date
1993
Auth party contact address
-
Data no
295035
Title
Portela - EU D121 response - appendix 100-2 - Mar 25
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295043
Title
C481W-US-16-049 - Low dose pharmacokinetics of anti-NGF monoclonal antibodies ZTS-00084768 and ZTS-00511205 in cats
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295192
Title
Guidance for Industry - Immunogenicity assessment for therapeutic protein products
Study date
2014
Auth party contact address
-
Data no
294843
Title
module 3.2.P.3.3 - Description of Manufacturing Process and Process Controls
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295092
Title
module 3.2.S - GMP Certificate Site A
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295335
Title
C382N-US-17-069 - A 6-month study of ZTS-00084768 by subcutaneous injection in adult domestic cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294943
Title
Chemical arthrodesis of the distal tarsal joints using sodium monoiodoacetate in 104 horses
Study date
2004
Auth party contact address
-
Data no
294992
Title
Beta-NGF and beta-NGF receptor upregulation in blood and synovial fluid in osteoarthritis
Study date
2017
Auth party contact address
-
Data no
295064
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 3
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295087
Title
Data List 2 - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295302
Title
C491R-US-24-205 - Pharmacokinetics of ZTS-00084768 in human FcRn transgenic mouse model
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294947
Title
CVMP assessment report for Solensia
Study date
2021
Auth party contact address
-
Data no
295110
Title
The placenta, transfer of immunoglobulins, and safety assessment of biopharmaceuticals in pregnancy
Study date
2012
Auth party contact address
-
Data no
295279
Title
Recommendations for the assessment and management of pre-existing drug-reactive antibodies during biotherapeutic development
Study date
2017
Auth party contact address
-
Data no
294924
Title
Nerve Growth Factor in the Synovial Fluid of Patients with Chronic Arthritis
Study date
1992
Auth party contact address
-
Data no
295133
Title
Zoetis Safety Assessment - assessment of human exposure cases received following use of Librela or Solensia
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295256
Title
A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
Study date
2007
Auth party contact address
-
Data no
294901
Title
C687Z-US-20-228 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibody NV-02 (xxx) against canine(feline)/human/rat/mouse NGFs, feline/human neurotrophins and feline/human/rat FcRns
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295156
Title
One hundred years of Rita
Study date
2009
Auth party contact address
-
Data no
295227
Title
Kinetic evaluation of normal walking and jumping in cats, using a pressure-sensitive walkway
Study date
2007
Auth party contact address
-
Data no
294878
Title
module 3.2.P.8.3 - Annex 1 - VICH Real time stability Report
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295204
Title
Theoretical analysis of antibody targeting of tumor spheroids - importance of dosage for penetration and affinity for retention
Study date
2003
Auth party contact address
-
Data no
294855
Title
module 3.2.P.4 - Control of Excipients
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295273
Title
First-in-human randomized clinical trials of the safety and efficacy of tanezumab for treatment of chronic knee osteoarthritis pain or acute bunionectomy pain
Study date
2018
Auth party contact address
-
Data no
294832
Title
module 3.2.P.5.3 - Annex 7 - GM103 Method Validation
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295250
Title
Mechanistic determinants of biotherapeutics absoption following SC administration
Study date
2012
Auth party contact address
-
Data no
295070
Title
Independent expert review and opinion on bone/cartilage findings in two repeat dose studies with ZTS-00084768 in male and female domestic short-haired cats
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295319
Title
C386R-US-20-192 - Safety evaluation of a single 5X dose of three batches of ZTS-00084768 in cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294964
Title
Evaluation of Osteoarthritis in Cats: Novel Information from a Pilot Study
Study date
2012
Auth party contact address
-
Data no
295024
Title
Monoclonal Antibody Pharmacokinetics and Pharmacodynamics
Study date
2008
Auth party contact address
-
Data no
295010
Title
Zoetis Safety Assessment - assessment of human exposure cases received following use of Librela or Solensia
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295310
Title
C667Z-US-20-377 - Anti-NGF mAb inhibitiion of NGF induced matrix metalloproteinase production in PC-12 cells
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294872
Title
VICH GL 17 - Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products
Study date
2000
Auth party contact address
-
Data no
295210
Title
Determination of salivary and serum immunoglobulin concentrations in the cat
Study date
1998
Auth party contact address
-
Data no
295216
Title
Chapter 2 - Neurotrophic factors and nociceptor sensitization
Study date
2009
Auth party contact address
-
Data no
295018
Title
Somatosensory evoked potentials of the dog: recording techniques and normal values
Study date
1989
Auth party contact address
-
Data no
294918
Title
C486Z-US-18-125 - Validation of a competitive ligand binding electrochemiluminescence assay for the detection of neutralizing anti-ZTS-00084768 antibodies in feline serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295164
Title
Osteoarthritis in the cat - 1. how common is it and how easy to recognise
Study date
2012
Auth party contact address
-
Data no
294981
Title
Nerve growth factor inhibition with tanezumab influences weight-bearing and subsequent cartilage damage in the rat medial meniscal tear model
Study date
2016
Auth party contact address
-
Data no
294958
Title
In vitro and in vivo characterisation of a fully felinized therapeutic anti-nerve growth factor monoclonal antibody for the treatment of pain in cats
Study date
2016
Auth party contact address
-
Data no
295124
Title
Tear volume in normal eyes and keratoconjunctivitis sicca
Study date
1974
Auth party contact address
-
Data no
294864
Title
module 3.2.P.7.2 - Annex 1 - Primary packaging specifications and Certificates of Analysis
Study date
2016
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295193
Title
Guidance for Industry - Immunogenicity testing of therapeutic protein products - developing and validating assays for anti-drug antibody detection
Study date
2019
Auth party contact address
-
Data no
295267
Title
Pharmacokinetics of nerve growth factor (NGF) following different routes of administration to adult rats
Study date
1994
Auth party contact address
-
Data no
294838
Title
module 3.2.S - Flowchart of Manufacturers
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294907
Title
C461W-US-21-463 - Exploratory pharmacokinetics study of anti-NGF mAbs and their respective complexes in healthy adult Beagle dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295073
Title
Fecal protease activity is associated with compositional alterations in the intestinal microbiota
Study date
2013
Auth party contact address
-
Data no
295150
Title
Part 3a4 - Formulation description relfovetmab
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295001
Title
Species-specific variation in glycosylation of IgG: evidence for the species-specific sialylation and branch-specific galactosylation and importance for engineering recombinant glycoprotein therapeutics
Study date
2000
Auth party contact address
-
Data no
295007
Title
A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
Study date
2007
Auth party contact address
-
Data no
295050
Title
C181C-US-17-065 - Field stafety and efficacy of ZTS-00084768 compared to placebo for the treatment of pain associated with osteoarthritis in cats - contributing scientist report - pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295173
Title
Neurotrophins and their receptors - a convergence point for many signalling pathways
Study date
2003
Auth party contact address
-
Data no
294858
Title
module 3.2.P.5.1 - Specification Drug Product
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295030
Title
Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects
Study date
2010
Auth party contact address
-
Data no
295101
Title
Module 4a - Metabolism & Kinetics Overview - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294881
Title
module 3.2.P.8.3 - Annex 4 - Photostability report
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294987
Title
Regulation of TrkA and ChAT expression in developing rat basal forebrain: evidence that both exogenous and endogenous NGF regulate differentiation of cholinergic neurons
Study date
1995
Auth party contact address
-
Data no
295236
Title
Anti-NGF monoclonal antibody muMab 911 does not deplete neurons in the superior cervical ganglia of young or old adult rats
Study date
2016
Auth party contact address
-
Data no
295081
Title
Cover letter - Portela registration application
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295093
Title
module 3.2.S - GMP Certificate Site B
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295130
Title
Needlestick injuries among femal veterinarians - frequency, syringe contents and side-effects
Study date
1997
Auth party contact address
-
Data no
294938
Title
Feline osteoarthritis: a prospective study of 28 cats
Study date
2006
Auth party contact address
-
Data no
295293
Title
C883C-XC-18-078 - Dose determination of ZTS-00084768 for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients in Europe - stats
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295330
Title
C481W-US-18-094 - Pharmacokinetics of a pH 7 formulation of anti-NGF monoclonal antibody ZTS-00084768 in cats
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295342
Title
C181C-XC-19-168 - Efficacy and safety of ZTS-00084768 administration every three months for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294895
Title
C181C-XC-19-168 - Efficacy and safety of ZTS-00084768 administration every three months for the treatment of pain associated with osteoarthritis in cats presented as veterinary patients - stats
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295144
Title
C481W-US-16-044 - Reagent generation of polyclonal antibodies to anti-NGF monoclonal antibodies ZTS-00084768, ZTS-00511205 and ZTS-00507082 in cats
Study date
2017
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295038
Title
Part 3a2 - Pharmacology
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295044
Title
C481W-US-17-066 - Pharmacokinetics of two formulations of anti-NGF monoclonal antibodies ZTS-00084768 in cats
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294944
Title
A review of current animal models of osteoarthritis pain
Study date
2011
Auth party contact address
-
Data no
295187
Title
CVMP assessment report for Solensia (EMEA/V/C/005179/0000)
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294844
Title
module 3.2.P.3.4 - Controls of Critical Steps and Intermediates
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295287
Title
C382R-US-17-051 - A 3-month exploratory safety study of ZTS-00084768 in adult laboratory cats
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295336
Title
Expert opinion on ECG result comparisons across two target animal safety studies with ZTS-00084768
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294898
Title
Part 3a1 - Precise identification of the product and of its active substance(s)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295230
Title
Relationship of orthopedic examination, goniometric measurements, and radiographic signs of degenerative joint disease in cats
Study date
2012
Auth party contact address
-
Data no
294921
Title
Heart rate and heart rate variability of healthy cats in home and hospital environments
Study date
2005
Auth party contact address
-
Data no
295136
Title
Part 3a1 - Precise identification of the product and of its active substance(s)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295253
Title
Evaluation of genotoxicity testing of FDA approved large molecule therapeutics
Study date
2014
Auth party contact address
-
Data no
294852
Title
module 3.2.P.3.5 - Annex 7 - Extractable report VAL-AS-002790-ER1
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295184
Title
EMA scientific advice - NV-01
Study date
2014
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294875
Title
module 3.2.P.8.1 - Stability Summary and Conclusions
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295207
Title
Mechanisms of drug toxicity and relevance to pharmaceutical development
Study date
2011
Auth party contact address
-
Data no
295322
Title
C182W-US-16-048 - Comparing efficacy of the felinized anti-NGF monoclonal antibody ZTS-00084768 and ZTS-00511205 in the feline MIA model of osteoarthritis
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295276
Title
Lymphatic transport and catabolism of therapeutic proteins after subcutaneous administration to rats and dogs
Study date
2012
Auth party contact address
-
Data no
295299
Title
C360R-US-21-420 - Mode of action comparative study with ZTS-00075623 and ZTS-00103182 in Beagle dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294975
Title
Cartilage stem/progenitor cells are activated in osteoarthritis via interleukin-1beta/nerve growth factor signaling
Study date
2015
Auth party contact address
-
Data no
295153
Title
C782Z-US-18-127 - Validation of a GYROS method for the quantification of ZTS-00084768 in feline serum
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294915
Title
C782Z-US-18-111 - Quantification of an electrochemiluminescence assay for the detection of anti-ZTS-00084768 antibodies in feline serum
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294927
Title
Evaluation of the White-Coat Effect in Cats
Study date
1999
Auth party contact address
-
Data no
295259
Title
Zoetis Safety Assessment - assessment of human exposure cases received following use of Librela or Solensia
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295021
Title
Guideline on Target Animal Safety For Veterinary Live and Inactivated Vaccines
Study date
2008
Auth party contact address
-
Data no
295107
Title
Monograph for ingredient X - ace
Study date
2020
Auth party contact address
-
Data no
295270
Title
VICH GL 43 - Target Animal Safety for Veterinary Pharmaceutical Products
Study date
2008
Auth party contact address
-
Data no
294961
Title
Theoretical analysis of antibody targeting of tumor spheroids - importance of dosage for penetration and affinity for retention
Study date
2003
Auth party contact address
-
Data no
295061
Title
Part 3c -Conclusions on safety
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295067
Title
C386R-US-20-192 - Safety evaluation of a single 5X dose of three batches of ZTS-00084768 in cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295316
Title
C360R-CA-21-426 - Effects of anti-NGF monoclonal antibodies on nerve growth factor (NGF)-induced sensitization using nerve conduction testing in dogs
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295167
Title
Osteoarthritis, angiogenesis and inflammation
Study date
2005
Auth party contact address
-
Data no
295113
Title
US FDA Inactive Ingredients Database - ingredient X - ace
Study date
2025
Auth party contact address
-
Data no
294967
Title
Considering older cats
Study date
2006
Auth party contact address
-
Data no
295213
Title
Preclinical safety evaluation of biotechnology-derived pharmaceuticals, S6(R1)
Study date
2011
Auth party contact address
-
Data no
295147
Title
C782Z-US-18-128 - Validation of an electrochemiluminescence assay for the detection of anti-ZTS-00084768 antibodies in feline serum
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295313
Title
C687Z-US-22-272 - Binding kinetics of anti-nerve growth factor (NGF) monoclonal antibody felinized ZTS-00084768 (xxx) against canine(feline)/human/rat/mouse NGFs, feline/human neurotrophins and feline/human/rat FcRns
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295290
Title
C181C-US-17-065 - Field stafety and efficacy of ZTS-00084768 compared to placebo for the treatment of pain associated with osteoarthritis in cats - stats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294861
Title
module 3.2.P.6 - Reference Standards or Materials
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294935
Title
Neurotrophins and their receptors - a convergence point for many signalling pathways
Study date
2003
Auth party contact address
-
Data no
295196
Title
Feline idiopathic cystitis
Study date
2015
Auth party contact address
-
Data no
295121
Title
Choreographing immunity in the skin epithelial barrier
Study date
2019
Auth party contact address
-
Data no
295170
Title
The Transmission of Immunity from mother to young and the catabolism of immunoglobulins
Study date
1966
Auth party contact address
-
Data no
295219
Title
Clinical pharmacokinetics of therapeutic monoclonal antibodies
Study date
2010
Auth party contact address
-
Data no
294978
Title
Serum nerve growth factor in horses with osteoarthritis-associated lameness
Study date
2023
Auth party contact address
-
Data no
294984
Title
Cross-sectional study of the prevalence of radiographic degenerative joint disease in domesticated cats
Study date
2010
Auth party contact address
-
Data no
294835
Title
module 3.2.P.5.4 - Annex 1 - Registration Batch Certificates of Analysis
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294884
Title
Part 4A2 Pre-Clinical Trials - Portela
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295027
Title
Guidelines for Recognition, Assessment and Treatment of Pain
Study date
2014
Auth party contact address
-
Data no
295104
Title
FcRn, but not Fc gamma Rs, drives maternal-fetal transplacental transport of human IgG antibodies
Study date
2020
Auth party contact address
-
Data no
294955
Title
Rapidly progressive osteoarthritis - a review of the clinical and radiologic presentation
Study date
2017
Auth party contact address
-
Data no
295004
Title
Pharmacokinetics of monoclonal antibodies
Study date
2017
Auth party contact address
-
Data no
295127
Title
Monograph for ingredient X - lme
Study date
2009
Auth party contact address
-
Data no
295176
Title
Prevalence of radiographic signs of degenerative joint disease in a hospital population of cats
Study date
2005
Auth party contact address
-
Data no
294892
Title
C382N-US-17-069 - A 6-month study of ZTS-00084768 by subcutaneous injection in adult domestic cats
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294904
Title
C182W-CA-17-064 - Study of biological agents in cats with naturally-occurring osteoarthritis - principal investigator report - bioanalytical, pharmacokinetics and immunogenicity
Study date
2021
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295247
Title
Lymphatic transport of proteins after subcutaneous administration
Study date
2000
Auth party contact address
-
Data no
295296
Title
C7X4Z-US-23-379 - Electron microscopy study of ZTS-00075623: cytokine complex
Study date
2018
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294998
Title
Pleiotropic activity of nerve growth factor in regulating cardiac functions and counteracting pathogenesis
Study date
2021
Auth party contact address
-
Data no
295047
Title
C481R-CA-20-213 - Absolute bioavailability and pharmacokinetics of ZTS-00084768 in cats with naturally occurring osteoarthritis - amended individual scientist report - pharmacokinetics and immunogenicity
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295084
Title
eLabel - Portela 2.5 mg solution for injection for cats
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294990
Title
Familial insensitivity to pain (HSAN V) and a mutation in the NGFB gene. A neurophysiological and pathological study
Study date
2004
Auth party contact address
-
Data no
295233
Title
Regulation of TrkA and ChAT expression in developing rat basal forebrain: evidence that both exogenous and endogenous NGF regulate differentiation of cholinergic neurons
Study date
1995
Auth party contact address
-
Data no
295239
Title
NGF and its receptors in the regulation of inflammatory response
Study date
2017
Auth party contact address
-
Data no
294841
Title
module 3.2.P.3.1 - Manufacturer(s)
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295333
Title
C182W-CA-17-064 - Study of biological agents in cats with naturally-occurring osteoarthritis
Study date
2019
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295339
Title
C382N-US-19-180 - A safety evaluation of ZTS-00084768 in laboratory cats - volume 2
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294941
Title
Mice lacking nerve growth factor display perinatal loss of sensory and sympathetic neurons yet develop basal forebrain cholinergic neurons
Study date
1994
Auth party contact address
-
Data no
295190
Title
Anti-nerve growth factor monoclonal antibodies for the control of pain in dogs and cats
Study date
2018
Auth party contact address
-
Data no
295041
Title
C665Z-US-20-380 - In vitro functional potency of anti-nerve growth factor (NGF) mAbs
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
295090
Title
GMP Certificate Site E
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
150541
Product/Active constituent Name
Application Product Name
Portela 2.5 mg Solution for Injection for Cats
Application Date
Application Number
150541
Application Product Name
Portela 2.5 mg Solution for Injection for Cats
Application details
Product name:
Portela 2.5 mg Solution for Injection for Cats
Product number:
96737
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 2.5 mg/mL relfovetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in cats in conjunction with the approval of the active ingredient relfovetmab.
Active constituents:
Active constituent name
96735 - Relfovetmab