Application summaries

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

12 Jul 2024

Application No

144506

Product/Active constituent Name

Forthyron 400µg Flavoured Tablets

Application details

Product name:

Forthyron 400µg Flavoured Tablets

Product number:

92445

Applicant Name:

DECHRA REGULATORY B.V.

Application purpose and description of use:

Variation of product registration to include an alternate product manufacture.

Active constituents:

56385 - THYROXINE SODIUM

Description of data provided:

Data no

273512

Author

Agency for Medicinal Products and Medical Devices of Croatia

Title

Certificate of GMP Compliance of a Manufacturer

Study date

8 February 2024

Authorising party

Public

Auth party contact address

Data no

273513

Author

Republic of Croatia Agency for Medicinal Products and Medical Devices

Title

GMP inspection report

Study date

8 February 2024

Authorising party

Applicant

Auth party contact address

Handelsweg 25 AE Bladel Netherlands

Data no

273514

Author

Republic of Croatia Agency for Medicinal Products and Medical Devices

Title

Good Manufacturing Practice (GMP) Inspection Report

Study date

8 February 2024

Authorising party

Applicant

Auth party contact address

Handelsweg 25 AE Bladel Netherlands

Data no

273515

Author

J Todd

Title

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Study date

17 August 2022

Authorising party

Public

Auth party contact address

Data no

273516

Author

Medicines and Healthcare products Regulatory Agency

Title

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Study date

February 2024

Authorising party

Public

Auth party contact address

Date

12 Jul 2024

Application No

144602

Product/Active constituent Name

Vetmec Sheep LA Injection

Application details

Product name:

Vetmec Sheep LA Injection

Product number:

95081

Applicant Name:

CHEMVET AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 20 g/L Moxidectin injectable product for the treatment and control of parasites sensitive to moxidectin in sheep.

Reference details:

87525 - Neovemox Long Acting Injection for Sheep

Active constituents:

92482 - Moxidectin

Description of data provided:

Data no

273855

Author

Anon

Title

Finished goods Specification

Study date

2024

Authorising party

Applicant

Auth party contact address

1/8 ROCKLEA DRIVE PORT MELBOURNE Australia

Data no

279819

Author

CHEMVET AUSTRALIA PTY LTD

Title

Product specifications

Study date

15.10.24

Authorising party

Applicant

Auth party contact address

1/8 ROCKLEA DRIVE PORT MELBOURNE Australia

Date

11 Jul 2024

Application No

144679

Product/Active constituent Name

Triclabendazole

Application details

Product name:

Triclabendazole

Active name:

Triclabendazole

Applicant Name:

B.J. BLUE PTY LTD

Application purpose and description of use:

Approval of triclabendazole active constituent for use in veterinary chemical products.

Description of data provided:

Data no

274096

Author

Anon

Title

Certificates of analysis

Study date

9/7/2024

Authorising party

Applicant

Auth party contact address

Unit 10 2-8 Daniel Street WETHERILL PARK NSW Australia

Date

11 Jul 2024

Application No

144700

Product/Active constituent Name

AXIOM FLEXI FUNGICIDE

Application details

Product name:

AXIOM FLEXI FUNGICIDE

Product number:

93113

Applicant Name:

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use:

Variation of label approval to remove the use on turf.

Active constituents:

81437 - Metalaxyl-M

Description of data provided:

Data no

274307

Author

Adama Australia Pty Ltd

Title

RLP with marked up changes

Study date

June 2024

Authorising party

Applicant

Auth party contact address

Level 1 Building B 207 Pacific Highway St Leonards Australia

Date

11 Jul 2024

Application No

144322

Product/Active constituent Name

Alfaxan Multidose Anaesthetic Injection

Application details

Product name:

Alfaxan Multidose Anaesthetic Injection

Product number:

83248

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to add additional claims.

Active constituents:

83437 - ALFAXALONE

Description of data provided:

Data no

272700

Author

Angela Lennox, Nigel Caulkett, Gregory Lewbart, Cora Lau

Title

AMD IDX Expert Panel Report

Study date

23 November 2018

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272701

Author

Anon

Title

Freedom of Information Summary Alfaxan Multidose IDX

Study date

22 January 2020

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272702

Author

Laboratory Animals Journal

Title

Alfaxalone-butorphanol versus alfaxalone

Study date

2016

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272703

Author

Jurox

Title

UK ART0484 v3.0-3

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272704

Author

Zoetis

Title

US ART0862 v0.0-7

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272705

Author

Jurox

Title

label comparison table (002) and references

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

273908

Author

Chiara Adami, Dario d'Ovidio and Daniela Casoni

Title

Alfaxalone-butorphanol versus alfaxalone-morphine combination for immersion anaesthesia in oriental fire-bellied toads (Bombina orientalis)

Study date

2016

Authorising party

Public

Auth party contact address

Data no

273909

Author

Chiara Adami, Claudia Spadavecchia, Giovanni Angeli and Dario d'Ovidio

Title

SHORT COMMUNICATION - Alfaxalone anesthesia by immersion in oriental fire-bellied toads (Bombina orientalis)

Study date

2015

Authorising party

Public

Auth party contact address

Data no

273910

Author

Anna Andaluz, Laura Santos, Felix Garcia, Rosa I. Ferrer et al

Title

Maternal and Foetal Cardiovascular Effects of the Anaesthetic Alfaxalone in 2-Hydroxypropyl-beta-cyclodextrin in the Pregnant Ewe

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273911

Author

Tobin V Ansel, Ann K Nour, and Alexandra Benavente-Perez

Title

The Effect of Anesthesia on Blood Pressure Measured Noninvasively by Using the Tail-Cuff Method in Marmosets (Callithrix jacchus)

Study date

2016

Authorising party

Public

Auth party contact address

Data no

273912

Author

Mario Arenillas and Ignacio A Gomez de Segura

Title

Anaesthetic effects of alfaxalone administered intraperitoneally alone or combined with dexmedetomidine
and fentanyl in the rat

Study date

2018

Authorising party

Public

Auth party contact address

Data no

273913

Author

Elizabeth A Bailey, Dale L Bailey, Stephen Hunyor, Leigh Ladd et al

Title

Translation of Methodology Used In Human Myocardial Imaging to a Sheep Model of Acute Myocardial Infarction

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273914

Author

Jaco Bakker, Rianne Klomp, Milene WM Rijnbeek, Saskia S Arndt et al

Title

Recovery time after intra-abdominal transmitter placement for telemetric (neuro) physiological measurement in freely moving common marmosets (Callitrix jacchus)

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273915

Author

Jaco Bakker, Joost J Uilenreef, Eva RJ Pelt, Herbert PM Brok et al

Title

Comparison of three different sedativeanaesthetic protocols (ketamine, ketaminemedetomidine and alphaxalone) in common marmosets (Callithrix jacchus)

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273916

Author

Anon

Title

Assessment of Alfaxalone as an anaesthetic induction agent in mute swans (Cygnus olor)

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273917

Author

Not identified

Title

2 Abstracts

Study date

2017

Authorising party

Public

Auth party contact address

Data no

273918

Author

S.H. Bauquier, J. Greenwood, T. Whittem

Title

Evaluation of the sedative and anaesthetic effects of five different concentrations of alfaxalone in goldfish, Carassius auratus

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273919

Author

Marjorie Bercier, Isabelle Langlois, Marilyn Dunn et al

Title

Cytological analysis of bronchoalveolar lavage fluid acquired by bronchoscopy in healthy ferrets: A pilot study

Study date

2016

Authorising party

Public

Auth party contact address

Data no

273920

Author

Mads F Bertelsen & Cathrine D Sauer

Title

Alfaxalone anaesthesia in the green iguana (Iguana iguana)

Study date

2011

Authorising party

Public

Auth party contact address

Data no

273921

Author

AS Bischofberger, CM Dart and AJ Dart

Title

Surgical treatment of osteomyelitis and sequestration of the ilium by a cranial partial hemipelvectomy in an alpaca cria

Study date

2010

Authorising party

Public

Auth party contact address

Data no

273922

Author

Tim Bouts, D.V.M., M.Sc., M.R.C.V.S., Dananjaya Karunaratna, B.V.Sc. et al

Title

EVALUATION OF MEDETOMIDINE-ALFAXALONE AND MEDETOMIDINE- KETAMINE IN SEMI-FREE RANGING BENNETT'S WALLABIES (MACROPUS RUFOGRISEUS)

Study date

2011

Authorising party

Public

Auth party contact address

Data no

273923

Author

Alice M. Bugman et al

Title

Evaluation of the anesthetic efficacy of alfaxalone in oscar fish (Astronotus ocellatus)

Study date

2016

Authorising party

Public

Auth party contact address

Data no

273924

Author

Daniela Casoni, Eva M Amen, Mathieu Brecheisen et al

Title

LETTER TO THE EDITOR - A combination of alfaxalone and medetomidine followed by an alfaxalone continuous rate infusion in cynomolgus monkeys (Macaca fascicularis) undergoing pharmacoMRS

Study date

2015

Authorising party

Public

Auth party contact address

Data no

273925

Author

Saul Chemonges, Kiran Shekar, John-Paul Tung et al

Title

Optimal Management of the Critically Ill: Anaesthesia, Monitoring, Data Capture, and Point-of-Care Technological Practices in Ovine Models of Critical Care

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273926

Author

T. D. Clark et al

Title

Factorial Aerobic Scope Is Independent of Temperature and Primarily Modulated by Heart Rate in Exercising Murray Cod (Maccullochella peelii peelii)

Study date

2005

Authorising party

Public

Auth party contact address

Data no

273927

Author

Christoph CURTHS, Judy WICHMANN, Sarah DUNKER et al

Title

Airway hyper-responsiveness in lipopolysaccharide-challenged common marmosets (Callithrix jacchus)

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273928

Author

Justin M. Dean, Sherly George, Andrew S. Naylor et al

Title

Partial neuroprotection with low-dose infusion of the a2-adrenergic receptor agonist clonidine after severe hypoxia in preterm fetal sheep

Study date

2008

Authorising party

Public

Auth party contact address

Data no

273929

Author

Justin M. Dean, Sherly A. George, Guido Wassink et al

Title

Suppression of post-hypoxic-ischemic EEG transients with dizocilpine is associated with partial striatal protection in the preterm fetal sheep

Study date

2006

Authorising party

Public

Auth party contact address

Data no

273930

Author

Ana M del Alamo, Ron E Mandsager, Thomas W Riebold et al

Title

Evaluation of intravenous administration of alfaxalone, propofol, and ketamine-diazepam for anesthesia in alpacas

Study date

2015

Authorising party

Public

Auth party contact address

Data no

273931

Author

Grayson A Doss, Dustin M Fink, Kurt K Sladky & Christoph Mans

Title

Comparison of subcutaneous dexmedetomidineemidazolam versus alfaxaloneemidazolam sedation in leopard geckos (Eublepharis macularius)

Study date

2017

Authorising party

Public

Auth party contact address

Data no

273932

Author

Dario d'Ovidio, Francesco Marino, Emilio Noviello et al

Title

Sedative effects of intramuscular alfaxalone in pet guinea pigs (Cavia porcellus)

Study date

2018

Authorising party

Public

Auth party contact address

Data no

273933

Author

Brighton T. Dzikiti, Patience S. Ndawana, Loveness N. Dzikiti, Frik G. Stegmann

Title

The minimum infusion rate of alfaxalone during its co-administration with lidocaine at
three different doses by constant rate infusion in goats

Study date

2017

Authorising party

Public

Auth party contact address

Data no

273934

Author

Brighton T Dzikiti, Patience S Ndawana, Gareth Zeiler et al

Title

Determination of the minimum infusion rate of alfaxalone during its co-administration with fentanyl at three different doses by constant rate infusion intravenously in goats

Study date

2016

Authorising party

Public

Auth party contact address

Data no

273935

Author

T. B. Dzikiti, P. S. Ndawana,G. Zeiler, L. Bester, L. N. Dzikiti

Title

Determination of the minimum infusion rate of alfaxalone during its co-administration with midazolam
in goats

Study date

2015

Authorising party

Public

Auth party contact address

Data no

273936

Author

T. B. Dzikiti, P. S. Ndawana, G. Zeiler, L. Bester and L. N. Dzikiti

Title

Determination of the minimum infusion rate of alfaxalone during its co-administration with midazolam in goats

Study date

2015

Authorising party

Public

Auth party contact address

Data no

273937

Author

T. Brighton Dzikiti et al

Title

The effects of midazolam and butorphanol, administered alone or combined, on the dose and quality of anaesthetic induction with alfaxalone in goats

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273938

Author

Kevin Eatwell

Title

Options for analgesia and anaesthesia in reptiles

Study date

2010

Authorising party

Public

Auth party contact address

Data no

273939

Author

Eugenio Gaudio, Laura Voltan & Giulia Maria De Benedictis

Title

Alfaxalone anaesthesia in Lemur catta following dexmedetomidineebutorphanole midazolam sedation

Study date

2018

Authorising party

Public

Auth party contact address

Data no

273940

Author

S. George, J. Scotter, J.M. Dean, L. Bennet et al

Title

Induced cerebral hypothermia reduces post-hypoxic loss of phenotypic striatal neurons in preterm fetal sheep

Study date

2007

Authorising party

Public

Auth party contact address

Data no

273941

Author

Jenessa Gjeltema and Lysa P. Posner

Title

THE USE OF INJECTABLE ALPHAXALONE AS A SINGLE AGENT AND IN COMBINATION WITH KETAMINE, XYLAZINE, AND MORPHINE IN THE CHILEAN ROSE TARANTULA, GRAMMOSTOLA ROSEA

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273942

Author

M. M. Granados, J. M. Dominguez, A. Fernandez-Sarmiento et al

Title

Anaesthetic and cardiorespiratory effects of a constant-rate infusion of alfaxalone in desflurane-anaesthetised sheep

Study date

2012

Authorising party

Public

Auth party contact address

Data no

273943

Author

Rachael A. Grundon, Gary A. Anderson, Michael Lynch et al

Title

Schirmer tear tests and intraocular pressures in conscious and anesthetized koalas (Phascolarctus cinereus)

Study date

2011

Authorising party

Public

Auth party contact address

Data no

273944

Author

M Giral, D C Garcia-Olmo, M Gomez-Juarez and I A Gomez de Segura

Title

Anaesthetic effects in the ferret of alfaxalone alone and in combination with medetomidine or tramadol: a pilot study

Study date

17 June 2014

Authorising party

Public

Auth party contact address

Data no

273945

Author

Gabriela C. Escalante, Julie A. Balko, Sathya K. Chinnadurai

Title

Intramuscular alfaxalone or butorphanol and midazolam in budgerigars. Comparison of the sedative effects of intramuscular alfaxalone with intramuscular butorphanol midazolam in the budgerigar (Melopsittacus undulatus)

Study date

2024

Authorising party

Public

Auth party contact address

Data no

273946

Author

N. Farrow, D. Miller, P. Cmielewski, M. Donnelley, R. Bright & D. W. Parsons

Title

Airway gene transfer in a non-human primate: Lentiviral gene expression in marmoset lungs

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273947

Author

J. Hedley, S. Woods and K. Eatwell

Title

The use of negative pressure wound therapy following subcarapacial abscess excision in a tortoise

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273948

Author

Lone L Hansen and Mads F Bertelsen

Title

Assessment of the effects of intramuscular administration of alfaxalone with and without medetomidine in Horsfield's tortoises (Agrionemys horsfieldii)

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273949

Author

Shot a Higuchil, Riku Yamadal, Asami Hashimotol et al

Title

Evaluation of a combination of alfaxalone with medetomidine and butorphanol for inducing
surgical anesthesia in laboratory mice

Study date

2016

Authorising party

Public

Auth party contact address

Data no

273950

Author

J.McC. Howell, K.R. Walker, L. Davies, and E. Dunton

Title

Adenovirus and adeno-associated virus-mediated delivery of human myophosphorylase cDNA and LacZ cDNA to muscle in the ovine model of McArdle's disease: Expression and re-expression of glycogen phosphorylase

Study date

2008

Authorising party

Public

Auth party contact address

Data no

273951

Author

EM Hoffman, K Garrett and RJT Doneley

Title

Pneumocoelom causing cloacal prolapse in a perentie monitor (Varanus giganteus)

Study date

2017

Authorising party

Public

Auth party contact address

Data no

273952

Author

Lauren E James, Catherine JA Williams, Mads F Bertelsen and Tobias Wang

Title

Anaesthetic induction with alfaxalone in the ball python (Python regius): dose response and effect of injection site

Study date

2018

Authorising party

Public

Auth party contact address

Data no

273953

Author

Sarah J. Karlen and Leah Krubitzer

Title

Effects of Bilateral Enucleation on the Size of Visual and Nonvisual Areas of the Brain

Study date

2009

Authorising party

Public

Auth party contact address

Data no

273954

Author

Michelle Kischinovsky, Anna Duse, Tobias Wang and Mads F Bertelsen

Title

Intramuscular administration of alfaxalone in red-eared sliders (Trachemys scripta elegans) - effects of dose and body temperature

Study date

2012

Authorising party

Public

Auth party contact address

Data no

273955

Author

Zdenek Knotek, Anna Hrda, Zora Knotkova, Sarka Trnkova, Vladimir Babak

Title

Alfaxalone anaesthesia in the green iguana (Iguana iguana)

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273956

Author

Z. Knotek

Title

Induction to inhalation anaesthesia in agamid lizards with alfaxalone

Study date

2017

Authorising party

Public

Auth party contact address

Data no

273957

Author

Angela M. Lennox

Title

ALFAXALONE AS AN INTRAMUSCULAR INDUCTION AGENT IN REPTILES

Study date

2011

Authorising party

Public

Auth party contact address

Data no

273958

Author

C. Lau, M. G. Ranasinghe, I. Shiels, H. Keates et al

Title

Plasma pharmacokinetics of alfaxalone after a single intraperitoneal or intravenous injection of Alfaxan in rats

Study date

2009

Authorising party

Public

Auth party contact address

Data no

273959

Author

Patience S Ndawana, Brighton T Dzikiti, Gareth Zeiler and Loveness N Dzikiti

Title

Determination of the Minimum Infusion Rate (MIR) of alfaxalone required to prevent purposeful movement of the extremities in response to a standardised noxious stimulus in goats

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273960

Author

Wayne M. Koster, David R. Dawson, Damien J. O'Mahony, Paul D. Moloney, David A. Crook

Title

Timing, Frequency and Environmental Conditions Associated with Mainstem Tributary Movement by a Lowland River Fish, Golden Perch (Macquaria ambigua)

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273961

Author

Z. Knotek

Title

Alfaxalone as an induction agent for terrapins and tortoises anaesthesia

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273962

Author

VL Liddle, C Naranjo and ME Bernays

Title

Anterior chamber collapse syndrome in a koala

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273963

Author

Bryan Markey, Charles Wan, Jon Hanger, Che Phillips, Peter Timms

Title

Use of quantitative real-time PCR to monitor the shedding and treatment of chlamydiae in the koala (Phascolarctos cinereus)

Study date

2007

Authorising party

Public

Auth party contact address

Data no

273964

Author

Amelie Mathieu, Nigel Caulkett, Patrick M. Stent and Helen M. Schwantje

Title

CAPTURE OF FREE-RANGING MULE DEER (ODOCOILEUS HEMIONUS) WITH A COMBINATION OF MEDETOMIDINE, AZAPERONE AND ALFAXALONE

Study date

2017

Authorising party

Public

Auth party contact address

Data no

273965

Author

L. M. McInnes, A. Gillett, U.M. Ryan, J. Austen, R.S.F. Campbell

Title

Trypanosoma irwini n. sp (Sarcomastigophora: Trypanosomatidae) from the koala (Phascolarctos cinereus)

Study date

2009

Authorising party

Public

Auth party contact address

Data no

273966

Author

L. M. McInnes, J. Hanger, G. Simmons, S.A. Reid and U. M. Ryan

Title

Novel trypanosome Trypanosoma gilletti sp. (Euglenozoa: Trypanosomatidae) and the extension of the host range of Trypanosoma copemani to include the koala (Phascolarctos cinereus)

Study date

2011

Authorising party

Public

Auth party contact address

Data no

273967

Author

Matthew W McMillan and Elizabeth A Leece

Title

Immersion and branchial/transcutaneous irrigation anaesthesia with alfaxalone in a Mexican axolotl

Study date

2011

Authorising party

Public

Auth party contact address

Data no

273968

Author

Larry J Minter, Kate M Bailey, Craig A Harms, Gregory A Lewbart and Lysa P Posner

Title

The efficacy of alfaxalone for immersion anesthesia in koi carp (Cyprinus carpio)

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273969

Author

Larry J. Minter, Craig A. Harms et al

Title

EFFICACY OF ALFAXALONE FOR INTRAVASCULAR ANESTHESIA AND EUTHANASIA IN BLUE CRABS (CALLINECTES SAPIDUS)

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273970

Author

Manuel Morici, Marco DiGiuseppe, Filippo Spadola, Matteo Oliveri et al

Title

Intravenous alfaxalone anaesthesia in leopard geckos (Eublepharis macularius)

Study date

2017

Authorising party

Public

Auth party contact address

Data no

272532

Author

Munehiro Shiraishi, MD, IZUDli Shibuya, PhD, Kouichiro Minami, MD, PhD, Yasuhito Uezono, MD, PhD, Takashi Okamoto, MD, Nabuyuki Yanagihara, PhD, Susumu Dena, MD, PhD, Yoichi Veta, MD, PhD, and Akio Shigematsu, MD, PhD

Title

A Neurosteroid Anesthetic, Alphaxalone, Inhibits' Nicotinic Acetylcholine Receptors in Cultured Bovine Adrenal Cilromaffin Cells

Study date

2002

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272533

Author

Weir, C. J.et al

Title

The interaction of anaesthetic steroids with recombinant glycine and GABAA receptors

Study date

May 2004

Authorising party

Public

Auth party contact address

Data no

272534

Author

Jun TAMURA1), Tomohito ISHIZUKA1), Sho FUKUI1), Norihiko OYAMA1), Kodai KAWASE1), Takaharu ITAMI1), Kenjiro MIYOSHI1), Tadashi SANO2), Kirby PASLOSKE3) and Kazuto YAMASHITA1

Title

Sedative effects of intramuscular alfaxalone administered to cats

Study date

19 March 2015

Authorising party

Public

Auth party contact address

Data no

272535

Author

D Rodrigo-Mocholi, E Escudero, E Belda, FG Laredo, V Hernandis & P Marin

Title

Pharmacokinetics and effects of alfaxalone after intravenous and intramuscular administration to cats

Study date

21 March 2018

Authorising party

Public

Auth party contact address

Data no

272536

Author

Diego Rodrigo-Mocholi, Eliseo Belda, Tim Bosmans & Francisco G. Laredo

Title

Clinical efficacy and cardiorespiratory effects of intramuscular administration of alfaxalone alone or in combination with dexmedetomidine in cats

Study date

2016

Authorising party

Public

Auth party contact address

Data no

272537

Author

Bruno H Pypendopa, Linda S Bartera, Peter J Pascoea, MG Ranasingheb & Kirby Pasloskeb

Title

Hemodynamic effects of subclinical, clinical and supraclinical plasma alfaxalone concentrations in cats

Study date

2019

Authorising party

Public

Auth party contact address

Data no

272538

Author

Jurox Pty Limited

Title

An in vivo dose ranging study evaluating the pharmacokinetics, pharmacodynamics and safety of formulation RD0327 as an anaesthetic and sedative in rabbits after IV and IM administration.

Study date

Nov 2015

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272539

Author

A.C. Hyslop; A.M. Shelby;

Title

Efficacy of butorphanol and alfaxalone administered intramuscularly in cats at clinical doses in one syringe or separate syringes for the purpose of sedation and blood collection.

Study date

September 12, 2021

Authorising party

Public

Auth party contact address

Data no

272540

Author

Jurox Inc. (USA)

Title

Compatibility and efficacy of butorphanol and Alfaxan Multidose administered IM in cats at clinically relevant doses in one syringe or separate syringes for the purpose of sedation and blood collection (60 mL).

Study date

31JUL2019

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272541

Author

Andrew Hyslop,

Title

The efficacy of alfaxalone and butorphanol administered intramuscularly in cats at clinical doses 3 in one syringe or separate syringes for the purpose of sedation and blood collection.

Study date

May 2024

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272543

Author

Anon

Title

Part 4 Efficacy Detailed and Critical Summary

Study date

Nov 2016

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272545

Author

Jurox (UK) Limited

Title

Alfaxan Multidose 10 mg/ml solution for injection for dogs, cats and pet rabbits Part

Study date

April 2017

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272557

Author

Molly Varga BVetMed DZooMed MRCVS

Title

Challenges encountered when anaesthetizing rabbits

Study date

2014

Authorising party

Public

Auth party contact address

Data no

272558

Author

Jurox Pty Limited

Title

A Multicentre Clinical Trial in Rabbits Evaluating the Efficacy and Safety of Formulation RD0327 Adm inistered intravenously to Veterinary Patients for Induction of i\naesthesia.

Study date

31 May 2016

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272559

Author

Jurox Pty Limited

Title

A Multicentre Clinical Trial in Rabbits Evaluating the Efficacy and Safety of Formulation RD0327 Administered Intravenously to Veterinary Patients for Induction of Anaesthesia

Study date

06 Feb 15

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272560

Author

Molly Varga BVetMed DZooMed MRCVS

Title

Challenges encountered when anaesthetizing rabbits

Study date

2014

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272561

Author

Esther van Praagf

Title

Anesthesia of the rabbit Part II: lntra anesthett'C period* and its monitoring

Study date

OCTOBER 2003

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272562

Author

Molly Varga

Title

TEXTBOOK OF RABBIT MEDICINE

Study date

2014

Authorising party

Public

Auth party contact address

Data no

272563

Author

Paul Flecknell

Title

Laboratory Animal Anaesthsia

Study date

May 2024

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272564

Author

Dr Narelle Walter

Title

Rabbit Anaesthesia ASAP Webinar 2014

Study date

2014

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272565

Author

Anon

Title

Alfaxan Multidose 10 mg/ml Solution for Injection for Dogs, Cats and Pet Rabbits CONSOLIDATED LIST OF QUESTIONS

Study date

19/09/2017

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272566

Author

Anon

Title

DAY 30 CLOQ + APPLICANT'S RESPONSES + RMS COMMENTS

Study date

2024

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

273987

Author

M. N. Rowland

Title

Fibrosing myopathy of the temporal muscles causing lockjaw in a veiled chameleon (Chamaeleo calyptratus)

Study date

2011

Authorising party

Public

Auth party contact address

Data no

273988

Author

Kathryn L. Perrin, Jesper B. Nielsen, Anders F. Thomsen and Mads F. Bertelsen

Title

ALFAXALONE ANESTHESIA IN THE BENGALESE FINCH (LONCHURA DOMESTICA)

Study date

2017

Authorising party

Public

Auth party contact address

Data no

273989

Author

A. Sadoun, K. Strelnikov, E. Bonte, C. Fonta and P. Girard

Title

Cognitive impairment in a young marmoset reveals lateral ventriculomegaly and a mild hippocampal atrophy: a case report

Study date

2015

Authorising party

Public

Auth party contact address

Data no

273990

Author

D Strahl-Heldreth, S Clark-Price, S Keating, L Graham and S Chinnadurai

Title

Abstract - The effect of intracoelomic alfaxalone on righting reflex and response to Semmes-
Weinstein monofilaments in the common garter snake (Thamnophis sirtalis)

Study date

2017

Authorising party

Public

Auth party contact address

Data no

273991

Author

Sripriya Sundararajan, Sami C. Dodhy, Roland N. Pittman, and Stephen J. Lewis

Title

Effects of non-leukocyte-reduced and leukocyte-reduced packed red blood cell transfusions on oxygenation of rat spinotrapezius muscle

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273992

Author

Inge Thas

Title

Acquired salivary mucoceles in two domestic ferrets (Mustela putorius furo)

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273993

Author

T. Franciscus Scheelings, Rupert T. Baker, Gerry Hammersley, Kim Hollis, Ian Elton and Peter Holz

Title

A Preliminary Investigation into the Chemical Restraint of Selected Australian Squamate Species with Alfaxalone

Study date

2011

Authorising party

Public

Auth party contact address

Data no

273994

Author

T. Franciscus Scheelings

Title

Use of Intravenous and Intramuscular Alfaxalone in Macquarie River Turtles (Emydura macquarii)

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273995

Author

Molly K Shepard, Stephen Divers, Christina Braun and Erik H Hofmeister

Title

Pharmacodynamics of alfaxalone after single-dose intramuscular administration in red-eared sliders (Trachemys scripta elegans): a comparison of two different doses at two different ambient temperatures

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273996

Author

Izidora Sladakovic, Robert S. Johnson and Larry Vogelnest

Title

Evaluation of Intramuscular Alfaxalone in Three Australian Frog Species (Litoria caerulea, Litoria aurea, Litoria booroolongensis)

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273997

Author

Parkpoom Siriarchavatana, Jessica D Ayers and Lon V Kendall

Title

Anesthetic Activity of Alfaxalone Compared with Ketamine in Mice

Study date

2016

Authorising party

Public

Auth party contact address

Data no

273998

Author

A A Thomas, M C Leach and P A Flecknell

Title

An alternative method of endotracheal intubation of common marmosets (Callithrix jacchus)

Study date

2012

Authorising party

Public

Auth party contact address

Data no

273999

Author

M-D Torres, A. Andaluz, F. Garcia, L. Fresno and X. Moll

Title

Effects of an intravenous bolus of alfaxalone versus propofol on intraocular pressure in sheep.

Study date

2012

Authorising party

Public

Auth party contact address

Data no

274000

Author

Jordi L Tremoleda, Angela Kerton and Willy Gsell

Title

Anaesthesia and physiological monitoring during in vivo imaging of laboratory rodents: considerations on experimental outcomes and animal welfare

Study date

2012

Authorising party

Public

Auth party contact address

Data no

274001

Author

Andrew Tribe, Jon Hanger, Ian J. McDonald, Jo Loader, Ben J. Nottidge et al

Title

A Reproductive Management Program for an Urban Population of Eastern Grey Kangaroos (Macropus giganteus)

Study date

2014

Authorising party

Public

Auth party contact address

Data no

274002

Author

Silvia Villaverde-Morcillo, Javier Benito, Ruben Garcia-Sanchez et al

Title

COMPARISON OF ISOFLURANE AND ALFAXALONE (ALFAXAN) FOR THE INDUCTION OF ANESTHESIA IN FLAMINGOS (PHOENICOPTERUS ROSEUS) UNDERGOING ORTHOPEDIC SURGERY

Study date

2014

Authorising party

Public

Auth party contact address

Data no

274003

Author

Larry Vogelnest

Title

Chapter 33 - Marsupialia (Marsupials)

Study date

2014

Authorising party

Public

Auth party contact address

Data no

274004

Author

VP Walsh, M Gieseg, PM Singh , SL Mitchinson and JP Chambers

Title

A comparison of two different ketamine and diazepam combinations with an alphaxalone and medetomidine
combination for induction of anaesthesia in sheep

Study date

2011

Authorising party

Public

Auth party contact address

Data no

274005

Author

Guido Wassink, Laura Bennet, Joanne O. Davidson, Jenny A. Westgate, Alistair J. Gunn

Title

Pre-Existing Hypoxia Is Associated with Greater EEG Suppression and Early Onset of Evolving Seizure Activity
during Brief Repeated Asphyxia in Near-Term Fetal Sheep

Study date

2013

Authorising party

Public

Auth party contact address

Data no

274006

Author

Courtney Waugh, Shahneaz Ali Khan, Scott Carver, Jonathan Hanger et al

Title

A Prototype Recombinant-Protein Based Chlamydia pecorum Vaccine Results in Reduced Chlamydial Burden and Less Clinical Disease in Free-Ranging Koalas (Phascolarctos cinereus)

Study date

2016

Authorising party

Public

Auth party contact address

Data no

274007

Author

Kate L White, Stuart Paine and John Harris

Title

A clinical evaluation of the pharmacokinetics and pharmacodynamics of intravenous alfaxalone in cyclodextrin in male and female rats following a loading dose and constant rate infusion

Study date

2017

Authorising party

Public

Auth party contact address

Data no

274008

Author

Taylor J. Yaw, Christoph Mans, Christoph Mans and Kurt Sladky

Title

Comparative Efficacy of Alfaxalone-Midazolam and Dexmedetomidine-Midazolam Sedation in Ball
Pythons (Python regius)

Study date

2017

Authorising party

Public

Auth party contact address

Data no

274009

Author

T. J. Yaw, C. Mans, S. M. Johnson, G. A. Doss and K. K. Sladky

Title

Effect of injection site on alfaxalone induced sedation in ball pythons (Python regius)

Study date

2018

Authorising party

Public

Auth party contact address

Data no

274010

Author

Trish Farry, Cora Lau, Helen Keates, Kirby Pasloske, Solomon Woldeyohannes, Rachel Allaven and Wendy Goodwin

Title

Comparison of two formulations of alfaxalone for immersion anaesthesia in laboratory zebrafish (Danio
rerio)

Study date

2022

Authorising party

Public

Auth party contact address

Data no

274011

Author

Zoetis Australia Pty Ltd

Title

Literature summary table Part 8a Cat

Study date

June 2024

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

274012

Author

Carolyn M. Doerning, Michael P. Bradley, Patrick A. Lester, Megan H. Nowland

Title

Accepted Manuscript - Effects of subcutaneous alfaxalone alone and in combination with dexmedetomidine
and buprenorphine in guinea pigs (Cavia porcellus)

Study date

2018

Authorising party

Public

Auth party contact address

Data no

274013

Author

Zoetis Australia Pty Ltd

Title

Literature Part 8c minor species summary table

Study date

June 2024

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

273972

Author

L. M. McInnes, A. Gillett, J. Hanger, S.A. Reid and U. M. Ryan

Title

The potential impact of native Australian trypanosome infections on the health of koalas (Phascolarctos cinereus)

Study date

2011

Authorising party

Public

Auth party contact address

Data no

273973

Author

Bradley J. O'Hagan and Shane R. Raidal

Title

Surgical Removal of Retrobulbar Hemangioma in a Goldfish (Carassius auratus)

Study date

2006

Authorising party

Public

Auth party contact address

Data no

273974

Author

Annabelle Olsson, David Phalen and Christina Dart

Title

Preliminary studies of alfaxalone for intravenous immobilization of juvenile captive estuarine crocodiles (Crocodylus porosus) and Australian freshwater crocodiles (Crocodylus johnstoni) at optimal and selected sub-optimal thermal zones

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273975

Author

Lily Parkinson and Christoph Mans

Title

Anesthetic and Postanesthetic Effects of Alfaxalone-Butorphanol Compared with Dexmedetomidine-Ketamine in Chinchillas (Chinchilla lanigera)

Study date

2017

Authorising party

Public

Auth party contact address

Data no

273976

Author

Lauretta Passarelli, Marcello G. P. Rosa, Michela Gamberini, Sophia Bakola, Kathleen J. Burman,

Title

Cortical Connections of Area V6Av in the Macaque: A Visual-Input Node to the Eye/Hand Coordination System

Study date

2011

Authorising party

Public

Auth party contact address

Data no

273977

Author

David Perpinan, Albert Martinez-Silvestre, Ferran Bargallo, Marco Di Giuseppe et al

Title

Correlation between endoscopic sex determination and gonad histology in pond sliders, Trachemys scripta (Reptilia: Testudines: Emydidae)

Study date

2016

Authorising party

Public

Auth party contact address

Data no

273978

Author

Kathryn L. Perrin and Mads F. Bertelsen

Title

Intravenous Alfaxalone and Propofol Anesthesia in the Bearded Dragon (Pogona vitticeps)

Study date

2017

Authorising party

Public

Auth party contact address

Data no

273979

Author

Brianne E. Phillips, Lysa P. Posner, Gregory A. Lewbart, Emily F. Christiansen and Craig A. Harms

Title

Effects of alfaxalone administered intravenously to healthy yearling loggerhead sea turtles (Caretta caretta) at three different doses

Study date

2017

Authorising party

Public

Auth party contact address

Data no

273980

Author

Kylie Pon, Nigel Caulkett and Murray Woodbury

Title

EFFICACY AND SAFETY OF A MEDETOMIDINE-AZAPERONE-ALFAXALONE COMBINATION IN CAPTIVE WHITE-TAILED DEER (ODOCOILEUS VIRGINIANUS)

Study date

2016

Authorising party

Public

Auth party contact address

Data no

273981

Author

Lysa Pam Posner, Kate M. Bailey, Erika Y. Richardson, Alison A. Motsinger-Reif and Craig A. Harms

Title

ALFAXALONE ANESTHESIA IN BULLFROGS (LITHOBATES CATESBEIANA) BY INJECTION OR IMMERSION

Study date

2013

Authorising party

Public

Auth party contact address

Data no

273982

Author

P. S. Reynolds, Seokhan Kyle Song, Francisco J. Tamariz and R. Wayne Barbee

Title

Hypertension and Vulnerability to Hemorrhagic Shock in a Rat Model

Study date

2014

Authorising party

Public

Auth party contact address

Data no

273983

Author

C.W.H. Rumball, F.H. Bloomfield, J.E. Harding

Title

Cardiovascular Adaptations to Pregnancy in Sheep and Effects of Periconceptional Undernutrition

Study date

2008

Authorising party

Public

Auth party contact address

Data no

273984

Author

Charlotte Romeijer, Hugues Beaufrere, Delphine Laniesse, Sarah M. Birch et al

Title

Vomiting and Gastrointestinal Obstruction in a Red-Footed Tortoise (Chelonoidis carbonaria)

Study date

2016

Authorising party

Public

Auth party contact address

Data no

272548

Author

N. J. Grint, H. E. Smith, J. M. Senior

Title

Clinical evaluation of alfaxalone in cyclodextrin for the induction of anaesthesia in rabbits

Study date

2008

Authorising party

Public

Auth party contact address

Data no

272549

Author

P. L. TOUTAIN & A. BOUSQUET-MELOU

Title

Plasma clearance

Study date

2004

Authorising party

Public

Auth party contact address

Data no

272550

Author

Jurox Pty Limited

Title

An in vivo dose ranging study evaluating the pharmacokinetics, pharmacodynamics and safety of formulation RD0327 as an anaesthetic and sedative in rabbits after IV and IM administration

Study date

4 Nov 2015

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272551

Author

Jurox Pty Limited

Title

An in vivo dose ranging study evaluating the pharmacokinetics, pharmacodynamics and safety of formulation RD0327 as an anaesthetic and sedative in rabbits after IV and IM administration.

Study date

20 March 2013

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272555

Author

R. Navarrete-Calvo, R. J. Gomez-Villamandos, J. Morgaz, J. Manuel Dominguez, A. Fernandez-Sarmiento, P. Munoz-Rascon, I. Lopez Villalba, M. Del Mar Granados

Title

Cardiorespiratory, anaesthetic and recovery effects of morphine combined with medetomidine and alfaxalone in rabbits

Study date

January 25, 2014

Authorising party

Public

Auth party contact address

Data no

272556

Author

Alexandru C Tutunaru, Alexandru Sonea, Pierre Drion, Didier Serteyn & Charlotte Sandersen

Title

Anaesthetic induction with alfaxalone may produce hypoxemia in rabbits premedicated with fentanyl/ droperidol

Study date

2013

Authorising party

Public

Auth party contact address

Data no

272554

Author

Jurox Pty Limited

Title

The Safety and Pharmacokinetics of Formulation RD0327 Administered Intravenously at Clinical and Supra-Clinical Dose Rates on Repeated Occasions in Rabbits.

Study date

17 Dec 2014

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272552

Author

Jurox Pty Limited

Title

Validation of an HPLC-MS/MS Method for the Quantification of Alfaxalone in Rabbit Plasma

Study date

22 June 2015

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

273985

Author

Mark Rowland

Title

Veterinary care of bearded dragons

Study date

2009

Authorising party

Public

Auth party contact address

Data no

273986

Author

Mark Rowland

Title

Veterinary care of snakes

Study date

2011

Authorising party

Public

Auth party contact address

Data no

272546

Author

Jurox (UK) Limited

Title

Alfaxan Multidose 10 mg/ml solution for injection for dogs, cats and pet rabbits Part 4

Study date

April 2017

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272547

Author

Jurox (UK) Limited

Title

Alfaxan Multidose 10 mg/ml solution for injection for dogs, cats and pet rabbits Part 4

Study date

April 2017

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272544

Author

Jurox (UK) Limited

Title

Alfaxan Multidose 10 mg/ml solution for injection for dogs, cats and pet rabbits Part 3

Study date

April 2017

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272526

Author

Zoetis Australia Pty Ltd

Title

Part 8a Summary Report

Study date

April 2024

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272527

Author

Zoetis Australia Pty Ltd

Title

Part 8b Summary Report

Study date

May 2024

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272528

Author

Zoetis Australia Pty Ltd

Title

Part 8c Summary Report

Study date

May 2024

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272529

Author

Anon

Title

Alfaxan label

Study date

May 2024

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272530

Author

Ming-Chu Xi, Francisco R. Morales,and Michael H. Chas

Title

Interactions between GABAergic and Cholinergic Processes in the Nucleus Pontis Oralis: Neuronal Mechanisms Controlling Active (Rapid Eye Movement) Sleep and Wakefulness

Study date

Nov 24, 2004

Authorising party

Public

Auth party contact address

Data no

272531

Author

M.L AL-Khawashld, R.A. Ghaleb, Nawal EI-Gawhary, M.K. l\iadkour, A.M. Radwan and A.M. El-Sherhiay

Title

EFFECIS OF ALTHESIN AND ITS STFROIDAL COMPONENTS ON NEUROMUSCULAR TRANSi'dISSION AND SKELETAL MUSCLE

Study date

1979

Authorising party

Public

Auth party contact address

Data no

273971

Author

NHMRC

Title

A guide to the use of Australian native mammals in biomedical research Public Consultation Draft

Study date

March 2012

Authorising party

Public

Auth party contact address

Data no

272542

Author

Anon

Title

Part 3 Safety Detailed and Critical Summary

Study date

Nov 2016

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272567

Author

Wendy Goodwin et al.

Title

JX1501-K007 An in vivo dose characterization study evaluating the pharmacodynamics and safety of formulation RD0387 as a sedative/anaesthetic in cats after IM administration

Study date

2022

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272568

Author

Wendy Goodwin et al.

Title

JX1501-L031 Comparative plasma pharmacokinetics and bioavailability of alfaxalone in cats single dose Alfaxan Multidose IV versus RD0387 IM at 5 mg/kg body weight

Study date

29 Dec 2024

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272553

Author

Jurox Pty Limited

Title

The Safety and Pharmacokinetics of Fo1mulation RD0327 Administered Intravenously at Clinical and Supra-Clinical Dose Rates on Repeated Occasions in Rabbits.

Study date

4 July 2016

Authorising party

Applicant

Auth party contact address

LEVEL 6, 5 RIDER BOULEVARD RHODES Australia

Data no

272569

Author

Rowe RC, Sheskey PJ, Cook WG, and Fenton ME.

Title

Chlorcresol

Study date

2012

Authorising party

Public

Auth party contact address

Data no

272570

Author

Baggot JD

Title

Principles of drugs disposition in domestic animals.

Study date

1977

Authorising party

Public

Auth party contact address

Data no

272571

Author

Bridges J, French MR, Smith RL and Williams RT

Title

The fate of benzoic acid in various species

Study date

1970

Authorising party

Public

Auth party contact address

Data no

272572

Author

Court M

Title

Feline drug metabolism and disposition: pharmacokinetic evidence for species differences and molecular mechanisms.

Study date

2013

Authorising party

Public

Auth party contact address

Data no

272573

Author

Armstrong EJ and Tocco TP

Title

principles of pharmacology

Study date

2008

Authorising party

Public

Auth party contact address

Data no

272574

Author

Connally HE, Hamar DW and Thrall M,

Title

Inhibition of canine and feline alcohol dehydrogenase activity by fomepizole.

Study date

2000

Authorising party

Public

Auth party contact address

Data no

272575

Author

Ettinger SJ and Feldman EC (editors)

Title

TEXTBOOK OF VETERINARY INTERNAL MEDICINE

Study date

1995

Authorising party

Public

Auth party contact address

Date

11 Jul 2024

Application No

144373

Product/Active constituent Name

Metacoxx 30 Horse Paste

Application details

Product name:

Metacoxx 30 Horse Paste

Product number:

83019

Applicant Name:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

Application purpose and description of use:

Variation of product registration label approval to update the shelf life.

Active constituents:

82924 - Meloxicam

Description of data provided:

Data no

272706

Author

Dechra Veterinary Products (Australia)

Title

Module 2.4 - Chemistry and Manufacture

Study date

June 2024

Authorising party

Applicant

Auth party contact address

2 Cal Close Somersby Australia

Data no

272707

Author

Dechra Veterinary Products (Australia)

Title

Stability Tables

Study date

June 2024

Authorising party

Applicant

Auth party contact address

2 Cal Close Somersby Australia

Date

10 Jul 2024

Application No

144686

Product/Active constituent Name

Methoxyfenozide

Application details

Product name:

Methoxyfenozide

Active name:

Methoxyfenozide

Applicant Name:

CORTEVA AGRISCIENCE AUSTRALIA PTY LTD

Application purpose and description of use:

Approval of a new source of methoxyfenozide for use in agricultural chemical products.

Description of data provided:

Data no

274166

Author

Luo, S.

Title

Analysis of five representative production batches of methoxyfenozide technical grade active ingredient (TGAI) to identify and quantify methoxyfenozide and its associate impurities

Study date

9 March 2020

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

274167

Author

Luo, S.

Title

Analysis of five representative production batches of methoxyfenozide technical grade active ingredient (TGAI) to identify and quantify methoxyfenozide and its associate impurities

Study date

9 March 2020

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

274168

Author

Luo, S.

Title

Study of relevant impurities in five batches of methoxyfenozide technical

Study date

28 February 2020

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

274169

Author

Jinfeng, C.

Title

Analysis of three commercial batches (lot 202310003, 202310004, 202310005)

Study date

3 October 2023

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

274164

Author

Speak, T.

Title

Methoxyfenozide Declaration of Composition

Study date

9 July 2024

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

274165

Author

Danqun, C.

Title

Manufacturing process description for methoxyfenozide

Study date

2021

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

274163

Author

Speak, T.

Title

Part 2.Chemistry & Manufacture Methoxyfenozide

Study date

9 July 2024

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Date

10 Jul 2024

Application No

143971

Product/Active constituent Name

PREV-AM CONTACT INSECTICIDE, MITICIDE and FUNGICIDE

Application details

Product name:

PREV-AM CONTACT INSECTICIDE, MITICIDE and FUNGICIDE

Product number:

89248

Applicant Name:

ORO AGRI INC

Application purpose and description of use:

Variation of product registration and label approval to add additional crops and pests.

Active constituents:

66412 - ORANGE OIL (COLD PRESSED)

Description of data provided:

Data no

271560

Author

Tetuan, B

Title

ES19 Determination of efficacy of formulated product 030-S-3-D against whiteflies on cabbage under open field conditions in one site in Spain.

Study date

2019

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271561

Author

Su??er, J

Title

ES20 Determination of efficacy of formulated product 030-S-3-D against whiteflies on cabbage under open field conditions in one site in Spain.

Study date

2020

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271562

Author

Renovell, A

Title

ES21 EFFICACY EVALUATION OF 030-S-3-D AGAINST WHITEFLIES IN OPEN FIELD CABBAGE. FRANCE EPPOMED.

Study date

2020

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271563

Author

Chau, E

Title

ES22 Evaluation of OR-009-A for control of green peach aphid (Myzus persicae) in capsicum cv. Plato

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271564

Author

Chau, E

Title

ES23 Evaluation of OR-009-A for control of green peach aphid (Myzus persicae) in capsicum cv. Warlock

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271565

Author

Cookson, L & Watson, C

Title

ES24 Evaluation of OR 009-A for the control of aphids in capsicums

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271566

Author

Faint, M

Title

ES25 To evaluate OR 009-A for the control of green peach aphid (Myzus persicae) in capsicum cv.6947

Study date

2023

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271567

Author

Chau, E

Title

ES26 Evaluation of OR-009-A 60 ME for control of green peach aphid (Myzus persicae) and tomato thrips (Frankliniella schultzei) in eggplant

Study date

2021

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271568

Author

Chau, E

Title

ES27 Evaluation of OR-009-A for control of Two-spotted mites (Tetranychus urticae) and western flower thrips (Frankliniella occidentalis) in snow peas cv. Green Devil

Study date

2021

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271569

Author

Chau, E

Title

ES28 Evaluation of OR-009-A pest and beneficial in zucchini cv. Congo

Study date

2023

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271570

Author

Chau, E

Title

ES29 Evaluation of OR-009-A for insect control in lychee cv. Kwai Mai Pink

Study date

2021

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271571

Author

Norwall, M

Title

ES30 The Effects of OR009 on erinose mites and scale in lychee and crop safety of OR009 on lychee.

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271572

Author

Norwall, M

Title

ES31 The Effects of OR009 on erinose mites and mealybug in lychee and crop safety of OR009 on Lychee

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271573

Author

Chau, E

Title

ES32 Evaluation of OR-009-A 60 for control of powdery mildew (Podosphaera leucotricha) in apple cv. Bravo

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271574

Author

Pung, H, Kohler, D & Cross, S

Title

ES33 Efficacy of OR009-A for control of powdery mildew (Podosphaera leucotricha) in apples cv. Royal Gala

Study date

2021

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271575

Author

Gibson, D

Title

ES34 Efficacy evaluation of 030-S-3-D against powdery mildew in Apples.

Study date

2019

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271576

Author

CARDIET, G

Title

ES35 Essicacy evaluation of 030-S-3-D against Podosphaera leucotricha in apple trees.

Study date

2019

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271577

Author

Zanetti, DG

Title

ES36 Evaluation of preventive/curative efficacy of 030-S-3-D and PREV-AM PLUS solo and in mix against powdery mildew and secondary against apple scab in Italy.

Study date

2017

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271578

Author

Donati, G

Title

ES37 Efficacy evaluation of 030-S-3-D against Powdery mildew (Podosphaera leucotricha - PODOLE) on apple.

Study date

2018

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271579

Author

Chau, E

Title

ES38 Evaluation of OR-009-A 60 ME for control of woolly aphid (Eriosoma lanigerum) in apple cv. Granny Smith

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271580

Author

Pung, H, Kohler, D & Cross, S

Title

ES39 Efficacy of OR009-A for control of woolly aphid (Eriosoma lanigerum) in apples cv. Fuji

Study date

2021

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271581

Author

Chau, E

Title

ES40 Evaluation of OR-009-A for control of apple woolly aphid (Eriosoma lanigerum) in apple

Study date

2023

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271582

Author

Su??er, J

Title

ES41 Determination of Efficacy of 030-S-3-D Against Eriosoma lanigerum on Apple under Field Conditions in One Site in Spain

Study date

2018

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271583

Author

Martorell, N

Title

ES42 Efficacy of 030-S-3-D against Eriosoma lanigerum on apple. Spain, 2018.

Study date

2018

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271584

Author

Cardiet, G

Title

ES43 Efficacy evaluation of 030-S-3-D against Erisoma lanigerum in apple trees.

Study date

2018

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271585

Author

Chau, E

Title

ES44 Evaluation of OR-009-A for the control of long-tailed mealybug (Pseudococcus longispinus) in apples

Study date

2024

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271586

Author

Chau, E

Title

ES45 Evaluation of OR009-A for the control of western flower thrips (Frankliniella occidentalis) in green bean cv. SVGG1312

Study date

2023

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271543

Author

Chau, E

Title

ES1 Efficacy of PREV-AM against downy mildew in onions.

Study date

2021

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271544

Author

Chau, E

Title

ES2 Efficacy of PREV-AM against downy mildew in onions.

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271545

Author

Chau, E

Title

ES3 Efficacy of PREV-AM against onion thrips in onions.

Study date

2021

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271546

Author

Chau, E

Title

ES4 Efficacy of PREV-AM against onion thrips in onions.

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271547

Author

Chau, E

Title

ES5 Efficacy of PREV-AM against onion thrips in onions.

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271548

Author

Pung, H, Cross, S & Batt, P

Title

ES6 Evaluations on the effects of OR-009A and OR-097A on the control of onion thrips (Thrips tabaci) in onion cv. Plutonus

Study date

2023

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271549

Author

Ashton, J

Title

ES7 The efficacy of 030-S-3-D against Thrips in onion.

Study date

2019

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271550

Author

Lisbino, S & Esposito, V

Title

ES8 Efficacy and selectivity evaluation of 030-S-3-D for the control of Thrips tabaci in Scallion (Allium cepa), Italy 2020. Open field.

Study date

2020

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271551

Author

Lisbino, S & Esposito, V Evaluate the efficacy and selectivity of 030-S-3-D for the control of Thrips in Onion, Italy, 2019.

Title

ES9

Study date

2019

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271592

Author

Hands, H

Title

ES51 Evaluation of PREV-AM for control of mites in wine grapes

Study date

2021

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271593

Author

Chau, E

Title

ES52 Evaluation of OR-009-A for control of botrytis (Botrytis cinerea) in Strawberries cv. Red Rhapsody

Study date

2021

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271594

Author

McDougall, L

Title

ES53 Evaluation of OR-009-A, OR-159-B, OR-278-F and AGS132 for the control of grey mould (Botrytis cinerea) in grapevines cv. Chardonnay.

Study date

2021

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271595

Author

Braybrook, D

Title

ES54 Evaluation of the efficacy and crop safety of various products on Botrytis

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271596

Author

Hiebler, A

Title

ES55 Field test to evaluate the efficacy of 030-S-3-D and 030-S-1-A Against Botrytis cinerea

Study date

2016

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271597

Author

Richter, T

Title

ES56 Field test to evaluate the efficacy of OR-030-A on Botritis fuckeliana in grapevine.

Study date

2015

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271598

Author

Richter, T

Title

ES57 Field test to evaluate the efficacy of OR-030-A on Botritis fuckeliana in grapevine.

Study date

2015

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271599

Author

H????bner, H

Title

ES58 Determination of efficacy of 030-S-3-D against Grey Mould (Botrytis cinerea) in grapevine

Study date

2020

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271600

Author

Heinzmann, S

Title

ES59 Determination of efficacy of 030-S-3-D against Grey Mould (Botrytis cinerea) in grapevine

Study date

2020

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271602

Author

Chau, E

Title

ES61 Evaluation of OR-009A for control of serpentine leaf miner (Liriomyza huidobrensis) in green bean cv. Tendergreen

Study date

2023

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271603

Author

Sumner, MW

Title

ES62 Comparison of PREV-AM 141.5 SL with a spray program containing Prosper 500 EC, Topas 100 EC, Talendo 200 EC and Mycloss Xtra 200 EW each alone or with WETCIT 141.5 SL for the control of powdery mildew (Erysiphe necator) in grapevines cv. Chenin Blanc

Study date

2016

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271604

Author

Frost, P & Pung, H

Title

Evaluation of OR-159 and Prevam for foliar and fruit disease control in wine grapes.cv. Chardonnay

Study date

2021

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271605

Author

Giner, J

Title

ES64 Detemintaion of efficacy of 030-S-3-D against powdery mildew on grapevine in South Europe under filed conditions.

Study date

2017

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271606

Author

Pedro, J

Title

ES65 Evaluation of 030-S-3-A-1 Fungicide efficacy on the control of powdery mildew (Erysiphe necator-UNCINE) in grapevine.

Study date

2019

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271607

Author

Richter, T

Title

ES66 Field test to evaluate the efficacy of OR-030-D on powdery mildew (Erysiphe necator) in grapevines.

Study date

2016

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271608

Author

Hiebler, A

Title

ES67 Field test to evaluate the eiifcacy of 030-S-3-D and 030-S-1-A against Uncinula necator.

Study date

2016

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271609

Author

Coster, S

Title

ES68 Evaluation of OR 009-A for control of Two Spotted Mite in Citrus

Study date

2023

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271610

Author

Norwall, M

Title

ES69 The Effects of OR009 on mites in lemons compared with Abamectin and Bio Pest Oil Crop safety of OR009 on Citrus

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271611

Author

Giner, J

Title

ES70 Determination of efficacy of 030-S-3-D against Tetranychus urticae on citrus tree under field conditions in one site in Spain.

Study date

2017

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271612

Author

Su????er, J

Title

ES71 Determination of Efficacy of 030-S-3-D Against Panonychus citri on Citrus in One Site in South Europe Under Field Conditions

Study date

2017

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271613

Author

Lopez, F

Title

ES72 Efficacy and selectivity of 030-S-3-D & 030-S-1-A against Texas citrus mite (Eutetranychus banksi) on Citrus, Portugal 2016

Study date

2016

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271614

Author

Su????er, J

Title

ES73 Determination of Efficacy of 030-S-3-D Against Eutetranychus sp. on Citrus in One Site in South Europe Under Field Conditions

Study date

2017

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271615

Author

Chau, E

Title

ES74 Evaluation of OR-009-A for control of longtailed mealybug (Pseudococcus longispinus) in Oranges cv. Rhode

Study date

2021

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271616

Author

Kerns, DL

Title

ES75 Chemical Control and Integrated Pest Management of Woolly Whitefly

Study date

2007

Authorising party

Public

Auth party contact address

Data no

271617

Author

Norwall, M

Title

ES76 The Effects of OR009 on mites in Pawpaw compared with Abamectin and Bio Pest Oil Crop safety of OR009 on Citrus

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271618

Author

Norwall, M

Title

ES77 The Effects of OR009 on mites in Pawpaw compared with Abamectin and Bio Pest Oil Crop safety of OR009 on Citrus

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271553

Author

Chau, E

Title

ES11 Evaluation of OR-009-A and OR-618 for the control of insect pests in celery cv. Kelvin

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271554

Author

Chau, E

Title

ES12 Evaluation of OR-009-A for control of serpentine leafminer (Liriomyza huidobrensis) in celery cv. Kelvin

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271555

Author

Chau, E

Title

ES13 Evaluation of OR-009-A 60 ME for control of green peach aphid (Myzus persicae) in cabbage cv. Warrior

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271556

Author

Whaley, C

Title

ES14 THE EFFICACY OF 0303-S-3-D ON APHIDS IN LETTUCE

Study date

2019

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271557

Author

Stognienko, M

Title

ES15 Efficacy of 030-S-3-D against Mealy Cabbage Aphid (Brevicoryne brassicae) in brussels sprouts in Germany, 2017

Study date

2017

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271558

Author

Kohler, D, Cross, S & Batt, P

Title

ES17 Efficacy of OR-009-A for control of cabbage aphid (Brevicoryne brassicae) in broccoli cv. Ironman

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271589

Author

Mansour, R, Grissa Lebdi, K & Rezgui, S

Title

ES48 Assessment of the performance of some new insecticides for the control of the vine mealybug Planococcus ficus in a Tunisian vineyard

Study date

2010

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271590

Author

Braybrook, D

Title

ES49 Evaluation of OR 009-A on long tailed mealybug in grapes

Study date

2023

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271623

Author

Zanetti, D

Title

ES82 Efficacy of OR-030-D against Pseudococcus species

Study date

2017

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271624

Author

L????ck, S

Title

ES83 Efficacy of OR-030-D against Pseudococcus species

Study date

2018

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271625

Author

Zanetti, D

Title

ES84 Efficacy of OR-030-D against Coccidae

Study date

2017

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271626

Author

Forte, JJ

Title

ES85 Efficacy of OR-030-D against Aonidiella aurantii (Coccidae), Spain.

Study date

2018

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271627

Author

L????ck, S

Title

ES86 Efficacy of OR-030-D against Coccidae

Study date

2018

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271628

Author

Benitez, MF

Title

ES87 To test the control of White Fly and others pests in tomato.

Study date

2005

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271629

Author

Benitez, MF

Title

ES88 To test the control of White Fly and others pests in tomato.

Study date

2005

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271630

Author

Puig, E

Title

ES89 Efficacy of Code 51904 for White fly control on Tomatoes

Study date

2005

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271631

Author

Anon

Title

Part 8 PREV-AM Part 8-Crop efficacy and safety 2nd extension 240513

Study date

2024

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271632

Author

Anon

Title

Part 8 Appendix PREV-AM Trial Summaries 240513

Study date

2024

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271591

Author

Sui, E

Title

ES50 Fermentation and sensory evaluation of wines relating to the application of PREV-AM pesticide to winegrapes.

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271620

Author

Chau, E

Title

ES79 Evaluation of crop safety of OR-009-A and OR-097-A in blueberries cv. Rabbiteye

Study date

2024

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271621

Author

Chau, E

Title

ES80 Evaluation of OR-009-A for crop safety in coriander

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271622

Author

Chau, E

Title

ES81 Evaluation of OR-009-A for crop safety in herbs

Study date

2024

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271559

Author

Chau, E

Title

ES18 Evaluation crop safety and compatibility of OR-009-A and OR-097-A with various crop protection product in broccoli cv. Aurora

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271552

Author

Chau, E

Title

ES10 Crop safety evaluation of OR-009-A on spring onion cv. Everlast

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271587

Author

Chau, E

Title

ES46 Crop safety of OR-009-A 60 ME to green bean cv. SVGG1312

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271588

Author

Chau, E

Title

ES47 Evaluation crop safety of OR-009-A in grape cv. Pinot Noir

Study date

2022

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271601

Author

Page, J

Title

ES60 Toxicity assessment of PRE-VAM on four species of beneficial insects

Study date

2023

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Data no

271619

Author

OroAgri INC

Title

ES78 Beneficial insects and mites guide

Study date

2020

Authorising party

Applicant

Auth party contact address

2788 S Maple Ave Fresno United States

Date

10 Jul 2024

Application No

144639

Product/Active constituent Name

AC Antler Herbicide

Application details

Product name:

AC Antler Herbicide

Applicant Name:

AXICHEM PTY LTD

Application purpose and description of use:

Registration of a 30 g/L MESOSULFURON-METHYL, 90 g/L MEFENPYRDIETHYL, 200 g/L Aromatic Hydrocarbon, oil based suspension concentrate product for the post-emergent control of wild oats and annual phalaris, and suppression of brome grass, barley grass and annual ryegrass in wheat as per the Directions for Use Table

Date

10 Jul 2024

Application No

144640

Product/Active constituent Name

BOLLGARD 3

Application details

Product name:

BOLLGARD 3

Product number:

69656

Applicant Name:

MONSANTO AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to amend the Resistance Management Plan as part of the conditions of registration

Active constituents:

69067 - BACILLUS THURINGIENSIS STRAIN AB88 EXOTOXIN, VIP3A, AS PRODUCED BY VIP3A(A) GENE

Description of data provided:

Data no

274146

Author

McCollum, D.

Title

TIMS support for amendments to the Bollgard 3 Northern RMP

Study date

2024-06-26

Authorising party

Applicant

Auth party contact address

Level 4, 109 Burwood Road Hawthorn Australia

Data no

274147

Author

Anon.

Title

Resistance Management Plan for Bollgard 3 Cotton for Northern Australia - marked-up version

Study date

2024-07-03

Authorising party

Applicant

Auth party contact address

Level 4, 109 Burwood Road Hawthorn Australia

Data no

274148

Author

Anon.

Title

Resistance Management Plan for Bollgard 3 Cotton for Northern Australia

Study date

2024-07-03

Authorising party

Applicant

Auth party contact address

Level 4, 109 Burwood Road Hawthorn Australia

Date

10 Jul 2024

Application No

144638

Product/Active constituent Name

Avilive Clopyralid 750SG Herbicide

Application details

Product name:

Avilive Clopyralid 750SG Herbicide

Product number:

95089

Applicant Name:

ZHEJIANG HENGDIAN IMP. & EXP. CO LTD

Application purpose and description of use:

Registration of a 750 g/kg clopyralid water soluble granule product for control of a wide range of broadleaf weeds in forests, wheat, barley, oats, triticale, canola, pastures and fallow land.

Reference details:

59934 - KENSO AGCARE KEN-TREL 750 SG HERBICIDE

Active constituents:

68235 - CLOPYRALID

Description of data provided:

Data no

274095

Author

ZHEJIANG HENGDIAN IMP. & EXP. CO LTD

Title

Clopyralid Certificate of Analysis

Study date

2024

Authorising party

Applicant

Auth party contact address

13F, T1, Hengdian Center No. 136 Fuchun Road Shangcheng District Hangzhou China

Date

10 Jul 2024

Application No

144674

Product/Active constituent Name

SULFADOXINE

Application details

Product name:

SULFADOXINE

Active name:

SULFADOXINE

Applicant Name:

BIMEDA (AUSTRALIA) PTY. LIMITED

Application purpose and description of use:

Approval of sulfadoxine for use in veterinary chemical products.

Description of data provided:

Data no

274088

Author

Anon

Title

Certificates of analysis

Study date

2023

Authorising party

Applicant

Auth party contact address

C/- KPMG, LEVEL 38,Tower Three International Towers 300 Barangaroo Avenue SYDNEY Australia

Date

10 Jul 2024

Application No

144684

Product/Active constituent Name

Fludioxonil

Application details

Product name:

Fludioxonil

Active name:

Fludioxonil

Applicant Name:

Rudong Zhongyi Chemical Co. Ltd

Application purpose and description of use:

Approval of Fludioxonil for use in agricultural chemical products.

Description of data provided:

Data no

274144

Author

Thamiris Scarparo Ciquinatto

Title

Qualitative And Quantitative Profile of Fludioxonil (Five Batch Analysis).

Study date

3 June 2024

Authorising party

Applicant

Auth party contact address

The Second Haibin Road Coastal Economic Development Zone Rudong China

Data no

274142

Author

Zhang Jin

Title

Manufacturing Process and Formation of Impurities of Fludioxonil Technical

Study date

16 May 2024

Authorising party

Applicant

Auth party contact address

The Second Haibin Road Coastal Economic Development Zone Rudong China

Data no

274143

Author

Zhang Jin

Title

Declaration of Composition

Study date

4 July 2024

Authorising party

Applicant

Auth party contact address

The Second Haibin Road Coastal Economic Development Zone Rudong China

Data no

274145

Author

Anon

Title

Fludioxonil Technical

Study date

5 July 2024

Authorising party

Applicant

Auth party contact address

The Second Haibin Road Coastal Economic Development Zone Rudong China

Data no

274141

Author

Anon

Title

Executive Summary

Study date

July 2024

Authorising party

Applicant

Auth party contact address

The Second Haibin Road Coastal Economic Development Zone Rudong China

Date

10 Jul 2024

Application No

144643

Product/Active constituent Name

Halauxifen-methyl

Application details

Product name:

Halauxifen-methyl

Active name:

Halauxifen-methyl

Applicant Name:

CORTEVA AGRISCIENCE AUSTRALIA PTY LTD

Application purpose and description of use:

Approval of a new source of halauxifen-methyl for use in agricultural chemical products.

Description of data provided:

Data no

274104

Author

Comb, T.

Title

BATCH ANALYSIS STUDY FOR HALAUXIFEN-METHYL

Study date

27 NOVEMBER 2023

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

274102

Author

Guenthenspberger, K.

Title

Manufacture of halauxifen-methyl using direct coupling process

Study date

5 July 2024

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

274103

Author

Speak, T.

Title

Halauxifen-methyl DoC

Study date

5 July 2024

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

274101

Author

Speak, T.

Title

Part 2. Chemistry & Manufacture Halauxifen-methyl

Study date

5 July 2024

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Date

9 Jul 2024

Application No

144303

Product/Active constituent Name

UPTAKE SPRAYING OIL

Application details

Product name:

UPTAKE SPRAYING OIL

Product number:

41255

Applicant Name:

CORTEVA AGRISCIENCE AUSTRALIA PTY LTD

Application purpose and description of use:

Corteva is proposing to add an alternate paraffinic oil and ethoxylated alcohol to the formulation composition in order to align with other geographies and increase flexibility of supply.

Active constituents:

60259 - PARAFFIN OIL

60005 - ALCOHOL ALKOXYLATE

Description of data provided:

Data no

271980

Author

High, C.

Title

COF CH 101 / COF 3064: Qualification of Orchex 976 in GF-303

Study date

23 March 2022

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

271978

Author

Speak, T.

Title

Part 2 - Chemistry & Manufacture

Study date

26 April 2024

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

271979

Author

Linton, M.

Title

Accelerated Storage Stability of Uptake Spraying Oil (GF-303)

Study date

15 Dec 2000

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

271981

Author

Cornally, S.

Title

Part 8 - Efficacy and crop safety

Study date

26 April 2024

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

271985

Author

Wells, G.

Title

Trial 2 - 222025JD - Arylex brand crop safety and efficacy when tank mixed with Uptake Spraying Oil or Gateway, Australia, 2022

Study date

18-Sep-23

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

271986

Author

Wells, G.

Title

Trial 3 - 225016ML - Uptake and Gateway bioequivalency with Verdict and Select herbicides, Australia, 2022

Study date

18-Sep-23

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

271987

Author

Wells, G.

Title

Trial 4 - 222028JD - Verdict +/- partners safety and efficacy when tank mixed with Uptake Spraying Oil or Gateway, Australia, 2022

Study date

18-Sep-23

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

271988

Author

Wells, G.

Title

Trial 5 - KA22-1839 - Verdict +/- partners safety and efficacy when tank mixed with Uptake Spraying Oil or Gateway, Australia, 2022

Study date

18-Sep-23

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

271989

Author

Wells, G.

Title

Trial 6 - KA22-1840 - Uptake and Gateway bioequivalency with Verdict - summer, Australia, 2022

Study date

18-Sep-23

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

271982

Author

Corteva Agriscience

Title

Product Label for Gateway Adjuvant

Study date

Feb 2021

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

271983

Author

Corteva Agriscience

Title

Safety Data Sheet for Gateway Adjuvant

Study date

25/11/2020

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Data no

271984

Author

Wells, G.

Title

Trial 1 - 225017ML - Arylex brand crop safety and efficacy when tank mixed with Uptake Spraying Oil or Gateway, Australia, 2022

Study date

18-Sep-23

Authorising party

Applicant

Auth party contact address

LEVEL 9, 67 Albert Avenue CHATSWOOD Australia

Date

8 Jul 2024

Application No

144306

Product/Active constituent Name

JY LAND TEBUCONAZOLE 430 SC FUNGICIDE

Application details

Product name:

JY LAND TEBUCONAZOLE 430 SC FUNGICIDE

Product number:

94959

Applicant Name:

Anhui JiuYi Agriculture Co., Ltd.

Application purpose and description of use:

Registration of a 430 g/L Tebuconazole suspension concentrate product for the control of leaf spot and leaf speckle on bananas; rust, leaf spot and net blotch of peanuts; foliar diseases on cereal crops; and other diseases on beans, peas, onions, pawpaw, pyrethrum and ryegrass and fescue seed crops

Reference details:

66643 - AGRO-ESSENCE TEBUCONAZOLE 430 SC FUNGICIDE

Active constituents:

56317 - TEBUCONAZOLE

Date

8 Jul 2024

Application No

144539

Product/Active constituent Name

Q Fly F Wick

Application details

Product name:

Q Fly F Wick

Product number:

95043

Applicant Name:

BUGS FOR BUGS PTY LTD

Application purpose and description of use:

Registration of a 3.4 g/kg fipronil and 1 mL/wick (674 g/kg) 4-(p-Acetoxyphenyl)-2-butanone bait product as an attractant for the male Queensland fruit fly Bactrocera (Dacus) tryoni containing an insecticide.

Reference details:

60664 - NUFARM AMULET CUE-LURE FRUIT FLY STATIONS

Description of data provided:

Data no

273683

Author

Bugs For Bugs

Title

Part 8 Efficacy Q Fly F Wick

Study date

21 June 2024

Authorising party

Applicant

Auth party contact address

3 Rocla Court, Qld 4350. Glenvale Australia

Date

8 Jul 2024

Application No

144549

Product/Active constituent Name

TYLOVET 200 TYLOSIN INJECTION

Application details

Product name:

TYLOVET 200 TYLOSIN INJECTION

Product number:

82653

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

Variation of product registration and label approval for Tylovet 200 Tylosin Injection.

Active constituents:

82948 - TYLOSIN TARTRATE

Date

8 Jul 2024

Application No

144603

Product/Active constituent Name

VETSENSE Ivermectin LV Pour-on for Cattle

Application details

Product name:

VETSENSE Ivermectin LV Pour-on for Cattle

Product number:

95082

Applicant Name:

VETSENSE PTY LTD

Application purpose and description of use:

Registration of a 10 mg/mL Ivermectin pour-on for the treatment and control of ivermectin sensitive internal and external parasites of beef and dairy cattle.

Reference details:

56736 - VIRBAC VIRBAMEC LV POUR-ON ENDECTOCIDE FOR CATTLE

Active constituents:

85908 - IVERMECTIN

Description of data provided:

Data no

273863

Author

Anon

Title

certificate of Analysis - Active

Study date

2023

Authorising party

Applicant

Auth party contact address

1/36 CURTIS ROAD MULGRAVE Australia

Data no

273865

Author

Not Identified

Title

Supporting Information 2

Study date

2024

Authorising party

Applicant

Auth party contact address

1/36 CURTIS ROAD MULGRAVE Australia

Data no

273864

Author

Not identified

Title

Supporting information 1

Study date

2023

Authorising party

Applicant

Auth party contact address

1/36 CURTIS ROAD MULGRAVE Australia

Date

8 Jul 2024

Application No

144607

Product/Active constituent Name

BIMOTRIM INJECTION

Application details

Product name:

BIMOTRIM INJECTION

Product number:

68669

Applicant Name:

BIMEDA (AUSTRALIA) PTY. LIMITED

Application purpose and description of use:

Variation of product registration and label approval to update the relevant label particulars so as to comply with the current labelling code.

Application summaries

Application Date

Application Number

Application Product Name

Application details

Product name:

Product number:

Applicant Name:

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Active constituents:

Description of data provided:

Application Date

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Application Product Name

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Product name:

Product number:

Applicant Name:

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Reference details:

Active constituents:

Description of data provided:

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Application Product Name

Application details

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Active name:

Applicant Name:

Application purpose and description of use:

Description of data provided:

Application Date

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Application Product Name

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Product number:

Applicant Name:

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Active constituents:

Description of data provided:

Application Date

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Application Product Name

Application details

Product name:

Product number:

Applicant Name:

Application purpose and description of use:

Active constituents:

Description of data provided:

Application Date

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Application Product Name

Application details

Product name:

Product number:

Applicant Name:

Application purpose and description of use:

Active constituents:

Description of data provided:

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Product name:

Active name:

Applicant Name:

Application purpose and description of use:

Description of data provided:

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Product number:

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Active constituents:

Description of data provided: