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
147001
Product/Active constituent Name
Application Product Name
Finacil Xtra Herbicide
Application Date
Application Number
147001
Application Product Name
Finacil Xtra Herbicide
Application details
Product name:
Finacil Xtra Herbicide
Product number:
95719
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Registration of an 700 g/kg Saflufenacil water dispersible granule formulation (WG) product for the control of a range of broadleaf weeds prior to establishment of crops and forestry plantations, fallows, established citrus, pome and almond orchards, and around commercial, industrial, and agricultural buildings and yards, on established lucerne crops harvest-aid application in pulse crops, and late application in cereals; as per the DIRECTIONS FOR USE table..
Reference details:
62853 - SHARPEN HERBICIDE
Description of data provided:
Data no
304972
Title
Acute oral toxicty study of saflufenacil 70% WG in rats
Study date
2019
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
305854
Title
Acute Inhalation Toxicity Study of Saflufenacil 70% WG in Rats
Study date
2019
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
304967
Title
Response to s159 Notice for Finacil Xtra Herbicide
Study date
2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
305855
Title
Acute eye irritation study of saflufenacil 70% WG in rabbits
Study date
2019
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
305852
Title
Acute Dermal Toxicity Study of Saflufenacil 70% WG in Rats
Study date
2019
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
305853
Title
Acute Dermal irritation study of saflufenacil 70% WG in rabbits
Study date
2019
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
304971
Title
Skin sensitisation study of saflufenacil 70% WF in Guinea Pigs
Study date
2019
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
147002
Product/Active constituent Name
Application Product Name
Quantum Dicamba 700 WG Herbicide
Application Date
Application Number
147002
Application Product Name
Quantum Dicamba 700 WG Herbicide
Application details
Product name:
Quantum Dicamba 700 WG Herbicide
Product number:
95720
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 700 g/kg dicamba present as the sodium salt Water Dispersible Granule WG product for control of broadleaf weeds in winter cereals, pastures, conservation tillage, sugarcane, rice, turf, grain sorghum and non-crop areas
Reference details:
88627 - CADENCE Herbicide
Date
Application Date
Application No
Application Number
147000
Product/Active constituent Name
Application Product Name
Quantum Glyphosate 540 K Herbicide
Application Date
Application Number
147000
Application Product Name
Quantum Glyphosate 540 K Herbicide
Application details
Product name:
Quantum Glyphosate 540 K Herbicide
Product number:
95718
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 540 g/L Glyphosate present as the potassium salt Soluble Concentrate SL product for the control of many annual and perennial weeds
Reference details:
87155 - F.S.A. Glyphosate 540 K Herbicide
Active constituents:
Active constituent name
51693 - GLYPHOSATE
Date
Application Date
Application No
Application Number
147080
Product/Active constituent Name
Application Product Name
Tetanus Antitoxin 1500 IU/mL
Application Date
Application Number
147080
Application Product Name
Tetanus Antitoxin 1500 IU/mL
Application details
Product name:
Tetanus Antitoxin 1500 IU/mL
Product number:
83905
Applicant Name:
PADULA SERUMS PTY. LTD.
Application purpose and description of use:
Submission of product stability data as requested by APVMA.
Active constituents:
Active constituent name
83901 - EQUINE IMMUNOGLOBULIN PROTEIN
Description of data provided:
Data no
282224
Title
Stability
Study date
Dec 2024
Auth party contact address
100 Bosworth Road BAIRNSDALE Australia
Data no
282225
Title
Notice of variation
Study date
Dec 2022
Auth party contact address
100 Bosworth Road BAIRNSDALE Australia
Date
Application Date
Application No
Application Number
146954
Product/Active constituent Name
Application Product Name
Verpixo Adavelt active Fungicide
Application Date
Application Number
146954
Application Product Name
Verpixo Adavelt active Fungicide
Application details
Product name:
Verpixo Adavelt active Fungicide
Product number:
91871
Applicant Name:
CORTEVA AGRISCIENCE AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of label approval to add IPM statements and to clarify other sections including DFU table
Description of data provided:
Data no
282776
Title
Part 7 - Environment
Study date
2024
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
282777
Title
Toxicity assessment GF-4536 on eight beneficial species
Study date
2024
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
282778
Title
draft label with highlighted changes
Study date
2024
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
290192
Title
DETERMINATION OF THE EFFICACY OF VERPIXO (XDE-659) (GF-4536) FOR THE CONTROL OF GREY MOULD IN TOMATO
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
291051
Title
Efficacy of XDE-659 (GF-4536) for control of powdery mildew (caused by Podosphaera xanthii) in cucumbers cv. Carmen
Study date
2021
Data no
291097
Title
Efficacy of GF-4536 (Adavelt) for control of grey mould (caused by Botrytis cinerea) in tomato cv. Admiro
Study date
2023
Data no
291098
Title
Effective chemical use. Determining dilute water volumes for spraying.
Study date
2016
Auth party contact address
-
Data no
291099
Title
Effective chemical use. A single rate per hectare - why it shouldn't be used.
Study date
2016
Auth party contact address
-
Date
Application Date
Application No
Application Number
146775
Product/Active constituent Name
Application Product Name
Cefoven Injection for Dogs and Cats
Application Date
Application Number
146775
Application Product Name
Cefoven Injection for Dogs and Cats
Application details
Product name:
Cefoven Injection for Dogs and Cats
Product number:
95666
Applicant Name:
INVETRO PTY LTD
Application purpose and description of use:
Registration of an 80 mg/mL cefovecin injectable antibiotic for the treatment of bacterial infections sensitive to cefovecin in dogs and cats.
Reference details:
60461 - CONVENIA
Date
Application Date
Application No
Application Number
146865
Product/Active constituent Name
Application Product Name
Fascinate Dry Herbicide
Application Date
Application Number
146865
Application Product Name
Fascinate Dry Herbicide
Application details
Product name:
Fascinate Dry Herbicide
Product number:
85197
Applicant Name:
UPL AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of the label approval to extend the use to include the control of various broadleaf and grass weeds on sugarcane
Active constituents:
Active constituent name
69470 - GLUFOSINATE-AMMONIUM
Description of data provided:
Data no
282310
Title
GLUA800_Part 8 Fascinate Dry Herbicide
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
282311
Title
Comparisons of efficacy and crop safety of glufosinate ammonium products Fascinate 280 SL, Fascinate 500 WG and the glufosinate-P-ammonium product Aurora 280 SL with Basta 200 SL applied as directed sprays in ratoon sugar cane.
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
282312
Title
Comparisons of efficacy and crop safety of glufosinate ammonium products Fascinate 280 SL, Fascinate 500 WG and the glufosinate-P-ammonium product Aurora 280 SL with Basta 200 SL applied as directed sprays in plant sugar cane.
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
282313
Title
Bio-equivalency trial to compare Fascinate 280SL, Fascinate 500SG and Basta for weed control in ratoon sugarcane
Study date
2020
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
282314
Title
Efficacy and crop safety of Glufosinate in plant Sugarcane.
Study date
2020
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
282315
Title
Bio-equivalency Trials to Compare the Efficacy of Fascinate 280 SL and Fascinate Dry to Basta for Weed Control in Sugarcane
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Date
Application Date
Application No
Application Number
146864
Product/Active constituent Name
Application Product Name
QUIKHEAL OINTMENT
Application Date
Application Number
146864
Application Product Name
QUIKHEAL OINTMENT
Application details
Product name:
QUIKHEAL OINTMENT
Product number:
45334
Applicant Name:
KELATO ANIMAL HEALTH A DIV OF EVOLUTION ANIMAL HEALTH PL
Application purpose and description of use:
To update the approved sites of manufacture for the registered veterinary chemical product, APVMA No. 45334, and to align the label with the current Veterinary Labelling Code.
Description of data provided:
Data no
281716
Title
Certificate of GMP Compliance of Manufacturer
Study date
2024
Auth party contact address
14/205 PORT HACKING RD MIRANDA Australia
Date
Application Date
Application No
Application Number
146752
Product/Active constituent Name
Application Product Name
Metarhizium
Application Date
Application Number
146752
Application Product Name
Metarhizium
Application details
Product name:
Metarhizium
Active name:
Metarhizium
Applicant Name:
Australian Plague Locust Commission
Application purpose and description of use:
Approval of Metarhizium acridum for use in agricultural chemical products for the biological control Australian plague locust.
Description of data provided:
Data no
282135
Title
Process development ? a five step process
Study date
5/12/2024
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
282136
Title
DETERMINATION OF THE BULK DENSITY OF THE TEST ITEM "METARHIZIUM ACRIDUM STRAIN EVCH 077, DRY SPORES
Study date
1/12/2016
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
282137
Title
Suitability for enumeration method of active ingradient of METARHIZIUM ACRIDUM STRAIN EVCH 077, DRY SPORES
Study date
3/11/2026
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
282138
Title
STORAGE STABILITY at 30?C for 18 weeks on Metarizium acridum strain EVCH 077, dry spores
Study date
2/02/2017
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
282139
Title
Declaration of COMPOSITION OF THE FORMULATION
Study date
5/12/2023
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
282140
Title
Novacrid Manufacturer flow chart
Study date
26/11/2024
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
282141
Title
5-BA TCH ANALYSIS Content of Active Ingredient and microbial contaminants on Metarhizium acridum Strain Evch 077, Dry Spores
Study date
14/12/2016
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
292657
Title
s159 response letter
Study date
09 Sep 2025
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
292658
Title
GMP certificate
Study date
27 June 2025
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
292659
Title
Audit report
Study date
07/06/2022
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
293076
Title
Novacrid Manufacturing process
Study date
12/09/2025
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
293077
Title
Novacrid molecular identification and sequential comparison
Study date
12/09/2025
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
293078
Title
Novacrid molecular identification and sequential comparison
Study date
12/09/2025
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
293079
Title
Novacrid identification and confirmation
Study date
12/09/2025
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
293080
Title
Novacrid Batch analysis
Study date
12/09/2025
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
293081
Title
Novacrid CoA by Keyun 2020
Study date
12/09/2025
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
293082
Title
FAO specification
Study date
12/09/2025
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
293083
Title
A copy of FAO BAFO signed
Study date
12/09/2025
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Data no
293084
Title
Signed manufacturer declation
Study date
12/09/2025
Auth party contact address
unit 7 / 50 Collie Street Fyshwick Australia
Date
Application Date
Application No
Application Number
146788
Product/Active constituent Name
Application Product Name
Farmalinx Dinomite Insecticide
Application Date
Application Number
146788
Application Product Name
Farmalinx Dinomite Insecticide
Application details
Product name:
Farmalinx Dinomite Insecticide
Product number:
95675
Applicant Name:
FARMALINX PTY LTD
Application purpose and description of use:
Registration of a 200 g/kg Water Soluble Granule (SG) product for control of various pests in Turf.
Reference details:
69398 - STARKLE 200 SG INSECTICIDE
83011 - Seclira WSG Insecticide
Active constituents:
Active constituent name
94519 - Dinotefuran
Description of data provided:
Data no
282077
Title
Chemistry and Manufacturing data for Farmalinx Dinotmite Insecticide
Study date
May 2023
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282078
Title
Method Validation for the determination of dinotefuran in a water-soluble granule (SG)
Study date
2 May 2023
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282079
Title
Certificate of Analysis -- Stability
Study date
2 May 2023
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282080
Title
Raw Material Specifications
Study date
December 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282081
Title
HEALTH 5 Farmalinx Dinomite Insecticide
Study date
16 November 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282082
Title
Raw material specs
Study date
16 November 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282083
Title
Proposed RLP
Study date
16 November 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282084
Title
Efficacy Farmalinx Dinomite Insecticide
Study date
16 November 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282085
Title
Proposed RLP
Study date
16 November 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282086
Title
Reference label 1
Study date
16 November 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282087
Title
Reference label 2
Study date
16 November 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282088
Title
Evaluation of a range of Insecticides for Turfgrass pest control.
Study date
29 August 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282089
Title
Evaluation of a range of Insecticides for Turfgrass pest control
Study date
16 October 2023
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282090
Title
Evaluation of a range of Insecticides for Turfgrass pest control
Study date
16 October 2023
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282091
Title
Evaluation of a range of Insecticides for Turfgrass pest control.
Study date
29 August 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282092
Title
Evaluation of a range of Insecticides for Turfgrass pest control.
Study date
3 September, 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282093
Title
Evaluation of a range of Insecticides for Turfgrass pest control.
Study date
10 April 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282094
Title
US label
Study date
November 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282095
Title
Ground Pearls, Margarodes spp.
Study date
September 2021
Auth party contact address
-
Data no
282096
Title
Part 7 Environmental Safety
Study date
November 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282097
Title
Proposed Draft Label
Study date
November 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
282098
Title
US label
Study date
November 2024
Auth party contact address
-
Date
Application Date
Application No
Application Number
146579
Product/Active constituent Name
Application Product Name
Sheepguard Spinosad Pour-On for Sheep
Application Date
Application Number
146579
Application Product Name
Sheepguard Spinosad Pour-On for Sheep
Application details
Product name:
Sheepguard Spinosad Pour-On for Sheep
Product number:
95636
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a drench product for the control of Spinosad-susceptible lice (Bovicola ovis), including strains resistant to Synthetic Pyrethroids (SPs), in sheep up to 7 days of-shears and sheep with long wool.
Reference details:
60117 - ELANCO AH0493 EXTINOSAD POUR-ON FOR SHEEP
Active constituents:
Active constituent name
89208 - SPINOSAD
Description of data provided:
Data no
281119
Title
Product Specification
Study date
November 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
147031
Product/Active constituent Name
Application Product Name
Albendazole oxide
Application Date
Application Number
147031
Application Product Name
Albendazole oxide
Application details
Product name:
Albendazole oxide
Active name:
Albendazole oxide
Applicant Name:
JIANGSU QUALITY HORIZONS PHARMTECH CO., LTD.
Application purpose and description of use:
Approval of Albendazole oxide for use in veterinary chemical products.
Description of data provided:
Data no
282132
Title
Certificates of analysis
Study date
12/2024
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Data no
282133
Title
241231 DMF of Albendazole sulfoxide (CPV-A-01)
Study date
2024
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Data no
282134
Title
241231DMF of Albendazole sulfoxide (CPV-R-01)
Study date
2024
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Data no
289668
Title
Response letter
Study date
06/2025
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Data no
289669
Title
Albendazole sulfoxide characterisation and validation of analytical procedure
Study date
13/06/2025
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Data no
303384
Title
Response letter
Study date
03/2026
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Data no
303385
Title
Albendazole sulfoxide ASMF/CPV/R/01/630 Ver.01
Study date
27/02/2026
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Data no
303386
Title
Albendazole sulfoxide ASMF/CPV/R/01/630 Ver.01
Study date
27/02/2026
Auth party contact address
No.18,Jinlong Road Chunjiang Town Xinbei District Changzhou China
Date
Application Date
Application No
Application Number
146680
Product/Active constituent Name
Application Product Name
Vectothor Inzecto Larvicidal Mosquito Chips
Application Date
Application Number
146680
Application Product Name
Vectothor Inzecto Larvicidal Mosquito Chips
Application details
Product name:
Vectothor Inzecto Larvicidal Mosquito Chips
Product number:
95643
Applicant Name:
ENSYSTEX AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a 0.26 g/kg pyriproxyfen tablet for direct application (DT) product for control of mosquitoes in outdoor water containers.
Reference details:
70077 - SUMILARV GRANULAR INSECT GROWTH REGULATOR
Date
Application Date
Application No
Application Number
146677
Product/Active constituent Name
Application Product Name
ATEKA 480 SC Insecticide
Application Date
Application Number
146677
Application Product Name
ATEKA 480 SC Insecticide
Application details
Product name:
ATEKA 480 SC Insecticide
Product number:
95641
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 480 g/L Spirotetramat Suspension concentrate for uses as proposed in the Directions for Use.
Reference details:
61864 - MOVENTO 240 SC INSECTICIDE
Date
Application Date
Application No
Application Number
145533
Product/Active constituent Name
Application Product Name
Rabbit haemorrhagic disease virus type 2 (RHDV2) VP1ab
Application Date
Application Number
145533
Application Product Name
Rabbit haemorrhagic disease virus type 2 (RHDV2) VP1ab
Application details
Product name:
Rabbit haemorrhagic disease virus type 2 (RHDV2) VP1ab
Product number:
95408
Applicant Name:
INVETRO PTY LTD
Application purpose and description of use:
Registration of a RHD suspension for injection product for the immunisation of rabbits, in conjunction with approval of the actives.
Date
Application Date
Application No
Application Number
145534
Product/Active constituent Name
Application Product Name
Rabbit haemorrhagic disease virus 1 (RHDV1) VP1a
Application Date
Application Number
145534
Application Product Name
Rabbit haemorrhagic disease virus 1 (RHDV1) VP1a
Application details
Product name:
Rabbit haemorrhagic disease virus 1 (RHDV1) VP1a
Product number:
95409
Applicant Name:
INVETRO PTY LTD
Application purpose and description of use:
Registration of a RHD suspension for injection product for the immunisation of rabbits, in conjunction with approval of the actives.
Date
Application Date
Application No
Application Number
145535
Product/Active constituent Name
Application Product Name
Fatrovax RHD Inactivated Vaccine for Rabbits
Application Date
Application Number
145535
Application Product Name
Fatrovax RHD Inactivated Vaccine for Rabbits
Application details
Product name:
Fatrovax RHD Inactivated Vaccine for Rabbits
Product number:
95410
Applicant Name:
INVETRO PTY LTD
Application purpose and description of use:
Registration of a RHD suspension for injection product for the immunisation of rabbits, in conjunction with approval of the actives.
Reference details:
92254 - FILAVAC VHD K C+V INACTIVATED VACCINE FOR RABBITS
Active constituents:
Active constituent name
95409 - Rabbit haemorrhagic disease virus 1 (RHDV1) VP1a
Active constituent name
95408 - Rabbit haemorrhagic disease virus type 2 (RHDV2) VP1ab
Description of data provided:
Data no
278428
Title
Application Overview
Study date
September 2024
Data no
278756
Title
PAA Advice
Study date
September 2024
Data no
278757
Title
Project Plan
Study date
September 2024
Data no
278758
Title
GMP Certificate
Study date
March 2023
Auth party contact address
-
Data no
278759
Title
Letter of Support
Study date
October 2023
Data no
278760
Title
Sales and Pharmacovigilance Data
Study date
July 2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278761
Title
Import Permit Application
Study date
September 2023
Data no
278762
Title
Data List Summary
Study date
September 2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278763
Title
A single introduction of wild rabbits triggered the biological invasion of Australia
Study date
August 2022
Auth party contact address
-
Data no
278764
Title
Sustained Impact of RHDV2 on Wild Rabbit Populations across Australia Eight Years after Its Initial Detection
Study date
2023
Auth party contact address
-
Data no
278765
Title
Epidemiological characterization and risk assessment of rabbit haemorrhagic disease virus 2 (RHDV2/b/GI.2) in the world.
Study date
March 2024
Auth party contact address
-
Data no
278766
Title
Rabbit haemorrhagic disease (RHD) and rabbit haemorrhagic disease virus (RHDV): a review.
Study date
February 2012
Auth party contact address
-
Data no
278767
Title
EU Directive No 37/2010
Study date
2009
Auth party contact address
-
Data no
278768
Title
European Pharmacopeia Monograph 0062
Study date
2023
Auth party contact address
-
Data no
278769
Title
genetic-comparison-with-rhdv2-australian-strains
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278770
Title
Official Journal of the EU extract - Fatrovax Marketing Authorisation
Study date
2021
Auth party contact address
-
Data no
278771
Title
Recombination in Australian rabbit caliciviruses
Study date
2021
Auth party contact address
-
Data no
278772
Title
Immunological Cross-Protection between Different Rabbit Hemorrhagic Disease Viruses-Implications for Rabbit Biocontrol and Vaccine Development.
Study date
April 2022
Auth party contact address
-
Data no
278773
Title
Detection and Circulation of a Novel Rabbit Hemorrhagic Disease Virus in Australia
Study date
March 2018
Auth party contact address
-
Data no
278774
Title
admin info
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278775
Title
spc
Study date
2021
Auth party contact address
-
Data no
278776
Title
Concise deatiled and critical summary on analytical, safety and efficacy documenttion
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278777
Title
Concise deatiled and critical summary on analytical, safety and efficacy documenttion
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278778
Title
LOQ responses
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278779
Title
DDPS
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278780
Title
GMP Certificate
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278781
Title
Purity Method Validation
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278782
Title
Evolution and function of the insect hexamerins
Study date
1999
Auth party contact address
-
Data no
278783
Title
Detection and quantification of residual Baculovirus DNA in the active substances of Fatrovax RHD
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278784
Title
Evaluation of infectious titer in crude extracts
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278785
Title
Fatrovax RHD Additional study on validation of inactivation of baculovirus
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278786
Title
Cetrification for pre-Master baculovirus seeds
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278787
Title
GMO certification
Study date
2017
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278788
Title
Certification of plasmid origin
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278789
Title
Development of a low-cost, insect larvae-derived recombinant subunit vaccine against RHDV
Study date
2007
Auth party contact address
-
Data no
278790
Title
Horizontal transmissible protection against myxomatosis and rabbit hemorrhagic disease by using a recombinant myxoma virus
Study date
2000
Auth party contact address
-
Data no
278791
Title
Certificate of Analysis -donor plasmid
Study date
2016
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278792
Title
Arbovirus Evolution
Study date
2008
Auth party contact address
-
Data no
278793
Title
Transmission cycles, host range, evolution and emergence of arboviral disease
Study date
2004
Auth party contact address
-
Data no
278794
Title
The coat protein of Rabbit hemorrhagic disease virus contains a molecular switch at the N-terminal region facing the inner surface of the capsid
Study date
2004
Auth party contact address
-
Data no
278795
Title
Atomic model of rabbit hemorrhagic disease virus by cryo-electron microscopy and crystallography
Study date
2013
Auth party contact address
-
Data no
278796
Title
Analysis of the ratio T1/T3 in recombinant RHDV VLPs preparations
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278797
Title
sarkosyl-determination-method-validation
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278798
Title
npeo-determination-method-validation
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278799
Title
04co-3lab3-safety-dwarf-rabbit
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278800
Title
clinical necroscopic and histological description of viral haemorrhagic disease/ Variant RHD Virus in young rabbits Spain
Study date
2012
Auth party contact address
-
Data no
278801
Title
validation-sterilisation-primary-packaging
Study date
2018
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278802
Title
Recombinant Rabbit Hemorrhagic Disease Virus Capsid ProteinExpressed in Baculovirus Self-Assembles into ViruslikeParticles and Induces Protection
Study date
1994
Auth party contact address
-
Data no
278803
Title
Recombinant VP60 in the form of virion-like particles as a potential vaccine against rabbit hemorrhagic disease virus
Study date
2006
Auth party contact address
-
Data no
278804
Title
integrated-tip-cap
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278805
Title
documentation-needles
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278806
Title
Virus-host interations
Study date
1992
Auth party contact address
-
Data no
278807
Title
Cabbage Loopers
Study date
1966
Auth party contact address
-
Data no
278808
Title
Coevolution of viruses with hosts and vectors and possible paleontology
Study date
2003
Auth party contact address
-
Data no
278809
Title
RNA viruses infecting pest insects
Study date
2012
Auth party contact address
-
Data no
278810
Title
Altered antigenicity and immunogenicity of human papillomavirus virus-like particles in the presence of thimerosal
Study date
2019
Auth party contact address
-
Data no
278811
Title
statistics-on-potency-from-stability-study
Study date
2018
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278812
Title
Alternative gene expression certification
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278813
Title
certificate-algenex-iso-9001
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278814
Title
Ausit Final Report
Study date
2016
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278815
Title
Study on effect of inoculum titer and incubation timeon protein expression in pupae
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278816
Title
plastic-for-plastic-trays
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278817
Title
stability-of-infected-frozen-pupae
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278818
Title
CoA detergents
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278819
Title
celpure-c300
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278820
Title
tem-analysis-tff-samples
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278821
Title
yield-method-validation
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278822
Title
validation-protocol-bv-inactivation.
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278823
Title
maximum-volume-on-sf21-for-ki
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278824
Title
maximum-volume-on-sf21-interference-storage-buffer.
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278825
Title
Characterization of a Baculovirus-Encoded Protein That Is Associated with Infected-Cell Membranes and Budded Virions
Study date
2001
Auth party contact address
-
Data no
278826
Title
bv-growth-low-moi
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278827
Title
antibody-baculovirus-envelope-gp64
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278828
Title
wb-images-sensitivity-of-inactivation-control-test.
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278829
Title
vlp-monomer-proportion.
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278830
Title
certification-algenex-on-generation-and-transfer-recombinant-bv
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278831
Title
statement-pI-storage
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278832
Title
cert-conf-nunc-vials
Study date
2018
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278833
Title
working-seeds-stability-report
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278834
Title
pfu-count-method-and-validation
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278835
Title
Significant Productivity Improvement of the Baculovirus Expression Vector System by Engineering a Novel Expression Cassette
Study date
2014
Auth party contact address
-
Data no
278836
Title
-retesting-master-seeds
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278837
Title
Outbreeding depression, but no inbreeding depression in haplodiploid Ambrosia beetles with regular sibling mating
Study date
2005
Auth party contact address
-
Data no
278838
Title
Antiseptics and Disinfectants: Activity, action and resistance
Study date
1999
Auth party contact address
-
Data no
278839
Title
stability-pupae-before-inoculation
Study date
2017
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278840
Title
ea-pcr-method-validation
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278841
Title
pupae-productivity
Study date
2017
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278842
Title
ea-pcr-method-validation
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278843
Title
coa-pupae-diet-components
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278844
Title
risk-assessment-sao
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278845
Title
A structured review of baculovirus infection process: integration of mathematical models and biomolecular information on cell-virus interaction
Study date
2018
Auth party contact address
-
Data no
278846
Title
sterility-purified-antigen-method
Study date
2020
Auth party contact address
-
Data no
278847
Title
absence-mycoplasmas-additional-validation-study
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278848
Title
purification-polyclonal-sera
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278849
Title
protocol-identification-active-substancess-method-validation.
Study date
2017
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278850
Title
in-house-purification-method-std
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278851
Title
quantification-sds-page-method
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278852
Title
identification-active-substances-additional-validation-study
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278853
Title
v-mco-125-rev
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278854
Title
method-ph-determination
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278855
Title
production-coating-antigens
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278856
Title
stability-coating-antigens-and-standards
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278857
Title
management-reagents
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278858
Title
potency-validation-report-track-version
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278859
Title
specificity-elisa-validation-report
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278860
Title
elisa-validation-protocol.
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278861
Title
elisa-method-revised
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278862
Title
revised-sterility-test
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278863
Title
stability-purified-antigens-rev
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278864
Title
finished-product-stability-report.
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278865
Title
Role of the Vector in Arbovirus Transmission
Study date
2015
Auth party contact address
-
Data no
278866
Title
Characterization of a Trichoplusia ni hexamerin-derived promoter in the AcMNPV baculovirus vector
Study date
2013
Auth party contact address
-
Data no
278867
Title
Concise detailed and critical summary on analytical, safety and efficacy documentation
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278868
Title
stability-study-protocol-additiona
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278869
Title
compatibility-study
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278870
Title
in-use-shelf-life-broached-vial-test.
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278871
Title
Dwarfism and Altered Craniofacial Development in Rabbits Is Caused by a 12.1 kb Deletion at the HMGA2 Locus
Study date
2017
Auth party contact address
-
Data no
278872
Title
comparative-serology-study-04co-34lab2
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278873
Title
p17rhdk1-ingezim-rabbit-prototype
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278874
Title
comparative-serology-study-064-17
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278875
Title
Appropriate handling of pet rabbits: a literature review
Study date
2016
Auth party contact address
-
Data no
278876
Title
Physiological stress levels predict survival probabilities in wild rabbits
Study date
2007
Auth party contact address
-
Data no
278877
Title
validation-report-elisa-rhdv-rhdv2-izsler
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278878
Title
challenge-strains.
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278879
Title
-immunochromatographic-kit.
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278880
Title
validation-pcr-rhdv2
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278881
Title
Transmission of maternal antibody prenatally and from milk into serum of neonatal rabbits
Study date
1986
Auth party contact address
-
Data no
278882
Title
coa-1803.
Study date
2018
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278883
Title
12-month-doi-challenge
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278884
Title
responses-to-the-loi
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278885
Title
reference-serum-control-charts
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278886
Title
committment-pam
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278887
Title
degradation-products
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278888
Title
plaque-count-method
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278889
Title
staining-protocols-pfu-titration
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278890
Title
bpr-template
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278891
Title
sop-v173
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278892
Title
coa-wheat-germ-with-translation
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278893
Title
sterility-purified-antigen-method
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278894
Title
pupae-storage-pre-inoculation
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278895
Title
extractables-study-on-de
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278896
Title
validation-removal-hypochlorite
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278897
Title
inactivation-high-titres
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278898
Title
cvmp-summary-positive-opinion-fatrovax-rhd_en
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278899
Title
committment-pam
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278900
Title
fatrovax-rhd-loi-and-so
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278901
Title
fatrovax-rhd-d120-loq-and-so
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278902
Title
qual-quant-partic
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278903
Title
bpr-batches-used-in-studies
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278904
Title
The coat protein of Rabbit hemorrhagic disease virus contains a molecular switch at the N-terminal region facing the inner surface of the capsid.
Study date
2004
Auth party contact address
-
Data no
278905
Title
Emergence of a new lagovirus related to Rabbit Haemorrhagic Disease Virus
Study date
2013
Auth party contact address
-
Data no
278906
Title
Comparative analysis of rabbit hemorrhagic disease virus (RHDV) and new RHDV2 virus antigenicity, using specific virus-like particles
Study date
2015
Auth party contact address
-
Data no
278907
Title
Detection of a new variant of RHDV in France
Study date
2011
Auth party contact address
-
Data no
278908
Title
manuf
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278909
Title
process-validation-report
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278910
Title
start-mat-in-ph
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278911
Title
certificates-of-analysis
Study date
2018
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278912
Title
start-mat-not-in-ph
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278913
Title
certificate-esf-af-medium
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278914
Title
Can Plant Viruses Cross the Kingdom Border and Be Pathogenic to Human
Study date
2015
Auth party contact address
-
Data no
278915
Title
Feeding Mechanisms of Adult Lepidoptera: Structure, Function, and Evolution of the Mouthparts
Study date
2010
Auth party contact address
-
Data no
278916
Title
Baculovirus Host-Range
Study date
2009
Auth party contact address
-
Data no
278917
Title
Baculovirus host-range
Study date
2016
Auth party contact address
-
Data no
278918
Title
Ascoviruses
Study date
2008
Auth party contact address
-
Data no
278919
Title
Sex ratio distortion and severe inbreeding depression in the gypsy moth Lymantria dispar L. in Hokkaido, Japan
Study date
1999
Auth party contact address
-
Data no
278920
Title
not supplied
Study date
1999
Auth party contact address
-
Data no
278921
Title
Inbreeding Depression and Laboratory Adaptation in Heliothis virescens (Lepidoptera: Noctuidae)
Study date
1986
Auth party contact address
-
Data no
278922
Title
SEVERE INBREEDING DEPRESSION AND RAPID FITNESS REBOUND IN THE BUTTERFLY BICYCLUS ANYNANA (SATYRIDAE)
Study date
1996
Auth party contact address
-
Data no
278923
Title
Generation-based life table analysis reveals manifold effects of inbreeding on the population fitness in Plutella xylostella
Study date
2015
Auth party contact address
-
Data no
278924
Title
Comparative effects of inbreeding and outbreeding on the ontogeny of Heliconius erato phyllis (Lepidoptera: Nymphalidae)
Study date
2018
Auth party contact address
-
Data no
278925
Title
Minimum Viable Population
Study date
2015
Auth party contact address
-
Data no
278926
Title
Outbreeding depression, but no inbreeding depression in haplodiploid Ambrosia beetles with regular sibling mating
Study date
2005
Auth party contact address
-
Data no
278927
Title
control-card-t-ni-pupae
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278928
Title
certificate-analysis-mcl-fc744
Study date
2016
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278929
Title
absence-rhabdovirus-contamination.
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278930
Title
-identification-species-spodoptera-frugiperda
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278931
Title
Characterization of an Sf-rhabdovirus-negative Spodoptera frugiperda cell line as an alternative host for recombinant protein production in the baculovirus-insect cell system
Study date
2016
Auth party contact address
-
Data no
278932
Title
karyotyping-sf-rvn
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278933
Title
certificate-analysis-mcp-fc737
Study date
2016
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278934
Title
certificate-working-seed-rhdv2ab-194
Study date
2017
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278935
Title
certificate-master-seed-rhdv2ab-194
Study date
2016
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278936
Title
certificate-working-seed-rhdva-131
Study date
2017
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278937
Title
absence-extraneous-agents-method
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278938
Title
plaque-count-method-validation
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278939
Title
certificate-master-seed-rhdva-131
Study date
2016
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278940
Title
contr-manuf
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278941
Title
wb-method-baculovirus-proteins
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278942
Title
residual-bv-dna-method
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278943
Title
validation-report-inactivation-rev-1
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278944
Title
quantification-sds-page-method-rev-1
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278945
Title
identification-active-substances-method-validation
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278946
Title
absence-mycoplasmas-method-validation
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278947
Title
sterility-purified-antigen-method-validation
Study date
2018
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278948
Title
test-fin-prod
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278949
Title
-potency-validation-report-rev-1
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278950
Title
elisa-validation-report-rev-1
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278951
Title
determination-adjuvant-method-validation
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278952
Title
determination-preservative-method-validation
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278953
Title
sterility-test-method-validation
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278954
Title
-batch-consist
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278955
Title
bpr-consistency-batches
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278956
Title
2-bpr-additional-batches
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278957
Title
-bpr-sub-potent
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278958
Title
stab
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278959
Title
-finished-product-stability-report
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278960
Title
in-use-shelf-life-broached-vial-test
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278961
Title
preservative-efficacy-study-rev.
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278962
Title
gen-requ
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278963
Title
-lab-tests
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278964
Title
f020217hk-safey-intradermic-route
Study date
2017
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278965
Title
-statistics-on-study-064-17.
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278966
Title
safety-does-rev-2
Study date
2021
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278967
Title
statistics-on-04co-34lab2-rev-1
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278968
Title
04co-34lab2-safety-single-dose-rev-1.
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278969
Title
field-stud
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278970
Title
04co-3pc-1-clinical-study-dwarf-rabbit-rev-1
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278971
Title
era
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278972
Title
gen-requ
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278973
Title
lab-trials
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278974
Title
serology-competitive-elisa
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278975
Title
study-report-04co-4lab3-doi
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278976
Title
study-report-bef74-1-doi
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278977
Title
statistics-on-006-18-007-18
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278978
Title
study-report-006-007-18-rev-1
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278979
Title
statistics-on-04co-34lab2-rev-1
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278980
Title
study-report-04co-34lab2-rev-1
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278981
Title
statistics-on-04co-4lab1
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278982
Title
study-report-04co-4lab1-rev-1
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278983
Title
study-report-04co-4rs2-rev-1
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278984
Title
1-study-report-04co-4rs1-rev-1
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278985
Title
field-trials
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278986
Title
ddps
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278987
Title
qp-declaration-active-substances
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278988
Title
mock-ups
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278989
Title
GMP Certificate
Study date
2020
Auth party contact address
-
Data no
278990
Title
flow-chart
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278991
Title
letter-of-authorisation.
Study date
2019
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278992
Title
proof-establishment-eea
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278993
Title
cover-letter
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278994
Title
approved-end-shelf-life-specifications
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
278995
Title
manufacturing-authorisation
Study date
2020
Auth party contact address
-
Data no
278996
Title
individual-anatomo-patological-data
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279336
Title
Details - primary packaging
Study date
2018
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279337
Title
re-testing RHDV2ab-194
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279338
Title
Routine quality control of pupae
Study date
2017
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279339
Title
Acceptability range productivity study
Study date
2016
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279340
Title
CoA - starting material
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279341
Title
Certificate of conformity
Study date
2018
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279342
Title
Comparative analysis - detection of antibodies
Study date
2018
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279343
Title
Efficacy study - duration of immunity
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279344
Title
Validation pcr-rhdv
Study date
2020
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279345
Title
2024-07-12_Fatrovax_CVMP-opinion
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279346
Title
Fatrovax RHD - marketing authorisation validity
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279347
Title
Fatrovax RHD Updated SPC following variation approval
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279348
Title
Fatrovax variation application
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279349
Title
Summary table of antigen batches consistency data
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279350
Title
Batch review committment-batches
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279351
Title
Stability Study report - pilot and commercial batch
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
279352
Title
Fatrovax finished product stability report for shelf life extension
Study date
2024
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
292997
Title
2025-08-14 - s1591a Notice - 95410_145535 LOQ ANSWERS
Study date
2025
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
292998
Title
coa-glycerol
Study date
September 2025
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
292999
Title
coa-hydrochloric-acid
Study date
July 2023
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
293000
Title
coa-sodium-hydroxide
Study date
February 2025
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
293001
Title
logbook-group-c
Study date
2018
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
293002
Title
logbook-group-d
Study date
2018
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
293003
Title
sales-phv-data
Study date
2025
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Data no
293004
Title
up-to-date-reference-serum-control-charts
Study date
2025
Auth party contact address
VIA EMILIA 285 OZZANO DELL’EMILIA Italy
Date
Application Date
Application No
Application Number
146780
Product/Active constituent Name
Application Product Name
MAXICAM ORAL SUSPENSION FOR DOGS
Application Date
Application Number
146780
Application Product Name
MAXICAM ORAL SUSPENSION FOR DOGS
Application details
Product name:
MAXICAM ORAL SUSPENSION FOR DOGS
Product number:
95670
Applicant Name:
VETPHARM LABORATORIES IP PTY LTD
Application purpose and description of use:
Registration of a 1.5 mg/mL meloxicam oral suspension for the alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders such as discospondylosis, arthropathy and soft tissue injuries in dogs.
Reference details:
49655 - METACAM ANTI-INFLAMMATORY ORAL SUSPENSION FOR DOGS
Active constituents:
Active constituent name
84110 - Meloxicam
Description of data provided:
Data no
281642
Title
Product specifications
Study date
2024
Auth party contact address
7/20 St Johns Avenue GORDON Australia
Date
Application Date
Application No
Application Number
146727
Product/Active constituent Name
Application Product Name
Fenbendazole
Application Date
Application Number
146727
Application Product Name
Fenbendazole
Application details
Product name:
Fenbendazole
Active name:
Fenbendazole
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Fenbendazole for use in veterinary chemical products.
Description of data provided:
Data no
281460
Title
Certificate of analysis
Study date
24/03/2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
281461
Title
Certificate of analysis
Study date
27/03/2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
281462
Title
Certificate of analysis
Study date
30/03/2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
284936
Title
s159 response
Study date
27/03/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
289599
Title
s159 response letter
Study date
14/07/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date
Application Date
Application No
Application Number
146386
Product/Active constituent Name
Application Product Name
Picomix 240 Herbicide
Application Date
Application Number
146386
Application Product Name
Picomix 240 Herbicide
Application details
Product name:
Picomix 240 Herbicide
Product number:
95569
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Registration of an 240 g/L Piclporam Soluble Concentrate (SL) product for for:
CROPS/SITUATION:
Agricultural Non-Crop Areas, Cereals, Commercial and Industrial Areas, Fallow, Linseed,
Linola, Maize, Pasture, Rights of Way, Sorghum and Sugarcane
CONTROLS:
A wide range of annual, perennial, noxious and woody weeds as per the Directions for Use
Reference details:
84465 - PICOFLEX HERBICIDE
Active constituents:
Active constituent name
66576 - PICLORAM
Description of data provided:
Data no
280953
Title
Chemistry dossier
Study date
04/11/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
280954
Title
RAWS
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
280955
Title
Manufacturing process, Soecs, CoA of Picomix 240 Herbicide
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
280956
Title
Accelerated Storage Stability Study on Acetamiprid Picomix 240 Herbicide
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
280957
Title
LOW TEMPERATURE STORAGE STABILITY TEST REPORT of Picomix 240 Herbicide
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
280958
Title
METHOD VALIDATION FOR THE DETERMINATION OF Picomix 240 Herbicide in soluble concentrate (SL).
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
280959
Title
Efficacy dossier
Study date
12/11/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
280960
Title
Reference standard label
Study date
2024
Auth party contact address
-
Data no
280961
Title
Picomix label
Study date
2024
Auth party contact address
-
Data no
280962
Title
Evaluation of Picloram formulations in mixes with 2,4-D
Study date
October 20 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
280963
Title
Evaluation of Picloram formulations in mixes with MCPA
Study date
October 20 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
286327
Title
Scientific Argument
Study date
March, 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
286328
Title
SDS of Inert Ingredient
Study date
March, 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
286329
Title
CoA of Inert Ingredient
Study date
March, 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
286330
Title
Technical Information of Inert Ingredient
Study date
March, 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China