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
144475
Product/Active constituent Name
Application Product Name
ADVANTIX FOR DOGS 10-25KG
Application Date
Application Number
144475
Application Product Name
ADVANTIX FOR DOGS 10-25KG
Application details
Product name:
ADVANTIX FOR DOGS 10-25KG
Product number:
58260
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Elanco is submitting this application to request a reduction in the storage conditions for Advantix for Dogs 10-25 kg (APVMA no.58260).
Active constituents:
Active constituent name
49016 - IMIDACLOPRID
Active constituent name
54244 - PERMETHRIN
Date
Application Date
Application No
Application Number
144476
Product/Active constituent Name
Application Product Name
ADVANTIX FOR DOGS 4-10KG
Application Date
Application Number
144476
Application Product Name
ADVANTIX FOR DOGS 4-10KG
Application details
Product name:
ADVANTIX FOR DOGS 4-10KG
Product number:
58261
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Elanco is submitting this application to request a reduction in the storage condition for Advantix for Dogs 4-10 kg (APVMA no. 58261).
Active constituents:
Active constituent name
49016 - IMIDACLOPRID
Active constituent name
54244 - PERMETHRIN
Date
Application Date
Application No
Application Number
144477
Product/Active constituent Name
Application Product Name
ADVANTIX FOR PUPPIES AND SMALL DOGS UP TO 4KG
Application Date
Application Number
144477
Application Product Name
ADVANTIX FOR PUPPIES AND SMALL DOGS UP TO 4KG
Application details
Product name:
ADVANTIX FOR PUPPIES AND SMALL DOGS UP TO 4KG
Product number:
58259
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Elanco is submitting this application to request a reduction in the storage conditions for Advantix for Puppies and Small Dogs up to 4 kg (APVMA no. 58259).
Active constituents:
Active constituent name
49016 - IMIDACLOPRID
Active constituent name
54244 - PERMETHRIN
Date
Application Date
Application No
Application Number
144636
Product/Active constituent Name
Application Product Name
PROTEKU SULPHUR DIOXIDE LAMINATED PADS
Application Date
Application Number
144636
Application Product Name
PROTEKU SULPHUR DIOXIDE LAMINATED PADS
Application details
Product name:
PROTEKU SULPHUR DIOXIDE LAMINATED PADS
Product number:
64119
Applicant Name:
E.E. MUIR & SONS PTY LIMITED
Application purpose and description of use:
Variation of product registration and label approval to add an additional pack size.
Active constituents:
Active constituent name
60365 - SODIUM METABISULPHITE
Date
Application Date
Application No
Application Number
144887
Product/Active constituent Name
Application Product Name
Azoxystrobin
Application Date
Application Number
144887
Application Product Name
Azoxystrobin
Application details
Product name:
Azoxystrobin
Active name:
Azoxystrobin
Applicant Name:
SHANGHAI E-TONG CHEMICAL CO LTD
Application purpose and description of use:
Approval of azoxystrobin for use in agricultural chemical products.
Description of data provided:
Data no
275793
Title
Five Batches Analysis of Azoxystrobin TGAI
Study date
2023
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
275792
Title
Description Of Manufacturing Process Of Azoxystrobin And Impurity Information of Azoxystronbin Technical
Study date
2023
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
275791
Title
Part 2 Azoxystrobin Chemistry and Manufacturing
Study date
2023
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
275794
Title
Azoxystrobin Declaration of Composition (DoC)
Study date
2023
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
275795
Title
Azoxystrobin COA, Declaration of Manufacture (DoM) and Letter of Support (LoS)
Study date
2023
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
275796
Title
Azoxystrobin MSDS
Study date
2023
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
275797
Title
Azoxystrobin FAO Specification
Study date
2009
Auth party contact address
-
Date
Application Date
Application No
Application Number
143997
Product/Active constituent Name
Application Product Name
moxidectin
Application Date
Application Number
143997
Application Product Name
moxidectin
Application details
Product name:
moxidectin
Product number:
94904
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a 900 / 657.1 / 228 / 0.9 LOTILANER/ PYRANTEL PAMOATE / PRAZIQUANTEL / MOXIDECTIN oral chewable tablet (solid oral dose form) for the treatment and control of tick species, treatment and prevention of fleas, prevention of heartworm, treatment and control of intestinal worms.
Description of data provided:
Data no
286171
Title
CoA 1 Moxidectin
Study date
June 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286172
Title
CoA 2 Moxidectin
Study date
June 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286173
Title
CoA 3 Moxidectin
Study date
June 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
274350
Title
API Batch analyses
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283287
Title
3.2.S.4.2 Active constituents CoAs
Study date
2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286174
Title
11Apr2025 Declaration for moxidectin
Study date
Apr 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286175
Title
01APR2025 s159 API Response to Questions AU
Study date
Apr 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
143996
Product/Active constituent Name
Application Product Name
Pyrantel Embonate
Application Date
Application Number
143996
Application Product Name
Pyrantel Embonate
Application details
Product name:
Pyrantel Embonate
Product number:
94903
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a 900 / 657.1 / 228 / 0.9 LOTILANER/ PYRANTEL PAMOATE / PRAZIQUANTEL / MOXIDECTIN oral chewable tablet (solid oral dose form) for the treatment and control of tick species, treatment and prevention of fleas, prevention of heartworm, treatment and control of intestinal worms.
Description of data provided:
Data no
286167
Title
CoA 1 Pyrantel
Study date
July 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286168
Title
CoA 2 Pyrantel
Study date
July 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286170
Title
CoA 3 Pyrantel
Study date
July 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286169
Title
01APR2025 s159 API Responses to Questions AU
Study date
Apr 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
143998
Product/Active constituent Name
Application Product Name
ADVOCATE ULTRA CHEW for Dogs 22.1 – 45 kg
Application Date
Application Number
143998
Application Product Name
ADVOCATE ULTRA CHEW for Dogs 22.1 – 45 kg
Application details
Product name:
ADVOCATE ULTRA CHEW for Dogs 22.1 – 45 kg
Product number:
94905
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a 900 / 657.1 / 228 / 0.9 LOTILANER/ PYRANTEL PAMOATE / PRAZIQUANTEL / MOXIDECTIN oral chewable tablet (solid oral dose form) for the treatment and control of tick species, treatment and prevention of fleas, prevention of heartworm, treatment and control of intestinal worms.
Reference details:
82857 - CREDELIO 450 mg CHEWABLE TABLETS FOR DOGS
82856 - CREDELIO 225 mg CHEWABLE TABLETS FOR DOGS
82853 - CREDELIO 900 mg CHEWABLE TABLETS FOR DOGS
82855 - CREDELIO 112.5 mg CHEWABLE TABLETS FOR DOGS
82854 - CREDELIO 56.25 mg CHEWABLE TABLETS FOR DOGS
88307 - Lotilaner
89319 - Credelio Plus Chewable Tablets for Very Large Dogs
89318 - Credelio Plus Chewable Tablets for Large Dogs
89317 - Credelio Plus Chewable Tablets for Medium Dogs
89316 - Credelio Plus Chewable Tablets for Small Dogs
89315 - Credelio Plus Chewable Tablets for Very Small Dogs
81958 - PRAZIQUANTEL
Active constituents:
Active constituent name
81958 - PRAZIQUANTEL
Active constituent name
88307 - Lotilaner
Description of data provided:
Data no
283270
Title
3.2.P.5.2 Analytical procedures
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283271
Title
3.2.P.5.3 Validation analytical procedures
Study date
24 Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283272
Title
3.2.P.5.3 Validation analytical procedures - Attachment 2
Study date
27 Jun 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283273
Title
3.2.P.5.3 Validation analytical procedures - Attachment 3
Study date
18 Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283274
Title
3.2.P.5.3 Validation analytical procedures - Attchment 4
Study date
22 Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283275
Title
3.2.P.5.3 Validation analytical procedures - Attachment 5
Study date
28 Jul 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283276
Title
3.2.P.5.3 Validation analytical procedures - Attachment 6
Study date
06 Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283277
Title
3.2.P.5.3 Validation analytical procedures - Attachment 7
Study date
24 Jun 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283278
Title
3.2.P.5.3 Validation analytical procedures - Attachment 8
Study date
23 Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283279
Title
3.2.P.5.3 Validation analytical procedures - Attachment 1
Study date
06 Jul 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283267
Title
3.2.P.4.3 Validation analytical procedures non-active constituents
Study date
24 Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283251
Title
3.2.P.5.4 Batch analyses
Study date
17 Feb 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283252
Title
3.2.P.5.5 Characterisation of impurities
Study date
25 Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
274340
Title
GMP Evidence 1
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
274341
Title
GMP Evidence 2
Study date
Sept 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
274342
Title
GMP Evidence 3
Study date
June 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
274343
Title
GMP Evidence 4
Study date
Oct 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
274344
Title
GMP Evidence 5
Study date
Jan 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
274345
Title
GMP Evidence 6
Study date
Dec 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
274347
Title
GMP Evidence 7
Study date
May 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
274348
Title
GMP Evidence 8
Study date
Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
290657
Title
Evidence of GMP
Study date
Jul 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
290658
Title
AU section 13 manufacturing details
Study date
Jul 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
290655
Title
CTFG
Study date
Jul 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283268
Title
3.2.P.4.5 Excipients of animal origin
Study date
24 Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283269
Title
3.2.P.5.1 Specification
Study date
06 Dec 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283250
Title
3.2.P.1 Description and composition fo the drug product
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283286
Title
Part 2: Chemistry and Manufacture - Overview
Study date
December 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283257
Title
3.2.P.2 Pharmaceutical development
Study date
24 Jul 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283258
Title
3.2.P.2.2 Formulation development
Study date
01 Sep 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283259
Title
3.2.P.2.3 Manufacturing process development
Study date
28 Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283260
Title
3.2.P.3.1 Manufacturer(s)
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283261
Title
3.2.P.3.1.2 GMP certificates
Study date
2020
Auth party contact address
-
Data no
283262
Title
3.2.P.3.2 Batch formula
Study date
14 Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283263
Title
3.2.P.3.3 Description of Manufacturing Process and Process Controls
Study date
20 Jun 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283264
Title
3.2.P.3.4 Control of critical steps and intermediates
Study date
04 Apr 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283265
Title
3.2.P.3.5 Process validation and evaluation
Study date
23 Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283266
Title
3.2.P.4.1 Excipients specification and CoA
Study date
09 Apr 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283253
Title
3.2.P.5.6 Justification of specifications
Study date
24 Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283254
Title
3.2.P.6 Reference standards
Study date
26 May 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283255
Title
3.2.P.7 Container closure system
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283256
Title
3.2.P.8 Stability data
Study date
21 Oct 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281270
Title
NAH-15-084
Study date
Sep 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281271
Title
NAH-14-042
Study date
Sep 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281272
Title
ELAZA150145
Study date
Oct 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281273
Title
NAH-14-037
Study date
Aug 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281274
Title
ELAVV200173
Study date
Aug2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281275
Title
ELAVV200358
Study date
Aug 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281276
Title
ELA220839
Study date
Jun 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281233
Title
ELA220875
Study date
Oct 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281234
Title
ELA210701
Study date
Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281235
Title
ELA210219
Study date
Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281236
Title
ELA210218
Study date
Oct 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281237
Title
ELA210571
Study date
May 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281238
Title
ELA210486
Study date
May 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281239
Title
ELA210487
Study date
Nov 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281240
Title
ELA210612
Study date
Sep 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281241
Title
ELA210049
Study date
Jun 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281242
Title
ELA210601
Study date
Jun 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281243
Title
ELA1900500
Study date
Mar2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281247
Title
ELA220912
Study date
Sep 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281248
Title
App 8-44 Cavalleri-et-al- 2017
Study date
2017
Auth party contact address
-
Data no
281249
Title
App 8-45 Mochel-et-al-2014
Study date
2014
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281250
Title
ELAJP150245
Study date
Jan 2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281251
Title
Additional statistical analysis for study ELA220839
Study date
Nov 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281252
Title
App 8-48 Toutain-et-al-2017
Study date
2017
Auth party contact address
-
Data no
281253
Title
App 8-49 Kopp-et-al-2008
Study date
2008
Auth party contact address
-
Data no
281254
Title
ELA2000071
Study date
Apr2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281255
Title
App 8-50 Clark-et-al-1991
Study date
1991
Auth party contact address
-
Data no
281256
Title
App 8-51 Soontorn-et-al-2005
Study date
2005
Auth party contact address
-
Data no
281257
Title
ELA221321
Study date
Oct 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281258
Title
App 8-53 Buescher-et-al-1998
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281259
Title
ELA1800748
Study date
Aug 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281260
Title
ELAZA160033
Study date
May 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281261
Title
ELA1900123
Study date
Oct 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281262
Title
Gyul'gyazli
Study date
1977
Auth party contact address
-
Data no
281263
Title
App 8-57 Marchant-et-al-2024
Study date
2024
Auth party contact address
-
Data no
281264
Title
App 8-58 Dey-Hazra-1976
Study date
1976
Auth party contact address
-
Data no
281265
Title
App 8-59 Gemmel-et-al-1980
Study date
1980
Auth party contact address
-
Data no
281266
Title
ELAVV200174
Study date
Dec2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281267
Title
App 8-61 Rommel et al
Study date
1976
Auth party contact address
-
Data no
281268
Title
App 8-62 Kobulej-Varga-1976
Study date
1976
Auth party contact address
-
Data no
281211
Title
ELA210285
Study date
Aug 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281212
Title
ELA220892
Study date
Aug 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281213
Title
ELA220840
Study date
Jun 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281214
Title
ELA210461
Study date
Oct 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281215
Title
ELA220838
Study date
Oct 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281216
Title
ELA210055
Study date
Sep 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281217
Title
ELAVV200359
Study date
Oct 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281218
Title
ELA210539
Study date
Dec 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281219
Title
ELA210611
Study date
Dec 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281220
Title
ELA210524
Study date
Jun 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281222
Title
ELA220857
Study date
May 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281223
Title
ELA210573
Study date
Jan 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281224
Title
ELA220832
Study date
Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281225
Title
ELA220819
Study date
May 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281226
Title
ELA220985
Study date
Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281227
Title
ELA220854
Study date
Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281228
Title
ELA210278
Study date
Sep 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281229
Title
ELA210217
Study date
Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281230
Title
ELA220841
Study date
May 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281231
Title
ELA220842
Study date
Jun 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
290645
Title
Efficacy, safety and palatability of a new broad-spectrum anthelmintic formulation in dogs.
Study date
2010
Auth party contact address
-
Data no
290646
Title
World Association for the Advancement of Veterinary Parasitology (WAAVP): Second edition of guidelines for evaluating the efficacy of anthelmintics for dogs and cats
Study date
2022
Auth party contact address
-
Data no
290647
Title
Canine echinococcosis: Global epidemiology and genotypic diversity.
Study date
2013
Auth party contact address
-
Data no
290648
Title
Geographical distribution and risk factors for Echinococcus granulosus infection in peri-urban wild dog populations.
Study date
2019
Auth party contact address
-
Data no
290649
Title
Emergence/re-emergence of Echinococcus spp.?a global update.
Study date
2005
Auth party contact address
-
Data no
290650
Title
Encroachment of Echinococcus granulosus into urban areas in eastern Queensland, Australia
Study date
2008
Auth party contact address
-
Data no
290651
Title
Efficacy of a new oral chewable tablet containing sarolaner, moxidectin and pyrantel (Simparica Trio?) against induced ascarid infections in dogs
Study date
2020
Auth party contact address
-
Data no
290652
Title
Efficacy of Simparica Trio?, a novel chewable tablet containing sarolaner, moxidectin and pyrantel, against induced hookworm infections in dogs
Study date
2020
Auth party contact address
-
Data no
290653
Title
Field efficacy and safety of a novel oral chewable tablet containing sarolaner, moxidectin and pyrantel (Simparica Trio?) against naturally acquired gastrointestinal nematode infections in dogs presented as veterinary patients in Europe and the USA
Study date
2020
Auth party contact address
-
Data no
290654
Title
Efficacy of Simparica Trio? against induced infections of Ancylostoma braziliense and Ancylostoma ceylanicum in dogs.
Study date
2025
Auth party contact address
-
Data no
290656
Title
Efficacy of Emodepside plus Praziquantel Tablets (Profender? Tablets for Dogs) against Mature and Immature Cestode Infections in Dogs
Study date
2009
Auth party contact address
-
Data no
290661
Title
The effect of route of administration on the efficacy of praziquantel against Echinococcus granulosus infections in dogs
Study date
1980
Auth party contact address
-
Data no
290662
Title
Efficacy of Droncit Against Echinococcus granulosus Infection in Dogs
Study date
1978
Auth party contact address
-
Data no
290663
Title
Efficacy of Injectable and Tablet Formulations of Praziquantel Against Mature Echinococcus granulosus.
Study date
1978
Auth party contact address
-
Data no
290664
Title
Efficacy of Injectable and Tablet Formulations of Praziquantel Against Mature Echinococcus granulosus.
Study date
1979
Auth party contact address
-
Data no
290665
Title
Droncit - a milestone in the control of Echinococcus granulosus in dogs
Study date
1976
Auth party contact address
-
Data no
290666
Title
The efficacy of Droncit (praziquantel) against tapeworm infections in dog and cat.
Study date
1976
Auth party contact address
-
Data no
290667
Title
Global distribution and definitive host range of Echinococcus species and genotypes: A systematic review.
Study date
2024
Auth party contact address
-
Data no
281232
Title
ELA221088
Study date
May2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281221
Title
ELA221112
Study date
Dec 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281244
Title
ELA210202
Study date
Aug 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281245
Title
ELA210751
Study date
Jun 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281246
Title
ELA210157
Study date
Jun 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281209
Title
App 8-0 Part 8 Overview
Study date
Nov 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
290659
Title
s159 response pt1
Study date
Aug2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
290660
Title
s159 response pt2
Study date
Aug2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281210
Title
PAA record and advice
Study date
Feb 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271690
Title
PAA 141403
Study date
Apr 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271691
Title
Part 3 Overview
Study date
May 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281269
Title
App 8-63 Project Plan- PAA
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271687
Title
ELA221098: Eye hazard potential assessment
Study date
Nov 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283288
Title
8447424: Oral gavage tolerability study
Study date
Jan 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283289
Title
8447422: Oral gavage dose range study
Study date
Mar 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283290
Title
8447423: Oral gavage and toxicokinetics study
Study date
Hester J
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283291
Title
020200.001: Max dose tolerability study
Study date
Oct 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283292
Title
020200.003: Topical tox study
Study date
Jun 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283293
Title
020200.002: Dermal tox study
Study date
Oct 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283294
Title
ELA221097 Skin sensitisation (lymph node) study
Study date
Apr 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271686
Title
ELA221096: Acute oral tox study
Study date
May 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271688
Title
ELA221099: Skin irritation study
Study date
Feb 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271689
Title
Human User Safety Assessment
Study date
Jun 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271682
Title
excipient SDS
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271683
Title
ELA221112: Plasma PK study a
Study date
Dec 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271684
Title
ELA221112: Plasma PK study b
Study date
Dec 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271685
Title
ELA221112: Plasma PK study c
Study date
Dec 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
143999
Product/Active constituent Name
Application Product Name
ADVOCATE ULTRA CHEW for Dogs 5.6 – 11 kg
Application Date
Application Number
143999
Application Product Name
ADVOCATE ULTRA CHEW for Dogs 5.6 – 11 kg
Application details
Product name:
ADVOCATE ULTRA CHEW for Dogs 5.6 – 11 kg
Product number:
94906
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a 225 / 164.3 / 57 / 0.225 MG LOTILANER/ PYRANTEL PAMOATE / PRAZIQUANTEL / MOXIDECTIN oral chewable tablet (solid oral dose form) for the treatment and control of tick species, treatment and prevention of fleas, prevention of heartworm, treatment and control of intestinal worms.
Reference details:
82857 - CREDELIO 450 mg CHEWABLE TABLETS FOR DOGS
82856 - CREDELIO 225 mg CHEWABLE TABLETS FOR DOGS
82853 - CREDELIO 900 mg CHEWABLE TABLETS FOR DOGS
82855 - CREDELIO 112.5 mg CHEWABLE TABLETS FOR DOGS
82854 - CREDELIO 56.25 mg CHEWABLE TABLETS FOR DOGS
88307 - Lotilaner
89319 - Credelio Plus Chewable Tablets for Very Large Dogs
89318 - Credelio Plus Chewable Tablets for Large Dogs
89317 - Credelio Plus Chewable Tablets for Medium Dogs
89316 - Credelio Plus Chewable Tablets for Small Dogs
89315 - Credelio Plus Chewable Tablets for Very Small Dogs
81958 - PRAZIQUANTEL
Active constituents:
Active constituent name
81958 - PRAZIQUANTEL
Active constituent name
88307 - Lotilaner
Date
Application Date
Application No
Application Number
144000
Product/Active constituent Name
Application Product Name
ADVOCATE ULTRA CHEW for Dogs 11.1 – 22 kg
Application Date
Application Number
144000
Application Product Name
ADVOCATE ULTRA CHEW for Dogs 11.1 – 22 kg
Application details
Product name:
ADVOCATE ULTRA CHEW for Dogs 11.1 – 22 kg
Product number:
94907
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a 450 / 328.6 / 114 / 0.45 LOTILANER/ PYRANTEL PAMOATE / PRAZIQUANTEL / MOXIDECTIN oral chewable tablet (solid oral dose form) for the treatment and control of tick species, treatment and prevention of fleas, prevention of heartworm, treatment and control of intestinal worms.
Reference details:
82857 - CREDELIO 450 mg CHEWABLE TABLETS FOR DOGS
82856 - CREDELIO 225 mg CHEWABLE TABLETS FOR DOGS
82853 - CREDELIO 900 mg CHEWABLE TABLETS FOR DOGS
82855 - CREDELIO 112.5 mg CHEWABLE TABLETS FOR DOGS
82854 - CREDELIO 56.25 mg CHEWABLE TABLETS FOR DOGS
88307 - Lotilaner
89319 - Credelio Plus Chewable Tablets for Very Large Dogs
89318 - Credelio Plus Chewable Tablets for Large Dogs
89317 - Credelio Plus Chewable Tablets for Medium Dogs
89316 - Credelio Plus Chewable Tablets for Small Dogs
89315 - Credelio Plus Chewable Tablets for Very Small Dogs
81958 - PRAZIQUANTEL
Active constituents:
Active constituent name
81958 - PRAZIQUANTEL
Active constituent name
88307 - Lotilaner
Date
Application Date
Application No
Application Number
144001
Product/Active constituent Name
Application Product Name
ADVOCATE ULTRA CHEW for Dogs 2.9 – 5.5 kg
Application Date
Application Number
144001
Application Product Name
ADVOCATE ULTRA CHEW for Dogs 2.9 – 5.5 kg
Application details
Product name:
ADVOCATE ULTRA CHEW for Dogs 2.9 – 5.5 kg
Product number:
94908
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a 112.5 / 82.14 / 28.5 / 0.11 LOTILANER/ PYRANTEL PAMOATE / PRAZIQUANTEL / MOXIDECTIN oral chewable tablet (solid oral dose form) for the treatment and control of tick species, treatment and prevention of fleas, prevention of heartworm, treatment and control of intestinal worms.
Reference details:
82857 - CREDELIO 450 mg CHEWABLE TABLETS FOR DOGS
82856 - CREDELIO 225 mg CHEWABLE TABLETS FOR DOGS
82853 - CREDELIO 900 mg CHEWABLE TABLETS FOR DOGS
82855 - CREDELIO 112.5 mg CHEWABLE TABLETS FOR DOGS
82854 - CREDELIO 56.25 mg CHEWABLE TABLETS FOR DOGS
88307 - Lotilaner
89319 - Credelio Plus Chewable Tablets for Very Large Dogs
89318 - Credelio Plus Chewable Tablets for Large Dogs
89317 - Credelio Plus Chewable Tablets for Medium Dogs
89316 - Credelio Plus Chewable Tablets for Small Dogs
89315 - Credelio Plus Chewable Tablets for Very Small Dogs
81958 - PRAZIQUANTEL
Active constituents:
Active constituent name
81958 - PRAZIQUANTEL
Active constituent name
88307 - Lotilaner
Date
Application Date
Application No
Application Number
144002
Product/Active constituent Name
Application Product Name
ADVOCATE ULTRA CHEW for Dogs 2.0 – 2.8 kg
Application Date
Application Number
144002
Application Product Name
ADVOCATE ULTRA CHEW for Dogs 2.0 – 2.8 kg
Application details
Product name:
ADVOCATE ULTRA CHEW for Dogs 2.0 – 2.8 kg
Product number:
94909
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a 56.25 / 41.07 / 14.25 / 0.056 LOTILANER/ PYRANTEL PAMOATE / PRAZIQUANTEL / MOXIDECTIN oral chewable tablet (solid oral dose form) for the treatment and control of tick species, treatment and prevention of fleas, prevention of heartworm, treatment and control of intestinal worms.
Reference details:
82857 - CREDELIO 450 mg CHEWABLE TABLETS FOR DOGS
82856 - CREDELIO 225 mg CHEWABLE TABLETS FOR DOGS
82853 - CREDELIO 900 mg CHEWABLE TABLETS FOR DOGS
82855 - CREDELIO 112.5 mg CHEWABLE TABLETS FOR DOGS
82854 - CREDELIO 56.25 mg CHEWABLE TABLETS FOR DOGS
88307 - Lotilaner
89319 - Credelio Plus Chewable Tablets for Very Large Dogs
89318 - Credelio Plus Chewable Tablets for Large Dogs
89317 - Credelio Plus Chewable Tablets for Medium Dogs
89316 - Credelio Plus Chewable Tablets for Small Dogs
89315 - Credelio Plus Chewable Tablets for Very Small Dogs
81958 - PRAZIQUANTEL
Active constituents:
Active constituent name
81958 - PRAZIQUANTEL
Active constituent name
88307 - Lotilaner
Date
Application Date
Application No
Application Number
144822
Product/Active constituent Name
Application Product Name
YATES DOUBLE ACTION LIQUID WEED'N'FEED EXTRA STRENGTH
Application Date
Application Number
144822
Application Product Name
YATES DOUBLE ACTION LIQUID WEED'N'FEED EXTRA STRENGTH
Application details
Product name:
YATES DOUBLE ACTION LIQUID WEED'N'FEED EXTRA STRENGTH
Product number:
52845
Applicant Name:
DULUXGROUP (AUSTRALIA) PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to YATES DOUBLE ACTION LIQUID WEED'N'FEED EXTRA STRENGTH
Reference details:
93094 - Yates Weed 'N' Feed Weed Killer and Lawn Fertiliser Hose On
Active constituents:
Active constituent name
44515 - MCPA
Active constituent name
44512 - DICAMBA
Active constituent name
44518 - MCPA
Description of data provided:
Data no
275543
Title
Validation report
Study date
20 June 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
275539
Title
Chemistry dossier
Study date
23 July 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
275540
Title
Fornulation
Study date
23 July 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
275541
Title
SDSs
Study date
2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
275542
Title
Stability report
Study date
20 June 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
275536
Title
Executive summary
Study date
15 July 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
275537
Title
Formulators
Study date
03 June 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
275538
Title
Label changes
Study date
15 July 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Date
Application Date
Application No
Application Number
144868
Product/Active constituent Name
Application Product Name
Q-DRENCH MULTI-COMBINATION DRENCH FOR SHEEP
Application Date
Application Number
144868
Application Product Name
Q-DRENCH MULTI-COMBINATION DRENCH FOR SHEEP
Application details
Product name:
Q-DRENCH MULTI-COMBINATION DRENCH FOR SHEEP
Product number:
56573
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to vary pack sizes.
Active constituents:
Active constituent name
56935 - LEVAMISOLE HYDROCHLORIDE
Active constituent name
54901 - CLOSANTEL
Active constituent name
48801 - ABAMECTIN
Active constituent name
54560 - ALBENDAZOLE
Active constituent name
83598 - ALBENDAZOLE
Active constituent name
83902 - CLOSANTEL BASE
Active constituent name
83906 - LEVAMISOLE HYDROCHLORIDE
Active constituent name
84969 - ABAMECTIN
Date
Application Date
Application No
Application Number
144689
Product/Active constituent Name
Application Product Name
Revolution Plus (selamectin/sarolaner) monthly topical solution for large cats 5.1 – 10 kg
Application Date
Application Number
144689
Application Product Name
Revolution Plus (selamectin/sarolaner) monthly topical solution for large cats 5.1 – 10 kg
Application details
Product name:
Revolution Plus (selamectin/sarolaner) monthly topical solution for large cats 5.1 – 10 kg
Product number:
87222
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
This application proposes to vary the REVOLUTION PLUS product range to add a label claim for a new parasite.
Active constituents:
Active constituent name
56261 - SELAMECTIN
Active constituent name
80944 - SAROLANER
Active constituent name
86826 - SELAMECTIN
Date
Application Date
Application No
Application Number
144690
Product/Active constituent Name
Application Product Name
Revolution Plus (selamectin/sarolaner) monthly topical solution for medium cats 2.6 – 5 kg
Application Date
Application Number
144690
Application Product Name
Revolution Plus (selamectin/sarolaner) monthly topical solution for medium cats 2.6 – 5 kg
Application details
Product name:
Revolution Plus (selamectin/sarolaner) monthly topical solution for medium cats 2.6 – 5 kg
Product number:
87224
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
This application proposes to vary the REVOLUTION PLUS product range to add a label claim for a new parasite.
Active constituents:
Active constituent name
56261 - SELAMECTIN
Active constituent name
80944 - SAROLANER
Active constituent name
86826 - SELAMECTIN
Date
Application Date
Application No
Application Number
144760
Product/Active constituent Name
Application Product Name
SABAKEM IMIDACLOPRID 350SC SOIL INSECTICIDE
Application Date
Application Number
144760
Application Product Name
SABAKEM IMIDACLOPRID 350SC SOIL INSECTICIDE
Application details
Product name:
SABAKEM IMIDACLOPRID 350SC SOIL INSECTICIDE
Product number:
69122
Applicant Name:
SABAKEM PTY LTD
Application purpose and description of use:
Variation of label approval to update the application timing for sugarcane (ratoons and plant cane)
Active constituents:
Active constituent name
64766 - IMIDACLOPRID
Description of data provided:
Data no
274409
Title
Executive Summary
Study date
July 2024
Auth party contact address
Suite 809, Level 8, 2 Queen Street Melbourne Australia
Date
Application Date
Application No
Application Number
144781
Product/Active constituent Name
Application Product Name
Florasulam
Application Date
Application Number
144781
Application Product Name
Florasulam
Application details
Product name:
Florasulam
Active name:
Florasulam
Applicant Name:
CONQUEST CROP PROTECTION PTY LTD
Application purpose and description of use:
Approval of a new source of florasulam for use in agricultural products
Description of data provided:
Data no
274819
Title
Five Batch Analysis of Florasulam
Study date
July 2024
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
274820
Title
Manufacturing Process of Florasulam
Study date
Jan 2024
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
274821
Title
Declaration of Composition-Florasulam
Study date
Jan 2024
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
274818
Title
Chemistry and Manufacture
Study date
July 2024
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Date
Application Date
Application No
Application Number
144835
Product/Active constituent Name
Application Product Name
Fluopyram
Application Date
Application Number
144835
Application Product Name
Fluopyram
Application details
Product name:
Fluopyram
Active name:
Fluopyram
Applicant Name:
Thai Harvest Limited
Application purpose and description of use:
Approval of a new active constituent for use in agricultural chemical products.
Description of data provided:
Data no
275655
Title
Qualitative and Quantitative Profile of Fluopyram Technical (Five Batch Analysis)
Study date
July 22, 2024
Auth party contact address
RMG, BLK 4, 13/F Kwun Tong Industrial Center Kwun Tong Road KwunTong KLN Hong Kong
Data no
275656
Title
Manufacturing process and Impurities Formation of Fluopyram Technical
Study date
July 24, 2024
Auth party contact address
RMG, BLK 4, 13/F Kwun Tong Industrial Center Kwun Tong Road KwunTong KLN Hong Kong
Data no
275657
Title
Declaration of Composition of Fluopyram TC
Study date
July 24, 2024
Auth party contact address
RMG, BLK 4, 13/F Kwun Tong Industrial Center Kwun Tong Road KwunTong KLN Hong Kong
Date
Application Date
Application No
Application Number
144641
Product/Active constituent Name
Application Product Name
Aluminium Phosphide
Application Date
Application Number
144641
Application Product Name
Aluminium Phosphide
Application details
Product name:
Aluminium Phosphide
Active name:
Aluminium Phosphide
Applicant Name:
NATIONAL FUMIGANTS PTY LTD
Application purpose and description of use:
Approval of new additional source of an approved active constituent, ALUMINIUM PHOSPHIDE, for use in agricultural chemical products.
Description of data provided:
Data no
274100
Title
DC17-73929443 Analysis
Study date
05 May 2023
Auth party contact address
Level 28 AMP Tower 140 St Georges Terrace Perth Australia
Data no
274098
Title
DC17-73929443 Dossier
Study date
03 July 2024
Auth party contact address
Level 28 AMP Tower 140 St Georges Terrace Perth Australia
Data no
274099
Title
DC17-73929443 Declarations
Study date
05 May 2023
Auth party contact address
Level 28 AMP Tower 140 St Georges Terrace Perth Australia