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
150208
Product/Active constituent Name
Application Product Name
Mirataz Transdermal Ointment for Cats
Application Date
Application Number
150208
Application Product Name
Mirataz Transdermal Ointment for Cats
Application details
Product name:
Mirataz Transdermal Ointment for Cats
Product number:
96641
Applicant Name:
DECHRA REGULATORY B.V.
Application purpose and description of use:
Registration of a 20 mg/g mirtazapine ointment product for cats for body weight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions, in conjunction with approval of mirtazapine.
Description of data provided:
Data no
300140
Title
Raw Material Specification RMS A1701
Study date
24 September 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292308
Title
Mirtazapine may be useful in treating nausea and insomnia of cancer chemotherapy
Study date
2001
Auth party contact address
-
Data no
292320
Title
kb119
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292268
Title
Excipient 4 SDS
Study date
23 January 2025
Auth party contact address
-
Data no
292314
Title
Effects of risperidone treatment on the expression of hypothalamic neuropeptide in appetite regulation in Wistar rats
Study date
2015
Auth party contact address
-
Data no
292214
Title
Declaration of Compliance
Study date
20 November 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292231
Title
Laboratory Study: Randomized, Multi-dose Pharmacokinetics, Pharmacodynamics, and Tolerance Study of Two Doses of Mirtazapine Administered Topically (Transdermally) to Adult Cats
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292208
Title
Stability Protocol TN:24-066
Study date
15 May 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292274
Title
KB100PK
Study date
2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292225
Title
Pharmacokinetics of mirtazapine and its main metabolites in Beagle dogs: A pilot study
Study date
2012
Auth party contact address
-
Data no
292202
Title
Certificates of Analysis
Study date
August 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292251
Title
Mirtazapine exposure in pregnancy and foetal safety: A nationwide cohort study
Study date
2022
Auth party contact address
-
Data no
292300
Title
Stahl's essential psychopharmacology: neuroscientific basis and practical applications a
Study date
2008
Auth party contact address
-
Data no
292245
Title
A Pilot Laboratory Safety Study of 2% Mirtazapine Ointment Administered Topically (Transdermally) to Adult Cats at 5x the Target Therapeutic Dosage
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292294
Title
Megestrol Acetate and Mirtazapine for the Treatment of Unplanned Weight Loss in the Elderly
Study date
2009
Auth party contact address
-
Data no
292237
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292288
Title
Drug exposure and clinical effect of transdermal mirtazapine in healthy young cats: a pilot study
Study date
2016
Auth party contact address
-
Data no
292194
Title
GMP Inspection Report
Study date
2 April 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292265
Title
Excipient 1 SDS
Study date
20 February 2017
Auth party contact address
-
Data no
292217
Title
Certificate of Test
Study date
07 June 2023
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
300143
Title
Justification of System Suitability Criteria
Study date
02 September 2020
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292271
Title
Excipient 7 SDS
Study date
15 November 2017
Auth party contact address
-
Data no
292211
Title
Validation of Stability indicating Assay for Quantification of Mirtazapine and its Degradants in KIN010 Topical Ointment.
Study date
14 January 2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292317
Title
kb110pk
Study date
2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292257
Title
Mirtazapine fatal poisoning
Study date
2017
Auth party contact address
-
Data no
292311
Title
Ghrelin and leptin pathophysiology in chronic kidney disease
Study date
2013
Auth party contact address
-
Data no
292277
Title
Study KB111PK
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292205
Title
Freeze Thaw Results
Study date
23 September 2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292254
Title
SSRI and SNRI use during pregnancy and the risk of persistent pulmonary hypertension of the newborn
Study date
2017
Auth party contact address
-
Data no
292297
Title
The Pharmacologic Profile of Mirtazapine
Study date
1996
Auth party contact address
-
Data no
292228
Title
The Pharmacokinetics of Mirtazapine in Cats with Chronic Kidney Disease and In Age-Matched Control Cats
Study date
2011
Auth party contact address
-
Data no
292248
Title
Molecular Consequences of Depression Treatment: A Potential In Vitro Mechanism for Antidepressants-Induced Reprotoxic Side Effects
Study date
2021
Auth party contact address
-
Data no
292234
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292191
Title
Chemistry and Manufacture
Study date
August 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292291
Title
Study KB104P
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292289
Title
Evaluation of Weight Loss Over Time in Cats with Chronic Kidney Disease
Study date
2016
Auth party contact address
-
Data no
292266
Title
Excipient 2 SDS
Study date
21 November 2020
Auth party contact address
-
Data no
292243
Title
Pfizer product monograph (mirtazapine orally disintegrating tablets 15 mg, 30 mg, and 45 mg)
Study date
2012
Auth party contact address
-
Data no
292220
Title
Toxicology
Study date
June 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292197
Title
Excipient monographs and certificates of analysis
Study date
July 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292212
Title
Method Validation of BHT in KIN010 Topical Ointment, 2%
Study date
20 October 2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292260
Title
The Rat - Drug Metabolism
Study date
2016
Auth party contact address
-
Data no
292272
Title
kb119
Study date
26 September 2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292306
Title
Efficacy of mirtazapine in preventing intrathecal morphine-induced nausea and vomiting after orthopaedic surgery
Study date
2010
Auth party contact address
-
Data no
292312
Title
5-HT2C Receptor Agonists and the Control of Appetite
Study date
2012
Auth party contact address
-
Data no
292206
Title
Photostability Results
Study date
23 September 2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292229
Title
Drug exposure and clinical effect of transdermal mirtazapine in healthy young cats: a pilot study
Study date
2016
Auth party contact address
-
Data no
292280
Title
KB115T part c
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292249
Title
Exposure to Mirtazapine During Pregnancy: A Prospective, Comparative Study of Birth Outcomes
Study date
2006
Auth party contact address
-
Data no
292323
Title
kb118
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292200
Title
Topical and Transdermal Drug Products - Product Quality Tests
Study date
12 May 2025
Auth party contact address
-
Data no
292286
Title
KB115T part i
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292292
Title
Mirtazapine toxicity in cats: retrospective study of 84 cases (2006, 2011)
Study date
2016
Auth party contact address
-
Data no
300141
Title
Raw material method RMM A1701
Study date
26 September 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292223
Title
Mirtazapine - a Review of its Pharmacology and Therapeutic Potential in the Management of Major Depression
Study date
1996
Auth party contact address
-
Data no
292269
Title
Excipient 5 SDS
Study date
18 March 2021
Auth party contact address
-
Data no
292209
Title
Stability Summary Tables
Study date
May 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292309
Title
Low-dose mirtazapine may be successful treatment option for severe nausea and vomiting
Study date
2006
Auth party contact address
-
Data no
292315
Title
Involvement of hypothalamic histamine H1 receptor in the regulation of feeding rhythm and obesity
Study date
2004
Auth party contact address
-
Data no
292263
Title
Work Health and Safety
Study date
June 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292232
Title
A Laboratory, Randomized, Cross-Over Pharmacokinetic Study of Orally and Topically (Transdermal) Administered Mirtazapine 2% Ointment in Adult Cats
Study date
2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292203
Title
Part 2F2
Study date
26 March 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292303
Title
Pharmacological appetite stimulation - rational choices in the inappetent cat
Study date
2014
Auth party contact address
-
Data no
292252
Title
Mirtazapine in pregnancy and lactation: A systematic review of adverse outcomes
Study date
2025
Auth party contact address
-
Data no
292326
Title
ACOG Guidelines on Psychiatric Medication Use during Pregnancy and Lactation
Study date
2008
Auth party contact address
-
Data no
292226
Title
Pharmacokinetics of Mirtazapine and its Main Metabolites after Single Oral Administration in Fasting/Fed Horses.
Study date
2013
Auth party contact address
-
Data no
292283
Title
KB115T part f
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292295
Title
Let Them Eat During Dialysis: An Overlooked Opportunity to Improve Outcomes in Maintenance Hemodialysis Patients
Study date
2013
Auth party contact address
-
Data no
292246
Title
Full prescribing information - Remeron
Study date
November 2021
Auth party contact address
-
Data no
292240
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292218
Title
Pre-application Assistance APVMA Written Assistance
Study date
19 October 2021
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292241
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292195
Title
License to Manufacture Veterinary Chemical Products
Study date
11 October 2023
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292224
Title
Pharmacokinetics of mirtazapine and its main metabolites after single intravenous and oral administrations in rats at two dose rates.
Study date
2014
Auth party contact address
-
Data no
292258
Title
High blood mirtazapine concentration in a newborn ???????? A case of suspected postpartum infanticide
Study date
2021
Auth party contact address
-
Data no
292318
Title
KB108T
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292310
Title
The role of histaminergic H1 and H3 receptors in food intake: a mechanism for atypical antipsychotic-induced weight gain?
Study date
2010
Auth party contact address
-
Data no
292264
Title
Mirataz SDS
Study date
20 March 2020
Auth party contact address
-
Data no
292278
Title
KB115T part a
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292255
Title
Antidepressant use during pregnancy and risk of adverse neonatal outcomes: A comprehensive investigation of previously identified associations
Study date
2022
Auth party contact address
-
Data no
292227
Title
Studies on the pharmacokinetics and pharmacodynamics of mirtazapine in healthy young cats.
Study date
2010
Auth party contact address
-
Data no
292298
Title
The Role of Hypothalamic H1 Receptor Antagonism in Antipsychotic-Induced Weight Gain
Study date
2013
Auth party contact address
-
Data no
292304
Title
Cancer chemotherapy and cachexia: mirtazapine and olanzapine are 5-HT3 antagonists with good antinausea effects
Study date
2007
Auth party contact address
-
Data no
292204
Title
Stability Summary Tables
Study date
September 2019
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292321
Title
Mirtazapine (Plumbs Veterinary Medication Guides)
Study date
2017
Auth party contact address
-
Data no
292235
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292247
Title
Developing rat testicular organoid models for assessing the reproductive toxicity of antidepression drugs in vitro
Study date
2022
Auth party contact address
-
Data no
292284
Title
KB115T part g
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292192
Title
Certificate of GMP Compliance of a Manufacturer
Study date
12 August 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292290
Title
Study KB105
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292267
Title
Excipient 3 SDS
Study date
31 August 2021
Auth party contact address
-
Data no
292244
Title
Laboratory, Safety Study of Topical (Transdermal) Mirtazapine 2% Ointment Dosed Orally in Cats at 5X the Targeted Label Dose
Study date
2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292221
Title
Mirtazapine (Plumbs Veterinary Medication Guides)
Study date
2017
Auth party contact address
-
Data no
292198
Title
PRO-SK-MS&T0021
Study date
24 February 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292307
Title
Premedication with mirtazapine reduces preoperative anxiety and postoperative nausea and vomiting
Study date
2008
Auth party contact address
-
Data no
292215
Title
Tube Drawing
Study date
12 September 2022
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292261
Title
Pharmacokinetics of a Single Transdermal Dose of Mirtazapine in Rhesus Macaques (Macaca mulatta)
Study date
2023
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292301
Title
Stahl's essential psychopharmacology: neuroscientific basis and practical applications b
Study date
2008
Auth party contact address
-
Data no
292207
Title
In use stability results
Study date
01 December 2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292201
Title
Antimicrobial Agents - Content
Study date
12 May 2025
Auth party contact address
-
Data no
292275
Title
Study KB101PK
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292324
Title
kb116
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292281
Title
KB115T part d
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292238
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292287
Title
Studies on the pharmacokinetics and pharmacodynamics of mirtazapine in healthy young cats
Study date
2010
Auth party contact address
-
Data no
292193
Title
Certificate of GMP Compliance of a Manufacturer
Study date
16 June 2023
Auth party contact address
-
Data no
300142
Title
Method Transfer Report V-OS-065/EE-24/1
Study date
10 September 2020
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292222
Title
Metabolism of the Antidepressant Mirtazapine In Vitro: Contribution of Cytochromes P-450 1A2, 2D6, and 3A4
Study date
2000
Auth party contact address
-
Data no
292199
Title
Elemental Impurities Product Risk Assessment
Study date
26 June 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292270
Title
Excipient 6 SDS
Study date
13 May 2019
Auth party contact address
-
Data no
292316
Title
The Pharmacokinetics of Mirtazapine in Cats with Chronic Kidney Disease and In Age-Matched Control Cats
Study date
2011
Auth party contact address
-
Data no
292210
Title
Antimicrobial Effectiveness Testing
Study date
13 May 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292216
Title
Barrier properties of Polyfoil laminate tubes
Study date
2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292262
Title
Determination of KIND-010 2% Ointment Dislodged upon Petting Following Repeated Topical (Transdermal) Administrations in Cats
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292325
Title
Mirtazapine exposure in pregnancy and foetal safety: A nationwide cohort study
Study date
2022
Auth party contact address
-
Data no
292253
Title
Risk of congenital anomalies associated with pyschotropic medications: a review of neonatal reports in the FDA adverse event reporting system
Study date
2024
Auth party contact address
-
Data no
292302
Title
H1-histamine receptor affinity predicts weight gain with antidepressants
Study date
2016
Auth party contact address
-
Data no
292276
Title
Study KB103PK
Study date
2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292296
Title
Clinical Pharmacokinetics of Mirtazapine
Study date
2000
Auth party contact address
-
Data no
292282
Title
KB115T part e
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292233
Title
A Laboratory, Randomized, Effectiveness and Pharmacokinetic Study of Topically (Transdermal) Administered Mirtazapine Ointment at 0.5 mg/kg and 2 mg/kg in Adult Cats
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292239
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292242
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292313
Title
Eating disorder and epilepsy in mice lacking 5-HT2c serotonin receptors
Study date
1995
Auth party contact address
-
Data no
300139
Title
Finished product method FPM 806M
Study date
12 September 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292196
Title
Mirtazapine Transdermal Ointment Development Pharmaceutics Report
Study date
13 August 2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292219
Title
Environment
Study date
August 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292319
Title
Cachexia and Sarcopenia: Emerging Syndromes of Importance in Dogs and Cats
Study date
2012
Auth party contact address
-
Data no
292259
Title
Mirtazapine overdose is unlikely to cause major toxicity
Study date
2014
Auth party contact address
-
Data no
292305
Title
Mirtazapine as an appetite stimulant and anti-emetic in cats with chronic kidney disease: A masked placebo-controlled crossover clinical trial
Study date
2013
Auth party contact address
-
Data no
292213
Title
Test Method Transfer Report for the Analytical Method for the Assay & Identification of Mirtazapine, Related Substances & Butylated Hydroxytoluene
Study date
May 2023
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292230
Title
Laboratory Study: Pharmacokinetics of Mirtazapine Administered In Single Doses Orally and Topically (Transdermally) to Adult Cats
Study date
2015
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292279
Title
KB115T part b
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292256
Title
Mirtazapine in pregnancy and lactation ???????? A systematic review
Study date
2016
Auth party contact address
-
Data no
292322
Title
kb117
Study date
2016
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292273
Title
Efficacy and Safety
Study date
June 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292250
Title
Pregnancy Outcome Following Maternal Exposure to Mirtazapine A Multicenter, Prospective Study
Study date
2015
Auth party contact address
-
Data no
292299
Title
Ghrelin's Orexigenic Effect Is Modulated via a Serotonin 2C Receptor Interaction
Study date
2015
Auth party contact address
-
Data no
292236
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292293
Title
Phase II trial of mirtazapine for cancer-related cachexia and anorexia
Study date
2010
Auth party contact address
-
Data no
292285
Title
KB115T part h
Study date
2017
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Date
Application Date
Application No
Application Number
151444
Product/Active constituent Name
Application Product Name
POOL PRO ALGAE CONTROL
Application Date
Application Number
151444
Application Product Name
POOL PRO ALGAE CONTROL
Application details
Product name:
POOL PRO ALGAE CONTROL
Product number:
56321
Applicant Name:
THE POPS GROUP PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add a wider range of pack size.
Reference details:
89824 - Phoenix Blue Pool Algaecide
92808 - Aqua Pure All purpose Algaecide
94203 - Water TechniX Algaecide
94358 - Price Pool Products Algaecide
Description of data provided:
Data no
299748
Title
Executive Summary
Study date
July 2025
Auth party contact address
10-12 CAIRNS STREET LOGANHOLME Australia
Date
Application Date
Application No
Application Number
151526
Product/Active constituent Name
Application Product Name
Amtole 250 Herbicide
Application Date
Application Number
151526
Application Product Name
Amtole 250 Herbicide
Application details
Product name:
Amtole 250 Herbicide
Product number:
91975
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Variation of the product label approval to add uses from the reference product label.
Reference details:
31236 - NUFARM AMITROLE T HERBICIDE
Active constituents:
Active constituent name
68136 - AMITROLE
Description of data provided:
Data no
300104
Title
Nominated agent letter
Study date
05 Jan 2026
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
151577
Product/Active constituent Name
Application Product Name
Gold Motive Herbicide
Application Date
Application Number
151577
Application Product Name
Gold Motive Herbicide
Application details
Product name:
Gold Motive Herbicide
Product number:
94387
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Variation of the product label approval to add uses from the reference product label.
Active constituents:
Active constituent name
83962 - Prosulfocarb
Active constituent name
69340 - S-METOLACHLOR
Description of data provided:
Data no
300380
Title
Nominated agent letter
Study date
09 Jan 2026
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
151594
Product/Active constituent Name
Application Product Name
Mandipropamid
Application Date
Application Number
151594
Application Product Name
Mandipropamid
Application details
Product name:
Mandipropamid
Active name:
Mandipropamid
Applicant Name:
GREENCHEM HK LTD
Application purpose and description of use:
Approval of Mandipropamid for use in agricultural chemical products.
Description of data provided:
Data no
300383
Title
Synthesis and Impurities of Mandipropamid Technical
Study date
2026
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Data no
300386
Title
Five Batch Analysis of Mandipropamid Technical report 0816
Study date
24/12/2024
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Data no
300384
Title
COA for Mandipropamid TGAC
Study date
18/07/2025
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Data no
300385
Title
DoC for Mandipropamid TGAC
Study date
18/12/2025
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Date
Application Date
Application No
Application Number
151608
Product/Active constituent Name
Application Product Name
IMTRADE ENVIROPINK HOME & GARDEN GB MOLLUSCICIDE
Application Date
Application Number
151608
Application Product Name
IMTRADE ENVIROPINK HOME & GARDEN GB MOLLUSCICIDE
Application details
Product name:
IMTRADE ENVIROPINK HOME & GARDEN GB MOLLUSCICIDE
Product number:
97036
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 120g/kg IRON EDTA COMPLEX granular bait for the control of Snails and Slugs in Home & Garden situations as specified in the Directions for Use table.
Reference details:
90221 - 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT
Description of data provided:
Data no
300426
Title
Investigation into the Equivalency of IMTRADE ENVIROPINK?? GB MOLLUSCICIDE to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT for the control of Small Pointed Snails (Cochlicella Barbara). - One Trial, Kwinana, Western Australia.
Study date
24/04/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300432
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Prietocella barbara) in Lentils cv. Thunder and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Wasleys, South Australia.
Study date
05/01/2026
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300415
Title
Imtrade FeNa-EDTA (Iron Chelate)120 Bait Method Validation ??? August 2024
Study date
08/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300423
Title
Investigation into the Equivalency of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT for the control of Common White Snails. - One Trial, Kwinana, Western Australia.
Study date
28/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300429
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails (Cernuella virgata) in Canola cv. 44y94 and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Woodchester, South Australia.
Study date
08/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300435
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails (Cernuella virgata) in Chickpeas cv. Kalkee and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Serviceton, Victoria.
Study date
22/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300412
Title
Method of Manufacture ??? Imtrade Enviropink (FeNa-EDTA (iron chelate) 120g/kg) GB Molluscicide
Study date
29/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300424
Title
Investigation into the Equivalency of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT for the control of Conical Snails. - One Trial, Kwinana, Western Australia.
Study date
27/11/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300418
Title
Argument to satisfy AgVet Chemicals Code Act 1994 (Cth) s.14(3) in countering the commercial in confidence aspects of the reference product???s non-protected data
Study date
03/09/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300430
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Prietocella barbara) in Canola cv. 44y94 and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Woodchester, South Australia.
Study date
24/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300438
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Prietocella barbara) in a garden setting and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Kangarilla, South Australia.
Study date
15/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300421
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Garden Snails. - One Trial, Kwinana, Western Australia.
Study date
06/12/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300427
Title
Investigation into the Equivalency of IMTRADE ENVIROPINK?? GB MOLLUSCICIDE to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT for the control of Common White Snails (Cernuella virgata) in a commercial Canola cv. Bonito crop. - One Trial, Kwinana, Western Australia.
Study date
26/08/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300441
Title
Comments to Support Efficacy and Host Crop Safety data submitted
Study date
12/06/2026
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300422
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Cochlicella Barbara). - One Trial, Kwinana, Western Australia.
Study date
08/04/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300436
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Prietocella barbara) in Chickpeas cv. Kalkee and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Serviceton, Victoria.
Study date
24/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300413
Title
Formulation and Stability Report - Imtrade Enviropink (FeNa-EDTA (iron chelate) 120g/kg) GB Molluscicide
Study date
29/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300442
Title
Reference Material for Comments to Support Efficacy & HCS Data submitted
Study date
2002
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300419
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails. - One Trial, Kwinana, Western Australia.
Study date
16/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300425
Title
Investigation into the Equivalency of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT for the control of Garden Snails. - One Trial, Kwinana, Western Australia.
Study date
23/12/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300433
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails (Cernuella virgata) in Faba Beans cv. Samira and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Malinong, South Australia.
Study date
22/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300416
Title
Safety Data Sheets
Study date
29/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300439
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails (Cernuella virgata) in a native pasture and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Kangarilla, South Australia.
Study date
10/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300420
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Conical Snails. - One Trial, Kwinana, Western Australia.
Study date
27/09/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300428
Title
Investigation into the equivalency of IMTRADE ENVIROPINK?? GB MOLLUSCICIDE to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT for the control of Small Pointed Snails (Cochlicella Barbara) in a commercial Canola cv. Bonito crop. - One Trial, Kwinana, Western Australia.
Study date
11/08/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300434
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Prietocella barbara) in Faba Beans cv. Samira and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Malinong, South Australia.
Study date
29/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300440
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Small Pointed Snails (Prietocella barbara) in a native pasture and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Kangarilla, South Australia.
Study date
18/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300417
Title
CoA - FeNa-EDTA (iron chelate)
Study date
20/11/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300431
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails (Cernuella virgata) in Lentils cv. Thunder and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Wasleys, South Australia.
Study date
23/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300437
Title
Investigation into the Efficacy of IMTRADE ENVIROPINK?? SNAIL & SLUG BAIT for the control of Common White Snails (Cernuella virgata) in a garden setting and Equivalency to 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT. - One Trial, Kangarilla, South Australia.
Study date
10/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300414
Title
Imtrade FeNa-EDTA (Iron Chelate) 120 Bait 1 Batch Analysis ??? August 2024
Study date
08/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
151589
Product/Active constituent Name
Application Product Name
Call 50 EC Insecticide
Application Date
Application Number
151589
Application Product Name
Call 50 EC Insecticide
Application details
Product name:
Call 50 EC Insecticide
Applicant Name:
SHARDA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 500 g/L chlorpyrifos emulsifiable concentrate product for the control of a range of insect pests in various situations.
Date
Application Date
Application No
Application Number
151593
Product/Active constituent Name
Application Product Name
Axiom Roach Gel
Application Date
Application Number
151593
Application Product Name
Axiom Roach Gel
Application details
Product name:
Axiom Roach Gel
Applicant Name:
SHARDA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of an 8 g/kg Indoxacarb bait product for the control of Cockroaches in various situations
Date
Application Date
Application No
Application Number
151588
Product/Active constituent Name
Application Product Name
Calliope Insecticide
Application Date
Application Number
151588
Application Product Name
Calliope Insecticide
Application details
Product name:
Calliope Insecticide
Applicant Name:
SHARDA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 500 g/L chlorpyrifos emulsifiable concentrate product for the control of a range of insect pests in various situations.
Date
Application Date
Application No
Application Number
151591
Product/Active constituent Name
Application Product Name
Thumfast Fly Bait
Application Date
Application Number
151591
Application Product Name
Thumfast Fly Bait
Application details
Product name:
Thumfast Fly Bait
Applicant Name:
SHARDA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 10 g/kg thiamethoxam and 1 g/kg (z)-9-tricosene Bait product for the control of house flies (Musca domestica) in animal housing including dairies, cattle feedlots, abattoirs, piggeries, poultry facilities, horse stables, and kennels and for use in commercial, industrial and domestic areas
Date
Application Date
Application No
Application Number
151592
Product/Active constituent Name
Application Product Name
Thumjet Spray Fly Bait
Application Date
Application Number
151592
Application Product Name
Thumjet Spray Fly Bait
Application details
Product name:
Thumjet Spray Fly Bait
Applicant Name:
SHARDA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 100 g/kg thiamethoxam and 500 mg/kg (z)-9-tricosene product for the control of house flies (Musca domestica) in animal housing including dairies, cattle feedlots, abattoirs, piggeries, poultry facilities, horse stables, and kennels and for use in commercial, industrial and domestic areas
Date
Application Date
Application No
Application Number
151200
Product/Active constituent Name
Application Product Name
Esomeprazole Magnesium Trihydrate
Application Date
Application Number
151200
Application Product Name
Esomeprazole Magnesium Trihydrate
Application details
Product name:
Esomeprazole Magnesium Trihydrate
Product number:
96901
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 240mg/mL esomeprazole oral paste product for horses, in conjunction with approval of active constituent.
Description of data provided:
Data no
296608
Title
Chemistry and Manufacture Summary
Study date
October 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
300118
Title
Restricted DMF
Study date
2025
Data no
296609
Title
Certificates of Analysis
Study date
November 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296610
Title
Drug Master File
Study date
July 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date
Application Date
Application No
Application Number
151201
Product/Active constituent Name
Application Product Name
Esomeprazole Magnesium Trihydrate
Application Date
Application Number
151201
Application Product Name
Esomeprazole Magnesium Trihydrate
Application details
Product name:
Esomeprazole Magnesium Trihydrate
Product number:
96902
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 240mg/mL esomeprazole oral paste product for horses, in conjunction with approval of active constituent.
Description of data provided:
Data no
300117
Title
EDMF closed part
Study date
2025
Data no
296611
Title
Chemistry and Manufacture Summary
Study date
October 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296612
Title
Certificates of Analysis
Study date
April 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296613
Title
Drug Master File
Study date
March 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date
Application Date
Application No
Application Number
151202
Product/Active constituent Name
Application Product Name
Gastrozol Gold Oral Paste for Horses
Application Date
Application Number
151202
Application Product Name
Gastrozol Gold Oral Paste for Horses
Application details
Product name:
Gastrozol Gold Oral Paste for Horses
Product number:
96903
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 240mg/mL esomeprazole oral paste product for horses, in conjunction with approval of active constituent.
Active constituents:
Active constituent name
96901 - Esomeprazole Magnesium Trihydrate
Active constituent name
96902 - Esomeprazole Magnesium Trihydrate
Description of data provided:
Data no
296436
Title
Health Summary
Study date
October 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296459
Title
ESGD grades
Study date
2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296430
Title
Validation Report VAL_FTM1060-VALRPT-037
Study date
October 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296453
Title
Preliminary study of the gastric acidity in thoroughbred horses at rest after enteral administration of esomeprazole magnesium (Nexium)
Study date
2009
Auth party contact address
-
Data no
296410
Title
Project Plan
Study date
February 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296439
Title
Efficacy and Safety Summary
Study date
October 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296462
Title
VBAE22195A Study Master File
Study date
2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296433
Title
Ph.Eur Monograph
Study date
January 2021
Auth party contact address
-
Data no
296427
Title
Standard Operating Procedure AL-SOP-008
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296450
Title
Study Report
Study date
2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296456
Title
Esomeprazole in the treatment of equine glandular gastric disease
Study date
2021
Auth party contact address
-
Data no
296419
Title
Ph.Eur Monograph
Study date
July 2014
Auth party contact address
-
Data no
296434
Title
Component Specification SPECCP-1P3256
Study date
April 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296442
Title
Clinical pharmacology and safety profile of esomeprazole, the first enantiomerically pure proton pump inhibitor
Study date
2001
Auth party contact address
-
Data no
296448
Title
Study Report
Study date
January 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296451
Title
A novel placement method of a calibration-free pH capsule for continuous wireless measurement of intragastric pH in horses
Study date
2024
Auth party contact address
-
Data no
296428
Title
Test Method FD-SOP-010
Study date
March 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296408
Title
Cover Letter
Study date
November 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296457
Title
Oral esomeprazole as a treatment for Equine Gastric Ulcer Syndrome refractory to oral omeprazole.
Study date
2017
Auth party contact address
-
Data no
296422
Title
Certificate of Analysis
Study date
October 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296465
Title
Safety Data Sheet
Study date
July 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296414
Title
Certificates of Analysis
Study date
October 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296445
Title
A pilot study comparing the effect of orally administered esomeprazole and omeprazole on gastric fluid pH in horses
Study date
2017
Auth party contact address
-
Data no
296425
Title
Standard Operating Procedure AL-SOP-016
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296454
Title
The effects of dose and diet on the pharmacodynamics of esomeprazole in the horse
Study date
2017
Auth party contact address
-
Data no
296431
Title
Ph.Eur Monograph
Study date
January 2025
Auth party contact address
-
Data no
296411
Title
Chemistry and Manufacture Summary
Study date
October 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296463
Title
Product Label
Study date
October 2016
Auth party contact address
-
Data no
296440
Title
PAA 138680
Study date
March 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296446
Title
Pharmacokinetic and pharmacodynamic effects of two omeprazole formulations on stomach pH and gastric ulcer scores
Study date
2017
Auth party contact address
-
Data no
296426
Title
Standard Operating Procedure CRK-OI-060
Study date
November 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296449
Title
Summary of Product Characteristics
Study date
October 2024
Auth party contact address
-
Data no
296420
Title
Certificate of Analysis
Study date
October 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296437
Title
Consumer Medicine Information (CMI) summary
Study date
April 2025
Auth party contact address
-
Data no
296460
Title
Statistical Analysis
Study date
2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296443
Title
Enantiomer/enantiomer interactions between the S- and R-isomers of omeprazole in human cytochrome P450 enzymes: Major role of CYP2C19 and CYP3A4
Study date
2005
Auth party contact address
-
Data no
296452
Title
Effects of intravenously administered esomeprazole sodium on gastric juice pH in adult female horses
Study date
2011
Auth party contact address
-
Data no
296429
Title
Test Method FTM1060
Study date
October 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296409
Title
Application Summary
Study date
October 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296423
Title
Certificate of Analysis
Study date
October 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296466
Title
Summary of studies and literature
Study date
2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296438
Title
AUSTRALIAN PRODUCT INFORMATION
Study date
June 2025
Auth party contact address
-
Data no
296461
Title
Study Final Report VBAE22195A
Study date
March 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296444
Title
Assessment report
Study date
June 2013
Auth party contact address
-
Data no
296432
Title
Analytical Report ABH30457
Study date
February 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296455
Title
Comparison of oral esomeprazole and oral omeprazole in the treatment of equine squamous gastric disease
Study date
2023
Auth party contact address
-
Data no
296424
Title
Interim Stability Report
Study date
October 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296464
Title
Prophylactic therapy with omeprazole for prevention of equine gastric ulcer syndrome (EGUS) in horses in active training: A meta-analysis
Study date
2019
Auth party contact address
-
Data no
296435
Title
Component Specification SPECCP-1P3646
Study date
October 2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296447
Title
Comparative efficacy of esomeprazole and omeprazole: Racemate to single enantiomer switch
Study date
2015
Auth party contact address
-
Data no
296441
Title
European College of Equine Internal Medicine (ECEIM) Consensus Statement - Equine Gastric Ulcer Syndrome in Adult Horses
Study date
2015
Auth party contact address
-
Data no
296421
Title
Certificate of Analysis
Study date
May 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
296458
Title
Comparison of oral esomeprazole and oral omeprazole in the treatment of equine squamous gastric disease
Study date
July 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date
Application Date
Application No
Application Number
151299
Product/Active constituent Name
Application Product Name
GENFARM FLONICAMID 500 WG INSECTICIDE
Application Date
Application Number
151299
Application Product Name
GENFARM FLONICAMID 500 WG INSECTICIDE
Application details
Product name:
GENFARM FLONICAMID 500 WG INSECTICIDE
Product number:
96937
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Registration of a 500 g/kg WG Flonicamid product for the control of aphids and mealybug in apples, pears and nursery stock; for the control of aphids and mirids in cotton; for the control of aphids and silverleaf whitefly in cucurbits; for the control of aphids in potatoes; for the control of whitefly in tomatoes; for the control of aphids, whiteflies and green mirids in strawberries.
Reference details:
66373 - MAINMAN 500 WG INSECTICIDE
Active constituents:
Active constituent name
94135 - Flonicamid
Description of data provided:
Data no
299625
Title
Evaluation of Genfarm Flonicamid 500 WG Insecticide for control of Green Peach aphid in Potato (Solanum tuberosum) cv. Maranca.
Study date
18-Aug-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299613
Title
Executive Summary for Genfarm Flonicamid 500 WG Insecticide
Study date
05-Dec-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299619
Title
Manufacturing Process for Genfarm Flonicamid 500 WG Insecticide
Study date
10-Oct-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299622
Title
Evaluation of Genfarm Flonicamid 500 WG Insecticide for control of Green mirid in Strawberry (Fragaria x ananassa) cv. Red Gauntlet
Study date
9-May-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299616
Title
Safety Data Sheets
Study date
31-Jan-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299617
Title
Product Stability of Genfarm Flonicamid 500 WG Insecticide
Study date
10-Oct-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299614
Title
Part two, Chemistry and manufacture of Genfarm Flonicamid 500 WG Insecticide
Study date
05-Nov-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299620
Title
Part two, Chemistry and manufacture of Genfarm Flonicamid 500 WG Insecticide
Study date
5-Nov-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299623
Title
Evaluation of Genfarm Flonicamid 500 WG Insecticide for control of Green mirid in Cotton (Gossypium hirsutum) cv. 761 EXBRF
Study date
7-May-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299615
Title
Certificate of Analysis
Study date
15-Oct-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299626
Title
Label
Study date
Apr-2020
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299618
Title
Method Validation of Genfarm Flonicamid 500 WG Insecticide
Study date
10-Oct-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299621
Title
Evaluation\ of Genfarm Flonicamid 500 WG Insecticide for control of Silverleaf whitefly in Zucchini (Cucurbita pepo giromontiina) cv. Black Jack.
Study date
9-May-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
299624
Title
Evaluation of Genfarm Flonicamid 500 WG Insecticide for control of Tuber mealybug in Apple (Malus domestica) cv. Pink Lady.
Study date
7-May-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
151461
Product/Active constituent Name
Application Product Name
Serenade Prime Soil Ameliorant and Biofungicide
Application Date
Application Number
151461
Application Product Name
Serenade Prime Soil Ameliorant and Biofungicide
Application details
Product name:
Serenade Prime Soil Ameliorant and Biofungicide
Product number:
85292
Applicant Name:
BAYER CROPSCIENCE PTY LTD
Application purpose and description of use:
Variation of label approval to include additional uses in grapevines.
Active constituents:
Active constituent name
82243 - Bacillus amyloliquefaciens strain QST 713
Description of data provided:
Data no
299779
Title
Serenade ASO - Grapes botrytis cinerea efficacy and crop safety
Study date
08/09/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299785
Title
Serenade Prime - Grapes - Botrytis - Efficacy (Red Grape- Bioassay)
Study date
03/04/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299791
Title
Grapes - botrytis cinerea efficacy and crop safety
Study date
21/02/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299782
Title
Serenade ASO - Grapes botrytis cinerea efficacy and crop safety
Study date
27/10/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299788
Title
Serenade - Grapes botrytis cinerea efficacy and crop safety.
Study date
09/12/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299783
Title
Serenade - Grapes botrytis efficacy and crop safety
Study date
01/10/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299777
Title
Serenade ASO - Grapes botrytis cinerea efficacy and crop safety
Study date
16/09/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299774
Title
Serenade ASO - Grapes botrytis cinerea efficacy and crop safety
Study date
08/08/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299797
Title
App 25 Serenade Prime draft label grapes 2025.12
Study date
22/12/25
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299780
Title
Serenade ASO - Grapes botrytis cinerea efficacy and crop safety
Study date
09/09/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299786
Title
Serenade Prime - Grapes - Botrytis - Efficacy (Chardonnay- Bioassay)
Study date
03/04/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299794
Title
Serenade ??? Grapes botrytis efficacy and crop safety
Study date
15/08/2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299781
Title
Serenade ASO - Grapes botrytis cinerea efficacy and crop safety
Study date
27/10/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299789
Title
Serenade - Grapes botrytis cinerea efficacy and crop safety
Study date
09/12/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299795
Title
Serenade - Grapes botrytis cinerea efficacy and crop safety
Study date
02/04/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299778
Title
Serenade ASO - Grapes botrytis cinerea efficacy and crop safety
Study date
08/09/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299792
Title
Evaluation of Serenade in grapes for botrytis efficacy and crop safety
Study date
16/08/2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299798
Title
Module 8: Efficacy and Crop Safety of Serenade Prime Soil Ameliorant and Biofungicide in grape crops for disease control
Study date
12/12/25
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299775
Title
Serenade ASO - Grapes botrytis cinerea efficacy and crop safety
Study date
14/08/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299787
Title
Serenade - Grapes botrytis cinerea efficacy and crop safety
Study date
13/08/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299793
Title
Efficacy of fungicide for control of botrytis in grapevines, Langhorne Creek 2023-24
Study date
15/08/2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299776
Title
Serenade - Grapes botrytis cinerea efficacy and crop safety
Study date
15/11/2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299784
Title
Evaluation of fungicide for disease control in grapes, Lower Turners Marsh TAS
Study date
01/10/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299790
Title
Serenade Prime - Grapes botrytis cinerea efficacy and crop safety
Study date
08/08/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299796
Title
Serenade Prime ??? Table Grapes Crop Safety
Study date
27/11/25
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299773
Title
Serenade ASO - Grapes botrytis cinerea efficacy and crop safety
Study date
08/08/2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Date
Application Date
Application No
Application Number
151641
Product/Active constituent Name
Application Product Name
Owtbac Q-Action Multi-Combination Drench For Sheep
Application Date
Application Number
151641
Application Product Name
Owtbac Q-Action Multi-Combination Drench For Sheep
Application details
Product name:
Owtbac Q-Action Multi-Combination Drench For Sheep
Product number:
97052
Applicant Name:
OWTBAC AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 40 g/L levamisole hydrochloride, 37.5 g/L closantel, 25 g/L albendazole and 1.0 g/L abamectin oral drench product for the treatment and control in sheep of susceptible gastrointestinal roundworms, lungworm, tapeworms, mature and late immature liver fluke, nasal bot and itch mite.
Reference details:
56573 - Q-DRENCH MULTI-COMBINATION DRENCH FOR SHEEP
Active constituents:
Active constituent name
95585 - Levamisole hydrochloride
Active constituent name
92029 - Closantel
Active constituent name
95613 - Albendazole
Active constituent name
82843 - ABAMECTIN
Description of data provided:
Data no
300375
Title
CoA Closantel
Study date
12/2023
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
300376
Title
CoA Levamisole hydrochloride
Study date
16/07/2025
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
300373
Title
Product Specifications
Study date
13/12/2023
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
300374
Title
CoA Albendazole
Study date
15/02/2025
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
300377
Title
CoA Abamectin
Study date
01/2025
Auth party contact address
11 Condor Street Hawthorn East Australia
Date
Application Date
Application No
Application Number
151244
Product/Active constituent Name
Application Product Name
Surefire Exomite Selective Miticide
Application Date
Application Number
151244
Application Product Name
Surefire Exomite Selective Miticide
Application details
Product name:
Surefire Exomite Selective Miticide
Product number:
93660
Applicant Name:
PCT HOLDINGS PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to include additional uses in grapevines and turf.
Active constituents:
Active constituent name
89349 - Etoxazole
Description of data provided:
Data no
299742
Title
PCT Surefire Etoxazole for Couch Mite control in Turf.
Study date
24/02/2025
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
299745
Title
Part 8 Summary
Study date
December 2025
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
299743
Title
Surefire Exomite Selective Miticide
Study date
November 2025
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
299741
Title
PCT Surefire Etoxazole Miticide control of Two Spotted mite (Tetranychus urticae) in Grapevines.
Study date
28/02/2025
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
299744
Title
Paramite Selective Miticide
Study date
11/03/2022
Auth party contact address
-
Date
Application Date
Application No
Application Number
151590
Product/Active constituent Name
Application Product Name
Color 500 EC Insecticide
Application Date
Application Number
151590
Application Product Name
Color 500 EC Insecticide
Application details
Product name:
Color 500 EC Insecticide
Applicant Name:
SHARDA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 500 g/L chlorpyrifos emulsifiable concentrate product for the control of a range of insect pests in various situations.
Date
Application Date
Application No
Application Number
151004
Product/Active constituent Name
Application Product Name
ALBAUGH AVOBALANCE PLANT GROWTH REGULATOR
Application Date
Application Number
151004
Application Product Name
ALBAUGH AVOBALANCE PLANT GROWTH REGULATOR
Application details
Product name:
ALBAUGH AVOBALANCE PLANT GROWTH REGULATOR
Product number:
82649
Applicant Name:
ALBAUGH AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval for ALBAUGH AVOBALANCE PLANT GROWTH REGULATOR (APVMA No. 82649) to extend the approved pack size.
Reference details:
66861 - IMTRADE BOOST 250 SC PLANT GROWTH REGULATOR
Active constituents:
Active constituent name
62856 - PACLOBUTRAZOL