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

151666
Product/Active constituent Name

Application Product Name

Conquest Warrior EC Insecticide

Application details

Product name:

Conquest Warrior EC Insecticide

Product number:

89546

Applicant Name:

CONQUEST CROP PROTECTION PTY LTD

Application purpose and description of use:

Modify the direction for use for in the current Conquest Warrior Insecticide label

Reference details:

90105 - WARLOCK EC INSECTICIDE

Active constituents:

Active constituent name
68187 - EMAMECTIN BENZOATE

Description of data provided:

Data no
300614
Author
Anon
Title
(06) - Appendix 8.5 - Efficacy and Crop Safety
Study date
2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300612
Author
Anon
Title
(04) - Appendix 8.3 - Efficacy and Crop Safety
Study date
2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300610
Author
Flora Bavand
Title
(02) - Appendix 8.1 - Draft label with comments
Study date
Jan 2026
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300613
Author
Anon
Title
(05) - Appendix 8.4 - Efficacy and Crop Safety
Study date
2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300611
Author
Anon
Title
(03) - Appendix 8.2 - Efficacy and Crop Safety
Study date
2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300609
Author
Flora Bavand
Title
(01) - Efficacy and Crop Safety Overview ??? Conquest Warrior Insecticide
Study date
Jan 2026
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Date

Application Date

Application No

Application Number

150784
Product/Active constituent Name

Application Product Name

ZinClear Insect Repellent Sunscreen with Citronella Oil (ZinCLEAR SM02)

Application details

Product name:

ZinClear Insect Repellent Sunscreen with Citronella Oil (ZinCLEAR SM02)

Product number:

96826

Applicant Name:

VEGANIC SKN PTY LTD

Application purpose and description of use:

Registration of a 25 % w/w Zinc Oxide and 2 % w/w Cymbopogon nardus (Citronella) Oil, oil-in-water emulsion topical cream for use on human skin as a broad-spectrum sunscreen combined with natural insect-repellent protection.

Active constituents:

Active constituent name
58190 - GENCHEM METRIBUZIN 750 WG HERBICIDE
Active constituent name
49573 - VICTOR ROACH PHERMONE TRAP

Description of data provided:

Data no
296536
Author
Antaria Pty. Ltd.
Title
Stability Results - ZinCLEAR SM02
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296490
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet_Organic Citronella Oil
Study date
18/12/23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296496
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet-Organic Glyceryl Stearate Citrate
Study date
13/02/24
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296522
Author
Antaria Pty. Ltd.
Title
COA Polyglyceryl 4 oleate
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296502
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet- Sodium Chloride (Salt)
Study date
15NOV23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296516
Author
Antaria Pty. Ltd.
Title
COA Iron Oxide (Red)
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296510
Author
Antaria Pty. Ltd.
Title
COA-AUSTL Number: 444962
Study date
20 Feb 2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296533
Author
Antaria Pty. Ltd.
Title
COA-Vanillin
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296539
Author
Dr Perran Stott-Ross
Title
MOSQUITO REPELLENCY TESTS ??? AEDES AEGYPTI
Study date
22 May 2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296493
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet-Purified Water
Study date
15/11/23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296499
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet- Organic Isostearic Acid
Study date
15NOV23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296525
Author
Antaria Pty. Ltd.
Title
COA - Pelemol
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296513
Author
Antaria Pty. Ltd.
Title
Quality Control Test for Sachets
Study date
15APR2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296519
Author
Antaria Pty. Ltd.
Title
COA-Candelilla Wax
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296534
Author
Antaria Pty. Ltd.
Title
COA- Vegelight
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296511
Author
Antaria Pty. Ltd.
Title
Quality Control Test for Airless pumps (bottles and caps)
Study date
15APR2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296505
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet- VEGELIGHT
Study date
08MAY2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296494
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet-Organic Candelilla Wax
Study date
15/11/23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296528
Author
Antaria Pty. Ltd.
Title
COA-Vitamin E
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296514
Author
Antaria Pty. Ltd.
Title
Quality Control Test for Tubes
Study date
15APR2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296520
Author
Antaria Pty. Ltd.
Title
COA-Citronella Oil
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296531
Author
Antaria Pty. Ltd.
Title
COA-ZinClear XP
Study date
18 Nov 2024
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296508
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet- Iron Oxide (Yellow)
Study date
15NOV23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296537
Author
Richard Fenwick
Title
DETERMINATION OF THE EFFICACY OF CODED REPELLENTS AGAINST SANDFLIES (BITING MIDGES)
Study date
23 May 2024
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296491
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet_Non-Nano Zinc Oxide
Study date
15/11/23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296497
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet-Organic Polyglyceryl-4 Oleate
Study date
24/01/24
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296517
Author
Antaria Pty. Ltd.
Title
COA Iron Oxide (Yellow)
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296509
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet- Iron Oxide (Yellow)
Study date
15NOV23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296532
Author
Antaria Pty. Ltd.
Title
COA-Glycerine
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296492
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet_Organic Sunflower Oil
Study date
15/11/23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296500
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet- Organic Glycerin
Study date
01NOV23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296526
Author
Antaria Pty. Ltd.
Title
COA - Sodium Chloride
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296512
Author
Antaria Pty. Ltd.
Title
Quality Control Test for KG pumps (bottles and dispensers)
Study date
15APR2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296535
Author
Antaria Pty. Ltd.
Title
Citronella Content - Stability Results
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296506
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet- Organic Thuja Plicata Extract (Hinokitiol)
Study date
15NOV23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296529
Author
Antaria Pty. Ltd.
Title
COA-Hinokitiol
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296523
Author
Antaria Pty. Ltd.
Title
COA- Isostearic Acid
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296503
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet- Organic Xanthan Gum
Study date
15NOV23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296507
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet- Iron Oxide (Red)
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296530
Author
Antaria Pty. Ltd.
Title
COA-RO Water
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296538
Author
Sara Pengelly
Title
DETERMINATION OF THE EFFICACY OF CODED REPELLENTS AGAINST THE AUSTRALIAN PARALYSIS TICK
Study date
02 May 2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296524
Author
Antaria Pty. Ltd.
Title
COA -PGPR
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296498
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet- Organic Vanillin
Study date
17NOV23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296504
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet- D-Alpha Tocopheryl Acetate
Study date
08MAY2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296518
Author
Antaria Pty. Ltd.
Title
COA- Organic Sunflower Oil Refined ??? High Oleic
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296495
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet-Organic Polyglyceryl-3 Polyricinoleate (PGPR)
Study date
13/11/23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296521
Author
Antaria Pty. Ltd.
Title
COA Glyceryl Stearate Citrate
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296501
Author
Antaria Pty. Ltd.
Title
Product Declaration and Regulatory Information Sheet- Organic Polyhydroxystearic Acid
Study date
13NOV23
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296527
Author
Antaria Pty. Ltd.
Title
COA-Xanthan Gum
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Data no
296515
Author
Antaria Pty. Ltd.
Title
COA Iron Oxide (Black)
Study date
2025
Authorising party
Applicant
Auth party contact address
243 Milton Road Milton Australia
Date

Application Date

Application No

Application Number

151194
Product/Active constituent Name

Application Product Name

Vayego Forte Insecticide

Application details

Product name:

Vayego Forte Insecticide

Product number:

87936

Applicant Name:

BAYER CROPSCIENCE PTY LTD

Application purpose and description of use:

Variation of the label approval to vary the injection volume in banana

Active constituents:

Active constituent name
86755 - Tetraniliprole

Description of data provided:

Data no
300630
Author
Fitzgerald, M.
Title
Efficacy and safety module. M-888256-01-1
Study date
2025-11-27
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
300631
Author
Fitzgerald, T.
Title
Testing accurate and high-quality commercial injection equipment for banana applications using Vayego Forte Insecticide at 0.8 mL per plant in a total solution of 2 mL and 4 mL. M-888257-01-1
Study date
2025-10-03
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Date

Application Date

Application No

Application Number

151349
Product/Active constituent Name

Application Product Name

PROTECH C2I CANINE CORONAVIRUS & LEPTOSPIRA COPENHAGENI KILLED VACCINE

Application details

Product name:

PROTECH C2I CANINE CORONAVIRUS & LEPTOSPIRA COPENHAGENI KILLED VACCINE

Product number:

51488

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 registration.

Active constituents:

Active constituent name
57125 - CANINE CORONAVIRUS VACCINE - ANTIGEN
Active constituent name
57347 - LEPTOSPIRA ICTEROHAEMORRHAGIAE ANTIGEN
Active constituent name
83799 - LEPTOSPIRA INTERROGANS SEROVAR COPENHAGENI (INACTIVATED)
Active constituent name
83720 - CANINE CORONAVIRUS INACTIVATED

Description of data provided:

Data no
300000
Author
Boehringer Ingelheim
Title
3291021 batch report
Study date
20/05/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
300011
Author
Boehringer Ingelheim
Title
Executive summary Protech C2i
Study date
10/12/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
300008
Author
Boehringer Ingelheim
Title
LI3210TC inactivation kinetics protocol
Study date
30/03/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
300003
Author
APVMA
Title
PAA 133907 written advice
Study date
04/07/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
300009
Author
Boehringer Ingelheim
Title
LI3210TC inactivation kinetics QC results
Study date
02/09/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
308015
Author
Boehringer Ingelheim
Title
Interim Stability Report Protech C2i
Study date
17/06/2026
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
300006
Author
Boehringer Ingelheim
Title
CCV3198THV inactivation kinetics QC results
Study date
29/01/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
308016
Author
Boehringer Ingelheim
Title
QC test report LI3210TC 010
Study date
18/10/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
300001
Author
Boehringer Ingelheim
Title
3291022 batch report
Study date
09/07/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
300007
Author
Boehringer Ingelheim
Title
CCV3198THV inactivation kinetics report
Study date
11/03/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
300004
Author
Boehringer Ingelheim
Title
Stability report Protech C2I
Study date
30/10/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
300010
Author
Boehringer Ingelheim
Title
LI3210TC inactivation kinetics report
Study date
10/08/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
300005
Author
Boehringer Ingelheim
Title
CCV3198THV inactivation kinetics protocol
Study date
10/12/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299999
Author
Boehringer Ingelheim
Title
3291019 batch report
Study date
07/12/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
308017
Author
Boehringer Ingelheim
Title
Response to s159 notice - Protech C2i
Study date
09/07/2026
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
300002
Author
Boehringer Ingelheim
Title
Antigen stability
Study date
01/06/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date

Application Date

Application No

Application Number

151475
Product/Active constituent Name

Application Product Name

Saflufenacil

Application details

Product name:

Saflufenacil

Active name:

Saflufenacil

Applicant Name:

SHAOXING SHANGYU XIN YINBANG BIOCHEMICALCO., LTD.

Application purpose and description of use:

Approval of Saflufenacil for use in agricultural chemical products.

Description of data provided:

Data no
299985
Author
Anon
Title
Manufacturing process of Saflufenacil technical
Study date
27/11/2025
Authorising party
Applicant
Auth party contact address
No. 1 WEIWU ROAD,, Hangzhou Bay Shangyu Economic and Technological Development Area Zhejiang China
Data no
309446
Author
Anon
Title
Declaration of Composition
Study date
03/08/2026
Authorising party
Applicant
Auth party contact address
No. 1 WEIWU ROAD,, Hangzhou Bay Shangyu Economic and Technological Development Area Zhejiang China
Data no
299986
Author
Anon
Title
Five Batch Analysis of Saflufenacil Technical
Study date
15/08/2025
Authorising party
Applicant
Auth party contact address
No. 1 WEIWU ROAD,, Hangzhou Bay Shangyu Economic and Technological Development Area Zhejiang China
Data no
299987
Author
Anon
Title
Declaration of composition
Study date
12/2025
Authorising party
Applicant
Auth party contact address
No. 1 WEIWU ROAD,, Hangzhou Bay Shangyu Economic and Technological Development Area Zhejiang China
Date

Application Date

Application No

Application Number

151481
Product/Active constituent Name

Application Product Name

TREETMENT RTU TREE INJECTABLE INSECTICIDE

Application details

Product name:

TREETMENT RTU TREE INJECTABLE INSECTICIDE

Product number:

97008

Applicant Name:

SYMBIOTIC TREE SOLUTIONS PTY LTD

Application purpose and description of use:

Registration of a liquid tree-injectable formulation containing emamectin benzoate at 15g/L for the treatment of elm leaf beetle (Xanthogaleruca luteola) on elm trees (Ulmus spp), sycamore lace bug (Corythucha ciliata) on London plane trees (Platanus x Acerifolia) and red gum lerp on river red gum trees (Eucalyptus camaldulensis).

Reference details:

88692 - EMA-JECT RTU TREE INJECTABLE INSECTICIDE

Active constituents:

Active constituent name
69065 - EMAMECTIN BENZOATE

Description of data provided:

Data no
300054
Author
Sigma-Aldrich
Title
Propylene Carbonate SDS
Study date
02/03/2020
Authorising party
Public
Auth party contact address
-
Data no
300051
Author
ACS Laboratories
Title
Certificate of Analysis
Study date
26/06/2024
Authorising party
Applicant
Auth party contact address
27 Norwood Crescent Moonee Ponds Australia
Data no
300052
Author
Shandong Weifang Rainbow Chemical Co.,Ltd
Title
Emamectin Benzoate Technical
Study date
07/02/2024
Authorising party
Applicant
Auth party contact address
27 Norwood Crescent Moonee Ponds Australia
Data no
300055
Author
ELDERS TOLL FORMULATION PTY LTD
Title
The formulation of an emamectin RTU Tree Injectable Insecticide
Study date
October 2024
Authorising party
Applicant
Auth party contact address
27 Norwood Crescent Moonee Ponds Australia
Data no
300050
Author
ACS Laboratories
Title
Method Validation for the determination of emamectin benzoate in Emamectin benzoate Tree Injectable RTU
Study date
23/04/2024
Authorising party
Applicant
Auth party contact address
27 Norwood Crescent Moonee Ponds Australia
Data no
300056
Author
Supelco
Title
Emamectin Benzoate SDS
Study date
07/11/2025
Authorising party
Public
Auth party contact address
-
Data no
300053
Author
Sigma-Aldrich
Title
Dimethyl sulfoxide SDS
Study date
03/08/2023
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

151140
Product/Active constituent Name

Application Product Name

Excalia Fungicide

Application details

Product name:

Excalia Fungicide

Product number:

90901

Applicant Name:

SUMITOMO CHEMICAL AUSTRALIA PTY. LIMITED

Application purpose and description of use:

Variation of product registration and label approval to extend use to include control of Botrytis and Powdery mildew and suppression of Downy mildew in Table and Wine grapes.

Active constituents:

Active constituent name
90900 - Inpyrfluxam

Description of data provided:

Data no
299678
Author
M. Lindner, A. Bdel
Title
Storage Stability of S-2399 and its Metabolites in Processed Food Matrices of Plant Origin. [TPR-0101]
Study date
26/02/2019
Data no
299679
Author
S. Freedlander
Title
[14C]S-2399 - Nature of Residues in Processed Commodities High Temperature Hydrolysis. [TPM-0022]
Study date
25/07/2016
Data no
299680
Author
P. Lamond
Title
[14C]-OH-S-2840: OECD 507 Nature of Residue High Temperature Hydrolysis. [TPM-0054]
Study date
24/01/2018
Data no
299681
Author
J. Gilbert
Title
[14C] 1-CH2OH-S-2840: OECD 507 Nature of Residue High Temperature Hydrolysis.. [TPM-0055]
Study date
01/12/2017
Data no
299682
Author
M. Lindner
Title
Validation of an Analytical Method for the Determination of S-2399 and its Metabolites in Cereal (Whole Plant and Grain), Potato (Tubers), Grapes and Soybean (Seeds). [TPA-0057]
Study date
07/11/2017
Data no
299683
Author
Jalal M A F, Nguyen T, Whitby J
Title
Confined Accumulation of [Phenyl- 14C]S-2399 and [Pyrazolyl-4-14C]S- 2399 in Rotational C [TPM-0047]
Study date
05/01/2017
Data no
299684
Author
Jalal M A F, Nguyen T, Whitby J
Title
Confined Accumulation of [Phenyl- 14C]S-2399 and [Pyrazolyl-4-14C]S- 2399 in Rotational C [TPM-0047]
Study date
05/01/2017
Data no
299685
Author
David J Bell & Associates Pty Ltd
Title
Grape Powdery Mildew Trial Report 2015/16 [F15-008-2399-Grape]
Study date
Feb-2016
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299676
Author
B. VanMiddlesworth
Title
Magnitude of S-2399 and Metabolites 1-CH2OH-S-2840 A&B (including conjugate) and 1-COOH- S-2840 A&B Residues in Laying Hen Tissues and Eggs from a 28- Day Feeding Study. [TPR-0015]
Study date
01/03/2017
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299699
Author
David Kohler, Stuart Johnson, Kate Allen
Title
Efficacy of Excalia 400 SC and VBC80173 WG against botrytis bunch rot (Botrytis cinerea) in grapevines cv. Sauvignon Blanc Rosevears, Tasmania 2023-24. [V23-020-2399-80173-Grapev2]
Study date
6-Jun-2024
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299705
Author
David Kohler, Stuart Johnson, Kate Allen, Pam Batt
Title
Evaluation of SCAL5233 for control of downy mildew (Plasmopora viticola) in grapevines cv. Sauvignon Blanc Rosevears, Tasmania 2024-25. [F24-016-SCAL5233-GRAPE V2]
Study date
30-Apr-2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299688
Author
David Kohler
Title
Efficacy of fungicides for control of Powdery mildew (Erysiphe necator) and Botrytis bunch rot (Botrytis cinerea) in grapevines cv. Sauvignon Blanc Kayena, Tasmania. [V20-023-VBC80173-GRAPE]
Study date
16-Jun-2021
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299696
Author
David Kohler, Stuart Johnson, Pam Batt
Title
Efficacy of Excalia 400 SC, Prolectus 400 SC and Zorda WG against Powdery mildew (Erysiphe necator) in Grapevines cv. Pinot Noir Moriarty, Tasmania 2023-24. [F23-003-2399-Grape]
Study date
6-6-2024
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299673
Author
Sara Pengelly
Title
Determination of residues of Excalia (Inpyrfluxan) in Table grapes. [S24-0434]
Study date
5-Nov-2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299702
Author
Peter Cole
Title
Evaluation of chemicals for dormancy break and growth on Table grapes Swan Hill, Victoria. [F24-018-2399-GRAPE]
Study date
Feb 2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299708
Author
Andrew Dyson
Title
Excalia Part 8 Efficacy and crop safety 26-11-2025
Study date
26-Nov-2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299691
Author
Peter Cole
Title
Evaluation of fungicide efficacy for disease control in Table grapes Mildura, Victoria, Australia. [V22-008-80173-Grape]
Study date
July 2023
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299697
Author
Peter Cole
Title
Evaluation of fungicide efficacy for disease control in Table grapes Mildura, Victoria, Australia. [V23-018-2399-Grape]
Study date
July 2024
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299703
Author
Sam Hewavitharana
Title
Evaluation of Fungicides for Disease Control in Table Grapes Mundubbera, Wide Bay Burnett, QLD. [V24-014-80173-GRAPE]
Study date
Feb 2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299674
Author
T. Arndt, B. VanMiddlesworth
Title
Magnitude of S-2399 and Metabolites 1-CH2OH-S-2840 A&B (including conjugate) and 1-COOH- S-2840 A&B Residues in Bovine Tissues and Milk from a 28-Day Feeding Study. [TPR-0013]
Study date
14/12/2016
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299668
Author
Solomon, P.
Title
Determination of residues of Excalia (inpyrfluxam) in table grapes. [23-SUM-060 Analytical Report]
Study date
21-May-2024
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299711
Author
Andrew Dyson
Title
Excalia Part 5b Trade 26-Nov-2025
Study date
26-Nov-2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299694
Author
Kate Allen
Title
Efficacy of fungicides for control of Downy mildew (Plasmopora viticola) in grapevines cv. Pinot Noir Moriarty, Tasmania. [V22-025-VBC80173-Grape]
Study date
27-Aug-2024
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299700
Author
David Kohler, Stuart Johnson, Kate Allen
Title
Efficacy of Excalia 400 SC and VBC80173 WG against botrytis bunch rot (Botrytis cinerea) in grapevines in grapevines cv. Sauvignon Blanc Gawler, Tasmania 2023-24. [V23-021-2399-80173-Grape]
Study date
6-6-2024
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299677
Author
B. VanMiddlesworth
Title
Magnitude of S-2399 and Metabolites 1-CH2OH-S-2840 A&B (including conjugate) and 1-COOH- S-2840 A&B Residues in Laying Hen Tissues and Eggs from a 28- Day Feeding Study. [TPR-0015]
Study date
01/03/2017
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299671
Author
Eva Sui
Title
Fermentation and Sensory evaluation of wines relating to the application of S-2399 40SC and VBC-80173 to winegrapes. [PCS22126]
Study date
24-Nov-2023
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299714
Author
Andrew Dyson
Title
Excalia Part 6 Worker Health and Safety 24-Nov-2025
Study date
24-Nov-2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299712
Author
Anon
Title
EXCALIA Fungicide Label V18-Nov-2025 [EXCALIA Draft label 18-Nov-2025]
Study date
26-Nov-2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299695
Author
Alexander Monk
Title
Evaluation of a fungicides for disease control in Wine grapes Ballandean, QLD, 2022-23. [V22-038-VBC80173-Grape]
Study date
15-3-2023
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299689
Author
Peter Cole
Title
Evaluation of chemicals for fungal control in Wine grapes Portarlington, Bellarine Peninsula, Victoria, 2021-22. [V21-013-VBC80173-GRAPE]
Study date
Jun-2022
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299672
Author
Tim Ranchodbhai
Title
DETERMINATION OF RESIDUES OF EXCALIA (INPYRFLUXAM) 400 SC IN WINE GRAPES. AUSTRALIA, 2024/2025. [S24-0431]
Study date
3-Nov-2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299709
Author
Andrew Dyson
Title
Excalia Part 7 Environment 26-Nov-2025
Study date
26-Nov-2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299715
Author
APVMA
Title
Environmental Technical Report Excalia Fungicide Application Number: 130464, Product number: 90901.
Study date
11-Feb-2023
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299686
Author
Peter Cole
Title
Evaluation of a fungicide for Powdery mildew control and residue analysis in Wine grapes. Avoca, Victoria, 2019-20 [F19-004-2399-Grape]
Study date
Jun-2020
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299692
Author
Sam Hewavitharana, Patrick Press
Title
Evaluation of Fungicides for Disease Control in Table grapes Mundubbera, Wide Bay Burnett, QLD. [V22-019-VBC80173-Grape]
Study date
Feb-2023
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299698
Author
Peter Cole
Title
Evaluation of fungicide efficacy for disease control in Table grapes Mildura, Victoria, Australia. [V23-019-2399-80173-Grape]
Study date
July 2024
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299675
Author
T. Arndt, B. VanMiddlesworth
Title
Magnitude of S-2399 and Metabolites 1-CH2OH-S-2840 A&B (including conjugate) and 1-COOH- S-2840 A&B Residues in Bovine Tissues and Milk from a 28-Day Feeding Study. [TPR-0013]
Study date
14/12/2016
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299706
Author
Michaela Miller
Title
Determination of residues of S-2399 in wine grapes and wine. [V22-033-2399-V80173-GRAPE-RES]
Study date
19/1/2024
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299669
Author
Michaela Miller
Title
Determination of residues of S-2399 in wine grapes and wine. [22-SUM-042, V22-033-2399-V80173-GRAPE-RES][
Study date
19-Jan-2024
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299693
Author
Stephen Tancred
Title
Comparison of fungicides for disease control in wine grapes. Stanthorpe, Qld, 2022-23. [V22-020-VBC80173-Grape]
Study date
16-Jun-2023
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299687
Author
Peter Cole
Title
Evaluation of chemicals for fungal control in Wine grapes Coldstream, Yarra Valley, Victoria, 2020-21. [V20-010-VBC80173-Grape]
Study date
Jun-2021
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299701
Author
Peter Cole
Title
Evaluation of fungicides for taste taints on Table grapes Mildura, Victoria, Australia. [V23-031-2399-80173-Grape]
Study date
July 2024
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299670
Author
Solomon, P.
Title
Determination of residues of S-2399 in wine grapes and wine.
Study date
21-Aug-2023
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299707
Author
Jason Rittman
Title
Determination of residues of Excalia (inpyrfluxam) in table grapes. [V23-003-2399-TABLE GRAPE RES 23-SUM-060]
Study date
2/1/2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299713
Author
Andrew Dyson
Title
Excalia Part 1 Overview and portal application form 26-Nov-2025
Study date
26-Nov-2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299690
Author
Belinda Udy
Title
Evaluation of fungicides for control of Downy mildew (Plasmopara viticola) in grapes cv. Pinot Noir Moriarty, Tasmania. [V21-027-VBC80173-GRAPE]
Study date
16-Jun-2022
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299704
Author
Mark De Lisio
Title
Comparison of Downy mildew (caused by Plasmopara viticola) protection with surface protectant fungicides on grapevine cv. Chardonnay. [SA-21-F9 (AGX21177)]
Study date
24-May-2022
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299667
Author
Jason Rittman
Title
Determination of residues of Excalia (inpyrfluxam) in table grapes. [23-SUM-060 Field Phase]
Study date
2-Jan-2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
299710
Author
Andrew Dyson
Title
Excalia Part 5a Residues 26-Nov-2025
Study date
26-Nov-2025
Authorising party
Applicant
Auth party contact address
51 RAWSON STREET EPPING Australia
Date

Application Date

Application No

Application Number

151196
Product/Active constituent Name

Application Product Name

COMPANION SURFACTANT

Application details

Product name:

COMPANION SURFACTANT

Product number:

51664

Applicant Name:

AGRION CROP SOLUTIONS PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to add an alternate formulation and a marketing label.

Active constituents:

Active constituent name
59637 - SOYAL PHOSPHOLIPIDS
Active constituent name
59638 - PROPIONIC ACID

Description of data provided:

Data no
299662
Author
Anon.
Title
Efficacy of various adjuvants for control of susceptible sowthistle in mixture with a sub-lethal rate of glyphosate
Study date
Jan 2025
Authorising party
Applicant
Auth party contact address
70 Quantum Close DANDENONG SOUTH Australia
Data no
299659
Author
Applicant
Title
Formulation Stability Report ??? CDP-1503
Study date
Jun 2025
Authorising party
Applicant
Auth party contact address
70 Quantum Close DANDENONG SOUTH Australia
Data no
299665
Author
Anon.
Title
Evaluate crop safety of Companion and CDP-1503 in mixtures with common herbicides on a range of broadacre and pasture crops
Study date
May 2024
Authorising party
Applicant
Auth party contact address
70 Quantum Close DANDENONG SOUTH Australia
Data no
299660
Author
Applicant
Title
Efficacy Overview
Study date
Nov 2025
Authorising party
Applicant
Auth party contact address
70 Quantum Close DANDENONG SOUTH Australia
Data no
299657
Author
Applicant
Title
Chemistry & Manufacture Overview
Study date
Nov 2025
Authorising party
Applicant
Auth party contact address
70 Quantum Close DANDENONG SOUTH Australia
Data no
299666
Author
Anon.
Title
Stability investigation - dimethoate
Study date
Feb 2024
Authorising party
Applicant
Auth party contact address
70 Quantum Close DANDENONG SOUTH Australia
Data no
299663
Author
Anon.
Title
Efficacy of various adjuvants for control of susceptible ryegrass in mixtures with glyphosate.
Study date
Mar 2025
Authorising party
Applicant
Auth party contact address
70 Quantum Close DANDENONG SOUTH Australia
Data no
299658
Author
Applicant
Title
Confidential Data and Information
Study date
Nov 2025
Authorising party
Applicant
Auth party contact address
70 Quantum Close DANDENONG SOUTH Australia
Data no
299664
Author
Anon.
Title
Comparison of various adjuvants for control of broadleaf weeds and grasses in fallow when mixed with Glufosinate + AMS
Study date
Dec 2024
Authorising party
Applicant
Auth party contact address
70 Quantum Close DANDENONG SOUTH Australia
Data no
299661
Author
Anon.
Title
Bioequivalence of Companion and CDP-1503 in mixtures with common herbicides for control of grass and broadleaf weeds
Study date
May 2024
Authorising party
Applicant
Auth party contact address
70 Quantum Close DANDENONG SOUTH Australia
Date

Application Date

Application No

Application Number

151653
Product/Active constituent Name

Application Product Name

Sedaxane

Application details

Product name:

Sedaxane

Active name:

Sedaxane

Applicant Name:

KINGTAI CHEMICALS CO., LIMITED

Application purpose and description of use:

Approval of Sedaxane for use in agricultural chemical products.

Description of data provided:

Data no
300486
Author
Nicholas Wen
Title
Part 2 - Chemistry
Study date
January 7, 2026
Authorising party
Applicant
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
300484
Author
Nicholas Wen
Title
Declaration of Composition
Study date
January 7, 2026
Authorising party
Applicant
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
300485
Author
ANON
Title
Five batch analysis of Sedaxane Technical
Study date
January 7, 2026
Authorising party
Applicant
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
300483
Author
George Jiang
Title
The Manufacturing Process of Sedaxane Technical
Study date
January 7, 2026
Authorising party
Applicant
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Date

Application Date

Application No

Application Number

151188
Product/Active constituent Name

Application Product Name

N-octyl bicycloheptene dicarboximide

Application details

Product name:

N-octyl bicycloheptene dicarboximide

Active name:

N-octyl bicycloheptene dicarboximide

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Approval of n-octyl bicycloheptene dicarboximide (MGK 264) for use in veterinary chemical products.

Description of data provided:

Data no
298786
Author
APVMA
Title
Notice of variation to an approved active constituent
Study date
10 April 2025
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
298785
Author
Anon
Title
Certificates of Analysis
Study date
November 2025
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date

Application Date

Application No

Application Number

151333
Product/Active constituent Name

Application Product Name

Pyrimethanil

Application details

Product name:

Pyrimethanil

Active name:

Pyrimethanil

Applicant Name:

India Pesticides Limited

Application purpose and description of use:

Approval of pyrimethanil for use in agricultural chemical products.

Description of data provided:

Data no
300572
Author
India Pesticides Limited
Title
Part 2 Chemistry and Manufacturing
Study date
2025
Authorising party
Applicant
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
300575
Author
India Pesticides Limited
Title
Declaration of Composition (DoC) of Pyrimethanil
Study date
2025
Authorising party
Applicant
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
300576
Author
India Pesticides Limited
Title
Certificates of Analysis (COA) Technical and Reference Standards
Study date
2024
Authorising party
Applicant
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
300573
Author
India Pesticides Limited
Title
Manufacturing Process for Pyrimethanil Technical
Study date
2025
Authorising party
Applicant
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
300574
Author
India Pesticides Limited
Title
Validation Of Analytical Method, Determination Of Active Ingredient And Impurities In Five Batches Of Pyrimethanil Technical
Study date
2025
Authorising party
Applicant
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
300577
Author
India Pesticides Limited
Title
Pyrimethanil MATERIAL SAFETY DATA SHEET
Study date
2025
Authorising party
Applicant
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Date

Application Date

Application No

Application Number

151575
Product/Active constituent Name

Application Product Name

Conquest Vipyr 250 EC Fungicide

Application details

Product name:

Conquest Vipyr 250 EC Fungicide

Product number:

87896

Applicant Name:

CONQUEST CROP PROTECTION PTY LTD

Application purpose and description of use:

Modify the direction for use for in the current Conquest Vipyr Fungicide label

Reference details:

62753 - OPERA FUNGICIDE
67073 - CONQUEST EPOXIGUARD 125 FUNGICIDE
85527 - SOPRANO 500 FUNGICIDE

Active constituents:

Active constituent name
83671 - pyraclostrobin

Description of data provided:

Data no
300203
Author
Flora Bavand
Title
(01) - Efficacy and Crop Safety Overview ??? Conquest Vipyr 250 EC
Study date
Nov 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300206
Author
Anon
Title
(04) ??? Appendix 8.3 ??? Efficacy and crop safety
Study date
Dec 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300207
Author
Anon
Title
(05) ??? Appendix 8.4 ??? Efficacy and crop safety
Study date
Jan 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300204
Author
Flora Bavand
Title
(02) ??? Appendix 8.1 ??? draft label with comments
Study date
Dec 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
300205
Author
Anon
Title
(03) ??? Appendix 8.2 ??? Efficacy and crop safety
Study date
Feb 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Date

Application Date

Application No

Application Number

151628
Product/Active constituent Name

Application Product Name

SUREFIRE BROMA GRAIN BAIT RODENTICIDE

Application details

Product name:

SUREFIRE BROMA GRAIN BAIT RODENTICIDE

Product number:

67142

Applicant Name:

PCT HOLDINGS PTY LTD

Application purpose and description of use:

Variation of product registration to comply with Rodenticide Chemical Review outcome requirements for formulation composition.

Reference details:

64850 - SUREFIRE BROMA PELLETS RODENTICIDE

Active constituents:

Active constituent name
47790 - BROMADIOLONE MANUFACTURING CONCENTRATE
Active constituent name
67898 - BROMADIOLONE

Description of data provided:

Data no
300443
Author
G Francesco
Title
Certificate of analysis
Study date
18/03/2022
Date

Application Date

Application No

Application Number

151652
Product/Active constituent Name

Application Product Name

IMTRADE ENVIROPINK GB MOLLUSCICIDE

Application details

Product name:

IMTRADE ENVIROPINK GB MOLLUSCICIDE

Product number:

97055

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 certain Snails and Slugs in a range of Agricultural and Horticultural 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
300472
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300466
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300458
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300452
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300469
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300446
Author
N/A
Title
Imtrade FeNa-EDTA (Iron Chelate) 120 Bait 1 Batch Analysis ??? August 2024
Study date
08/08/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300449
Author
N/A
Title
CoA - FeNa-EDTA (iron chelate)
Study date
20/11/2025
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300455
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300447
Author
N/A
Title
Imtrade FeNa-EDTA (Iron Chelate)120 Bait Method Validation ??? August 2024
Study date
08/08/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300470
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300464
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300450
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300444
Author
N/A
Title
Method of Manufacture ??? Imtrade Enviropink (FeNa-EDTA (iron chelate) 120g/kg) GB Molluscicide
Study date
29/08/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300467
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300473
Author
N/A
Title
Comments to Support Efficacy and Host Crop Safety data submitted
Study date
12/01/2026
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300461
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300453
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300445
Author
N/A
Title
Formulation and Stability Report - Imtrade Enviropink (FeNa-EDTA (iron chelate) 120g/kg) GB Molluscicide
Study date
29/08/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300468
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300462
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300456
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300448
Author
N/A
Title
Safety Data Sheets
Study date
29/08/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300465
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300459
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300474
Author
N/A
Title
Reference Material for Comments to Support Efficacy & HCS Data submitted
Study date
2002
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300460
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300454
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300471
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300457
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300463
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
300451
Author
N/A
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
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date

Application Date

Application No

Application Number

151626
Product/Active constituent Name

Application Product Name

Haloxyfop-P-methyl

Application details

Product name:

Haloxyfop-P-methyl

Active name:

Haloxyfop-P-methyl

Applicant Name:

LEAD CHEMICAL CO., LTD.

Application purpose and description of use:

Approval of Haloxyfop-P-methyl for use in agricultural chemical products.

Description of data provided:

Data no
300409
Author
Ling Fu
Title
Preliminary Analysis and Enforcement Analytical Methods of Haloxyfop-P-methyl Technical
Study date
11 August, 2025
Authorising party
Applicant
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300403
Author
/
Title
Haloxyfop-P-methyl Chemistry And Manufacture
Study date
December 25, 2025
Authorising party
Applicant
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300406
Author
Ling Fu
Title
Preliminary Analysis and Enforcement Analytical Methods of Haloxyfop-P-methyl Technical
Study date
11 August, 2025
Authorising party
Applicant
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300407
Author
Ling Fu
Title
Preliminary Analysis and Enforcement Analytical Methods of Haloxyfop-P-methyl Technical
Study date
11 August, 2025
Authorising party
Applicant
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300410
Author
Xiao Xiao
Title
Declaration Letter
Study date
December 25, 2025
Authorising party
Applicant
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300404
Author
Xiao Xiao
Title
Manufacturing Process and Genesis of Impurities for Haloxyfop-P-methyl Technical
Study date
December 25, 2025
Authorising party
Applicant
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300405
Author
Xiao Xiao
Title
Declaration of Composition
Study date
December 25, 2025
Authorising party
Applicant
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Data no
300408
Author
Ling Fu
Title
Preliminary Analysis and Enforcement Analytical Methods of Haloxyfop-P-methyl Technical
Study date
11 August, 2025
Authorising party
Applicant
Auth party contact address
Qingtongxia Industrial Park Qingtongxia People's Republic of China
Date

Application Date

Application No

Application Number

149068
Product/Active constituent Name

Application Product Name

Live attenuated feline Chlamydia felis strain Baker

Application details

Product name:

Live attenuated feline Chlamydia felis strain Baker

Product number:

96356

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a live attenuated pentavalent vaccine comprising of feline calicivirus, feline herpesvirus, feline panleucopenia virus, Chlamydia felis and feline leukopenia virus RNA-particles, for use in cats. In conjunction with approval of two new active constituents, C. felis and RP-FeLV.

Description of data provided:

Data no
291172
Author
Intervet
Title
MCA L2i-6-INT-1
Study date
Jul 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291684
Author
Intervet
Title
B05-054-01R
Study date
Oct 2005
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291069
Author
Intervet
Title
170026 report
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291690
Author
Intervet
Title
SOP-256120-513
Study date
May 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291676
Author
OIE
Title
Chapter 8.8 WHO OIE. OIE Terrestrial Animal Health Code
Study date
Aug 2022
Data no
288533
Author
Intervet
Title
Specifications
Study date
Mar 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291687
Author
Sache, K et. al.
Title
Emendation of the family Chlamydiaceae- Proposal of a single genus, Chalmydia, to inclue all currently recognised species
Study date
2015
Data no
291046
Author
Koophandel K
Title
Site 1 register
Study date
Koophandel K
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291693
Author
Read, T. et. al.
Title
Genome sequences of C. trachomatis MoPn and C. pneumoniae AR39
Study date
2000
Data no
291556
Author
Steinfeldt, C et. al.
Title
The risk mitigation of food and mouth disease virus infection in pigs through consumption of contaminated feed.
Study date
May 2021
Data no
288562
Author
Intervet
Title
16f20 report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291679
Author
Intervet
Title
TI-5123-0006
Study date
Mar 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291067
Author
Intervet
Title
Site 1 Est. Lic.
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291682
Author
Intervet
Title
2d
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291688
Author
Sykes, J
Title
Feline chlamydiosis
Study date
2005
Data no
291685
Author
Gruffydd-Jones et. al.
Title
Guideline for Chlamydia felis
Study date
Jan 2009
Data no
288559
Author
Intervet
Title
011696 report
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291691
Author
Intervet
Title
Part 2
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291554
Author
Piccardo, P et. al.
Title
Candidate cell substrates, vaccine production and transmissible spongiform encephalopathies
Study date
Dec 2001
Data no
291176
Author
Intervet
Title
Certificates_statements
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291677
Author
Intervet
Title
TI-4066-0756
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291047
Author
Intervet
Title
Site 1 GMP
Study date
Jan 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291686
Author
Harley, R et. al.
Title
Molecular characterisation of 12 C. felis polymorphic membrane protein genes
Study date
Apr 2007
Data no
288560
Author
Intervet
Title
14l21 coa
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291694
Author
Confidential
Title
Part 2.h Ph. Eur. monographs
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288563
Author
Intervet
Title
2c
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291680
Author
Intervet
Title
TI-4066-0756
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291674
Author
Kamolsiripichaiport, S et. al.
Title
Thermal inactivation of foot and mouth disease viruses in suspension.
Study date
Nov 2007
Data no
291683
Author
Intervet
Title
B02-193-01R
Study date
Oct 2005
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291070
Author
Intervet
Title
170027 report
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291174
Author
Intervet
Title
98R/0421 report
Study date
May 1998
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291675
Author
Intervet
Title
Response ready guide
Study date
Oct 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288532
Author
Intervet
Title
QP dec.
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291071
Author
Intervet
Title
170028 report
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291692
Author
May, S et. al.
Title
Virulence of feline Chalmydia psittaci in mice not a function of MOMP
Study date
Aug 1996
Data no
291555
Author
Intervet
Title
Guideline
Study date
Oct 2012
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291678
Author
Intervet
Title
TI-5123-0001
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291681
Author
Intervet
Title
2b
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291689
Author
Intervet
Title
Clamydial infections
Study date
Clamydial infections
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

149069
Product/Active constituent Name

Application Product Name

Nobivac NXT HCPChFeLV Live Vaccine for cats

Application details

Product name:

Nobivac NXT HCPChFeLV Live Vaccine for cats

Product number:

96357

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a live attenuated pentavalent vaccine comprising of feline calicivirus, feline herpesvirus, feline panleucopenia virus, Chlamydia felis and feline leukopenia virus RNA-particles, for use in cats. In conjunction with approval of two new active constituents, C. felis and RP-FeLV.

Active constituents:

Active constituent name
85857 - FELINE CALICIVIRUS (Live)
Active constituent name
85861 - FELINE HERPES VIRUS TYPE 1 (Live)
Active constituent name
85859 - FELINE PANLEUCOPENIA VIRUS (Live)
Active constituent name
96356 - Live attenuated feline Chlamydia felis strain Baker
Active constituent name
96358 - Feline leukemia virus glycoprotein RNA Particles

Description of data provided:

Data no
288115
Author
August, J
Title
The control and eradication of feline upper respiratory infections in cluster populations
Study date
1990
Authorising party
Public
Auth party contact address
-
Data no
288186
Author
Intervet
Title
Table A
Study date
2003
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288447
Author
Intervet
Title
Validation FCT-T-22-48-104
Study date
Jun 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291435
Author
van Steenis, G and van Wezel, A
Title
Use of atg treated newborn rat for in vivo tumorigenicity testing of cell substrates
Study date
1982
Data no
288209
Author
OIE
Title
Malignant catarrhal fever
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
288424
Author
Fastier, L
Title
A new feline virus isolated in tissue culture
Study date
1957
Authorising party
Public
Auth party contact address
-
Data no
307797
Author
Eudra
Title
Eudra GMP Site 4, USA
Study date
24 Apr 2026
Authorising party
Public
Auth party contact address
-
Data no
288470
Author
Intervet
Title
FCT-T 20-48-058 study Am 1
Study date
Jun 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288524
Author
Intervet
Title
Part 7
Study date
May 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288238
Author
DeFrabitius, L et. al.
Title
Utilisation of ISA Reverse genetics and large scale random codon re-encoding to produce attenuated strains of tick-borne encephalitis virus within days
Study date
Aug 2016
Authorising party
Public
Auth party contact address
-
Data no
288324
Author
Intervet
Title
FCT-T 21-48-098 Am 1
Study date
Apr 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288278
Author
Intervet
Title
LIVE-IMPR-24059 report
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288284
Author
Intervet
Title
06B24 Protocol
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291521
Author
Intervet
Title
antigen test kit
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288178
Author
Brown, F
Title
Inactivation of viruses by aziridines.
Study date
Jul 2001
Authorising party
Public
Auth party contact address
-
Data no
288332
Author
Intervet
Title
FCT-T 21-48-132 Report
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288232
Author
OIE
Title
Epidemiology and host spectrum of borna disease virus infection 2.9.1 bunyaviral diseases of animals
Study date
May 2014
Authorising party
Public
Auth party contact address
-
Data no
288478
Author
Intervet
Title
PV on efficacy
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288132
Author
Vaz, P. et. al.
Title
Low genetic diversity among historical and contemporary clinical isolates of felid herpesvirus 1. BMC
Study date
Sep 2016
Authorising party
Public
Auth party contact address
-
Data no
288378
Author
Intervet
Title
s21019-00 study Am 1
Study date
May 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288103
Author
Intervet
Title
QP CV
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288364
Author
Intervet
Title
FCT-T 19-48-029 Am 7
Study date
Nov 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291447
Author
Intervet
Title
Validation FCT-T 21-48-078
Study date
Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291518
Author
Intervet
Title
fpl071390T report
Study date
Jun 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288221
Author
OIE
Title
Nipah and hendra virus diseases
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
288152
Author
Intervet
Title
29h19 protocol
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288481
Author
Intervet
Title
SPC
Study date
May 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288458
Author
Intervet
Title
FCT-T 20-48-065 study report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288507
Author
Intervet
Title
FCT-T 20-48-054 study protocol
Study date
Oct 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288272
Author
Intervet
Title
A003A protocol
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288438
Author
Intervet
Title
SOP 256120-533
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288123
Author
Intervet
Title
23151 coa
Study date
Jan 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288172
Author
Intervet
Title
MCA B2G11-INT
Study date
Mar 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288295
Author
Intervet
Title
FCT-T 21-48-093 protocol
Study date
Aug 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288338
Author
Intervet
Title
FCT-T 21-48-132 Am 13
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288344
Author
Intervet
Title
FCT-T 21-48-132 Am 5
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288146
Author
Intervet
Title
A542a protocol
Study date
Oct 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288315
Author
Intervet
Title
FCT-T-20-48-065 Report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288487
Author
Intervet
Title
FCT-T 20-48-055 study report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307791
Author
OGTR
Title
DIR 220 - RARMP Commercial supply of multivalent cat vaccines containing a genetically modified component for the prevention of feline leukemia virus infection
Study date
Apr 2026
Authorising party
Public
Auth party contact address
-
Data no
288415
Author
Intervet
Title
Merck Manual FPL
Study date
Aug 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288464
Author
Intervet
Title
FCT-T 20-48-081 study protocol
Study date
Jul 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288109
Author
Alfonso, M et. al.
Title
A multi national european cross sectional study of FCV epidemiology, diversite and cross-reactivity
Study date
Apr 2017
Authorising party
Public
Auth party contact address
-
Data no
288358
Author
Intervet
Title
FCT-T 19-48-029 Am 1
Study date
Apr 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291441
Author
Tanaka, T et. al.
Title
Development and evaluation of an efficient cell cul;tture system for hepatitis E virus
Study date
2007
Data no
288215
Author
Kinnunen, P et. al.
Title
Epidemiology and host spectrum of borna disease virus infections
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
288252
Author
Intervet
Title
TI-4066-0179
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288407
Author
Meli, M et. al.
Title
Feline laukemia virus and other pathogens as important threats to the survival of the Iberian Lynx
Study date
Mar 2009
Authorising party
Public
Auth party contact address
-
Data no
288450
Author
Intervet
Title
Statement
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288301
Author
Intervet
Title
FCT-T 21-48-093 Am 14
Study date
Jan 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288158
Author
Intervet
Title
117556 report
Study date
Feb 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288401
Author
Hartmann, K et. al.
Title
Quality of different in-clinic test kits for feline immunodeficiency virus and feline leukemia virus infection
Study date
Apr 2007
Authorising party
Public
Auth party contact address
-
Data no
288501
Author
Intervet
Title
FCT-T 20-48-059 study Am 2
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288281
Author
Intervet
Title
24B22A Protocol
Study date
Mar 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288352
Author
Intervet
Title
FCT-T 19-48-029 Am 10
Study date
Jul 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288258
Author
Intervet
Title
TI-5089-0006
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288235
Author
Nan, Y and Zhang, Y
Title
Molecular biology and infection of hepatitis E virus
Study date
Sep 2016
Authorising party
Public
Auth party contact address
-
Data no
288398
Author
Alfonso, M et. al.
Title
A multi-national European cross-sectional study of feline calicivirus epidemiology, diversity and vaccine cross-reactivity.
Study date
Apr 2017
Authorising party
Public
Auth party contact address
-
Data no
307800
Author
Intervet AH Pty Limited
Title
Applicant responses to s159 **READ FIRST**
Study date
10 July 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288089
Author
Intervet
Title
Site 5 GMP
Study date
Jan 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288212
Author
Tanaka, T et. al.
Title
Development and evaluation of an efficient cell-culture system for hepatitis E virus
Study date
Oct 2006
Authorising party
Public
Auth party contact address
-
Data no
288421
Author
Vaz, P et. al.
Title
Low genomic diversity among historical and contemporart clincal isolates of felie herpesvirus I
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
288444
Author
Intervet
Title
Method GLM 2026
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291438
Author
Intervet
Title
fcv110988D report
Study date
June 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288166
Author
Intervet
Title
FCT-T-20-48-069 report
Study date
Nov 2004
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288467
Author
Intervet
Title
FCT-T 20-48-081 study Am 3
Study date
Feb 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288490
Author
Intervet
Title
FCT-T 20-48-055 study Am 2
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307794
Author
Intervet AH Pty Limited
Title
Nobivac NXT HCPChFeLV Toxicology Risk Assessment
Study date
17 July 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288513
Author
Intervet
Title
s21019-00 Clinical study Protocol
Study date
Jan 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288275
Author
Intervet
Title
A189T coa
Study date
Mar 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291524
Author
Intervet
Title
FPL seed lineage
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288381
Author
Intervet
Title
s21019-00 study Am 4
Study date
Feb 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288321
Author
Intervet
Title
FCT-T 21-48-098 Am 11
Study date
Mar 2044
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288335
Author
Intervet
Title
FCT-T 21-48-132 Am 10
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288521
Author
Intervet
Title
Efficacy Pre-clinical studies
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288527
Author
Burling, A et. al.
Title
Seroprevalences of feline leukemia virus and feline immunodeficiency virus infection in cats in US and Canada
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
288129
Author
Intervet
Title
110011766 coa
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288229
Author
Tanaka, T et. al.
Title
Development and evaluation of an efficient cell-culture system for hepatitis E virus
Study date
Oct 2006
Authorising party
Public
Auth party contact address
-
Data no
288427
Author
Gaskell, R et. al.
Title
Isolation of feline herpesvirus I from infected cats
Study date
Nov 1984
Authorising party
Public
Auth party contact address
-
Data no
288198
Author
Sexton, D et. al.
Title
Life threatening cache valley virus infection
Study date
Feb 1997
Authorising party
Public
Auth party contact address
-
Data no
288269
Author
Intervet
Title
TI-4066-0451
Study date
Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288149
Author
Intervet
Title
23g21a protocol
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288484
Author
King and Croghan
Title
Immunoflourescence of FPLV in cell culture- determination of immunological status
Study date
1965
Authorising party
Public
Auth party contact address
-
Data no
288126
Author
Intervet
Title
V9250 spec
Study date
May 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288361
Author
Intervet
Title
FCT-T 19-48-029 Am 4
Study date
Apr 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288367
Author
Intervet
Title
077789 Report
Study date
Jun 1990
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291444
Author
Crandell, R and Despeaux, W
Title
Cytopathology of FVR virus in tissue cultures of feline renal cells
Study date
1959
Data no
288461
Author
Intervet
Title
FCT-T 20-48-065 study Am 2
Study date
Apr 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288510
Author
Intervet
Title
FCT-T 20-48-054 study Am 3
Study date
Mar 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304328
Author
Intervet Australia Pty Limited
Title
Response to s159 notice dated 14 April 2026.
Study date
14 Apr 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288318
Author
Intervet
Title
FCT-T 21-48-098 Protocol
Study date
Apr 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288169
Author
Intervet
Title
FCT-T-23-48-121 report
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288292
Author
Intervet
Title
2f
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288341
Author
Intervet
Title
FCT-T 21-48-132 Am 2
Study date
Jun 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288312
Author
Intervet
Title
FCT-T 21-48-093 Am 7
Study date
Nov 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288261
Author
Intervet
Title
TI-4066-0199
Study date
Sep 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288298
Author
Intervet
Title
FCT-T 21-48-093 Am 11
Study date
Jul 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288112
Author
Richards, J et. al.
Title
The 2006 American association of feline practitioners. Feline vaccine advisory report
Study date
Nov 2006
Authorising party
Public
Auth party contact address
-
Data no
288355
Author
Intervet
Title
FCT-T 19-48-029 Am 13
Study date
Jan 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288498
Author
Intervet
Title
FCT-T 20-48-059 study report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288504
Author
Intervet
Title
FCT-T 20-48-073 study Am 1
Study date
Dec 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288155
Author
Intervet
Title
A514a protocol
Study date
Feb 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288404
Author
King and Croghan
Title
Immunoflourescence of FPLV in cell culture- determination of immunological status
Study date
1965
Authorising party
Public
Auth party contact address
-
Data no
288255
Author
Intervet
Title
TI-4066-0359
Study date
May 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288304
Author
Intervet
Title
FCT-T 21-48-093 Am 17
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288376
Author
Intervet
Title
s21019-00 Report
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288090
Author
Intervet
Title
Site 6 GMP
Study date
Dec 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288161
Author
Intervet
Title
COEM-21118 report
Study date
Nov 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288422
Author
Dawson, S et. al.
Title
Acute arthritis of cats associated with FCV infection
Study date
1994
Authorising party
Public
Auth party contact address
-
Data no
288493
Author
Intervet
Title
FCT-T 24-48-130 study Am 1
Study date
Mar 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288236
Author
Tanaka, T et. al.
Title
Development and evaluation of an efficient cell-culture system for hepatitis E virus
Study date
Oct 2006
Authorising party
Public
Auth party contact address
-
Data no
288445
Author
Intervet
Title
Validation FCT-T 22-48-102
Study date
Mar 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291433
Author
Intervet
Title
CoAs
Study date
Mar 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288190
Author
Ryder, S et. al.
Title
Inconsistent detection of prp in extraneural tissues of cats with feline spongiform encephalopathy
Study date
2001
Authorising party
Public
Auth party contact address
-
Data no
288516
Author
Intervet
Title
s21019-00 Clinical study Am 3
Study date
Dec 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307795
Author
Intervet AH Australia Pty Limited
Title
Site 2 - Steps of manufacture and Address
Study date
17 Jul 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288167
Author
Intervet
Title
FCT-T-23-48-120 report
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288144
Author
Intervet
Title
A520a protocol
Study date
Jul 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291439
Author
Intervet
Title
2.C Annex 4.1
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288121
Author
Jakel, V et. al.
Title
Vaccination against FPL. Field study in kittens
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
288370
Author
Intervet
Title
077791 Report
Study date
Jun 1990
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288382
Author
Intervet
Title
s21019-00 study Am 5
Study date
Oct 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288276
Author
Intervet
Title
LIVE-IMPR-24059 report
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288430
Author
Intervet
Title
RgFCT/00/SAR/010
Study date
Jul 2001
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288336
Author
Intervet
Title
FCT-T 21-48-132 Am 11
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288130
Author
Alfonso, M et. al.
Title
A multi-national European cross-sectional study of feline calicivirus epidemiology, diversity and vaccine cross-reactivity.
Study date
Apr 2017
Authorising party
Public
Auth party contact address
-
Data no
288184
Author
Intervet
Title
01R/0290 report
Study date
May 1998
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288522
Author
Intervet
Title
Efficacy Clinical studies
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288528
Author
Hartmann, K and Hofmann-Lehmann, R
Title
Whats new in feline Laukemia virus infection
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
288330
Author
Intervet
Title
FCT-T 21-48-098 Am 7
Study date
Jul 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
293245
Author
Intervet
Title
Application details 0010483783
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288476
Author
Intervet
Title
FCT-T 20-48-141 study Am 3
Study date
Mar 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291525
Author
AQIS
Title
1012-13 Import permit
Study date
Feb 2012
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288127
Author
Intervet
Title
110019580 coa
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288293
Author
Intervet
Title
2g
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288270
Author
Intervet
Title
A001A protocol
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288436
Author
Intervet
Title
Report-166562
Study date
Feb 2011
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288505
Author
Intervet
Title
FCT-T 20-48-073 study Am 2
Study date
Mar 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288101
Author
Intervet
Title
171018 label
Study date
2004
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288150
Author
Intervet
Title
24d19a protocol
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288462
Author
Intervet
Title
FCT-T 20-48-065 study Am 3
Study date
Feb 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288313
Author
Intervet
Title
FCT-T 21-48-093 Am 8
Study date
Jun 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288319
Author
Intervet
Title
FCT-T 21-48-098 Am 9
Study date
Oct 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288362
Author
Intervet
Title
FCT-T 19-48-029 Am 5
Study date
Nov 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288485
Author
Scott, F
Title
Comments on FPL biologics
Study date
1971
Authorising party
Public
Auth party contact address
-
Data no
307789
Author
EMA
Title
EMA.CVMP/75635/2026-Rev.1 Nobivac NXT HCPChFeLV
Study date
19 Jun 2026
Authorising party
Public
Auth party contact address
-
Data no
288170
Author
Intervet
Title
FCT-T-22-48-115 report
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288244
Author
Intervet
Title
TI-4066-0451
Study date
Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288413
Author
Scott, F et. al.
Title
Maternally derived immunity to FPL
Study date
1971
Authorising party
Public
Auth party contact address
-
Data no
288299
Author
Intervet
Title
FCT-T 21-48-093 Am 12
Study date
Nov 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288393
Author
Intervet
Title
Part 3b
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288201
Author
OIE
Title
Nipah and hendra virus diseases
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
288207
Author
OIE
Title
Epidemiology and host spectrum of borna disease virus infection 2.9.1 bunyaviral diseases of animals
Study date
May 2014
Authorising party
Public
Auth party contact address
-
Data no
288456
Author
Intervet
Title
FCT-T 19-48-043 study Am 1
Study date
Nov 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288307
Author
Intervet
Title
FCT-T 21-48-093 Am 2
Study date
Aug 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288350
Author
Intervet
Title
FCT-T 19-48-029 Protocol
Study date
Mar 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288356
Author
Intervet
Title
FCT-T 19-48-029 Am 14
Study date
Mar 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288256
Author
Intervet
Title
TI-5089-0003
Study date
Apr 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288499
Author
Intervet
Title
FCT-T 20-48-059 study protocol
Study date
Mar 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288210
Author
Johnson, R and Thomas, R
Title
FVR in Britain
Study date
Aug 1966
Authorising party
Public
Auth party contact address
-
Data no
288233
Author
OIE
Title
Nipah and hendra virus diseases
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
291436
Author
Intervet
Title
2.C Annex 2
Study date
Sep 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288164
Author
Intervet
Title
FCT/0004/04 report
Study date
Nov 2004
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288496
Author
Intervet
Title
FCT-T 20-48-061 study Am 1
Study date
Jun 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288187
Author
Intervet
Title
Table B
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288519
Author
Intervet
Title
s21019-00 Clinical study Am 6
Study date
Feb 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307798
Author
Eudra
Title
Eudra GMP Site 5
Study date
28 Jul 2025
Authorising party
Public
Auth party contact address
-
Data no
288118
Author
Flynn, J et. al.
Title
FeLV protective immunity mediated by virus specific lymphocytes
Study date
2000
Authorising party
Public
Auth party contact address
-
Data no
288141
Author
Intervet
Title
Product Description
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288287
Author
Intervet
Title
Photostability
Study date
2010
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288465
Author
Intervet
Title
FCT-T 20-48-081 study Am 1
Study date
Jul 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288227
Author
Intervet
Title
Flavivirus
Study date
2011
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288333
Author
Intervet
Title
FCT-T 21-48-132 Protocol
Study date
Jun 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288273
Author
Intervet
Title
A187T coa
Study date
Mar 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288373
Author
Intervet
Title
077792 Report
Study date
May 1991
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288379
Author
Intervet
Title
s21019-00 study Am 2
Study date
Oct 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288473
Author
Intervet
Title
FCT-T 20-48-141 study protocol
Study date
Nov 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288479
Author
Intervet
Title
SOP EXP.2188E
Study date
May 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291522
Author
Intervet
Title
Validation FCT-T 21-48-077
Study date
Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288327
Author
Intervet
Title
FCT-T 21-48-098 Am 4
Study date
Nov 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288181
Author
Gutekunst, E
Title
Humoral and cellular immune responses in swine after vaccination with inactivated pseudorabies virus
Study date
Apr 1979
Authorising party
Public
Auth party contact address
-
Data no
288279
Author
Intervet
Title
LIVE-IMPR-24063 report
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288525
Author
Intervet
Title
Part 8
Study date
June 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288459
Author
Intervet
Title
FCT-T 20-48-065 study protocol
Study date
Oct 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288104
Author
Intervet
Title
EMA/SA/0000057385
Study date
June 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288173
Author
Intervet
Title
MCA A2F8-INT
Study date
Jul 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288247
Author
Intervet
Title
TI-5089-0001
Study date
Oct 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288410
Author
Pederson, N et. al.
Title
A transient febrile limping sundromw of kittens caused by two different FCV strains
Study date
Feb 1983
Authorising party
Public
Auth party contact address
-
Data no
288433
Author
Confidential
Title
Report-166558
Study date
2006
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288482
Author
Fastier, L
Title
FPL- A serological study
Study date
1968
Authorising party
Public
Auth party contact address
-
Data no
291519
Author
Intervet
Title
17K21 coa
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288124
Author
Intervet
Title
AHC13.0005 spec
Study date
Sep 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288296
Author
Intervet
Title
FCT-T 21-48-093 Am 9
Study date
Jun 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288147
Author
Intervet
Title
a730b protocol
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288339
Author
Intervet
Title
FCT-T 21-48-132 Am 14
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288416
Author
Confidential
Title
2024 Guidelines for the vacination of dogs and cats
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
288316
Author
Not identified
Title
PER94256 permit
Study date
Nov 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288390
Author
Confidential
Title
19A5.D0 report Oct 2009
Study date
Oct 2009
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288439
Author
Intervet
Title
SOP 256120-523
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307792
Author
EU official departments
Title
EU Directive 2000-54-EC on the protection of workers from risks related to exposure to biological agents at work
Study date
17 Oct 2000
Authorising party
Public
Auth party contact address
-
Data no
288204
Author
Crandell, R and Madin, S
Title
Experimental studies on a new feline virus
Study date
Jul 1960
Authorising party
Public
Auth party contact address
-
Data no
288216
Author
Nan, Y and Zhang, Y
Title
Molecular biology and infection of hepatitis E virus
Study date
Sep 2016
Authorising party
Public
Auth party contact address
-
Data no
288453
Author
Intervet
Title
FCT-T 20-48-060 study Am 1
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288098
Author
Intervet
Title
Site 6 Est. Lic.
Study date
Jan 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288110
Author
Osterhaus, A et. al.
Title
Induction of protective immunity in cats by vaccination with FeLV iscom
Study date
1985
Authorising party
Public
Auth party contact address
-
Data no
291442
Author
Intervet
Title
121988 report
Study date
Jun 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288310
Author
Intervet
Title
FCT-T 21-48-093 Am 5
Study date
Nov 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288347
Author
Intervet
Title
FCT-T 21-48-132 Am 8
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288359
Author
Intervet
Title
FCT-T 19-48-029 Am 2
Study date
Apr 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291450
Author
DAFF
Title
09013566 Import permit
Study date
Aug 2009
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288253
Author
Intervet
Title
TI-4066-0032
Study date
May 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288502
Author
Intervet
Title
FCT-T 20-48-073 study report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288353
Author
Intervet
Title
FCT-T 19-48-029 Am 11
Study date
Oct 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288402
Author
Hartmann, K and Hofmann-Lehmann, R
Title
Whats new in feline Laukemia virus infection
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
288305
Author
Intervet
Title
FCT-T 21-48-093 Am 18
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288282
Author
Intervet
Title
21B22B Protocol
Study date
Mar 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288188
Author
Intervet
Title
Table C
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288520
Author
Intervet
Title
Efficacy- general requirements
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288113
Author
Sparkes, A
Title
Proceedings of the ESFM feline congress, Stockholm Sep 2002 FeLV and vaccination
Study date
Sep 2022
Authorising party
Public
Auth party contact address
-
Data no
288211
Author
Nan, Y and Zhang, Y
Title
Molecular biology and infection of hepatitis E virus
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
288142
Author
Intervet
Title
08c22b protocol
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288468
Author
Intervet
Title
FCT-T 20-48-058 study report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288165
Author
Intervet
Title
FCT/0006/04 report
Study date
Nov 2004
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288491
Author
Intervet
Title
FCT-T 24-48-130 study report
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288096
Author
Intervet
Title
Site 4 Est. Lic.
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288514
Author
Intervet
Title
s21019-00 Clinical study Am 1
Study date
May 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291437
Author
USP
Title
2.C Annex 3 USP monograph for a specific raw material of biol origin
Study date
May 2018
Data no
288119
Author
Flynn, J et. al.
Title
Longitudinal analysis of FeLV specific cytotoxic lymphocytes
Study date
Mar 2002
Authorising party
Public
Auth party contact address
-
Data no
288228
Author
Nan, Y and Zhang, Y
Title
Molecular biology and infection of hepatitis E virus
Study date
Sep 2016
Authorising party
Public
Auth party contact address
-
Data no
307793
Author
Intervet AH Pty Limited
Title
Information for TGA Scheduling application
Study date
17 July 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288288
Author
Intervet
Title
2a
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288322
Author
Intervet
Title
FCT-T 21-48-098 Am 12
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288334
Author
Intervet
Title
FCT-T 21-48-132 Am 9
Study date
Jun 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288474
Author
Intervet
Title
FCT-T 20-48-141 study Am 1
Study date
Dec 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288480
Author
Intervet
Title
SOP EXP.2190E
Study date
Feb 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288182
Author
Lei , J
Title
The symposium on vaccine adjuvants held in London 30 March 1981
Study date
Mar 1981
Authorising party
Public
Auth party contact address
-
Data no
288428
Author
Intervet
Title
RgFCT/01/SAR/011
Study date
Jul 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288328
Author
Intervet
Title
FCT-T 21-48-098 Am 5
Study date
Jun 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288460
Author
Intervet
Title
FCT-T 20-48-065 study Am 1
Study date
Oct 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288176
Author
Bahnemann, H
Title
Inactivation of viral antigens for vaccine preparation with particular reference to the application of binary ethylenimine.
Study date
Aug 1990
Authorising party
Public
Auth party contact address
-
Data no
288434
Author
Confidential
Title
Challenge strain info
Study date
2011
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291520
Author
Kinney, J et. al.
Title
Stability of RNA virus attenuation approaches
Study date
2011
Data no
288125
Author
Intervet
Title
40001106 coa
Study date
Sep 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288199
Author
Kinnunen, P et. al.
Title
Epidemiology and host spectrum of borna disease virus infection
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
291445
Author
Intervet
Title
291195 report
Study date
291195 report
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288148
Author
Intervet
Title
22e24a protocol
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288219
Author
Sexton, D et. al.
Title
Life threatening cache valley virus infection
Study date
1997
Authorising party
Public
Auth party contact address
-
Data no
288391
Author
Confidential
Title
19A5.D0 Report Dec 2009
Study date
Dec 2009
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288368
Author
Intervet
Title
RgFCT/00/SAR/008 Report
Study date
Jul 2000
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288268
Author
Intervet
Title
TI-4066-0839
Study date
Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288342
Author
Intervet
Title
FCT-T 21-48-132 Am 3
Study date
Jun 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288440
Author
Intervet
Title
SOP 256120-529
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288511
Author
Intervet
Title
FCT-T 24-48-0134 study report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288291
Author
Intervet
Title
2e
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288311
Author
Intervet
Title
FCT-T 21-48-093 Am 6
Study date
Jun 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288405
Author
Intervet
Title
Feline leukemia virus and related diseases
Study date
2016
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288454
Author
Intervet
Title
FCT-T 19-48-043 study report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288262
Author
Intervet
Title
WI-4066-0085
Study date
May 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288348
Author
Intervet
Title
FCT-FPLV/02/SAR/003 report
Study date
Sep 2003
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288397
Author
Intervet
Title
Part 3f
Study date
Oct 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288497
Author
Intervet
Title
FCT-T 20-48-061 study Am 2
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288105
Author
Intervet
Title
SPC, label
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288354
Author
Intervet
Title
FCT-T 19-48-029 Am 12
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288156
Author
Intervet
Title
FCT/0007/04 report
Study date
Nov 2004
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288205
Author
Lee, K et. al.
Title
Utilisation of various cell culture systems for propagation of certain feline viruses and canine herpesvirus
Study date
Oct 1969
Authorising party
Public
Auth party contact address
-
Data no
288471
Author
Intervet
Title
FCT-T 20-48-058 study Am 2
Study date
Sep 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288116
Author
Brun, A. et. al.
Title
Immunisation against panleucopenia
Study date
1979
Authorising party
Public
Auth party contact address
-
Data no
288448
Author
Intervet
Title
SOP/EXP 2190E
Study date
Feb 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288517
Author
Intervet
Title
s21019-00 Clinical study Am 4
Study date
Feb 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291434
Author
Johnson, J et. al.
Title
Tumorigenity of continuos cell line in vivo and in vitro systems
Study date
1982
Data no
288162
Author
Intervet
Title
QCO-2238 report
Study date
Nov 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288494
Author
Intervet
Title
FCT-T 20-48-061 study report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288093
Author
Intervet
Title
Site 7 GMP
Study date
Mar 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288168
Author
Intervet
Title
FCT-T-20-48-070 report
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288477
Author
Intervet
Title
FCT/0004/03 study report
Study date
Mar 2004
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288122
Author
Intervet
Title
10000096051 spec
Study date
Nov 2015
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288239
Author
Sexton, D et. al.
Title
Life threatening cache valley virus infection
Study date
1997
Authorising party
Public
Auth party contact address
-
Data no
288417
Author
Steinel, A et. al.
Title
Parvovirus infections in wild carnivores
Study date
2001
Authorising party
Public
Auth party contact address
-
Data no
288431
Author
Intervet
Title
RgFCT/00/SAR/010
Study date
Jul 2001
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288285
Author
Intervet
Title
18R/0175 Report
Study date
Jun 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288371
Author
Intervet
Title
RG FCT00SAR007 Report
Study date
Jul 2000
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288225
Author
OIE
Title
Epidemiology and host spectrum of borna disease virus infection 2.9.1 bunyaviral diseases of animals
Study date
May 2014
Authorising party
Public
Auth party contact address
-
Data no
288231
Author
Intervet
Title
CCT-00-12-400
Study date
Mar 2001
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288325
Author
Intervet
Title
FCT-T 21-48-098 Am 2
Study date
Apr 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288331
Author
Intervet
Title
FCT-T 21-48-098 Am 8
Study date
Jul 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288179
Author
Brown, F et. al.
Title
Application of agar gel diffusion analysis to a stydy of the antigenic structure of inactivated vaccines prepared from the virus of foot and mouth disease.
Study date
Oct 1958
Authorising party
Public
Auth party contact address
-
Data no
288425
Author
Fastier, L
Title
FPL- A serological study
Study date
1968
Authorising party
Public
Auth party contact address
-
Data no
288377
Author
Intervet
Title
s21019-00 protocol
Study date
Jan 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288222
Author
OIE
Title
Malignant catarrhal fever
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
288128
Author
Intervet
Title
V9024 spec
Study date
Sep 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288245
Author
Intervet
Title
TI-4066-0179
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288294
Author
Intervet
Title
FCT-T 21-48-093 Report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291448
Author
Intervet
Title
Validation FCT-T 21-48-079
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288102
Author
Intervet
Title
PSMF summary
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288271
Author
Intervet
Title
A002A protocol
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288508
Author
Intervet
Title
FCT-T 20-48-054 study Am 1
Study date
Oct 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291517
Author
Crandell, R
Title
A description of eight feline picornaviruses and an attempt to classify them
Study date
June 1967
Data no
288457
Author
Intervet
Title
FCT-T 19-48-043 study Am 2
Study date
Feb 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288314
Author
Intervet
Title
Expert report
Study date
Dec 1999
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307790
Author
OGTR
Title
Commercial supply of multivalent cat vaccines containing a genetically modified component for the prevention of feline leukemia virus infection.
Study date
6 Jul 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288265
Author
Intervet
Title
TI-4066-0505
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288437
Author
Intervet
Title
challenge stocks
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288365
Author
Intervet
Title
FCT-T 19-48-029 Am 8
Study date
Oct 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288488
Author
Intervet
Title
FCT-T 20-48-055 study protocol
Study date
Oct 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288145
Author
Intervet
Title
A520b protocol
Study date
Oct 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288394
Author
Intervet
Title
Part 3c
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288251
Author
Intervet
Title
TI-4066-0014
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288345
Author
Intervet
Title
FCT-T 21-48-132 Am 6
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288357
Author
Intervet
Title
FCT-T 19-48-029 Am 15
Study date
Jun 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288408
Author
Intervet
Title
Virus infections
Study date
1987
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288302
Author
Intervet
Title
FCT-T 21-48-093 Am 15
Study date
May 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288308
Author
Intervet
Title
FCT-T 21-48-093 Am 3
Study date
Nov 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288159
Author
Intervet
Title
117556 report
Study date
Oct 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288202
Author
OIE
Title
Malignant catarrhal fever
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
288208
Author
OIE
Title
Nipah and hendra virus diseases
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
288351
Author
Intervet
Title
FCT-T 19-48-029 Am 9
Study date
May 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288451
Author
Intervet
Title
FCT-T 20-48-060 study report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288500
Author
Intervet
Title
FCT-T 20-48-059 study Am 1
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288163
Author
Intervet
Title
00/01/0007 report
Study date
Aug 2000
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288234
Author
Intervet
Title
Flavivirus
Study date
2011
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288495
Author
Intervet
Title
FCT-T 20-48-061 study protocol
Study date
Jun 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307799
Author
Eudra
Title
Eudra GMP Site 6
Study date
4 Dec 2025
Authorising party
Public
Auth party contact address
-
Data no
288257
Author
Intervet
Title
TI-5089-0001
Study date
Oct 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288472
Author
Intervet
Title
FCT-T 20-48-058 study Am 3
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288518
Author
Intervet
Title
s21019-00 Clinical study. Am 5
Study date
Oct 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288117
Author
Decaro, N et. al.
Title
Genetic analysis of feline panleukopenia viruses from cats with gastroenteritis.
Study date
May 2008
Authorising party
Public
Auth party contact address
-
Data no
288094
Author
Intervet
Title
Site 8 GMP
Study date
Mar 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288240
Author
Intervet
Title
TI-4066-0039
Study date
Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288134
Author
Decaro, N et. al.
Title
Genetic analysis of feline panleukopenia viruses from cats with gastroenteritis.
Study date
May 2008
Authorising party
Public
Auth party contact address
-
Data no
288466
Author
Intervet
Title
FCT-T 20-48-081 study Am 2
Study date
Jan 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288274
Author
Intervet
Title
A188T coa
Study date
Mar 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288286
Author
Intervet
Title
119142 Report
Study date
Nov 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288372
Author
Intervet
Title
p9903 Report
Study date
Dec 1999
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288088
Author
Intervet
Title
Site 4 GMP
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288420
Author
Burling, A et. al.
Title
Seroprevalences of feline leukemia virus and feline immunodeficiency virus infection in cats in USA and Canada
Study date
Jul 2017
Authorising party
Public
Auth party contact address
-
Data no
288432
Author
Intervet
Title
Benefit Risk analysis
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288326
Author
Intervet
Title
FCT-T 21-48-098 Am 3
Study date
May 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288226
Author
OIE
Title
Nipah and hendra virus diseases
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
288380
Author
Intervet
Title
s21019-00 study Am 3
Study date
Dec 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288280
Author
Intervet
Title
LIVE-IMPR-24062 report
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288526
Author
Intervet
Title
BPSS
Study date
Apr 25
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291523
Author
Intervet
Title
FVR seed lineage
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288180
Author
Crick, J et. al.
Title
An inactivated baby hamster kidney cell rabies vaccine for use in dogs and cattle
Study date
Sep 1970
Authorising party
Public
Auth party contact address
-
Data no
288426
Author
Gaskell, R
Title
Vaccination of the young kitten
Study date
1989
Authorising party
Public
Auth party contact address
-
Data no
288317
Author
Intervet
Title
FCT-T 21-48-098 Report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288483
Author
Guiot, A et. al.
Title
Compatiility between two vaccines against 5 diseases
Study date
May 2008
Authorising party
Public
Auth party contact address
-
Data no
288197
Author
Intervet
Title
Apr 2012 Report
Study date
Apr 2012
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288409
Author
Intervet
Title
Chapter 70 Feline viral diseases
Study date
1995
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288509
Author
Intervet
Title
FCT-T 20-48-054I study Am 2
Study date
Nov 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288366
Author
Intervet
Title
TC94/008 Report
Study date
Aug 1989
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288217
Author
Tanaka, T et. al.
Title
Development and evaluation of an efficient cell-culture system for hepatitis E virus
Study date
Oct 2006
Authorising party
Public
Auth party contact address
-
Data no
288340
Author
Intervet
Title
FCT-T 21-48-132 Am 1
Study date
Jun 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288489
Author
Intervet
Title
FCT-T 20-48-055 study Am 1
Study date
Oct 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288097
Author
Intervet
Title
Site 5 Est. Lic.
Study date
Jan 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288111
Author
Patel, M et. al.
Title
Comparative efficacy of FeLV vaccine and canarypox vaccine during challenge and immunosuppression
Study date
Jul 2015
Authorising party
Public
Auth party contact address
-
Data no
288360
Author
Intervet
Title
FCT-T 19-48-029 Am 3
Study date
Apr 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291443
Author
Intervet
Title
15J08 coa
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288297
Author
Intervet
Title
FCT-T 21-48-093 Am 10
Study date
Jul 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288309
Author
Intervet
Title
FCT-T 21-48-093 Am 4
Study date
Nov 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288346
Author
Intervet
Title
FCT-T 21-48-132 Am 7
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288154
Author
Intervet
Title
A509a protocol
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288160
Author
Intervet
Title
QCM-10077 report
Study date
Sep 2010
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288403
Author
Hosie et. al.
Title
2015 ABCD recommendations for indoor/outdoor cats, rescue shelter cats and breeding catteries
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
288503
Author
Intervet
Title
FCT-T 20-48-073 study protocol
Study date
Dec 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288203
Author
Fastier, L
Title
A new feline virus isolated in tissue culture
Study date
Apr 1957
Authorising party
Public
Auth party contact address
-
Data no
288452
Author
Intervet
Title
FCT-T 20-48-060 study protocol
Study date
Jun 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291449
Author
Intervet
Title
FVR seed
Study date
Feb 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288254
Author
Intervet
Title
TI-4066-0034
Study date
May 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288303
Author
Intervet
Title
FCT-T 21-48-093 Am 16
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288329
Author
Intervet
Title
FCT-T 21-48-098 Am 6
Study date
Jun 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288306
Author
Intervet
Title
FCT-T 21-48-093 Am 1
Study date
Aug 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288423
Author
Decaro, N et. al.
Title
Genetic analysis of feline panleukopenia viruses from cats with gastroenteritis.
Study date
May 2008
Authorising party
Public
Auth party contact address
-
Data no
288114
Author
Intervet
Title
FeLV disease
Study date
Feb 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288283
Author
Intervet
Title
14L22 Protocol
Study date
Mar 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288446
Author
Intervet
Title
Validation FCT-T 22-48-105
Study date
Jun 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288469
Author
Intervet
Title
FCT-T 20-48-058 study protocol
Study date
May 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288237
Author
Kinnunen, P et. al.
Title
Epidemiology and host spectrum of borna disease virus infections
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
288492
Author
Intervet
Title
FCT-T 24-48-130 study protocol
Study date
Mar 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307796
Author
Eudra
Title
Eudra GMP Site 3
Study date
24 Apr 2026
Authorising party
Public
Auth party contact address
-
Data no
288214
Author
Sexton, D et. al.
Title
Life threatening cache valley virus infection
Study date
1997
Authorising party
Public
Auth party contact address
-
Data no
288515
Author
Intervet
Title
s21019-00 safety and efficacy Am 2
Study date
Oct 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288120
Author
Hartmann, K and Hofmann-Lehmann, R
Title
Whats new in feline Laukemia virus infection
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
291440
Author
Omerond, E and Jarret, O
Title
A classification of feline calicivirus isolates based on plaque morphology
Study date
Dec 1977
Data no
288143
Author
Intervet
Title
A519a protocol
Study date
Feb 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288323
Author
Intervet
Title
FCT-T 21-48-098 Am 13
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288429
Author
Intervet
Title
RgFCT/00/SAR/012
Study date
Jul 2001
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288369
Author
Intervet
Title
TC94/007 Report
Study date
Aug 1989
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288383
Author
Intervet
Title
s21019-00 study Am 6
Study date
Feb 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288177
Author
Brown, F et. al.
Title
The use of acetylethyleneimine in the production of inactivated foot and mouth disease vaccines.
Study date
Mar 1963
Authorising party
Public
Auth party contact address
-
Data no
288277
Author
Intervet
Title
LIVE-IMPR-24061 report
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288475
Author
Intervet
Title
FCT-T 20-48-141 study Am 2
Study date
Dec 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288151
Author
Intervet
Title
28j21a protocol
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288412
Author
Scott, F
Title
Comments on FPL biologics
Study date
1971
Authorising party
Public
Auth party contact address
-
Data no
288435
Author
Intervet
Title
Report-166561
Study date
Sep 2011
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288200
Author
OIE
Title
Epidemiology and host spectrum of borna disease virus infection 2.9.1 bunyaviral diseases of animals
Study date
May 2014
Authorising party
Public
Auth party contact address
-
Data no
291446
Author
Intervet
Title
Validation FCT-T 21-48-079
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288506
Author
Intervet
Title
FCT-T 20-48-054 study report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288243
Author
Intervet
Title
TI-5089-0006
Study date
Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288320
Author
Intervet
Title
FCT-T 21-48-098 Am 10
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288486
Author
Scott, F et. al.
Title
Maternally derived immunity to FPL
Study date
1971
Authorising party
Public
Auth party contact address
-
Data no
288171
Author
Intervet
Title
05q026 report
Study date
Jul 2005
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288220
Author
OIE
Title
Epidemiology and host spectrum of borna disease virus infection 2.9.1 bunyaviral diseases of animals
Study date
May 2014
Authorising party
Public
Auth party contact address
-
Data no
288337
Author
Intervet
Title
FCT-T 21-48-132 Am 12
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288343
Author
Intervet
Title
FCT-T 21-48-132 Am 4
Study date
Jun 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288392
Author
Intervet
Title
Part 3a
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288363
Author
Intervet
Title
FCT-T 19-48-029 Am 6
Study date
Mar 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288463
Author
Intervet
Title
FCT-T 20-48-081 study report
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288512
Author
Intervet
Title
s21019-00 Clinical study Report
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288406
Author
Longbottom, D et. al.
Title
Vaccination against chlamydial infections of man and animals
Study date
Sep 2004
Authorising party
Public
Auth party contact address
-
Data no
288263
Author
Intervet
Title
TI-4066-0401
Study date
Aug 2014
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288300
Author
Intervet
Title
FCT-T 21-48-093 Am 13
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288443
Author
Hartmann, K et. al.
Title
Quality in different in clinic test systems for feline immunodeficiency virus and FeLV
Study date
Apr 2007
Authorising party
Public
Auth party contact address
-
Data no
288455
Author
Intervet
Title
FCT-T 19-48-043 study protocol
Study date
Nov 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288100
Author
Intervet
Title
PSMF summary
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288349
Author
Intervet
Title
FCT-T 19-48-029 Report
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288206
Author
Nan, Y and Zhang, Y
Title
Molecular biology and infection of hepatitis E virus
Study date
Sep 2016
Authorising party
Public
Auth party contact address
-
Data no
288449
Author
Intervet
Title
SOP/EXP.2188E
Study date
May 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

149071
Product/Active constituent Name

Application Product Name

Feline leukemia virus glycoprotein RNA Particles

Application details

Product name:

Feline leukemia virus glycoprotein RNA Particles

Product number:

96358

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a live attenuated pentavalent vaccine comprising of feline calicivirus, feline herpesvirus, feline panleucopenia virus, Chlamydia felis and feline leukopenia virus RNA-particles, for use in cats. In conjunction with approval of two new active constituents, C. felis and RP-FeLV.

Description of data provided:

Data no
291126
Author
Intervet
Title
20-48-071 report
Study date
Feb 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292059
Author
Swanson, S et. al.
Title
Characterisation of V cells
Study date
1984
Data no
291913
Author
DeFrabitius, L et. al.
Title
Utilisation of ISA Reverse genetics and large scale random codon re-encoding to produce attenuated strains of tick-borne encephalitis virus within days
Study date
Aug 2016
Data no
291919
Author
Intervet
Title
TI-4066-0841
Study date
Jun 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291120
Author
Kinney, R et. al.
Title
The Full-Length Equine Encephalitis Nucleotide Sequences of the Virulent Trinidad Donkey Strain of Venezuelan Virus and Its Attenuated Vaccine Derivative, Strain TC-83.
Study date
Dec 1988
Data no
291933
Author
Intervet
Title
FeLV and related diseases
Study date
2016
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291175
Author
Montomoli, E et. al.
Title
Cell culture derived influenza vaccines from vero cells
Study date
2012
Data no
291123
Author
Lundstrom, K
Title
Lundstrom K. Replicon RNA viral vectors as vaccines (review).
Study date
Nov 2016
Data no
291916
Author
Hartmann, K
Title
Clinical aspects of feline retroviruses- a review
Study date
Oct 2012
Data no
291925
Author
Paessler, S et. al.
Title
Vaccines for venezuelan equine encephalitis
Study date
Nov 2009
Data no
292065
Author
Intervet
Title
29A19 coa
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291922
Author
Intervet
Title
STP-GMP-QCM-0035
Study date
Jun 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292062
Author
Intervet
Title
167810 report
Study date
Sep 2016
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291060
Author
Intervet
Title
Site 3 GMP
Study date
Intervet
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291934
Author
Intervet
Title
Test instructions
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291124
Author
Pushko, P et. al.
Title
Replicon-Helper Systems from Attenuated Venezuelan Equine Encephalitis Virus: Expression of Heterologous Genes in Vitro and Immunization against Heterologous. Pathogens in Vivo.
Study date
Oct 1997
Data no
291928
Author
Confidential
Title
Outcome letter
Study date
Apr 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292057
Author
Intervet
Title
10l18 report
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291917
Author
DeFrabitius, L et. al.
Title
Utilisation of ISA Reverse genetics and large scale random codon re-encoding to produce attenuated strains of tick-borne encephalitis virus within days
Study date
Aug 2016
Data no
292066
Author
deFabritius, L et. al.
Title
Utilisation of ISA reverse genetics and large scale random codon re-encoding to produce attenuated strains of tick-borne encephalitis virus within days
Study date
Aug 2016
Data no
292063
Author
Intervet
Title
28B19 coa
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291118
Author
Bloom, K et.al
Title
Self-amplifying RNA vaccines for infectious diseases (Review Article).
Study date
May 2008
Data no
291931
Author
Intervet
Title
Part 3d
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291121
Author
Kinney, R et. al.
Title
Attenuation of Venezuelan Equine Encephalitis Virus Strain TC-83 Is Encoded by the 5'-Noncoding Region and the E2 Envelope Glycoprotein.
Study date
Nov 1992
Data no
291914
Author
DeFrabitius, L et. al.
Title
Utilisation of ISA Reverse genetics and large scale random codon re-encoding to produce attenuated strains of tick-borne encephalitis virus within days
Study date
Aug 2016
Data no
292060
Author
Confidential
Title
167809 report
Study date
Sep 2016
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291920
Author
Intervet
Title
STP-GMP-QCB-0151
Study date
Jun 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291932
Author
Intervet
Title
Part 3e
Study date
Jun 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291122
Author
Kozak, M
Title
Compilation and analysis of sequences upstream from the translational start site in eukaryotic mRNAs.
Study date
Nov 1983
Data no
291915
Author
Hamre, D et. al.
Title
Morphological and other characteristics of the agent feline pneumonitis grown in the allantoic cavity of the chick embryo
Study date
Mar 1947
Data no
291926
Author
Stromberg, Z et. al.
Title
Vaccine advantages against Venuzuelan, Eastern and Western equine encephalitis viruses
Study date
Jun 2020
Data no
292061
Author
Intervet
Title
05B19 coa
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291923
Author
Intervet
Title
TI-4066-0848
Study date
Jul 2014
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291173
Author
Intervet
Title
MCA C11-D8-INT
Study date
Jan 2015
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291929
Author
De Noronha, F et. al.
Title
Influence of antisera to on GP71 on infections of cats with FeLV
Study date
Nov 1978
Data no
292058
Author
Levenbook, I et. al.
Title
Use of atg treated newborn rat for in vivo tumorigenicity testing of cell substrates
Study date
1984
Data no
291119
Author
Kamrud, K et. al.
Title
Development and characterization of promoterless helper RNAs for the production of alphavirus replicon particle.
Study date
Feb 2020
Data no
291930
Author
Ninberg, J et. al.
Title
Method to map antigenic determinants recognised by monoclonal antibodies
Study date
Mar 1984
Data no
291921
Author
Intervet
Title
STP-GMP-QCB-0176
Study date
Dec 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291125
Author
Intervet
Title
186 protocol
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291927
Author
WOAH
Title
Venezuelan Equine Encephalitis
Study date
Jan 2020
Data no
291918
Author
Intervet
Title
STP-GMP-QCM-0036
Study date
Jun 2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291068
Author
Intervet
Title
Site 3 Est. Lic.
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
292064
Author
Intervet
Title
1555P0-RR23 report
Study date
Sep 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291924
Author
Intervet
Title
TI-4066-0841
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291048
Author
Intervet
Title
Site 2 GMP
Study date
Feb 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
291117
Author
Rayner, J et. al.
Title
Alphavirus vectors and vaccination.
Study date
Mar 2002
Date

Application Date

Application No

Application Number

150207
Product/Active constituent Name

Application Product Name

Mirtazapine

Application details

Product name:

Mirtazapine

Product number:

96640

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
293473
Author
Not identified
Title
General Information
Study date
2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292122
Author
British Pharmacopoeial Commission
Title
Mirtazapine
Study date
09 May 2025
Authorising party
Public
Auth party contact address
-
Data no
293479
Author
Not identified
Title
Packaging
Study date
2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293476
Author
Not identified
Title
Impurities
Study date
2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293477
Author
Not identified
Title
Control of the Drug Substance
Study date
2018
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292123
Author
Bhavsar AP, Bhalerao SA, Ugale SW
Title
Mirtazapine certificates of analysis
Study date
March 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293474
Author
Not identified
Title
Method of Manufacture
Study date
2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293480
Author
Not identified
Title
Stability
Study date
2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293471
Author
Not identified
Title
Certificate of Analysis
Study date
6 March 2018
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293475
Author
Not identified
Title
Structure Elucidation and Confirmation
Study date
2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
300144
Author
Not identified
Title
Restricted DMF
Study date
2025
Authorising party
Manufacturer
Data no
293472
Author
Not identified
Title
Certificate of Analysis
Study date
27 August 2019
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293469
Author
Not identified
Title
Certificate of Analysis
Study date
28 July 2015
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292124
Author
Not known
Title
Mirtazapine residual solvents test method and validation
Study date
20 June 2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293481
Author
Not identified
Title
Drug Substance Specification
Study date
2 July 2018
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
294323
Author
Not identified
Title
Open DMF
Study date
2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293470
Author
Not identified
Title
Certificate of Analysis
Study date
17 December 2015
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
293478
Author
Not identified
Title
Reference Standards
Study date
2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
300145
Author
Not identified
Title
Letter of Access
Study date
7 November 2025
Authorising party
Manufacturer
Date

Application Date

Application No

Application Number

150208
Product/Active constituent Name

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
Author
K Grzeskowiak-Reed
Title
Raw Material Specification RMS A1701
Study date
24 September 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292308
Author
Kast RE
Title
Mirtazapine may be useful in treating nausea and insomnia of cancer chemotherapy
Study date
2001
Authorising party
Public
Auth party contact address
-
Data no
292320
Author
Miller L, Vila M
Title
kb119
Study date
2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292268
Author
Chemwatch
Title
Excipient 4 SDS
Study date
23 January 2025
Authorising party
Public
Auth party contact address
-
Data no
292314
Author
Kursungoz C, Ak M, Yanik T
Title
Effects of risperidone treatment on the expression of hypothalamic neuropeptide in appetite regulation in Wistar rats
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
292214
Author
O Kunzi
Title
Declaration of Compliance
Study date
20 November 2024
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292231
Author
Buhles W
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
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292208
Author
D Lawson
Title
Stability Protocol TN:24-066
Study date
15 May 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292274
Author
Buhles W
Title
KB100PK
Study date
2015
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292225
Author
Giorgi M, Yun H
Title
Pharmacokinetics of mirtazapine and its main metabolites in Beagle dogs: A pilot study
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
292202
Author
RD Burton
Title
Certificates of Analysis
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292251
Author
Ostenfeld A, Studsgaard Petersen T, Henning Pedersen L, Westergaard HB, Løkkegaard ECL, Trærup Andersen J
Title
Mirtazapine exposure in pregnancy and foetal safety: A nationwide cohort study
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
292300
Author
Stahl SM
Title
Stahl's essential psychopharmacology: neuroscientific basis and practical applications a
Study date
2008
Authorising party
Public
Auth party contact address
-
Data no
292245
Author
Masic A
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
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292294
Author
Fox CB, Treadway AK, Blaszczyk AT, Sleeper RB
Title
Megestrol Acetate and Mirtazapine for the Treatment of Unplanned Weight Loss in the Elderly
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
292237
Author
Young K
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292288
Author
Benson KK, Zajic LB, Morgan PK, Brown SR, Hansen RJ, Lunghofer PJ, Wittenburg LA, Gustafson DL, Quimby JM
Title
Drug exposure and clinical effect of transdermal mirtazapine in healthy young cats: a pilot study
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
292194
Author
Agency for Medicinal Products and Medical Devices of Croatia
Title
GMP Inspection Report
Study date
2 April 2024
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292265
Author
Chemwatch
Title
Excipient 1 SDS
Study date
20 February 2017
Authorising party
Public
Auth party contact address
-
Data no
292217
Author
A Delmotte
Title
Certificate of Test
Study date
07 June 2023
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
300143
Author
Drozdek S
Title
Justification of System Suitability Criteria
Study date
02 September 2020
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292271
Author
Chemwatch
Title
Excipient 7 SDS
Study date
15 November 2017
Authorising party
Public
Auth party contact address
-
Data no
292211
Author
I Huizar
Title
Validation of Stability indicating Assay for Quantification of Mirtazapine and its Degradants in KIN010 Topical Ointment.
Study date
14 January 2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292317
Author
Milgram W
Title
kb110pk
Study date
2015
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292257
Author
Vignali C, Groppi A, Brandolini F, Avato FM, Talarico A, Gaudio RM, Morini L
Title
Mirtazapine fatal poisoning
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
292311
Author
Gunta SS, Mak RH
Title
Ghrelin and leptin pathophysiology in chronic kidney disease
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
292277
Author
Milgram W
Title
Study KB111PK
Study date
2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292205
Author
Dechra
Title
Freeze Thaw Results
Study date
23 September 2015
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292254
Author
B?rard A, Sheehy O, Zhao JP, Vinet E, Bernatsky S, Abrahamowicz M
Title
SSRI and SNRI use during pregnancy and the risk of persistent pulmonary hypertension of the newborn
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
292297
Author
de Boer T
Title
The Pharmacologic Profile of Mirtazapine
Study date
1996
Authorising party
Public
Auth party contact address
-
Data no
292228
Author
Quimby JM, Gustafson DL, Lunn KF
Title
The Pharmacokinetics of Mirtazapine in Cats with Chronic Kidney Disease and In Age-Matched Control Cats
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
292248
Author
Solek, P.; Mytych, J.; Tabecka-Lonczynska, A.; Koziorowski, M
Title
Molecular Consequences of Depression Treatment: A Potential In Vitro Mechanism for Antidepressants-Induced Reprotoxic Side Effects
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
292234
Author
Young K
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292191
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Chemistry and Manufacture
Study date
August 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292291
Author
Poole O'Banion M
Title
Study KB104P
Study date
2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292289
Author
Freeman LM, Lachaud M-P, Matthews S, Rhodes L, Zollers B
Title
Evaluation of Weight Loss Over Time in Cats with Chronic Kidney Disease
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
292266
Author
Chemwatch
Title
Excipient 2 SDS
Study date
21 November 2020
Authorising party
Public
Auth party contact address
-
Data no
292243
Author
Not known
Title
Pfizer product monograph (mirtazapine orally disintegrating tablets 15 mg, 30 mg, and 45 mg)
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
292220
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Toxicology
Study date
June 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292197
Author
Not known
Title
Excipient monographs and certificates of analysis
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292212
Author
A Adomako-Mensah
Title
Method Validation of BHT in KIN010 Topical Ointment, 2%
Study date
20 October 2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292260
Author
Kemper CJ
Title
The Rat - Drug Metabolism
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
292272
Author
Miller L, Vila M
Title
kb119
Study date
26 September 2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292306
Author
Chang F-L, Ho ST, Sheen MJ
Title
Efficacy of mirtazapine in preventing intrathecal morphine-induced nausea and vomiting after orthopaedic surgery
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
292312
Author
Halford JCG, Harrold JA
Title
5-HT2C Receptor Agonists and the Control of Appetite
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
292206
Author
Dechra
Title
Photostability Results
Study date
23 September 2015
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292229
Author
Benson KK, Zajic LB, Morgan PK, Brown SR, Hansen RJ, Lunghofer PJ, Wittenburg LA, Gustafson DL, Quimby JM
Title
Drug exposure and clinical effect of transdermal mirtazapine in healthy young cats: a pilot study
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
292280
Author
Young K
Title
KB115T part c
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292249
Author
Djulus J, Koren G, Einarson TR, Wilton L, Shakir S, Diav-Citrin O, Kennedy D, Voyer Lavigne S, De Santis M, Einarson A
Title
Exposure to Mirtazapine During Pregnancy: A Prospective, Comparative Study of Birth Outcomes
Study date
2006
Authorising party
Public
Auth party contact address
-
Data no
292323
Author
Carathers M
Title
kb118
Study date
2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292200
Author
United States Pharmacopoeial Commission
Title
Topical and Transdermal Drug Products - Product Quality Tests
Study date
12 May 2025
Authorising party
Public
Auth party contact address
-
Data no
292286
Author
Young K
Title
KB115T part i
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292292
Author
Ferguson LE, McLean MK, Bates JA, Quimby JM
Title
Mirtazapine toxicity in cats: retrospective study of 84 cases (2006, 2011)
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
300141
Author
K Grzeskowiak-Reed
Title
Raw material method RMM A1701
Study date
26 September 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292223
Author
Davis R, Wilde MI
Title
Mirtazapine - a Review of its Pharmacology and Therapeutic Potential in the Management of Major Depression
Study date
1996
Authorising party
Public
Auth party contact address
-
Data no
292269
Author
Chemwatch
Title
Excipient 5 SDS
Study date
18 March 2021
Authorising party
Public
Auth party contact address
-
Data no
292209
Author
Not iknown
Title
Stability Summary Tables
Study date
May 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292309
Author
Pae C-U
Title
Low-dose mirtazapine may be successful treatment option for severe nausea and vomiting
Study date
2006
Authorising party
Public
Auth party contact address
-
Data no
292315
Author
Masaki T, Chiba S, Yasuda T, Noguchi H, Kakuma T, Watanabe T, Sakata T, Yoshimatsu H.
Title
Involvement of hypothalamic histamine H1 receptor in the regulation of feeding rhythm and obesity
Study date
2004
Authorising party
Public
Auth party contact address
-
Data no
292263
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Work Health and Safety
Study date
June 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292232
Author
Milgram W
Title
A Laboratory, Randomized, Cross-Over Pharmacokinetic Study of Orally and Topically (Transdermal) Administered Mirtazapine 2% Ointment in Adult Cats
Study date
2015
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292203
Author
Dechra
Title
Part 2F2
Study date
26 March 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292303
Author
Agnew W, Korman R
Title
Pharmacological appetite stimulation - rational choices in the inappetent cat
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
292252
Author
Ostenfeld A, Lyngholm S, Christensen SE, Studsgaard Petersen T, Trærup Andersen J, Westergaard HB, Henning Pedersen L, Lokkegaard ECL
Title
Mirtazapine in pregnancy and lactation: A systematic review of adverse outcomes
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
292326
Author
Armstrong C
Title
ACOG Guidelines on Psychiatric Medication Use during Pregnancy and Lactation
Study date
2008
Authorising party
Public
Auth party contact address
-
Data no
292226
Author
Rouini M-R, Lavasina H, Sheikholeslami B, Nikoui V, Bakhtiarian A, Sgorbini M, Giorgi M
Title
Pharmacokinetics of Mirtazapine and its Main Metabolites after Single Oral Administration in Fasting/Fed Horses.
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
292283
Author
Young K
Title
KB115T part f
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292295
Author
Kalantar-Zadeh K, Ikizler TA
Title
Let Them Eat During Dialysis: An Overlooked Opportunity to Improve Outcomes in Maintenance Hemodialysis Patients
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
292246
Author
Merck Sharp and Dohme
Title
Full prescribing information - Remeron
Study date
November 2021
Authorising party
Public
Auth party contact address
-
Data no
292240
Author
Young K
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292218
Author
Australian Pesticides and Veterinary Medicines Authority
Title
Pre-application Assistance APVMA Written Assistance
Study date
19 October 2021
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292241
Author
Young K
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292195
Author
Australian Pesticides and Veterinary Medicines Authority
Title
License to Manufacture Veterinary Chemical Products
Study date
11 October 2023
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292224
Author
Rouini M-R, Lavasani H, Sheikholeslami B, Owen H, Giorgi M
Title
Pharmacokinetics of mirtazapine and its main metabolites after single intravenous and oral administrations in rats at two dose rates.
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
292258
Author
Sasao A, Yonemitsu K, Ohtsu Y, Tsutsumi H, Furukawa S, Kimura-Mishima S, Nishitani Y
Title
High blood mirtazapine concentration in a newborn ???????? A case of suspected postpartum infanticide
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
292318
Author
Masic A
Title
KB108T
Study date
2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292310
Author
Deng C, Weston-Green K, Huang X-F
Title
The role of histaminergic H1 and H3 receptors in food intake: a mechanism for atypical antipsychotic-induced weight gain?
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
292264
Author
Dechra Veterinary Products
Title
Mirataz SDS
Study date
20 March 2020
Authorising party
Public
Auth party contact address
-
Data no
292278
Author
Young K
Title
KB115T part a
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292255
Author
Rommel A-S, Momen NC, Molenaar NM, Agerbo E, Bergink V, Munk-Olsen T, Liu XQ
Title
Antidepressant use during pregnancy and risk of adverse neonatal outcomes: A comprehensive investigation of previously identified associations
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
292227
Author
Quimby JM, Gustafson DL, Samber BJ, Lunn KF
Title
Studies on the pharmacokinetics and pharmacodynamics of mirtazapine in healthy young cats.
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
292298
Author
He M, Deng C, Huang X-F
Title
The Role of Hypothalamic H1 Receptor Antagonism in Antipsychotic-Induced Weight Gain
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
292304
Author
Kast RE, Foley KF
Title
Cancer chemotherapy and cachexia: mirtazapine and olanzapine are 5-HT3 antagonists with good antinausea effects
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
292204
Author
Dechra
Title
Stability Summary Tables
Study date
September 2019
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292321
Author
Phamavet, Inc
Title
Mirtazapine (Plumbs Veterinary Medication Guides)
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
292235
Author
Young K
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292247
Author
Wu SX, Li XL, Li PY, Li TT, Huang GL, Sun Q, Dinnyés A, Shang LJ, Xu WM
Title
Developing rat testicular organoid models for assessing the reproductive toxicity of antidepression drugs in vitro
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
292284
Author
Young K
Title
KB115T part g
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292192
Author
L Grist
Title
Certificate of GMP Compliance of a Manufacturer
Study date
12 August 2024
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292290
Author
Poole O'Banion M
Title
Study KB105
Study date
2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292267
Author
Chemwatch
Title
Excipient 3 SDS
Study date
31 August 2021
Authorising party
Public
Auth party contact address
-
Data no
292244
Author
Milgram W
Title
Laboratory, Safety Study of Topical (Transdermal) Mirtazapine 2% Ointment Dosed Orally in Cats at 5X the Targeted Label Dose
Study date
2015
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292221
Author
Phamavet, Inc
Title
Mirtazapine (Plumbs Veterinary Medication Guides)
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
292198
Author
J Alexander
Title
PRO-SK-MS&T0021
Study date
24 February 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292307
Author
Chen C-C, Lin C-S, Ko Y-P, Hung Y-C, Lao H-C, Hsu Y-W
Title
Premedication with mirtazapine reduces preoperative anxiety and postoperative nausea and vomiting
Study date
2008
Authorising party
Public
Auth party contact address
-
Data no
292215
Author
PDO
Title
Tube Drawing
Study date
12 September 2022
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292261
Author
Bissinger DW, Wittenburg LA, Garzel LM, Stockinger DE, Timmel GB
Title
Pharmacokinetics of a Single Transdermal Dose of Mirtazapine in Rhesus Macaques (Macaca mulatta)
Study date
2023
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292301
Author
Stahl SM
Title
Stahl's essential psychopharmacology: neuroscientific basis and practical applications b
Study date
2008
Authorising party
Public
Auth party contact address
-
Data no
292207
Author
Dechra
Title
In use stability results
Study date
01 December 2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292201
Author
United States Pharmacopoeial Commission
Title
Antimicrobial Agents - Content
Study date
12 May 2025
Authorising party
Public
Auth party contact address
-
Data no
292275
Author
Buhles W
Title
Study KB101PK
Study date
2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292324
Author
Hall DA
Title
kb116
Study date
2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292281
Author
Young K
Title
KB115T part d
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292238
Author
Young K
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292287
Author
Quimby JM, Gustafson DL, Samber BJ, Lunn KF
Title
Studies on the pharmacokinetics and pharmacodynamics of mirtazapine in healthy young cats
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
292193
Author
Agency for Medicinal Products and Medical Devices of Croatia
Title
Certificate of GMP Compliance of a Manufacturer
Study date
16 June 2023
Authorising party
Public
Auth party contact address
-
Data no
300142
Author
Zaracko M
Title
Method Transfer Report V-OS-065/EE-24/1
Study date
10 September 2020
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292222
Author
Störmer E, Von Moltke LL, Shader RI, Greenblatt DJ
Title
Metabolism of the Antidepressant Mirtazapine In Vitro: Contribution of Cytochromes P-450 1A2, 2D6, and 3A4
Study date
2000
Authorising party
Public
Auth party contact address
-
Data no
292199
Author
M Ikhlaq
Title
Elemental Impurities Product Risk Assessment
Study date
26 June 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292270
Author
Chemwatch
Title
Excipient 6 SDS
Study date
13 May 2019
Authorising party
Public
Auth party contact address
-
Data no
292316
Author
Quimby JM, Gustafson DL, Lunn KF
Title
The Pharmacokinetics of Mirtazapine in Cats with Chronic Kidney Disease and In Age-Matched Control Cats
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
292210
Author
United States Pharmacopoeial Commission
Title
Antimicrobial Effectiveness Testing
Study date
13 May 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292216
Author
Not known
Title
Barrier properties of Polyfoil laminate tubes
Study date
2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292262
Author
Miller L, Vila M
Title
Determination of KIND-010 2% Ointment Dislodged upon Petting Following Repeated Topical (Transdermal) Administrations in Cats
Study date
2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292325
Author
Ostenfeld A, Peterson TS, Pedersen LH, Westergaard HB, Lokkegaard ECL, Andersen JT
Title
Mirtazapine exposure in pregnancy and foetal safety: A nationwide cohort study
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
292253
Author
Zheng JP, Zhang ZP, Liang YK, Wu QM, Din CF, Wang YT, Ma L, Su L
Title
Risk of congenital anomalies associated with pyschotropic medications: a review of neonatal reports in the FDA adverse event reporting system
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
292302
Author
Salvi V, Mencacci C, Barone-Adesi F.
Title
H1-histamine receptor affinity predicts weight gain with antidepressants
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
292276
Author
Milgram W
Title
Study KB103PK
Study date
2015
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292296
Author
Timmer CJ, Ad Sitsen JM, Delbressine LP
Title
Clinical Pharmacokinetics of Mirtazapine
Study date
2000
Authorising party
Public
Auth party contact address
-
Data no
292282
Author
Young K
Title
KB115T part e
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292233
Author
Milgram W
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
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292239
Author
Young K
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292242
Author
Young K
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292313
Author
Tecott LH, Sun LM, Akana SF, Strack AM, Lowenstein DH, Dallman MF, Julius D
Title
Eating disorder and epilepsy in mice lacking 5-HT2c serotonin receptors
Study date
1995
Authorising party
Public
Auth party contact address
-
Data no
300139
Author
K Grzeskowiak-Reed
Title
Finished product method FPM 806M
Study date
12 September 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292196
Author
S Markey
Title
Mirtazapine Transdermal Ointment Development Pharmaceutics Report
Study date
13 August 2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292219
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Environment
Study date
August 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292319
Author
Freeman LM
Title
Cachexia and Sarcopenia: Emerging Syndromes of Importance in Dogs and Cats
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
292259
Author
Berling I, Isbister GK
Title
Mirtazapine overdose is unlikely to cause major toxicity
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
292305
Author
Quimby JM, Lunn KF
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
Authorising party
Public
Auth party contact address
-
Data no
292213
Author
R Cryer
Title
Test Method Transfer Report for the Analytical Method for the Assay & Identification of Mirtazapine, Related Substances & Butylated Hydroxytoluene
Study date
May 2023
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292230
Author
Buhles W
Title
Laboratory Study: Pharmacokinetics of Mirtazapine Administered In Single Doses Orally and Topically (Transdermally) to Adult Cats
Study date
2015
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292279
Author
Young K
Title
KB115T part b
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292256
Author
Smit M, Dolman KM, Honig A
Title
Mirtazapine in pregnancy and lactation ???????? A systematic review
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
292322
Author
Yasso B
Title
kb117
Study date
2016
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292273
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Efficacy and Safety
Study date
June 2025
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292250
Author
Winterfield U, Klinger G, Panchaud A, Stephens S, Arnon J, Malm H, te Winkel B, Clementi M, Pistelli A, Manáková E, Elefheriou G, Merlob P, Kaplan YC, Buclin T, Rothuizen LE
Title
Pregnancy Outcome Following Maternal Exposure to Mirtazapine A Multicenter, Prospective Study
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
292299
Author
Schellekens H, De Francesco PN, Kandil D, Theeuwes WF, McCarthy T, van Oeffelen WE, Perello M, Giblin L, Dinan TG, Cryan JF
Title
Ghrelin's Orexigenic Effect Is Modulated via a Serotonin 2C Receptor Interaction
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
292236
Author
Young K
Title
A 6-Week Target Animal Safety Study of Topical (Transdermal) Mirtazapine in Cats
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
292293
Author
Riechelmann RP, Burman D, Tannock IF, Rodin G, Zimmermann C
Title
Phase II trial of mirtazapine for cancer-related cachexia and anorexia
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
292285
Author
Young K
Title
KB115T part h
Study date
2017
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands