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

141949
Product/Active constituent Name

Application Product Name

flazasulfuron

Application details

Product name:

flazasulfuron

Active name:

flazasulfuron

Applicant Name:

ISHIHARA SANGYO KAISHA, LTD

Application purpose and description of use:

Approval of flazasulfuron for use in agricultural chemical products.

Description of data provided:

Data no
262016
Author
D Hirata
Title
Content analysis of SL-160 TGAI
Study date
30/11/2022
Authorising party
Applicant
Data no
262017
Author
D Hirata
Title
Final Report Amendment No. 1
Study date
05/12/2022
Authorising party
Applicant
Data no
262014
Author
T Oshima
Title
Support to register in Australia for SL-160 Flazasulfuron technical
Study date
1/11/2023
Authorising party
Applicant
Data no
262015
Author
T Shimura
Title
Product Chemistry Studies for Technical Flazasulfuron (SL-160)
Study date
29/01/2004
Authorising party
Applicant
Data no
273844
Author
Y Tada
Title
Manufacturing method for SL-160
Study date
13/06/2024
Authorising party
Applicant
Data no
273845
Author
Y Tada
Title
Declaration of composition
Study date
13/06/2024
Authorising party
Applicant
Data no
262018
Author
F Johnston
Title
Part 2 Summary
Study date
November 2023
Authorising party
Applicant
Date

Application Date

Application No

Application Number

141843
Product/Active constituent Name

Application Product Name

Mandipropamid

Application details

Product name:

Mandipropamid

Active name:

Mandipropamid

Applicant Name:

UPL AUSTRALIA PTY LTD

Application purpose and description of use:

Approval of mandipropamid for use in agricultural chemical products.

Description of data provided:

Data no
261345
Author
Desai, H
Title
Validation of analytical method for determination of mandipropamide and its associated impurities content in mandipropamide technical grade active ingredient (TGAI)
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
261343
Author
Desai, H.
Title
Analysis of five representative production batches of mandipropamide technical grade active ingredient (TGAI) to determine % mandipropamide and to quantify its associated impurities
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
261342
Author
Bhujabal N., Udawant D.
Title
The Manufacturing Process of Mandipropamid Technical
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
261341
Author
Rahate, S
Title
Part 2: Chemistry & Manufacture
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
261344
Author
Anon.
Title
Declaration of Composition
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
261346
Author
Prajapati, P
Title
Appearance (Colour, physical state and odour) of Mandipropamid Technical
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
261347
Author
Prajapati, P
Title
Melting point/melting range of Mandipropamid Technical
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
261348
Author
Prajapati, P
Title
Partition coefficient (n-Octanol/water) of Mandipropamid Technical
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
261349
Author
Prajapati, P
Title
Vapour pressure of Mandipropamid Technical
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
261350
Author
Prajapati, P
Title
Specific gravity of Mandipropamid Technical
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
273681
Author
Rathod, Janisha D.
Title
IN VITRO MAMMALIAN CELL GENE FORWARD MUTATION TEST AT THE HPRT LOCUS OF THE CHINESE HAMSTER OVARY (CHO)-K1 CELL LINE USING MANDIPROPAMID TECHNICAL
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
273682
Author
Rathod, Janisha D
Title
IN VITRO MAMMALIAN CHROMOSOMAL ABERRATION TEST OF MANDIPROAMID TECHNICAL IN HUMAN PERIPHERAL BLOOD LYMPHOCYTES
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Date

Application Date

Application No

Application Number

141873
Product/Active constituent Name

Application Product Name

Certainty Herbicide

Application details

Product name:

Certainty Herbicide

Product number:

94233

Applicant Name:

TURF CULTURE PTY LTD

Application purpose and description of use:

Registration of a 750 g/kg sulfosulfuron water dispersible granule (WG) product for the control of Sedges (Kyllinga, Mullumbimby Couch & Nutgrass) in Turf

Active constituents:

Active constituent name
65451 - SULFOSULFURON

Description of data provided:

Data no
261612
Author
C Tsibouklis
Title
Method Validation for the determination of sulfosulfuron* in a 750 WG formulation
Study date
31 October 2012
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261615
Author
W Braybon
Title
Part 2 - C&M - Certainty Herbicide
Study date
October 2023
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261616
Author
Various
Title
Certainty Herbicide - Excipient SDSs
Study date
2023
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261613
Author
A Yarnton
Title
750 g/kg Sulfosulfuron - Stability
Study date
2 June 2022
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261614
Author
Anon
Title
Sulfosulfuron 750 WDG Formulation Stability
Study date
November 2022
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
276629
Author
GF Smart
Title
Titan Fluroxypyr 333 EC Herbicide (88496/143096) :Scientific argument for replacement of the registered Titan Fluroxypyr 333 formulation
Study date
August 2024
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261623
Author
Turf Culture P/L
Title
To evaluate TC-036 for the post-emergent control of various sedge species and other weeds in a range of turf species
Study date
22 April 2020
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261624
Author
Turf Culture P/L
Title
To evaluate TC-036 for the post-emergent control of various sedge species and other weeds in a range of turf species.
Study date
17 March 2022
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261625
Author
Turf Culture P/L
Title
To evaluate TC-036 for the post-emergent control of various sedge species and other weeds in a range of turf species.
Study date
17 March 2022
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261626
Author
Turf Culture P/L
Title
To evaluate TC-036 for the post-emergent control of various sedge species and other weeds in a range of turf species.
Study date
19 March 2022
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261627
Author
Turf Culture P/L
Title
To evaluate TC-036 for the post-emergent control of various sedge species and other weeds in a range of turf species.
Study date
28 March 2022
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261628
Author
Turf Culture P/L
Title
To evaluate TC-036 for the post-emergent control of various sedge species and other weeds in a range of turf species.
Study date
28 March 2022
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261629
Author
Turf Culture P/L
Title
Evaluation of a TC-036 for Post Emergent Control of Various Sedges and Other Weeds in a Range of Turf Species
Study date
23 June 2020
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261630
Author
Turf Culture P/L
Title
Evaluation of TC-036 for Post Emergent Control of Various Sedges and Other Weeds in a Range of Turf Species
Study date
20 June 2020
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261631
Author
Turf Culture P/L
Title
To Evaluate TC-036 for phytotoxicity
Study date
26 July 2020
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261632
Author
Turf Culture P/L
Title
To evaluate the potential for phytotoxicity of TC-036
Study date
28 March 2022
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261633
Author
Turf Culture P/L
Title
Evaluate the Phytotoxic Potential of TC-036
Study date
2 March 2016
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261634
Author
Turf Culture P/L
Title
Evaluate the Phytotoxic Potential of TC-036
Study date
2 October 2017
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261622
Author
Turf Culture P/L
Title
Part 8 - Efficacy & Crop Safety - Certainty Herbicide
Study date
October 2023
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261617
Author
Turf Culture P/L
Title
SDS - Certainty Herbicide - October 2023
Study date
October 2023
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261618
Author
Turf Culture P/L
Title
Part 3 - Health - Certainty Herbicide
Study date
October 2023
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261619
Author
Turf Culture P/L
Title
Part 5 - Residues - Certainty Herbicide
Study date
October 2023
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261620
Author
US EPA
Title
US EPA Sulfosulfuron PP#6F7031 Human Health Risk Assessment for Proposed Uses of the Herbicide Sulfosulfuron on Grass Forage, Fodder and hay (crop Group 17), Forestry Conifer Release and Non-Crop Areas. DP#: 327363
Study date
28 February 2008
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
261621
Author
Turf Culture Pty Ltd
Title
Determination of the amount of edible turf available to grazing animals.
Study date
15 December 2021
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Date

Application Date

Application No

Application Number

141712
Product/Active constituent Name

Application Product Name

X-Pand Gibberellic Acid Growth Regulant

Application details

Product name:

X-Pand Gibberellic Acid Growth Regulant

Product number:

94155

Applicant Name:

STOLLER AUSTRALIA PTY. LIMITED

Application purpose and description of use:

Registration of a 133 g/L GIBBERRELLIC ACID soluble concentrate for foliar spray application to certain varieties of grapes, citrus And prunes to promote desirable harvest effects and to stimulate Production of winter dormant grass-dominant pastures for high Intensity grazing such as dairy pasture or sheep lambing paddocks.).

Reference details:

58244 - N-LARGE GIBBERELLIC ACID GROWTH REGULANT

Active constituents:

Active constituent name
90182 - Gibberellic acid

Description of data provided:

Data no
260278
Author
Puttaraju, K. A.
Title
Validation Of Analytical Method for the Determination of Active Ingredient Content of X-PAND by HPLC. Study Completion Date: 17 November 2020. Amended Report Date: 23 June 2021 Study No.: BIO-ANM 1609.
Study date
23 June 2021
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260279
Author
Rafeeq, M.
Title
Determination Of Density Of X-Pand. . Study No.: BIO-PHC 989.
Study date
24 June 2021
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260280
Author
Anon.
Title
X-Pand Chemistry Dossier DC10-09447864.
Study date
5 October 2023
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260276
Author
Anon
Title
SDSs for non-active constituent formulation components.
Study date
2023
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260277
Author
Puttaraju, K. A.
Title
Accelerated Storage Stability Of X-Pand. 30 December 2020 Amended 30 June 2021 . Study No.: BIO-PHC 742.
Study date
30 June 2021
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260288
Author
Hall, B.
Title
Bioequivalence of X-PAND and N-Large for use on orange cv. Washington navel Mypolonga, South Australia, 2021. Trial No. AGX21004
Study date
24 August 2021.
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260289
Author
Hill B.
Title
Bioequivalence of X-PAND and N-Large on table grapes cv. Sultana Thompson seedless Barmera, South Australia, 2020/21, 1. Trial No. AGX20153.
Study date
20 August 202
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260290
Author
Anon.
Title
Evaluation of X-Pand for equivalence with N-Large on Table Grapes.
Study date
May 2021.
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260291
Author
Murray, E.
Title
Evaluation of X-PAND for equivalence with N-Large on a Phalaris pasture Greenethorpe, NSW, 1. Trial No, KA20-1287.
Study date
19 March 202
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260292
Author
Murray, E.
Title
Evaluation of X-PAND for equivalence with N-Large on a ryegrass pasture Cowra, NSW, 2020. Trial No. KA20-1309.
Study date
19 March 2021
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260293
Author
Ryan, C and Hildebrand O.
Title
Evaluation of X-PAND for equivalence with N-Large on phalaris-based pasture cv. Advanced AT.
Study date
23 November 2020.
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260294
Author
Sewell, J.
Title
Evaluation of X-PAND for equivalence with N-LARGE on Pasture. Trial No: STL-20-XP-AU
Study date
2020
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260295
Author
Anon.
Title
Efficacy dossier DC10-09447864.
Study date
October 2023
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260282
Author
Murphy, V. A.
Title
Acute Dermal Toxicity in Rats study number: 11 Dec 2018, amended 18 Sept 2020. Report #22179-18.
Study date
18 September 2020
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260284
Author
Murphy, V. A.
Title
Acute Eye Irritation in Rabbits. 03 Dec 2019, amended 18 Sept 2020. Report # 22181-18.
Study date
18 September 2020
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260283
Author
Doig A.
Title
Acute Inhalation Toxicity in Rats. 04 Dec 2018, amended 18 Sept 2020. Study # 22180-18
Study date
18 September 2020
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260281
Author
Murphy, V. A.
Title
Acute Oral Toxicity (UDP) in Rats study number: Report 22287-18. 28 Dec 2018, amended 18 Sept 2020).
Study date
18 September 2020
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260285
Author
Murphy, V. A.
Title
Acute Dermal Irritation in Rabbits. 12 Nov 2018, amended 18 September 2020. Report # 22182-18.
Study date
18 September 2020.
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260286
Author
Murphy, V. A.
Title
Skin Sensitization- Assay in Guinea Pig study number: 15 Feb, 2019, amended 18 Sept 2020). Report # 22183-18.
Study date
18 September 2020
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Data no
260287
Author
Anon.
Title
X-Pand Toxicology Dossier DC10-09447864.
Study date
5 October 2023.
Authorising party
Applicant
Auth party contact address
1 Creswell Road Largs Bay Australia
Date

Application Date

Application No

Application Number

141862
Product/Active constituent Name

Application Product Name

Antclon Seed Treatment Insecticide

Application details

Product name:

Antclon Seed Treatment Insecticide

Product number:

94229

Applicant Name:

Shandong Rainbow International Co Ltd

Application purpose and description of use:

Registration of a 360G/L Clothianidin, and 240G/L Imidacloprid in Suspension Concentrate for Seed Treatment Formulation (FS) product For the control of various insect pests in a range of crops, as specified in the DIRECTIONS FOR USE table.

Reference details:

67779 - PONCHO PLUS INSECTICIDAL SEED TREATMENT

Active constituents:

Active constituent name
70306 - CLOTHIANIDIN
Active constituent name
93549 - Imidacloprid

Description of data provided:

Data no
261568
Author
-
Title
METHOD VALIDATION
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261569
Author
-
Title
PACKAGING OF CLOTHIANIDIN 360G/L + IMIDACLOPRID 240G/L FS
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261562
Author
Yasser Sokeirik
Title
Chemistry Dossier
Study date
17/10/2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261563
Author
-
Title
COAs
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261564
Author
-
Title
RAWS
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261565
Author
-
Title
MANUFACTURE PROCESS OF ANTCLON INSECTICIDE
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261566
Author
Wang Youxin
Title
Accelerated Storage Stability Study on Clothianidin 360G/L + Imidacloprid 240G/L FS
Study date
September 29, 2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261567
Author
Wang Qingwei
Title
LOW TEMPERATURE STORAGE STABILITY TEST REPORT Clothianidin 360G/L + Imidacloprid 240G/L FS
Study date
SEP. , 2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261570
Author
-
Title
Efficacy dossier
Study date
29/10/2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261571
Author
Alex Ford
Title
Determine bioequivalence of Antclon seed treatment with Poncho Plus for the control of pests in canola
Study date
Oct 2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261572
Author
-
Title
Ponco Plus Label
Study date
2023
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

141861
Product/Active constituent Name

Application Product Name

Munns Professional Lawn Fungicide Concentrate

Application details

Product name:

Munns Professional Lawn Fungicide Concentrate

Product number:

94228

Applicant Name:

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 125 g/L fludioxonil, suspension concentrate product for broad spectrum control and prevention of various fungal diseases of lawn in the home garden

Reference details:

69590 - MEDALLION TURF FUNGICIDE

Active constituents:

Active constituent name
60841 - FLUDIOXONIL
Active constituent name
65515 - FLUDIOXONIL

Description of data provided:

Data no
274445
Author
Hall C
Title
CoAs Fludioxonil
Study date
July 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
261561
Author
J Jackson, M Keats
Title
Medallion - 125 g/L Fludioxonil Storage Stability
Study date
5 May 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274444
Author
Jackson J, Keats M
Title
Medallion A17856B 125 g/L Fludioxonil Storage Stability (Revision no. 2)
Study date
12 July 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

141696
Product/Active constituent Name

Application Product Name

1-Methylcyclopropene

Application details

Product name:

1-Methylcyclopropene

Active name:

1-Methylcyclopropene

Applicant Name:

HAZEL TECHNOLOGIES, INC.

Application purpose and description of use:

created in conjunction with app 141619
Date

Application Date

Application No

Application Number

141297
Product/Active constituent Name

Application Product Name

Bayvarol Strips

Application details

Product name:

Bayvarol Strips

Product number:

94029

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

The purpose of this submission is to register Bayvarol Strips. The product contains the approved active ingredient flumethrin (approval number 62446) which contains 0.54 g/kg flumethrin in the form of an impregnated polymer strip, with each strip containing 3.6 mg flumethrin. The product is indicated for the diagnosis and control of Varroa mites (Varroa destructor) in beehives.

Active constituents:

Active constituent name
62446 - FLUMETHRIN

Description of data provided:

Data no
258556
Author
Elanco Australasia Pty Ltd
Title
Apx 2-6 - Certificates of Analysis API
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258558
Author
Elanco Australasia Pty Ltd
Title
Apx 2-8 - Certificates of Analysis API
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258557
Author
Elanco Australasia Pty Ltd
Title
Apx 2-7 - Manufacturer API
Study date
22/3/2019
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258555
Author
Elanco Australasia Pty Ltd
Title
Apx 2-5 Manufacturer API
Study date
9/3/2021
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258553
Author
Elanco Australasia Pty Ltd
Title
Apx 2-3 - Specification API
Study date
2/10/2015
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258568
Author
Elanco Australasia Pty Ltd
Title
Apx 2-18 - Product - Analytical method
Study date
27/6/2022
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258569
Author
Elanco Australasia Pty Ltd
Title
Apx 2-19 - Product - Validation
Study date
30/4/2020
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258564
Author
Elanco Australasia Pty Ltd
Title
Apx 2-14 - Product - Certificates of Analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258561
Author
Elanco Australasia Pty Ltd
Title
Apx 2-11 - Product - Batch analysis
Study date
20/5/2015
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258559
Author
Anon
Title
Apx 2-9 - GMP certificate product manufacturer
Study date
2021
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258560
Author
Elanco Australasia Pty Ltd
Title
Apx 2-10 - Product- manufacturing and in-process controls
Study date
24/6/2022
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
277233
Author
Elanco
Title
Ref 2 - In-process controls
Study date
2018
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
280766
Author
Elanco
Title
Certificate of Analysis - Excipient
Study date
30/9/2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
277232
Author
Elanco
Title
Ref 1 Annexure 1
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258657
Author
Elanco Australasia Pty Ltd
Title
Apx 2-0 - Part 2 - Applicants summary
Study date
September 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258554
Author
Elanco Australasia Pty Ltd
Title
Apx 2-4 - Specfication excipient
Study date
9/3/2007
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258551
Author
Elanco Australasia Pty Ltd
Title
Apx 2-1 - Product description
Study date
25/3/2021
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258552
Author
Elanco Australasia Pty Ltd
Title
Apx 2-2 - Formulation
Study date
27/9/2018
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258570
Author
Elanco Australasia Pty Ltd
Title
Apx 2-20 - Packaging
Study date
11/9/2014
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258562
Author
Elanco Australasia Pty Ltd
Title
Apx 2-12 - Product - Release Specification
Study date
26/9/2018
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258563
Author
Elanco Australasia Pty Ltd
Title
Apx 2-13 - Product - Shelf life specification
Study date
26/9/2018
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258565
Author
Elanco Australasia Pty Ltd
Title
Apx 2-15 - Product - Stability data
Study date
14/5/2013
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258566
Author
Elanco Australasia Pty Ltd
Title
Apx 2-16 - Product - Accelerated Stability Data
Study date
2/10/2007
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258567
Author
Elanco Australasia Pty Ltd
Title
Apx 2-17 - Product - Evaluation stability data
Study date
7/6/2013
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258629
Author
G.P. Santiago et al
Title
Ref 8-15, ID 00787 - Efficacy study
Study date
29/1/2001
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258630
Author
Bayer AG
Title
Ref 8-16, ID 90/13605 - Development of product
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258631
Author
N. Koeniger
Title
Ref 8-17, ID 90/13583 - Dose determination
Study date
22/7/1985
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258632
Author
S. Fuchs
Title
Ref 8-18, ID 90/13536 - Dose determination
Study date
28/12/1986
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258633
Author
A. Kohlich & R. Moosebeckhofer
Title
Ref 8-19, ID 90/13526 - Dose determination
Study date
5/4/1988
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258634
Author
S. Fuchs
Title
Ref 8-20, ID 90/13601 - dose confirmation
Study date
4/3/1987
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258635
Author
S. Fuchs
Title
Ref 8-21, ID 90/13604 - Dose confirmation
Study date
15/8/1987
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258636
Author
S. Fuchs
Title
Ref 8-22, ID 90/13528 - dose confirmation
Study date
1988
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258638
Author
K. Krieger
Title
Ref 8-24, ID 90/13534 - Field study
Study date
27/6/1989
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258639
Author
S. Fuchs
Title
Ref 8-25, ID 90/13529 - Field study
Study date
8/1/1990
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258640
Author
S. Fuchs
Title
Ref 8-26, ID 90/13530 - Field study
Study date
7/12/1989
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258641
Author
H.W. Schmidt
Title
Ref 8-27, ID 90/13533 - Field study
Study date
10/2/1988
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258642
Author
A. De Ruijter
Title
Ref 8-28, ID 90/13581 - Field study
Study date
25/10/1990
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258643
Author
N. Koeniger
Title
Ref 8-29, ID 90/13607 - Field study
Study date
26/11/90
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258654
Author
Elanco
Title
Ref 8-40, ID 61073 - PSUR 2016-2019
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258655
Author
Elanco
Title
Ref 8-41, ID 62453 - PSUR 2019-2022
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258628
Author
Anon
Title
Ref 8-14 - Langstroth hive
Study date
25/4/2023
Authorising party
Public
Auth party contact address
-
Data no
258659
Author
Elanco Australasia Pty Ltd
Title
Apx 8-0 - Part 8 - Applicants summary
Study date
September 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
280767
Author
Anon
Title
Ref 2- Efficacy-safety report
Study date
23/8/2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258637
Author
N. Koeniger & S. Fuchs
Title
Ref 8-23, ID 00493 - Control of Varroa Jacobsoni Oud. In honeybee colonies containing sealed brood cells.
Study date
1988
Authorising party
Public
Auth party contact address
-
Data no
258615
Author
Elanco Australasia
Title
Ref 8-1 - Product label
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258616
Author
M. Clarke & D. Le Feuvre
Title
Ref 8-2 - Size and Scope of the Australian Honey bee and pollination industry a snapshot
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
258617
Author
Anon
Title
Ref 8-3 - Honeybees
Study date
8/6/2022
Authorising party
Public
Auth party contact address
-
Data no
258618
Author
Anon
Title
Ref 8-4 - Varroa Mite detected at the Port of Newcastle Australian Honey Bee Industry Council.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
258619
Author
Anon
Title
Ref 8-5 - Varroa mite (Varroa destructor) Pest situation.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
258620
Author
Anon
Title
Ref 8-6 - Varroa mite emergency response. Current Situation Update: 28-Aug-23
Study date
28/8/2023
Authorising party
Public
Auth party contact address
-
Data no
258621
Author
Anon
Title
Ref 8-7 - What is varroa mite and how could it impact Australias bee industry and food production?
Study date
28/6/22
Authorising party
Public
Auth party contact address
-
Data no
258622
Author
Anon
Title
Ref 8-8 - Varroa mite - Alert
Study date
21/6/23
Authorising party
Public
Auth party contact address
-
Data no
258623
Author
Anon
Title
Ref 8-9 - Varroa Mite Life Cycle and Reproduction
Study date
27/1/2021
Authorising party
Public
Auth party contact address
-
Data no
258624
Author
S.D. Ramsey et al
Title
Ref 8-10 - Varroa destructor feeds primarily on honey bee fat body tissue and not hemolymph
Study date
15/1/2019
Authorising party
Public
Auth party contact address
-
Data no
258625
Author
Anon
Title
Ref 8-11 - Varroa Mite: Inside the Response
Study date
2/8/22
Authorising party
Public
Auth party contact address
-
Data no
258626
Author
Dr. Anne Dollin
Title
Ref 8-12 - The varroa mite crisis in New South Wales.
Study date
29/8/2023
Authorising party
Public
Auth party contact address
-
Data no
258644
Author
T. Blacquiere et al
Title
Ref 8-30, ID 41823 - Efficacy & Safety study
Study date
16/11/2015
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258645
Author
T. Blacquiere et al
Title
Ref 8-31 - Evaluation of the Efficacy and Safety of Flumethrin 275 mg Bee-hive Strips (PolyVar Yellow) against Varroa destructor in naturally infested honey bee colonies in a controlled study.
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
258646
Author
G. Braun & K. Hellmann
Title
Ref 8-32, ID 41833 - Efficacy & Safety study
Study date
30/11/2015
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258647
Author
G. Altreuther
Title
Ref 8-33 - ID 42585 - Efficacy & Safety study
Study date
2/8/2017
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258648
Author
K. Krieger
Title
Ref 8-34, ID 41836 - Efficacy & Safety Study
Study date
15/12/2015
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258649
Author
S. Fuchs
Title
Ref 8-35, ID 90/13584 - Safety study
Study date
7/11/1990
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258650
Author
H. Schulz
Title
Ref 8-36, ID 90/13531 - Safety study
Study date
27/11/1987
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258651
Author
S. Fuchs
Title
Ref 8-37, ID 90/13594 - Safety study
Study date
28/12/1986
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258652
Author
K. Krieger
Title
Ref 8-38, ID 99/13535 - Safety study
Study date
27/6/1989
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258653
Author
C. Otten
Title
Ref 8-39, ID 90/13585 - Safety study
Study date
27/4/1989
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258607
Author
C. Corsing
Title
Apx 7-0, ID 45178 - Environmental impact assessment
Study date
10/8/2017
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258608
Author
Anon
Title
Ref 7-1, VICH topic GL6
Study date
30/6/2000
Authorising party
Public
Auth party contact address
-
Data no
258609
Author
Anon
Title
Ref 7-2 - Revised GL GL6 and GL38
Study date
23/6/2008
Authorising party
Public
Auth party contact address
-
Data no
258610
Author
Anon
Title
Ref 7-3 - GL safety and residue data minor species
Study date
20/7/2006
Authorising party
Public
Auth party contact address
-
Data no
258611
Author
Anon
Title
Ref 7-4 - SPC
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258612
Author
Elanco
Title
Ref 7-5 - SDS
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258627
Author
Elanco
Title
Ref 8-13 - Meeting minutes APVMA
Study date
3/8/2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258578
Author
Elanco Australasia Pty Ltd
Title
Ref 5-8 - Product label
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258573
Author
Elanco Australasia Pty Ltd
Title
Ref 5-3 - meeting minutes
Study date
3/8/2022
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258591
Author
M. Clark & D. Le Feuvre
Title
Ref 5-21 - Size and scope of the Australian honey bee and pollination industry a snapshot.
Study date
Feb 2021
Authorising party
Public
Auth party contact address
-
Data no
258592
Author
Anon
Title
Ref 5-22 - ID API
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
259577
Author
Anon
Title
Ref 6-10 - risk assessment
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258606
Author
E.M. Krudewagen
Title
Ref 6-11, ID 39236 - Worker exposure study
Study date
12/11/2014
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258596
Author
Elanco
Title
Apx 6-0 - Human user safety risk assessment
Study date
April 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258593
Author
Anon
Title
Refe 5-23 - Analytical method
Study date
25/3/1986
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258594
Author
U. Heukamp & R. Krebber
Title
Ref 5-24 - ID 16000 - Analytical method
Study date
2/11/1993
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258595
Author
R. Krebber et al
Title
Ref 5-25 - ID 41150 - Analytical method
Study date
3/12/2015
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258579
Author
R. Krebber
Title
Ref 5-9 - ID 14313 - Residue study
Study date
11/3/1994
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258580
Author
R. Krebber
Title
Ref 5-10 - ID 14338 - Residue study
Study date
15/4/1994
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258581
Author
K. Riegner & K. Krieger
Title
Ref 5-11 - ID 15989 - Residue study
Study date
7/9/1990
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258582
Author
K. Riegner & K. Krieger
Title
Ref 5-12 - ID 15990 - Residue study
Study date
7/9/1990
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258583
Author
K. Riegner & K. Krieger
Title
Ref 5-13 - ID 15991 - Residue study
Study date
7/9/1990
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258584
Author
K. Riegner & K. Krieger
Title
Ref 5-14 - ID 15992 - Residue study
Study date
7/9/1990
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258585
Author
R. Krebber
Title
Ref 5-15 - ID 14583 - Residue study
Study date
26/7/1994
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258586
Author
R. Krebber
Title
Ref 5-16 - ID 147141 - Residue study
Study date
6/9/1994
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258587
Author
K. Riegner & K. Krieger
Title
Ref 5-17 - ID 15993 - Residue study
Study date
7/9/1990
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258588
Author
K. Riegner & K. Krieger
Title
Ref 5-18 - ID 15994 - Residue study
Study date
7/9/1990
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258589
Author
K. Riegner & K. Krieger
Title
Ref 5-19 - ID 15995 - Residue study
Study date
7/9/1990
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258590
Author
H.M. McBrydie et al
Title
Ref 5-20 - ID 27888 - Residue study
Study date
July 2004
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258574
Author
Anon
Title
Ref 5-4 - EMEA Committee for Veterinary Medicinal Products Flumethrin Summary Report 1
Study date
June 1998
Authorising party
Public
Auth party contact address
-
Data no
258575
Author
Anon
Title
Ref 5-5 - EMEA Committee for Veterinary Medicinal Products Flumethrin (extension to sheep) Summary Report 2
Study date
April 2000
Authorising party
Public
Auth party contact address
-
Data no
258576
Author
Anon
Title
Ref 5-6 - APVMA ADI intake
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
258577
Author
Anon
Title
Ref 5-7 - VICHGL 56
Study date
19/7/2018
Authorising party
Public
Auth party contact address
-
Data no
258571
Author
S.D. Ramsey et al
Title
Varroa destructor feeds primarily on honey bee fat body tissue and not hemolymph
Study date
15/1/2019
Authorising party
Public
Auth party contact address
-
Data no
258572
Author
Anon
Title
Ref 5-2 - Permit
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
258658
Author
Elanco Australasia Pty Ltd
Title
Apx 5-0 - Part 5a - Applicants summary
Study date
September 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258598
Author
J. Kuhn
Title
Ref 6-2 - ID 23941 - Acute dermal toxicity active
Study date
2/7/2008
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258599
Author
F. Krotlinger
Title
Ref 6-3 - ID 14967 - Skin eye irritation active
Study date
16/12/1994
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258600
Author
H.W. Vohr
Title
Ref 6-4 - ID 14561 - Skin sensitisation active
Study date
28/4/1994
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258604
Author
U. Wirnitzer & E. Hartmann
Title
Ref 6-8, ID 19383 - carcinogenicity study
Study date
28/7/1999
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258601
Author
L. Schladt & U. Deschl
Title
Ref 6-5, ID 19360 - chronic carcinogenecity
Study date
16/6/1999
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258597
Author
G. Schmuck
Title
Ref 6-1 - ID 44770 - API safety summary
Study date
20/1/2017
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258613
Author
Anon
Title
Ref-7-6 - CVMP summary report API
Study date
June 1998
Authorising party
Public
Auth party contact address
-
Data no
258614
Author
Anon
Title
Ref 7-7 - CVMP summary report 2 - API
Study date
April 2000
Authorising party
Public
Auth party contact address
-
Data no
258605
Author
S.K. Bommegowda
Title
Ref 6-9, ID 32545 - toxicology study
Study date
20/5/2008
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258656
Author
R. Grau
Title
Ref 8-42, ID FF-299 - Acute toxicity
Study date
25/10/1990
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258602
Author
K. Hoffmann
Title
Ref 6-6, ID 8252 - Subchronic study
Study date
10/1/1985
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258603
Author
L. Schladt
Title
Ref 6-7, ID 32570 - Sub-chronic study
Study date
28/8/2008
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

141619
Product/Active constituent Name

Application Product Name

HAZEL 100

Application details

Product name:

HAZEL 100

Product number:

94128

Applicant Name:

HAZEL TECHNOLOGIES, INC.

Application purpose and description of use:

Approval of a new manufacturing source of 1-Methylcyclopropene, and registration of a 1-Methylcyclopropene Vapour releasing product for use for post-harvest treatment of certain fruits for improved quality during shipping, storage or handling as specified in the Directions for Use.

Reference details:

59713 - SMARTFRESH SMARTTABS
89703 - SmartFresh InBox Post-Harvest Growth Regulator

Description of data provided:

Data no
260142
Author
L Ansah-Johnson
Title
Appendix 2.5 5-batch analysis for impurities
Study date
October 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260139
Author
D Sinning
Title
5-batch analysis for the active
Study date
October 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260141
Author
Anon
Title
DoC
Study date
October 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260140
Author
Anon
Title
Synthesis of 1-MCP and HAZEL 100
Study date
October 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260137
Author
Anon
Title
Chemistry dossier
Study date
October 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260138
Author
A Preslar
Title
Product Chemistry Group A for 1-Methylcyclopropene (1-MCP)
Study date
July 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260143
Author
Anon
Title
SDS for non-active ingredients
Study date
October 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260144
Author
C Wu
Title
Phys-chem properties
Study date
October 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260145
Author
J. Giner
Title
Expert Statement Phys-chem properties
Study date
October 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260146
Author
Anon
Title
Method of 1-MCP Measurement in HAZEL 100
Study date
October 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260147
Author
L Ansah-Johnson
Title
Storage Stability Report 12 months
Study date
October 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260148
Author
D Sinning
Title
Stability Study HAZEL 100 at - 20
Study date
October 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260163
Author
Anon
Title
Efficacy Dossier
Study date
August 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260164
Author
A. Preslar
Title
Air Inhalation Exposure Study
Study date
May 2018
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260165
Author
A Rivera and N Param
Title
Efficacy Avocado A
Study date
January 2022
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260166
Author
A Rivera and N Param
Title
Efficacy Avocado B
Study date
January 2022
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260167
Author
Anon
Title
Efficacy Avocado C
Study date
September 2019
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260168
Author
D Jiwan
Title
Efficacy Avocado D
Study date
September 2019
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260169
Author
N Param
Title
Efficacy Table Grapes A
Study date
September 2019
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260170
Author
N Param
Title
Efficacy Table Grapes B
Study date
February 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260171
Author
N Param
Title
Efficacy Table Grapes C
Study date
February 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260172
Author
A Rivera and S Maloney
Title
Efficacy Table Grapes D
Study date
February 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260173
Author
A Rivera and S Maloney
Title
Efficacy Table Grapes E
Study date
April 2022
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260174
Author
D Jiwan
Title
Efficacy Melon A
Study date
April 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260175
Author
D Jiwan
Title
Efficacy Melon B
Study date
October 2019
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260176
Author
N Param
Title
Efficacy Melon C
Study date
October 2019
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260177
Author
N Param
Title
Efficacy Melon D
Study date
October 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260178
Author
D Chen N Param
Title
Efficacy Apricot A
Study date
November 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260179
Author
N Param
Title
Efficacy Apricot B
Study date
November 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260180
Author
N Param
Title
Efficacy Cherries A
Study date
February 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260181
Author
N Param
Title
Efficacy Cherries B
Study date
February 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260182
Author
N Param
Title
Efficacy Cherries C
Study date
February 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260183
Author
N Param
Title
Efficacy Cherries D
Study date
February 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260184
Author
D Chen and N Param
Title
Efficacy Figs A
Study date
November 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260185
Author
D Chen and N Param
Title
Efficacy Figs B
Study date
November 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260186
Author
D Chen and N Param
Title
Efficacy Figs C
Study date
December 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260187
Author
N Param
Title
Efficacy Nectarine A
Study date
December 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260188
Author
N Param
Title
Efficacy Nectarine B
Study date
December 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260189
Author
N Param
Title
Efficacy Peach A
Study date
November 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260190
Author
N Param
Title
Efficacy Peach B
Study date
November 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260191
Author
N Param
Title
-
Study date
November 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260192
Author
D Chen and N Param
Title
Efficacy Plum A
Study date
October 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260193
Author
D Jiwan
Title
Efficacy Plum B
Study date
September 2019
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260194
Author
D Jiwan
Title
Efficacy Plum C
Study date
September 2019
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260195
Author
D Jiwan
Title
Efficacy Plum D
Study date
November 2019
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260196
Author
D Jiwan
Title
Efficacy Kiwi A
Study date
September 2019
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260197
Author
N Param
Title
Efficacy Kiwi B
Study date
October 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260198
Author
N Param
Title
Efficacy Kiwi C
Study date
October 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260199
Author
A Rivera N Param
Title
Efficacy Papaya A
Study date
December 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260200
Author
A Rivera N Param
Title
Efficacy Papaya B
Study date
December 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260201
Author
A Rivera S Maloney
Title
Efficacy Tomatoes A
Study date
December 2022
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260202
Author
A Rivera S Maloney
Title
Efficacy Tomatoes B
Study date
December 2022
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260203
Author
A Rivera S Maloney
Title
Efficacy Tomatoes C
Study date
December 2022
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260204
Author
A Rivera S Maloney
Title
Efficacy Tomatoes D
Study date
December 2022
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260136
Author
Anon
Title
Executive Summary
Study date
October 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260159
Author
L. Villamar-Bouza et al.
Title
EFSA 1-MCP Review
Study date
May 2018
Authorising party
Public
Auth party contact address
-
Data no
260160
Author
Anon
Title
HAZEL 100 Master Label US
Study date
November 2022
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260161
Author
Anon
Title
SDS for HAZEL 100
Study date
July 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260162
Author
J. Giner
Title
Expert Statement Phys-Chem properties
Study date
July 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260157
Author
Anon
Title
OHS dossier
Study date
August 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260158
Author
J. Johnston, L. Plunkett and A. Preslar
Title
Air Inhalation Exposure Study
Study date
December 2018
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260152
Author
J Durando
Title
Acute Dermal Toxicity Report
Study date
August 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260154
Author
J Durando
Title
Eye Irritation Report
Study date
September 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260153
Author
J Durando
Title
Acute Inhalation Toxicity Report
Study date
September 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260151
Author
J Durando
Title
Acute Oral Toxicity Report
Study date
September 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260155
Author
J Durando
Title
Skin Irritation Report
Study date
September 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260156
Author
J Durando
Title
Skin Sensitisation Report
Study date
August 2021
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260149
Author
Anon
Title
Toxicology Dossier
Study date
August 2023
Authorising party
Applicant
Auth party contact address
320 N Sangamon St Suite 400 Chicago United States
Data no
260150
Author
L. Villamar-Bouza et al.
Title
EFSA report 1-methylcyclopropene
Study date
May 2018
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

141845
Product/Active constituent Name

Application Product Name

GENFARM AZOXYSTROBIN 250 SC FUNGICIDE

Application details

Product name:

GENFARM AZOXYSTROBIN 250 SC FUNGICIDE

Product number:

67483

Applicant Name:

NUTRIEN AG SOLUTIONS LIMITED

Application purpose and description of use:

The purpose of this application is to add an alternative SC 250 g/L azoxystrobin formulation.

Reference details:

59267 - GENFARM TEBUCONAZOLE 430 FUNGICIDE
66867 - GENFARM PROPYZAMIDE 500SC HERBICIDE
67202 - GENFARM FLUTRIAFOL 500 SC FUNGICIDE
92572 - GENFARM ALPHA-CYPERMETHRIN 500 SC INSECTICIDE

Active constituents:

Active constituent name
44444 - AZOXYSTROBIN
Active constituent name
64692 - AZOXYSTROBIN

Description of data provided:

Data no
261355
Author
Baniago A
Title
Method Validation of Genfarm Azoxystrobin 250 SC Fungicide
Study date
07-Dec-2021
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
261356
Author
Baniago A
Title
Manufacturing Process for Genfarm Azoxystrobin 250 SC Fungicide
Study date
07-Dec-2021
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
261351
Author
Miller S
Title
Part 2 Chemistry and manufacture, Genfarm Azoxystrobin 250 SC Fungicide
Study date
18-Oct-2023
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
261352
Author
-
Title
Certificate of Analysis
Study date
27-Mar-2022
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
261353
Author
-
Title
Safety Data Sheets
Study date
06-Dec-2019
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
261354
Author
Baniago A
Title
Product Stability of Genfarm Azoxystrobin 250 SC Fungicide
Study date
07-Dec-2021
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
275804
Author
A. Lockley
Title
Comparison of pest control efficacy of two Azoxystrobin 250 fungicide formulations for control of Early blight (Alternaria solani) in Potato (Solanum tuberos) cv. Maranca.
Study date
26-Jul-2024
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
275805
Author
A. Lockley
Title
Comparison of pest control efficacy of two Azoxystrobin 250 fungicide formulations for control of Early blight (Alternaria solani) in Tomato (Solanum lycopersicum) cv. Grosse Lisse.
Study date
26-Jul-2024
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
275806
Author
A. Lockley
Title
Comparison of pest control efficacy of two Azoxystrobin 250 fungicide formulations for control of Downy mildew (Pseudoperonospora cubensis) in Cucumber (Cucumis sativus) cv. Lebanese.
Study date
26-Jul-2024
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
275807
Author
A. Lockley
Title
Comparison of pest control efficacy of two Azoxystrobin 250 fungicide formulations for control of Powdery mildew (Erysiphe necator) in European grape (Vitis vinifera) cv. Shiraz.
Study date
26-Jul-2024
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
261357
Author
Baniago A, Miller S
Title
Executive summary for Genfarm Azoxystrobin 250 SC Fungicide
Study date
27-Oct-2023
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

141830
Product/Active constituent Name

Application Product Name

Pendimethalin

Application details

Product name:

Pendimethalin

Active name:

Pendimethalin

Applicant Name:

Shandong Rainbow International Co Ltd

Application purpose and description of use:

Approval of Pendimethalin TC for use in agricultural chemical products.

Description of data provided:

Data no
261336
Author
Anon
Title
Doc
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261337
Author
anon
Title
The Statement of Batch Size of Pendimethalin Technicall in 5-Batch Report
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261338
Author
Anon
Title
CoA
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261333
Author
Mr. Justin Liu
Title
Study Title: Five Batch Analysis of Pendimethalin TC
Study date
Nov.04, 2020
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261334
Author
Anon
Title
MANUFACTURE PROCESS OF Pendimethalin Technical
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261332
Author
Shandong Rainbow International Co., Ltd.
Title
Chemistry &Manufacturing Dossier
Study date
25/10/2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
261335
Author
Anon
Title
THE JUSTIFICATION OF IMPURITIES OF Pendimethalin Technical
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
273676
Author
B. K. INDRANI, M.V.Sc.
Title
N-(1-ETHYLPROPYL)-3,4-XYLIDINE: IN VITRO MAMMALIAN CELL MICRONUCLEUS TEST IN HUMAN PERIPHERAL BLOOD LYMPHOCYTES
Study date
12 MAY 2022
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
273677
Author
P. V. SURESH REDDY, M.Sc.
Title
3, 4-dimethylaniline: IN VITRO MAMMALIAN CELL MICRONUCLEUS TEST IN HUMAN PERIPHERAL BLOOD LYMPHOCYTES
Study date
13 MAY 2022
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
273678
Author
Ms. M. Sunandha, B.Tech
Title
In Vitro Mammalian Cell Micronucleus Test of Pendimethalin Technical using Human Peripheral Blood Lymphocytes
Study date
29 July 2016
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
273679
Author
Mr. Ramkumar G, MSc
Title
Bacterial Reverse Mutation Assay with Pendimethalin Technical in Salmonella typhimurium tester strains
Study date
14/08/2020
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
273680
Author
G. JOEL SATHIYASEELAN, M.Sc.
Title
3, 4-dimethylaniline: BACTERIAL REVERSE MUTATION TEST
Study date
29 MARCH 2022
Authorising party
Applicant
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

141641
Product/Active constituent Name

Application Product Name

Enviromax IndoxaGuard 200SC Insecticide

Application details

Product name:

Enviromax IndoxaGuard 200SC Insecticide

Product number:

94130

Applicant Name:

ENVIROMAX TECHNOLOGIES PTY LTD

Application purpose and description of use:

Registration of a 222 g/L of indoxacarb (present as 200g/L of s-isomer) suspension concentrate product for the control of Argentine Stem Weevil adults and larvae, and Lepidoptera grub larvae in turf as per the Directions for Use.

Reference details:

85434 - PROVAUNT Turf Insecticide

Active constituents:

Active constituent name
84866 - Indoxacarb

Description of data provided:

Data no
259867
Author
Anon
Title
CoA Active
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259868
Author
Anon
Title
CoA Active
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259869
Author
Anon
Title
Validation Data
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259866
Author
Anon
Title
Manufacturing Information
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259865
Author
Anon
Title
Chemistry Dossier
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259870
Author
Anon
Title
SDS non-actives
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259881
Author
Anon
Title
Part 8 Dossier
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259882
Author
Anon
Title
Efficacy and Safety 1
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259883
Author
Anon
Title
Efficacy and Safety 2
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259884
Author
Anon
Title
Efficacy and Safety 3
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259875
Author
Anon
Title
Executive Summary
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259876
Author
Anon
Title
Part 6 Dossier
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259877
Author
Anon
Title
PRS AC
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259878
Author
Anon
Title
SDS Product
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259871
Author
Anon
Title
Part 3 Dossier
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259872
Author
Anon
Title
EFSA Report
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259873
Author
Anon
Title
PRS AC
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259874
Author
Anon
Title
SDS Non Actives
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259879
Author
Anon
Title
Part 7 Dossier
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Data no
259880
Author
Anon
Title
PRS AC
Study date
2023
Authorising party
Applicant
Auth party contact address
Suite 3, 6 Barbarra Street Stafford Australia
Date

Application Date

Application No

Application Number

141317
Product/Active constituent Name

Application Product Name

CLiK Extra Spray-On Sheep Blowfly Treatment

Application details

Product name:

CLiK Extra Spray-On Sheep Blowfly Treatment

Product number:

91837

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Variation of product registration to add an alternative excipient.

Active constituents:

Active constituent name
44028 - DICYCLANIL
Active constituent name
64467 - DICYCLANIL

Description of data provided:

Data no
269891
Author
Elanco Australasia Pty Ltd
Title
Comparative Efficacy of CLiK Extra and a Modified Formulation of CLiK Extra in Sheep Artificially Implanted with Dicyclanil Resistant Blowfly Larvae.
Study date
01 February 2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258725
Author
Elanco
Title
Summary of change
Study date
08 Sep 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258724
Author
APVMA
Title
Email from APVMA
Study date
25 Aug 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
269892
Author
Elanco Australasia Pty Ltd
Title
s159 response
Study date
12 February 2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
272576
Author
Elanco Australasia Pty Ltd
Title
Item14 Response s159 on 04JUN2024
Study date
04 JUN 2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258723
Author
Elanco
Title
Evaluation of Myverol 18-99K
Study date
31 Jul 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258726
Author
Elanco Australasia Pty Ltd
Title
Comparison of Wool Residues in Sheep Treated with CLiK Extra or a Modified Formulation of CLiK Extra following simulated rainfall exposure
Study date
20 Jul 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

141318
Product/Active constituent Name

Application Product Name

CLiK Ultra Spray-On Blowfly Treatment

Application details

Product name:

CLiK Ultra Spray-On Blowfly Treatment

Product number:

81863

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Variation of product registration to add an alternative excipient

Active constituents:

Active constituent name
44028 - DICYCLANIL
Active constituent name
64467 - DICYCLANIL

Description of data provided:

Data no
258729
Author
Elanco
Title
Summary of Change
Study date
08 Sep 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258728
Author
APVMA
Title
Email from APVMA
Study date
25 Aug 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258727
Author
Elanco
Title
Evaluation of Myverol 18-99K
Study date
31 Jul 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258730
Author
Elanco Australasia Pty Ltd
Title
Comparison of Wool Residues in Sheep Treated with CLiK Extra or a Modified Formulation of CLiK Extra Following Simulated Rainfall Exposure
Study date
20 Jul 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

141319
Product/Active constituent Name

Application Product Name

CLIK SPRAY-ON SHEEP BLOWFLY TREATMENT

Application details

Product name:

CLIK SPRAY-ON SHEEP BLOWFLY TREATMENT

Product number:

50005

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Variation of product registration to add an alternative excipient.

Active constituents:

Active constituent name
66726 - DICYCLANIL
Active constituent name
44028 - DICYCLANIL

Description of data provided:

Data no
258733
Author
Elanco
Title
Summary of change
Study date
08 Sep 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258732
Author
APVMA
Title
Email from APVMA
Study date
25 Aug 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258731
Author
Elanco
Title
Evaluation of Myverol 18-99K
Study date
31 Jul 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258734
Author
Elanco Australasia Pty Ltd
Title
Comparison of wool residues in sheep treated with CLiK Extra or a modified formulation of CLiK Extra following simulated rainfall exposure
Study date
20 Jul 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

141320
Product/Active constituent Name

Application Product Name

CLIKZIN SPRAY-ON SHEEP BLOWFLY TREATMENT

Application details

Product name:

CLIKZIN SPRAY-ON SHEEP BLOWFLY TREATMENT

Product number:

64628

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Variation of product registration to add an alternative excipient.

Active constituents:

Active constituent name
66726 - DICYCLANIL

Description of data provided:

Data no
258737
Author
Elanco
Title
Summary of chagne
Study date
08 Sep 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258736
Author
APVMA
Title
Email from APVMA
Study date
25 Aug 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258735
Author
Elanco
Title
Evaluation of Myverol 18-99K
Study date
31 Jul 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
258738
Author
Elanco Australasia Pty Ltd
Title
Comparison of Wool Residues in Sheep Treated with CLiK Extra or a Modified Formulation of CLiK Extra following Simulated Rainfall Exposure
Study date
20 Jul 2023
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

141516
Product/Active constituent Name

Application Product Name

Laverdia 22.5 mg Tablets for Dogs

Application details

Product name:

Laverdia 22.5 mg Tablets for Dogs

Product number:

94093

Applicant Name:

ANIVIVE LIFESCIENCES INC.

Application purpose and description of use:

Registration of a 22.5 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of verdinexor.
Date

Application Date

Application No

Application Number

141517
Product/Active constituent Name

Application Product Name

Laverdia 10 mg Tablets for Dogs

Application details

Product name:

Laverdia 10 mg Tablets for Dogs

Product number:

94094

Applicant Name:

ANIVIVE LIFESCIENCES INC.

Application purpose and description of use:

Registration of a 10 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of verdinexor.
Date

Application Date

Application No

Application Number

141518
Product/Active constituent Name

Application Product Name

Laverdia 2.5 mg Tablets for Dogs

Application details

Product name:

Laverdia 2.5 mg Tablets for Dogs

Product number:

94095

Applicant Name:

ANIVIVE LIFESCIENCES INC.

Application purpose and description of use:

Registration of a 2.5 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of verdinexor.
Date

Application Date

Application No

Application Number

141596
Product/Active constituent Name

Application Product Name

Firocoxib

Application details

Product name:

Firocoxib

Active name:

Firocoxib

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

Approval of new source of the active firocoxib

Description of data provided:

Data no
275748
Author
Not Identified
Title
Elucidation of structure and other characteristics
Study date
June 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
275749
Author
Not identified
Title
Impurities
Study date
June 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
275750
Author
Not Identified
Title
Validation of Analytical Procedures
Study date
June 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
275746
Author
Not Identified
Title
Description of manufacturing process and process controls
Study date
June 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
275747
Author
Not Identified
Title
Control of Critical steps and intermediates
Study date
June 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
259780
Author
Abbey Laboratories Pty Ltd
Title
Firocoxib Dossier V1SEP23
Study date
September 2023
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
275751
Author
Not Identified
Title
Response letter - 1st deficiencies
Study date
June 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia