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
146967
Product/Active constituent Name
Application Product Name
Spalding Metribuzin 750 WG Herbicide
Application Date
Application Number
146967
Application Product Name
Spalding Metribuzin 750 WG Herbicide
Application details
Product name:
Spalding Metribuzin 750 WG Herbicide
Product number:
95706
Applicant Name:
DGL GROUP LIMITED
Application purpose and description of use:
Registration of a 750 g/kg METRIBUZIN WG product for Selective Weed Control in Cereals, Pastures and other Crops, including Vegetables.
Reference details:
60976 - WHITESTAR METRIBUZIN WG HERBICIDE
Active constituents:
Active constituent name
59926 - METRIBUZIN
Description of data provided:
Data no
282789
Title
Formulation Details for Spalding Metribuzin 750 WG Herbicide
Study date
November 2024
Auth party contact address
120 Fulton Drive Derrimut Australia
Date
Application Date
Application No
Application Number
146940
Product/Active constituent Name
Application Product Name
SpectraDUST INSECTICIDAL DUSTING POWDER INDUSTRIAL STRENGTH
Application Date
Application Number
146940
Application Product Name
SpectraDUST INSECTICIDAL DUSTING POWDER INDUSTRIAL STRENGTH
Application details
Product name:
SpectraDUST INSECTICIDAL DUSTING POWDER INDUSTRIAL STRENGTH
Product number:
95694
Applicant Name:
SUNDEW SOLUTIONS PTY LTD
Application purpose and description of use:
Registration of a 10 g/kg permethrin DU product for the control of Cockroaches, Ants, Fleas, Termites, European Wasps and other insects as specified in the DIRECTIONS FOR USE
Reference details:
69690 - PEST CONTROLLERS OWN PERMETHRIN D PROFESSIONAL INSECTICIDE DUST
Active constituents:
Active constituent name
44502 - PERMETHRIN
Description of data provided:
Data no
282642
Title
SpectraDUST AA letter
Study date
19 December 2024
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Date
Application Date
Application No
Application Number
146942
Product/Active constituent Name
Application Product Name
Fluxapyroxad
Application Date
Application Number
146942
Application Product Name
Fluxapyroxad
Application details
Product name:
Fluxapyroxad
Active name:
Fluxapyroxad
Applicant Name:
Hebei Lansheng Biotech Co Ltd
Application purpose and description of use:
Approval of fluxapyroxad for use in agricultural chemical products.
Description of data provided:
Data no
282667
Title
Qualitative and Quantitative Profile of the test substance Fluxapyroxad (Five Batch Analysis) Study No. LS-011
Study date
2024
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
282669
Title
Certificate of Analysis (COA) of Fluxapyroxad
Study date
2024
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
282671
Title
Fluxapyroxad MATERIAL SAFETY DATA SHEET
Study date
2024
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
282666
Title
Synthesis and Impurities of Fluxapyroxad Technical
Study date
2024
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
282665
Title
Chemistry and Manufacture
Study date
2024
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
282668
Title
Declaration of Composition (DoC) of Fluxapyroxad
Study date
2024
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
282670
Title
Fluxapyroxad Pesticides Fact Sheet
Study date
2012
Auth party contact address
-
Date
Application Date
Application No
Application Number
147164
Product/Active constituent Name
Application Product Name
Tranexamic acid
Application Date
Application Number
147164
Application Product Name
Tranexamic acid
Application details
Product name:
Tranexamic acid
Active name:
Tranexamic acid
Applicant Name:
PROBUS PHARMACEUTICALS PTY LTD
Application purpose and description of use:
Approval of tranexamic acid for use in veterinary chemical products.
Description of data provided:
Data no
282714
Title
Certificate of analysis
Study date
2025
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Data no
282715
Title
Tranexamic Acid BP Monograph
Study date
2024
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Data no
282716
Title
Tranexamic Acid JP Monograph
Study date
2025
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Date
Application Date
Application No
Application Number
146941
Product/Active constituent Name
Application Product Name
Ezycrop Prosulfocarb 800 EC Herbicide
Application Date
Application Number
146941
Application Product Name
Ezycrop Prosulfocarb 800 EC Herbicide
Application details
Product name:
Ezycrop Prosulfocarb 800 EC Herbicide
Product number:
95695
Applicant Name:
EZYCROP PTY LTD
Application purpose and description of use:
Registration of a 800 g/L prosulfocarb emulsifiable concentrate product for the control of Annual Ryegrass (Lolium
rigidum) in Barley and Wheat.
Reference details:
86887 - Kelpie PROSULF 800 Herbicide
Active constituents:
Active constituent name
80726 - Prosulfocarb
Date
Application Date
Application No
Application Number
147208
Product/Active constituent Name
Application Product Name
Beransa 15 mg Solution for Injection for Dogs
Application Date
Application Number
147208
Application Product Name
Beransa 15 mg Solution for Injection for Dogs
Application details
Product name:
Beransa 15 mg Solution for Injection for Dogs
Product number:
89656
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product label approval to update the side effects section.
Active constituents:
Active constituent name
89654 - Bedinvetmab
Description of data provided:
Data no
282663
Title
EU SPC
Study date
January 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
146952
Product/Active constituent Name
Application Product Name
Mandiva 250SC Fungicide
Application Date
Application Number
146952
Application Product Name
Mandiva 250SC Fungicide
Application details
Product name:
Mandiva 250SC Fungicide
Applicant Name:
GROCHEM AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 250 g/L suspension concentrate formulation of mandipropamid for the control of Downy Mildew in Grapes, Lettuce, Leafy Vegetables and Oilseed Poppies
Date
Application Date
Application No
Application Number
146803
Product/Active constituent Name
Application Product Name
Roundup CNG Weedkiller
Application Date
Application Number
146803
Application Product Name
Roundup CNG Weedkiller
Application details
Product name:
Roundup CNG Weedkiller
Product number:
95678
Applicant Name:
EVERGREEN GARDEN CARE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 10g/L Nonanoic Acid, 1.5g/L Fluroxypyr (present as the methylheptyl ester) and 0.5 g/L Fluazifop-P (present as the butyl ester) ready to use liquid (AL) product for the control of various weeds in the home garden as per the label directions.
Reference details:
91909 - Roundup BNG Concentrate Weedkiller
90480 - Roundup FNG Weedkiller
62287 - STARANE ADVANCED HERBICIDE
93540 - Roundup BNGZ Weedkiller Concentrate
92050 - Roundup PNG Weedkiller
92044 - Roundup PNG Concentrate Weedkiller
93542 - Roundup PNGZ Concentrate Weedkiller
Active constituents:
Active constituent name
49139 - FLUROXYPYR-MEPTYL
Active constituent name
44001 - FLUAZIFOP-P-BUTYL
Description of data provided:
Data no
282144
Title
Non-active SDS
Study date
2025
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282145
Title
CoA Actives
Study date
2025
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282146
Title
Chemistry data
Study date
July 2024
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282143
Title
Part 2 - Chemistry and Manufacture
Study date
August 2024
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282163
Title
Part 8 - Efficacy and Safety
Study date
August 2024
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282164
Title
Evaluation of Evergreen Garden Care non-selective post-emergence home garden herbicides – WA
Study date
November 2023
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282165
Title
Evaluation of experimental ready-to-use formulations for the control of various common annual and perennial weeds – Bundaberg, QLD 2023
Study date
January 2024
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282166
Title
Evaluation of experimental ready-to-use formulations for the control of various common annual and perennial weeds – Moolboolaman, QLD 2023
Study date
January 2023
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282167
Title
Evaluation of the bio-equivalence of experimental ready-to-use formulations for the control of various common annual and perennial weeds – QLD 2024
Study date
May 2024
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282168
Title
Evaluation of experimental formulations for rainfastness when subjected to simulated rainfall events – QLD 2024
Study date
May 2024
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282142
Title
Executive summary
Study date
12 December 2024
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282156
Title
Part 6 - OHS
Study date
August 2024
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282157
Title
HHRA #1 - OHS
Study date
December 2023
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282158
Title
HHRA #2 - OHS
Study date
December 2023
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282159
Title
HHRA #3 - OHS
Study date
July 2021
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282160
Title
HHRA #4 - OHS
Study date
November 2022
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282161
Title
Non-active SDS
Study date
2025
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282162
Title
SDS for formulated product
Study date
August 2024
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282147
Title
Part 3 - Toxicology
Study date
August 2024
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282148
Title
HHRA No 1 - Tox
Study date
December 2023
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282149
Title
HHRA No 2 - Tox
Study date
December 2023
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282150
Title
HHRA No 3 - Tox
Study date
July 2021
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282151
Title
HHRA No 4 - Tox
Study date
November 2022
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282152
Title
EFSA Conclusion - Pelargonic acid
Study date
2013
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282153
Title
EFSA Conclusion - Fluroxypyr
Study date
2011
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282154
Title
EFSA Conclusion - Fluazifop
Study date
2012
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Data no
282155
Title
Non-active SDS
Study date
2025
Auth party contact address
BUILDING E, LEVEL 2, 32 LEXINGTON DRIVE BELLA VISTA Australia
Date
Application Date
Application No
Application Number
146943
Product/Active constituent Name
Application Product Name
Infinity Ultra Herbicide
Application Date
Application Number
146943
Application Product Name
Infinity Ultra Herbicide
Application details
Product name:
Infinity Ultra Herbicide
Product number:
91984
Applicant Name:
BAYER CROPSCIENCE PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add weeds and an application method.
Active constituents:
Active constituent name
60910 - PYRASULFOTOLE
Active constituent name
44135 - DIFLUFENICAN
Active constituent name
49416 - MEFENPYR-DIETHYL
Active constituent name
58207 - MEFENPYR-DIETHYL
Description of data provided:
Data no
282674
Title
DFF+PYS compatibility with knockdown herbicides for control of fleabane. M-838126-01-1
Study date
2023-07-15
Data no
282675
Title
Evaluation of DFF+PYS for control of fleabane in fallow. M-838206-01-1
Study date
2022-10-04
Data no
282676
Title
DFF+PYS compatibility with knockdown herbicides for control of chickpeas. M-840638-01-1
Study date
2023-03-30
Data no
282677
Title
DFF+PYS compatibility with knockdown herbicides for control of chickpeas. M-840651-01-1
Study date
2023-03-01
Data no
282678
Title
Infinity Ultra applied with OSST for control of milk thistle in fallow. M-864018-01-1
Study date
2024-07-24
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282679
Title
Infinity Ultra applied with OSST for control of milk thistle in fallow. M-864506-01-1
Study date
2024-09-04
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282680
Title
Infinity Ultra applied with OSST for control of milk thistle in fallow. M-864507-01-1
Study date
2024-09-03
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282681
Title
Infinity Ultra applied with OSST for control of milk thistle in fallow. M-864508-01-1
Study date
2023-11-28
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282682
Title
DFF+PYS compatibility with knockdown herbicides for control of fleabane. M-864702-01-1
Study date
2024-02-28
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282683
Title
DFF+PYS compatibility with knockdown herbicides for control of peachvine. M-864703-01-1
Study date
2023-07-15
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282684
Title
Infinity Ultra control of volunteer canola. M-866585-01-1
Study date
2024-10-09
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282685
Title
Infinity Ultra control of volunteer canola. M-866592-01-1
Study date
2024-11-01
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282686
Title
Infinity Ultra Herbicide crop matrix 2023. M-866794-01-1
Study date
2024-10-04
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282687
Title
M-866795-01-1
Study date
2024-10-25
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282688
Title
Efficacy and safety 2
Study date
2024-11-29
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282689
Title
Draft label
Study date
2024-12-18
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282672
Title
Pre-application assistance request. M-839662-01-1
Study date
2022-04-19
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282673
Title
Pre-application assistance (PAA) - APVMA written assistance. M-839712-01-1
Study date
2022-06-22
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Date
Application Date
Application No
Application Number
147218
Product/Active constituent Name
Application Product Name
VYTRATE LIQUID CONCENTRATE
Application Date
Application Number
147218
Application Product Name
VYTRATE LIQUID CONCENTRATE
Application details
Product name:
VYTRATE LIQUID CONCENTRATE
Product number:
53841
Applicant Name:
PHIBRO ANIMAL HEALTH PTY LIMITED
Application purpose and description of use:
Variation of label approval to comply with current Veterinary Labelling Code (VLC).
Active constituents:
Active constituent name
84482 - POTASSIUM PHOSPHATE MONOBASIC
Active constituent name
84479 - GLYCINE
Active constituent name
84484 - POTASSIUM CITRATE
Active constituent name
85734 - GLUCOSE
Date
Application Date
Application No
Application Number
146953
Product/Active constituent Name
Application Product Name
Nufarm Collide 700 Adjuvant
Application Date
Application Number
146953
Application Product Name
Nufarm Collide 700 Adjuvant
Application details
Product name:
Nufarm Collide 700 Adjuvant
Product number:
70329
Applicant Name:
NUFARM AUSTRALIA LIMITED
Application purpose and description of use:
Variation of product registration to add an alternative formulation and alternative manufacturing site for Nufarm Collide 700 Adjuvant.
Active constituents:
Active constituent name
59637 - SOYAL PHOSPHOLIPIDS
Active constituent name
59638 - PROPIONIC ACID
Date
Application Date
Application No
Application Number
146938
Product/Active constituent Name
Application Product Name
Lan's Boscalid 500 WDG Fungicide
Application Date
Application Number
146938
Application Product Name
Lan's Boscalid 500 WDG Fungicide
Application details
Product name:
Lan's Boscalid 500 WDG Fungicide
Product number:
95693
Applicant Name:
Hebei Lansheng Biotech Co Ltd
Application purpose and description of use:
Registration of a 500 g/kg BOSCALID Water Dispersible Granule (WG) for the control of Bunch Rot (Botrytis cinerea) in Grapevines as specified in the Directions for Use table.
Reference details:
70146 - FMC PATRON 500 WG FUNGICIDE
Active constituents:
Active constituent name
88346 - boscalid
Description of data provided:
Data no
282643
Title
Boscalid Certificate of Analysis
Study date
2024
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Date
Application Date
Application No
Application Number
147142
Product/Active constituent Name
Application Product Name
Farmers’ Own Moxidectin and Levamisole Pour-On for Cattle
Application Date
Application Number
147142
Application Product Name
Farmers’ Own Moxidectin and Levamisole Pour-On for Cattle
Application details
Product name:
Farmers’ Own Moxidectin and Levamisole Pour-On for Cattle
Product number:
95777
Applicant Name:
ARROVET PTY LTD
Application purpose and description of use:
Registration of a 200 g/L levamisole and 10 g/L moxidectin pour-on solution product for the treatment and control of gastrointestinal parasites in cattle.
Reference details:
88072 - Cydectin Platinum Dual Active LV Pour-On for Beef and Dairy Cattle
Active constituents:
Active constituent name
82834 - LEVAMISOLE BASE
Active constituent name
85141 - MOXIDECTIN
Description of data provided:
Data no
282396
Title
Product specifications
Study date
2025
Auth party contact address
MQX 4, Level 6 Giffnock Ave Macquarie Park Australia
Date
Application Date
Application No
Application Number
147203
Product/Active constituent Name
Application Product Name
Beransa 20 mg Solution for Injection for Dogs
Application Date
Application Number
147203
Application Product Name
Beransa 20 mg Solution for Injection for Dogs
Application details
Product name:
Beransa 20 mg Solution for Injection for Dogs
Product number:
89655
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product label approval to update the side effects section.
Active constituents:
Active constituent name
89654 - Bedinvetmab
Description of data provided:
Data no
282644
Title
EU SPC
Study date
January 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
147205
Product/Active constituent Name
Application Product Name
Beransa 30 mg Solution for Injection for Dogs
Application Date
Application Number
147205
Application Product Name
Beransa 30 mg Solution for Injection for Dogs
Application details
Product name:
Beransa 30 mg Solution for Injection for Dogs
Product number:
89695
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product label approval to update the side effects section.
Active constituents:
Active constituent name
89654 - Bedinvetmab
Description of data provided:
Data no
282645
Title
EU SPC
Study date
January 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
146851
Product/Active constituent Name
Application Product Name
BAYTICOL CATTLE DIP AND SPRAY
Application Date
Application Number
146851
Application Product Name
BAYTICOL CATTLE DIP AND SPRAY
Application details
Product name:
BAYTICOL CATTLE DIP AND SPRAY
Product number:
41037
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation to apply minor updates to the product label to align with the VLC.
Active constituents:
Active constituent name
41037 - BAYTICOL CATTLE DIP AND SPRAY
Date
Application Date
Application No
Application Number
147019
Product/Active constituent Name
Application Product Name
Moxispot for Cats over 4kg
Application Date
Application Number
147019
Application Product Name
Moxispot for Cats over 4kg
Application details
Product name:
Moxispot for Cats over 4kg
Product number:
95729
Applicant Name:
Jiyu Biopharm Co., Ltd.
Application purpose and description of use:
Registration of a 10 g/L moxidectin and 100 g/L imidacloprid spot-on product for the treatment and control of flea and worm, and the prevention of heartworm in cats over 4kg
Reference details:
55326 - ADVOCATE FOR CATS OVER 4KG
Active constituents:
Active constituent name
94834 - Moxidectin
Active constituent name
94833 - Imidacloprid
Description of data provided:
Data no
282070
Title
Appendix 1. Finished Product specifications Moxispot for Cats over 4Kg
Study date
2024
Auth party contact address
Building A1, Nanjing National Agricultural Innovation Park No. 10, Xingzhi Road, Pukou District NANJING China
Date
Application Date
Application No
Application Number
146989
Product/Active constituent Name
Application Product Name
MILBEMAX TASTY CHEWS FOR DOGS
Application Date
Application Number
146989
Application Product Name
MILBEMAX TASTY CHEWS FOR DOGS
Application details
Product name:
MILBEMAX TASTY CHEWS FOR DOGS
Product number:
66277
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product registration to update the details of the approved manufacturing sites.
Active constituents:
Active constituent name
84391 - PRAZIQUANTEL
Description of data provided:
Data no
282060
Title
GMP certificates
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
284934
Title
GMP certificate
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
146990
Product/Active constituent Name
Application Product Name
MILBEMAX TASTY CHEWS FOR SMALL DOGS AND PUPPIES
Application Date
Application Number
146990
Application Product Name
MILBEMAX TASTY CHEWS FOR SMALL DOGS AND PUPPIES
Application details
Product name:
MILBEMAX TASTY CHEWS FOR SMALL DOGS AND PUPPIES
Product number:
66278
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product registration to update the details of the approved manufacturing sites.
Active constituents:
Active constituent name
84391 - PRAZIQUANTEL
Description of data provided:
Data no
282061
Title
GMP certificates
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
284935
Title
GMP certificate
Study date
2023
Auth party contact address
-
Date
Application Date
Application No
Application Number
147147
Product/Active constituent Name
Application Product Name
Doxycycline Monohydrate
Application Date
Application Number
147147
Application Product Name
Doxycycline Monohydrate
Application details
Product name:
Doxycycline Monohydrate
Active name:
Doxycycline Monohydrate
Applicant Name:
Jiyu Biopharm Co., Ltd.
Application purpose and description of use:
Approval of Doxycycline Monohydrate for use in veterinary chemical products.
Description of data provided:
Data no
282454
Title
Doxycycline Monohydrate EP11
Study date
2024
Auth party contact address
-
Data no
282453
Title
COA-Doxycycline Monohydrate
Study date
2024
Auth party contact address
Building A1, Nanjing National Agricultural Innovation Park No. 10, Xingzhi Road, Pukou District NANJING China