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.
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Date
Application Date
Application No
Application Number
142939
Product/Active constituent Name
Application Product Name
Availa Chromium
Application Date
Application Number
142939
Application Product Name
Availa Chromium
Application details
Product name:
Availa Chromium
Product number:
94611
Applicant Name:
FEEDWORKS PTY. LTD.
Application purpose and description of use:
Registration of Availa Chromium powder product as a nutritional supplement to improve productivity of ruminants, pigs, poultry and fin fish, in conjunction with approval of chromium methionine(active constituent).
Description of data provided:
Data no
267412
Title
MSS Chromium & Methionine CoA_AvCr_HPA17165
Study date
July 2017
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267423
Title
Complexed Chromium analytical method
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267418
Title
Homogeneity AvCr final report ws 20161028
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267384
Title
Manufacturing process
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267401
Title
SAL Dioxin CoA AvCr1000
Study date
26 September 2016
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267402
Title
SAL Dioxin CoA_ AvCr1000_HPA16142
Study date
22 January 2017
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267403
Title
Availa Cr 3 - Dioxins
Study date
27/01/2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267404
Title
SAL Micro & Fluoride_AvCR1000_3 lots
Study date
26/09/2016
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267405
Title
Availa Cr 3 -Microbiology
Study date
19/12/2022
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267406
Title
SAL Mycotoxin CoA_AvCr1000 3 lots
Study date
26/09/2016
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267407
Title
IFF_Availa Cr_Density
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267408
Title
Availa Cr 3-Bulka Density
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267409
Title
IFF supplementary PSD & chromium content of dust
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267419
Title
Homogeneity of Availa Cr in pelleted feeds_final report
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277178
Title
II.3.1 Availa Cr
Study date
20/6/2013
Data no
277179
Title
II.3.2 Availa Cr
Study date
24/5/2012
Data no
277180
Title
II.3.3 Availa Cr
Study date
7/6/2012
Data no
277181
Title
II.3.4 Availa Cr
Study date
17/1/2012
Data no
277182
Title
II.3.5 Availa Cr
Study date
19/6/2015
Data no
267400
Title
Atability Availa Cr
Study date
20 October 2016
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
276500
Title
Effects of diets high in simple sugars on urinary chromium losses.
Study date
June 1986
Auth party contact address
-
Data no
275528
Title
esfa Safety and efficacy of chromium methionine Availa Cr as feed additive for all species.
Study date
29 April 2009
Auth party contact address
-
Data no
267437
Title
Efficacy of Chromium-DL-Methionine in Dairy Cows
Study date
2 November 2016
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267438
Title
Efficacy study of Availa-Cr in Broilers
Study date
18 March 2020
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267439
Title
Efficacy of Availa Cr in Atlantic Salmon
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267440
Title
Efficacy of chromium DL-methionine in Rainbow Trout
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267441
Title
Application dossier for Australia. Chromium Chelate of DL Methionine Efficay- edited Summary
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267442
Title
Effects of Cr methionine of supplementation on grower-finisher pigs
Study date
2017
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
276592
Title
Carcass characteristics and tissue-mineral contents of steers fed supplemental chromium.
Study date
1992
Auth party contact address
-
Data no
267392
Title
Safety for consumers
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267391
Title
Safety for target animals
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267424
Title
Efficacy & tolerance Availa Cr rainbow trout
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267425
Title
Tolerance of Dairy Cows to Availa-Cr
Study date
March 2018
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267426
Title
Efficacy & Tolerance studyof Availa-Cr in Broilers
Study date
March 2020
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
276501
Title
Production and carcase traits in broiler chickens given diets supplemented with inorganic trivalent chromium and an organic acid blend.
Study date
March 2008
Auth party contact address
-
Data no
276502
Title
Effects of starch, sucrose, fructose and glucose on chromium absorption and tissue concentrations in obese and lean mice.
Study date
Oct 1989
Auth party contact address
-
Data no
276498
Title
Dietary Chromium-methionine Chelate Supplementation and Animal Performance
Study date
16 Aug, 2022
Auth party contact address
-
Data no
267394
Title
Safety for environment
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267395
Title
Efficacy
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267414
Title
CoA_Availa Cr Active Substance_EPL 16207B
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277176
Title
Manufacturing Process and Site Declaration
Study date
13 Aug, 2024
Data no
277177
Title
Australia APVMA Supplementary information request letter May2024
Study date
9 May, 2024
Data no
267383
Title
Application Australia - Chromiun Chelate of DL Methionine
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267390
Title
Conditions of Use
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
275529
Title
5- Availa Cr - related to point 5
Study date
3 July 2024
Data no
275530
Title
6- Availa Cr 1000 and Availa Cr 3%
Study date
3 July 2024
Data no
275531
Title
7- Availa Cr- related to point 7
Study date
3 july 2024
Data no
275532
Title
8- 20190904 FDA Inspection report and closing letter Garner received 20200413
Study date
4 Sep 2019
Data no
276700
Title
Current Good manufacturing Practice Certificate (CGMP)Manufacturing
Study date
March 28, 2024
Data no
276576
Title
Anti-diabetic properties of chromium citrate complex in alloxan-induced diabetic rats.
Study date
December 2011
Auth party contact address
-
Data no
276503
Title
Distribution in the rat of physiological amounts of injected Cr51(III) with time.
Study date
1 Oct 1965
Auth party contact address
-
Data no
276504
Title
Biological activity and fate of trace quantities of intravenous chromium (III) in the rat
Study date
1 September 1965
Auth party contact address
-
Data no
276493
Title
Estimation of chromium bioavailability from the diet by an in vitro method.
Study date
July 2001
Auth party contact address
-
Data no
276494
Title
Determination of daily dietary intake of chromium by duplicate diet sampling: in vitro availability study
Study date
12 September 2007
Auth party contact address
-
Data no
276496
Title
Dietary chromium effects on tissue chromium concentrations and chromium absorption in rats.
Study date
July 1996
Auth party contact address
-
Data no
276508
Title
The time-dependent transport of chromium in adult rats from the bloodstream to the urine.
Study date
27 April, 2005
Auth party contact address
-
Data no
276512
Title
Compartment analysis of metabolism of chromium(III) in rats of various ages.
Study date
01 May, 1977
Auth party contact address
-
Data no
276524
Title
Tissue chromium exchange in the rat.
Study date
October, 1981
Auth party contact address
-
Data no
276525
Title
Transport of methionine hydroxy analog across the brush border membrane of rat jejunum.
Study date
July 1987
Auth party contact address
-
Data no
276522
Title
Study on the metabolism of physiological amounts of Cr(III) intragastrical administration in normal rats using activable enriched stable isotope Cr-50 compound as a tracer.
Study date
21 January, 1998
Auth party contact address
-
Data no
276549
Title
Absorption, excretion and retention of 51Cr from labelled Cr-(III)-picolinate in rats
Study date
Apr 2009
Auth party contact address
-
Data no
276562
Title
Lack of toxicity of chromium chloride and chromium picolinate in rats.
Study date
1997
Auth party contact address
-
Data no
276563
Title
Efficacy of chromium(III) supplementation on growth, body composition, serum parameters, and tissue chromium in rats
Study date
Oct 2007
Auth party contact address
-
Data no
276567
Title
Bioavailability of chromium(III)-supplements in rats and humans
Study date
Oct 2012
Auth party contact address
-
Data no
276573
Title
Effects of Chromium Histidinate on Renal Function, Oxidative Stress, and Heat-Shock Proteins in Fat-Fed and Streptozotocin-Treated Rats.
Study date
March 2010
Auth party contact address
-
Data no
276574
Title
Chromium dinicocysteinate supplementation can lower blood glucose, CRP, MCP-1, ICAM-1, creatinine, apparently mediated by elevated blood vitamin C and adiponectin and inhibition of NFkB, Akt, and Glut-2 in livers of Zucker diabetic fatty rats
Study date
Sep 2010
Auth party contact address
-
Data no
276579
Title
Impact of chromium histidinate on high fat diet induced obesity in rats.
Study date
May 2011
Auth party contact address
-
Data no
276580
Title
Interactions between chromium(III) and iron(III), molybdenum(III) or nickel(II): Cytotoxicity, genotoxicity and mutagenicity studies
Study date
June 2018
Auth party contact address
-
Data no
276581
Title
The genotoxicity of physiological concentrations of chromium (Cr(III) and Cr(VI)) and cobalt (Co(II)): an in vitro study.
Study date
June 2010
Auth party contact address
-
Data no
276582
Title
Chromium-induced genotoxicity and interference in human lymphoblastoid cell (TK6) repair processes.
Study date
2011
Auth party contact address
-
Data no
276583
Title
Genotoxicity assessment of chromium(III) propionate complex in the rat modelusing the comet assay
Study date
January, 2010
Auth party contact address
-
Data no
276575
Title
Insulin and chromium picolinate induce translocation of CD36 to the plasma membrane through different signaling pathways in 3T3-L1 adipocytes, and with a differential functionality of the CD36.
Study date
Sep 2011
Auth party contact address
-
Data no
276560
Title
The Effect of Supplemental Dietary Chromium on Performance, Some Blood Parameters and Tissue Chromium Contents of Some Blood Parameters and Tissue Chromium Contents of Rabbits .
Study date
1 January 2001
Auth party contact address
-
Data no
276568
Title
Safe Upper Levels for Vitamins and Minerals
Study date
May 2003
Auth party contact address
-
Data no
276569
Title
Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc.
Study date
2001
Auth party contact address
-
Data no
276570
Title
RDA Workshop: New Approaches, Endpoints and Paradigms for RDAs of Mineral Elements.- Safety Limits for Nutrients1'2
Study date
1996
Auth party contact address
-
Data no
276571
Title
Toxicological Profile for Manganese
Study date
Sep 2012
Auth party contact address
-
Data no
276572
Title
Collate literature data on toxicity of Chromium (Cr) and Nickel (Ni) in experimental animals and humans.
Study date
12 February, 2015
Auth party contact address
-
Data no
276564
Title
Selected trace and ultratrace elements: Biological role, content in feed and requirements in animal nutrition ? Elements for risk assessment.
Study date
28 July, 2010
Auth party contact address
-
Data no
276565
Title
Recommended Dietary Allowances: 10th Edition
Study date
1989
Auth party contact address
-
Data no
276566
Title
Improved glucose control associated with i.v. chromium administration in two patients receiving enteral nutrition
Study date
Apr 2010
Auth party contact address
-
Data no
276554
Title
Beneficial effects of chromium on glucose and lipid variables in control and somatotropin-treated pigs are associated with increased tissue chromium and altered tissue copper, iron, and zinc.
Study date
3 March 1997
Auth party contact address
-
Data no
276539
Title
Assessment of blood chemistry normal ranges in rainbow trout.
Study date
23 May 2006
Auth party contact address
-
Data no
276540
Title
In vitro oxidative decarboxylation of L-2-hydroxy-4-methylthiobutanoic acid by L-2-hydroxy acid oxidase A from chicken liver.
Study date
1995
Auth party contact address
-
Data no
276543
Title
The in vivo sparing of methionine by cysteine in sulfur amino acid requirements in animal models and adult humans.
Study date
June, 2006
Auth party contact address
-
Data no
276544
Title
Biochemistry of sulfur-containing amino acids.
Study date
1983
Auth party contact address
-
Data no
276545
Title
Methionine transamination in vivo.
Study date
1 Sep 1989
Auth party contact address
-
Data no
276546
Title
The sulfur-containing amino acids: an overview.
Study date
June, 2006
Auth party contact address
-
Data no
276547
Title
The effect of methanethiol and methionine toxicity on the activities of cytochrome c oxidase and enzymes involved in protection from peroxidative damage
Study date
Feb, 1986
Auth party contact address
-
Data no
276523
Title
Bioavailability of lysine in L-lysine.HCl
Study date
Oct 1988
Auth party contact address
-
Data no
276528
Title
Absorption and Bioavailability of DL-Methionine Hydroxy Analog Compared to DL-Methionine.
Study date
1 February, 1990
Auth party contact address
-
Data no
276531
Title
Monocarboxylate transporter 1 mediates DL-2-Hydroxy-(4-methylthio)butanoic acid transport across the apical membrane of Caco-2 cell monolayers.
Study date
Jan 2007
Auth party contact address
-
Data no
276513
Title
The trail of Chromium (III) in vivo from the blood to the urine: the roles of transferrin and chromodulin.
Study date
21 April, 2001
Auth party contact address
-
Data no
276516
Title
Acute and chronic resistive exercise increase urinary chromium excretion in men as measured with an enriched chromium stable isotope.
Study date
Jan 1998
Auth party contact address
-
Data no
276517
Title
Essentiality of chromium in humans.
Study date
Oct 1989
Auth party contact address
-
Data no
276518
Title
Renal excretion of chromium-51 chloride in the dog.
Study date
June 1984
Auth party contact address
-
Data no
276519
Title
Chromium (III) metabolism by the kidney.
Study date
1981
Auth party contact address
-
Data no
276520
Title
Biochemistry of the Essential Ultratrace Elements.
Study date
1984
Auth party contact address
-
Data no
276521
Title
The Nutritional Biochemistry of Chromium(III)
Study date
21 March, 2007
Auth party contact address
-
Data no
276509
Title
Reduced chromium retention in patients with hemochromatosis, a possible basis of hemochromatotic diabetes.
Study date
January 1979
Auth party contact address
-
Data no
276510
Title
Effects of over-the-counter drugs on 51chromium retention and urinary excretion in rats
Study date
February 1995
Auth party contact address
-
Data no
276511
Title
Evidence for synergism between chromium and nicotinic acid in the control of glucose tolerance in elderly humans
Study date
September, 1987
Auth party contact address
-
Data no
276497
Title
Opinion of the Scientific Committee on food on the tolerable upper intake level of trivalent chromium.
Study date
4 April, 2003
Auth party contact address
-
Data no
276499
Title
Comparison of acute absorption of commercially available chromium supplements.
Study date
26 January, 2007
Auth party contact address
-
Data no
276495
Title
Chromium intake, absorption and excretion of subjects consuming self-selected diets
Study date
June 1985
Auth party contact address
-
Data no
276505
Title
Study of chromium-containing proteins in subcellular fractions of rat liver by enriched stable isotopic tracer technique and gel filtration chromatography.
Study date
16 January, 2003
Auth party contact address
-
Data no
276506
Title
Chromium (III) binding to serum proteins, specifically siderophilin
Study date
4 September, 1964
Auth party contact address
-
Data no
276507
Title
Kinetics of trace element chromium(III) in the human body.
Study date
April, 1983
Auth party contact address
-
Data no
276481
Title
Interactions between chromium (ii) and Iron(iii), molybdenum (iii) or nickel (ii): Cytotoxicity,, genotoxicity and mutagenicity studies.
Study date
14 January 2018
Auth party contact address
-
Data no
276482
Title
The genotoxicity of physiological concentrations of chromium (Cr(iii) and Cr(vi)) and Cobalt (Co(ii)): An in vitro study.
Study date
2010
Auth party contact address
-
Data no
276484
Title
Genotoxicity assessment of chromium (iii) propionate complex in the rat model using the comet assay.
Study date
11 Sep 2009
Auth party contact address
-
Data no
276485
Title
Evaluation of the safety a Chromium (iii) Phosphate suspension for radiosynoviorthesis.
Study date
9 April, 2013
Auth party contact address
-
Data no
276486
Title
Genotoxicity of tri- and hexavalent chromium compounds In vivo and their modes of action on DNA damage in vitro.
Study date
26 June 2014
Auth party contact address
-
Data no
276487
Title
Cr-(iii) - organic compounds treatment causes genotoxicity and changes in DNA and protein level in Saccharomyces cerevisiae.
Study date
14 September, 2009
Auth party contact address
-
Data no
276488
Title
Intracellular and extracellular factors influencing Cr (vi) and Cr (iii) genotoxicity.
Study date
21 Oct 2011
Auth party contact address
-
Data no
276489
Title
Chronic toxicity and carcinogenicity studies of chromium picolinate monohydrate administered in feed to F344/N rats and B6C3F1 mice for 2 years.
Study date
8 Jan, 2009
Auth party contact address
-
Data no
276490
Title
Safety and efficacy of chromium methionine (Availa Cr) as feed additive for all species.
Study date
1 April 2009
Auth party contact address
-
Data no
276491
Title
Effect of chelating agents on chromium absorption in rats.
Study date
Aug 1973
Auth party contact address
-
Data no
276492
Title
Absorption of inorganic, trivalent chromium from the vascularly perfused rat small intestine.
Study date
Aug 1989
Auth party contact address
-
Data no
276577
Title
Effects of carbohydrate and chromium ingestion during intermittent high-intensity exercise to fatigue.
Study date
Dec 2000
Auth party contact address
-
Data no
276578
Title
Scientific Opinion on ChromoPrecise? cellular bound chromium yeast added for nutritional purposes as a source of chromium in food supplements and the bioavailability of chromium from this source
Study date
23 November, 2012
Auth party contact address
-
Data no
276591
Title
Evaluation of Bioavalability of Chromium from various organic sources.
Study date
2002
Data no
267443
Title
Application dossier for Australia. Chromium Chelate of DL Methionine. Metabolism and Kinetics
Study date
October 2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
276514
Title
Scientific Opinion on DL-methionine, DL-methionine sodium salt, the hydroxy analogue of methionine and the calcium salt of methionine hydroxy analogue in all animal species; on the isopropyl ester of methionine hydroxy analogue and DL-methionine technically pure protected with copolymer vinylpyridine/styrene in dairy cows; and on DL-methionine technically pure protected with ethylcellulose in rumi
Study date
30 March, 2012
Auth party contact address
-
Data no
276515
Title
Invited review: Amino acid bioavailability and digestibility in pig feed ingredients: Terminology and application
Study date
12 March, 2015
Auth party contact address
-
Data no
276532
Title
Partial Na+ Dependence of dl-2-Hydroxy-4-(Methylthio)Butanoic Acid Uptake in the Chicken Small Intestine.
Study date
1 July, 2008
Auth party contact address
-
Data no
276533
Title
Absorption of methionine and 2-hydroxy-4-methylthiobutoanic acid in conventional and germ-free chickens
Study date
1 July, 2003
Auth party contact address
-
Data no
276534
Title
Apparent absorption of methionine and 2-hydroxy-4-methylthiobutanoic acid from gastrointestinal tract of conventional and gnotobiotic pigs.
Study date
Oct 2009
Auth party contact address
-
Data no
276535
Title
Conversion of 2-hydroxy-4-(methylthio)butanoic acid to L-methionine in the chick: a stereospecific pathway
Study date
September 1984
Auth party contact address
-
Data no
276536
Title
Comparative in vitro and in vivo absorption of 2-hydroxy-4(methylthio) butanoic acid and methionine in the broiler chicken.
Study date
1 September, 2005
Auth party contact address
-
Data no
276537
Title
Conversion of Methionine Hydroxy Analogue to Methionine in the Chick.
Study date
1 May, 1965
Auth party contact address
-
Data no
276538
Title
Oxidation of methionine and 2-hydroxy 4-methylthiobutanoic acid stereoisomers in chicken tissues.
Study date
July, 1989
Auth party contact address
-
Data no
276529
Title
Methionine and 2-hydroxy-4-methylthiobutanoic acid are transported by distinct Na(+)-dependent and H(+)-dependent systems in the brush border membrane of the chick intestinal epithelium.
Study date
Feb, 1996
Auth party contact address
-
Data no
276530
Title
Oligomers Are Not the Limiting Factor in the Absorption of DL-2-Hydroxy-4-(methylthio)butanoic Acid in the Chicken Small Intestine.
Study date
1 January, 2006
Auth party contact address
-
Data no
276526
Title
Na+-independent and nonstereospecific transport of 2-hydroxy 4-methylthiobutanoic acid by brush border membrane vesicles from chick small intestine.
Study date
1989
Auth party contact address
-
Data no
276527
Title
Apparent and true amino acid digestibility of a crystalline amino acid mixture and of casein: comparison of values obtained with ileal-cannulated pigs and cecectomized cockerels.
Study date
Dec 1992
Auth party contact address
-
Data no
276548
Title
Effect of chromium source on tissue concentration of chromium in pigs
Study date
Nov 2008
Auth party contact address
-
Data no
276541
Title
Conversion of the Methionine Hydroxy Analogue dl-2-Hydroxy-(4-Methylthio) Butanoic Acid to Sulfur-Containing Amino Acids in the Chicken Small Intestine.
Study date
1 November, 2006
Auth party contact address
-
Data no
276542
Title
Transamination of 2-oxo-4-[methylthio]butanoic acid in chicken tissues
Study date
Jan 1998
Auth party contact address
-
Data no
276555
Title
Effect of Chromium Nanoparticle on Growth Performance, Carcass Characteristics, Pork Quality and Tissue Chromium in Finishing Pigs.
Study date
2004
Auth party contact address
-
Data no
276556
Title
Chromium supplementation of turkeys: effects on tissue chromium.
Study date
1 January, 1989
Auth party contact address
-
Data no
276557
Title
Effects of dietary chromium picolinate supplementation on serum and tissue mineral contents of laying Japanese Quails.
Study date
12 July, 2002
Auth party contact address
-
Data no
276558
Title
Effects of dietary chromium supplementation on performance, carcass traits, serum metabolites, and tissue chromium levels of Japanese quails.
Study date
2005
Auth party contact address
-
Data no
276559
Title
The effect of dietary supplementation with trivalent chromium on production performance of laying hens and the chromium content in the yolk.
Study date
21 April, 2003
Auth party contact address
-
Data no
276550
Title
Effect of supplemental chromium on tissue chromium concentrations in cattle.
Study date
January 2004
Auth party contact address
-
Data no
276551
Title
Effect of chromium supplementation on production and metabolic parameters in periparturient dairy cows.
Study date
May 2001
Auth party contact address
-
Data no
276552
Title
Oxidation of the supplemental methionine source L-2-hydroxy-4-methylthiobutanoic acid by pure L-2-hydroxy acid oxidase from chicken liver.
Study date
Oct 1990
Auth party contact address
-
Data no
276553
Title
A regional evaluation of chromium tripicolinate supplementation of diets fed to reproducing sows.
Study date
October 2004
Auth party contact address
-
Data no
276561
Title
Effects of dietary chromium picolinate supplementation on serum glucose, cholesterol and minerals of rainbow trout (Oncorhynchus mykiss).
Study date
10 December, 2005
Auth party contact address
-
Data no
276589
Title
Effects of Chromium Methionine Supplementation with Different Sources of Zinc on Growth Performance, Carcass Traits, Meat Quality, Serum Metabolites, Endocrine Parameters, and the Antioxidant Status in Growing-Finishing Pigs
Study date
Jan 2021
Auth party contact address
-
Data no
276590
Title
Dietary chromium supplementation for Pigs and Chickens.
Study date
1995
Auth party contact address
-
Data no
267420
Title
MSDS Availa Cr v1.0
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267393
Title
Safety for Users
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267452
Title
Cr Position Statement
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267430
Title
OECD 476 BioRel_In Vitro gene mutation test_Cr-DL-Meth
Study date
Dec 2008
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267436
Title
Availa Cr 3 - Acute eye irritation OECD 405
Study date
7 March 2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267433
Title
Availa Cr 1000 - Acute eye irritation OECD 405
Study date
13 December 2017
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267432
Title
Availa Cr 1000 -Acute skin irritation OECD 404
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267434
Title
Availa Cr 1000 - Skin sensitisation OECD 406
Study date
10 April 2019
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267435
Title
Availa Cr 3 - Acute skin irritation OECD 404
Study date
7 March 2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267451
Title
Chronic Toxicity and Carcinogenicity Studies of Chromium Picolinate Monohydrate Administered in Feed to F344/N Rats and B6C3F1 Mice for 2 Years
Study date
2009
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267431
Title
OECD 408 ATPL_90 day Repeat Dose Toxicity tudy
Study date
Jan 2009
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Date
Application Date
Application No
Application Number
143504
Product/Active constituent Name
Application Product Name
BUPRELIEVE INJECTION
Application Date
Application Number
143504
Application Product Name
BUPRELIEVE INJECTION
Application details
Product name:
BUPRELIEVE INJECTION
Product number:
69057
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of a product registration (Buprelieve Injection) vary the approved shelf life.
Active constituents:
Active constituent name
80831 - BUPRENORPHINE HYDROCHLORIDE
Active constituent name
69057 - BUPRELIEVE INJECTION
Active constituent name
80831 - BUPRENORPHINE HYDROCHLORIDE
Description of data provided:
Data no
269402
Title
PART 2 Chemistry 4a Buprelieve Injection
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
269406
Title
Attachment 2 - Registered Specifications
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
277058
Title
Buprelieve Injection Application 69057_143504 S159 response
Study date
August 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276997
Title
Attachment 8A-1 - Statistical Analysis
Study date
Jan 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276998
Title
Attachment s159-1 - VICH GL51
Study date
Feb 2013
Auth party contact address
-
Data no
269403
Title
PART 2 - Attachment 2-8v2
Study date
January 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
269404
Title
PART 2 - Attachment 2-9v2
Study date
November 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
269405
Title
Attachment 1 - DAFF BICON Permit
Study date
16 January 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
143492
Product/Active constituent Name
Application Product Name
Spinosad
Application Date
Application Number
143492
Application Product Name
Spinosad
Application details
Product name:
Spinosad
Active name:
Spinosad
Applicant Name:
NUFARM AUSTRALIA LIMITED
Application purpose and description of use:
Approval of spinosad for use in agricultural chemical products.
Description of data provided:
Data no
269363
Title
Validation of Analytical Methodology for the Assay of Active Ingredients of Spinosad TC for Solubility and Hydrolysis.
Study date
2016
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269371
Title
Validation of Analytical Methodology for the Assay of Active Ingredients of Spinosad TC.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269372
Title
Spinosad 90%: Validation of the Analytical method for the Determination of the active Ingredient Content.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269373
Title
Spinosad 90%: Validation of the Analytical method for the Determination of the Significant Impurities Content.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269367
Title
Declaration of Composition, Spinosad Technical
Study date
2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269368
Title
Declaration of Batch Sizes of Spinosad TC in 5 Batch Analysis Report
Study date
2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269369
Title
Spinosad 90%: Complete Analysis of Five Batch Samples.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269370
Title
Spinosad 90%: HPLC/MS/DAD Screening for Impurities Content in Five Batch Samples.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269366
Title
Manufacturing Process of Spinosad Technical.
Study date
2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269374
Title
Spinosad CoA.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269364
Title
Chemical and Physical Characterization of Spinosad TC: Color, Physical State, Odor, Melting Point, Partition Coefficient, Solubility and Active Ingredient Content.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269365
Title
Chemical and Physical Characterization of Spinosad TC: pH, Density, Explodability, Dissociation Constant, Corrosiveness to Packaging Materia, Hydrolysis Rate, Surface Tension and Corrosion Characteristics to Metal.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269360
Title
Spinosad 90%: Spectroscopic Characterization of Five Batch Samples.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269361
Title
Final Report Spinosad 90%: Spectroscopic Characterization of Five Batch Samples.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269362
Title
Determination of the Vapour Pressure of Spinosad TC according to OECD 104 resp. EU A.4 using the effusion method: Knudsen Cell.
Study date
2020
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269359
Title
DC17-39423393- ITEM 17, CHEMISTRY 3 SPINOSAD TGAC ??? NEW SOURCE
Study date
27 March 2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date
Application Date
Application No
Application Number
143281
Product/Active constituent Name
Application Product Name
PROMECTIN PLUS LV ALLWORMER PASTE FOR HORSES (300 KG - 600 KG)
Application Date
Application Number
143281
Application Product Name
PROMECTIN PLUS LV ALLWORMER PASTE FOR HORSES (300 KG - 600 KG)
Application details
Product name:
PROMECTIN PLUS LV ALLWORMER PASTE FOR HORSES (300 KG - 600 KG)
Product number:
62378
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration to make a minor variation to the registered formulation
Active constituents:
Active constituent name
83910 - PRAZIQUANTEL
Active constituent name
85708 - IVERMECTIN
Description of data provided:
Data no
268863
Title
Attachment 1-4
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268861
Title
Attachment 1-2
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268862
Title
Attachment 1-3
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276140
Title
Attachment 2-3 Draft PV Protocol
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268860
Title
Attachment 1-1
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276144
Title
Attachment 2-1 Raw Material Specification
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276138
Title
Part 2 Chemistry 3
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276139
Title
Attachment 2-2 Routine stability
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276141
Title
Part 8 Efficacy and Safety
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276142
Title
Attachment 8-1 VP extract
Study date
2007
Auth party contact address
-
Data no
276143
Title
Attachment 8-2 Figure 39.8
Study date
2018
Auth party contact address
-
Data no
268864
Title
Attachment 2 - DAFF List
Study date
11 January 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268865
Title
Attachment 3 - Extract 1 HBoPEv9
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268866
Title
Attachment 4 - Extract 2 HBoPEv9
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
143282
Product/Active constituent Name
Application Product Name
PROMECTIN PLUS LV ALLWORMER PASTE FOR FOALS AND PONIES (150KG - 300KG)
Application Date
Application Number
143282
Application Product Name
PROMECTIN PLUS LV ALLWORMER PASTE FOR FOALS AND PONIES (150KG - 300KG)
Application details
Product name:
PROMECTIN PLUS LV ALLWORMER PASTE FOR FOALS AND PONIES (150KG - 300KG)
Product number:
64400
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration to make a minor variation to the registered formulation
Active constituents:
Active constituent name
83910 - PRAZIQUANTEL
Active constituent name
85708 - IVERMECTIN
Description of data provided:
Data no
268871
Title
Attachment 1-4
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268869
Title
Attachment 1-2
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268870
Title
Attachment 1-3
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268868
Title
Attachment 1-1
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268872
Title
Attachment 2 - DAFF List
Study date
11 January 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268873
Title
Attachment 3 - Excerpt 1 HBoPEv9
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268874
Title
Attachment 4 - Excerpt 2 HBoPEv9
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
143262
Product/Active constituent Name
Application Product Name
Nufarm Chlorthal-Dimethyl 900 Herbicide
Application Date
Application Number
143262
Application Product Name
Nufarm Chlorthal-Dimethyl 900 Herbicide
Application details
Product name:
Nufarm Chlorthal-Dimethyl 900 Herbicide
Product number:
59137
Applicant Name:
NUFARM AUSTRALIA LIMITED
Application purpose and description of use:
Variation of product registration and label approval to add additional crops to the label.
Active constituents:
Active constituent name
53742 - CHLORTHAL-DIMETHYL
Description of data provided:
Data no
268965
Title
Evaluation of Dacthal 900 WG for crop safety in coriander
Study date
July 2022
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
268966
Title
Evaluation of Dacthal 900 WG for crop safety in coriander
Study date
July 2022
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
268967
Title
Evaluation of Dacthal 900 WG for crop safety in curly parsley
Study date
July 2022
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
268963
Title
Pre-application Assistance APVMA written assistance
Study date
Nov 2021
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
268964
Title
Residues of chlorthal-dimethyl in parsley following one application of Dacthal herbicide to parsley immediately prior to transplanting.
Study date
Jan 2002
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date
Application Date
Application No
Application Number
143442
Product/Active constituent Name
Application Product Name
ADAMA DIMETHOATE 400 SYSTEMIC INSECTICIDE
Application Date
Application Number
143442
Application Product Name
ADAMA DIMETHOATE 400 SYSTEMIC INSECTICIDE
Application details
Product name:
ADAMA DIMETHOATE 400 SYSTEMIC INSECTICIDE
Product number:
39239
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of Adama Dimethoate 400 Systemic Insecticide (400g/L Dimethoate) APVMA Approval no. 39239/RV2023), Emulsion Concentrate, EC product label to add additional pests, add a pack size range, update Withholding periods and remove State column.
Active constituents:
Active constituent name
44566 - DIMETHOATE MANUFACTURING CONCENTRATE
Description of data provided:
Data no
269107
Title
Supporting Argument
Study date
20-03-2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
274041
Title
Reference permit 3.0- to control mirid bugs.
Study date
1 June 2016
Auth party contact address
-
Data no
274042
Title
Reference Permit no, 4.0 to control insect pests in crops.
Study date
23 Mar 2018
Auth party contact address
-
Data no
274043
Title
Reference permit no. 4.0 to control various fruit flies.
Study date
1 Mar 2019
Auth party contact address
-
Data no
274044
Title
Reference Permit no. 6 to control fruit flies.
Study date
9 Feb 2025
Auth party contact address
-
Data no
274045
Title
Reference permit no. 7.0 to control Queensland fruit fly and mediterranean fruit fly
Study date
30 Jan 2013
Auth party contact address
-
Data no
274046
Title
Reference Permit no. 8 to control fruit fly pest.
Study date
18 Feb 2019
Auth party contact address
-
Data no
274047
Title
Reference Permit no. 9.0 to control Hemiptera, nursery stock , ornamentals.
Study date
11 May 2022
Auth party contact address
-
Data no
274048
Title
Supporting response to APVMA for Dimethoate 400 Insecticide application
Study date
5 July 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
274049
Title
Reference Permit -1.0 to control vegetable leafminer and pea leafminers.
Study date
3 Jul 2020
Auth party contact address
-
Data no
274050
Title
Reference Permit 2.0 to control of Red legged earthmite, blue oat mite, lucerne fleas.
Study date
3 June 2024
Auth party contact address
-
Date
Application Date
Application No
Application Number
143138
Product/Active constituent Name
Application Product Name
AzaMax Xtra Insecticide
Application Date
Application Number
143138
Application Product Name
AzaMax Xtra Insecticide
Application details
Product name:
AzaMax Xtra Insecticide
Product number:
90426
Applicant Name:
DULUXGROUP (AUSTRALIA) PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add additional uses.
Reference details:
63139 - ECO - NEEM BOTANICAL INSECTICIDE
Active constituents:
Active constituent name
53250 - AZADIRACHTIN MANUFACTURING CONCENTRATE
Description of data provided:
Data no
268449
Title
Evaluation of Organic Crop Protectants insecticides for control of ground pearls in Turf
Study date
2022
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
268450
Title
Evaluation of various insecticides for the control of Ground Pearl (Margoroides spp.) and Sting and Dagger nematodes (Ibipora lolii and Xiphinema)
Study date
2023
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
268451
Title
Evaluation of Organic Crop Protectants insecticides for Sod Webworm in Turf
Study date
2022
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
268452
Title
Evaluation of various biological insecticides for the control of Sod webworm (Herpetogramma licarsisalis)
Study date
2023
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
268453
Title
Efficacy ??? AzaMax Xtra Additional Uses
Study date
2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
268454
Title
Efficacy ??? Control of Sod webworm and Ground pearls in Turf
Study date
2024
Auth party contact address
1 GOW ST PADSTOW Australia
Date
Application Date
Application No
Application Number
143224
Product/Active constituent Name
Application Product Name
Solaris 500SC Fungicide
Application Date
Application Number
143224
Application Product Name
Solaris 500SC Fungicide
Application details
Product name:
Solaris 500SC Fungicide
Product number:
94698
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a new high-load Solaris 500 SC Fungicide (500 g/L Cyprodinil) Suspension Concentrate (SC) product label to control Various diseases in Almonds, Apples, Apricots, Grapes, Nectarines, Peaches, Pears, Plums crops.
Active constituents:
Active constituent name
91002 - Cyprodinil
Description of data provided:
Data no
268907
Title
CoA Cyprodinil technical.
Study date
Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268905
Title
Solaris 500SC manufacturing flow chart diagram.
Study date
Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268902
Title
Part 2 - Chemistry and Manufacture
Study date
15 Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268903
Title
SDS of CYPRODINIL technical and other ingredients.
Study date
Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268904
Title
SDS - Solaris 500 SC Fungicide
Study date
Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268908
Title
Specifications Cyprodinil technical
Study date
Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268909
Title
Certificate of composition, CoC - Solaris 500 SC Fungicide
Study date
Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268910
Title
Manufacturing Process - Solaris 500SC Fungicide
Study date
Feb 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268911
Title
Assay Solaris 500 SC ADM.01300.F.1.A MOA
Study date
Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268912
Title
Solaris 500 SC ADM.01300.F.1.A MIE- Minimum ignition energy test.
Study date
Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268906
Title
Cyprodinil 500 SC_storage stability-Physchem-Validation.
Study date
Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268913
Title
Part 8 - Crop Efficacy and Safety
Study date
15 Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268914
Title
Comparison of cyprodinil formulations for the control of grey mould in grapevines.
Study date
15 Sep 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268915
Title
Evaluation of cyprodinil formulations on Botrytis in table grapes.
Study date
April 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268916
Title
Evaluation of Cyprodinil formulations for the control of black spot, powdery mildew and Alternaria.
Study date
5 Jul 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268917
Title
Comparison of cyprodinil formulations for the control of brown rot in peaches.
Study date
16 May 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268918
Title
Evaluation of cyprodinil formulations on diseases in almonds.
Study date
Jul 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268919
Title
Solaris 500 proposed draft label.
Study date
Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268923
Title
Reference Market Industry label 3
Study date
Mar 2024
Auth party contact address
-
Data no
268920
Title
Reference Market Industry Label 1
Study date
Mar 2024
Auth party contact address
-
Data no
268921
Title
Reference - Solaris 300 EC label
Study date
Mar 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
268922
Title
Reference Market Industry Label 2
Study date
Mar 2024
Auth party contact address
-
Date
Application Date
Application No
Application Number
143130
Product/Active constituent Name
Application Product Name
BRAVECTO PLUS FLEA, TICK AND WORM 250 MG FLURALANER AND 12.5 MG MOXIDECTIN SPOT-ON SOLUTION FOR MEDIUM CATS
Application Date
Application Number
143130
Application Product Name
BRAVECTO PLUS FLEA, TICK AND WORM 250 MG FLURALANER AND 12.5 MG MOXIDECTIN SPOT-ON SOLUTION FOR MEDIUM CATS
Application details
Product name:
BRAVECTO PLUS FLEA, TICK AND WORM 250 MG FLURALANER AND 12.5 MG MOXIDECTIN SPOT-ON SOLUTION FOR MEDIUM CATS
Product number:
85416
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product label approval to add a claim for additional parasite species.
Active constituents:
Active constituent name
80697 - FLURALANER
Active constituent name
85368 - MOXIDECTIN
Date
Application Date
Application No
Application Number
143129
Product/Active constituent Name
Application Product Name
BRAVECTO PLUS FLEA, TICK AND WORM 112.5 MG FLURALANER AND 5.6 MG MOXIDECTIN SPOT-ON SOLUTION FOR KITTENS AND SMALL CATS
Application Date
Application Number
143129
Application Product Name
BRAVECTO PLUS FLEA, TICK AND WORM 112.5 MG FLURALANER AND 5.6 MG MOXIDECTIN SPOT-ON SOLUTION FOR KITTENS AND SMALL CATS
Application details
Product name:
BRAVECTO PLUS FLEA, TICK AND WORM 112.5 MG FLURALANER AND 5.6 MG MOXIDECTIN SPOT-ON SOLUTION FOR KITTENS AND SMALL CATS
Product number:
85418
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product label approval to add a claim for additional parasite species.
Active constituents:
Active constituent name
80697 - FLURALANER
Active constituent name
85368 - MOXIDECTIN
Date
Application Date
Application No
Application Number
143131
Product/Active constituent Name
Application Product Name
BRAVECTO PLUS FLEA, TICK AND WORM 500 MG FLURALANER AND 25 MG MOXIDECTIN SPOT-ON SOLUTION FOR LARGE CATS
Application Date
Application Number
143131
Application Product Name
BRAVECTO PLUS FLEA, TICK AND WORM 500 MG FLURALANER AND 25 MG MOXIDECTIN SPOT-ON SOLUTION FOR LARGE CATS
Application details
Product name:
BRAVECTO PLUS FLEA, TICK AND WORM 500 MG FLURALANER AND 25 MG MOXIDECTIN SPOT-ON SOLUTION FOR LARGE CATS
Product number:
85413
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product label approval to add a claim for additional parasite species.
Active constituents:
Active constituent name
80697 - FLURALANER
Active constituent name
85368 - MOXIDECTIN
Description of data provided:
Data no
278664
Title
Gastrointestinal parasites of feral cats from Christmas Island. Aust
Study date
2008
Auth party contact address
-
Data no
278665
Title
A. Aelurostrongylus abstrusus in wild felids of South Africa. Parasitol Res. 2016 Oct;115
Study date
1981
Auth party contact address
-
Data no
278666
Title
A. Aelurostrongylus abstrusus in wild felids of South Africa.
Study date
2016
Auth party contact address
-
Data no
278667
Title
Occurrence of Aelurostrongylus abstrusus in domestic cats in Vilhena, Rond?nia, Brazil
Study date
2022
Auth party contact address
-
Data no
278668
Title
Aelurostrongylus abstrusus Infections in Domestic Cats (Felis silvestris catus) from Antioquia, Colombia
Study date
2021
Auth party contact address
-
Data no
278669
Title
Aelurostrongylus abstrusus and Troglostrongylus brevior (Nematoda, Metastrongyloidea) from domestic and wild felids
Study date
2017
Auth party contact address
-
Data no
281651
Title
Scientific argument - s159 response
Study date
2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
279033
Title
Efficacy Critical Expert Report
Study date
2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
279030
Title
S18134-00
Study date
2020
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
279031
Title
S19178-00
Study date
2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
279032
Title
S19240-00
Study date
2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Date
Application Date
Application No
Application Number
143305
Product/Active constituent Name
Application Product Name
METCAMIFEN
Application Date
Application Number
143305
Application Product Name
METCAMIFEN
Application details
Product name:
METCAMIFEN
Active name:
METCAMIFEN
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of metcamifen for use in agricultural chemical products
Description of data provided:
Data no
268980
Title
CGA246783. Analytical Method SB-128/2
Study date
6-Jul-2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
269961
Title
CGA246783. Analytical Method SA-128/1
Study date
4-Jul-2016
Data no
269962
Title
CGA246783 ??? Validation of Analytical Method SA-128/1
Study date
4-Jul-2016
Data no
269963
Title
CGA246783 ??? Validation of Analytical Method SB-128/2
Study date
4-Jul-2016
Data no
268976
Title
Metcamifen - Analysis of Five Representative Batches
Study date
11-Mar-2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
268985
Title
Metcamifen Confirmation of Analyte Identity by IR spectroscopy
Study date
15-Mar-2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
268977
Title
Declaration of Composition for Metcamifen
Study date
20-Mar-2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
268978
Title
Metcamifen - Purity and By-Products of Technical AI
Study date
23-Oct-2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
268984
Title
Manufacturing Process CGA246783
Study date
19-Mar-2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
269964
Title
Manufacturing Process CGA246783 (Monthey)
Study date
11-Sep-2018
Data no
268986
Title
Part 2 - Chemistry and Manufacture
Study date
20-Mar-2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
142568
Product/Active constituent Name
Application Product Name
Salmonella Typhimurium strain DT104
Application Date
Application Number
142568
Application Product Name
Salmonella Typhimurium strain DT104
Application details
Product name:
Salmonella Typhimurium strain DT104
Product number:
94484
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a trivalent Salmonella vaccine for injection for chickens.
Approval of three salmonella active constituents.
Date
Application Date
Application No
Application Number
143104
Product/Active constituent Name
Application Product Name
BIORELEASE ALTRENO INJECTION
Application Date
Application Number
143104
Application Product Name
BIORELEASE ALTRENO INJECTION
Application details
Product name:
BIORELEASE ALTRENO INJECTION
Product number:
94657
Applicant Name:
DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.
Application purpose and description of use:
Registration of a 150 mg/ml ALTRENOGEST parenteral liquid product for the suppression of oestrus in normally cycling mares.
Reference details:
61665 - NV READYSERVE ORAL PROGESTAGEN FOR HORSES
Active constituents:
Active constituent name
85635 - ALTRENOGEST
Description of data provided:
Data no
267792
Title
Active CoAs and Specification
Study date
2023
Auth party contact address
2 Cal Close Somersby Australia
Data no
267798
Title
Test Methods
Study date
2015
Auth party contact address
2 Cal Close Somersby Australia
Data no
267799
Title
Method Validation
Study date
2015
Auth party contact address
2 Cal Close Somersby Australia
Data no
267796
Title
Batch Analyses
Study date
2017
Auth party contact address
2 Cal Close Somersby Australia
Data no
267794
Title
Manufacturing Instructions
Study date
2017
Auth party contact address
2 Cal Close Somersby Australia
Data no
267795
Title
Process Validation
Study date
2017
Auth party contact address
2 Cal Close Somersby Australia
Data no
267793
Title
Excipient CoAs
Study date
2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
267800
Title
Packaging Specification
Study date
2016
Auth party contact address
2 Cal Close Somersby Australia
Data no
267801
Title
Chemistry and Manufacture Overview
Study date
2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
283224
Title
BioRelease Altreno Injection - Volume 1 - Chemistry, Manufacturing, Stability - Part 1 of 2
Study date
2017
Auth party contact address
2 Cal Close Somersby Australia
Data no
283225
Title
Chemistry Overview v2
Study date
December 2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
283226
Title
BioRelease Altreno Injection - Volume 1 - Chemistry, Manufacturing, Stability - Part 2 of 2
Study date
2017
Auth party contact address
2 Cal Close Somersby Australia
Data no
267791
Title
GMP Certificates
Study date
2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
267797
Title
Stability Study
Study date
2017
Auth party contact address
2 Cal Close Somersby Australia
Data no
267806
Title
Evaluation of Injectable Sustained Release Progestin Formulations for Suppression of Estrus and Ovulation in Mares
Study date
2009
Auth party contact address
2 Cal Close Somersby Australia
Data no
267807
Title
Evaluation of Methods for Suppressing Estrus and Ovulation in Mares: Sustained Release Injections of Altrenogest versus Deslorelin acetate
Study date
2012
Auth party contact address
2 Cal Close Somersby Australia
Data no
267808
Title
Efficacy & Safety Oestrus suppression in normally cycling mares.
Study date
2018
Auth party contact address
2 Cal Close Somersby Australia
Data no
267804
Title
Efficacy and Safety Overview
Study date
2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
267805
Title
ACVM Data Assessment Reports
Study date
2018
Auth party contact address
2 Cal Close Somersby Australia
Data no
267809
Title
Target animal safety study of an injectable altrenogest formulation in the horse.
Study date
2018
Auth party contact address
2 Cal Close Somersby Australia
Data no
283227
Title
s159 Response 19 December 2024
Study date
2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
267802
Title
Health Overview
Study date
2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
267803
Title
New Zealand Environmental Protection Authority: BioRelease Altreno Injection Assessment
Study date
2018
Auth party contact address
2 Cal Close Somersby Australia
Date
Application Date
Application No
Application Number
143226
Product/Active constituent Name
Application Product Name
Duotic Ear Gel for Dogs
Application Date
Application Number
143226
Application Product Name
Duotic Ear Gel for Dogs
Application details
Product name:
Duotic Ear Gel for Dogs
Product number:
94699
Applicant Name:
DECHRA LTD
Application purpose and description of use:
Registration of a 10 mg/mL terbinafine and 1 mg/mL betamethasone acetate ear gel product for the treatment of otitis
externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis).
Reference details:
69931 - OSURNIA EAR GEL FOR DOGS
Active constituents:
Active constituent name
88081 - Terbinafine
Active constituent name
82454 - BETAMETHASONE ACETATE
Description of data provided:
Data no
268547
Title
Terbinafine hydrochloride, betamethasone acetate monographs and certificates of analysis
Study date
17 January 2024
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268548
Title
3.2.S Drug Substance (Terbinafine Base)
Study date
September 2023
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268549
Title
3.2.S Drug Substance (Betamethasone Acetate)
Study date
September 2023
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268550
Title
3.2.S Drug Substance (Betamethasone Acetate)
Study date
September 2023
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268568
Title
Quality Control Method of Analysis
Study date
September 2023
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268569
Title
Risk Assessment - Omission of AMV for project Otis
Study date
26 April 2018
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268570
Title
Method Validation Report - Determination of dynamic viscosity
Study date
13 December 2010
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268571
Title
Validation Report: Determination of Water in Auricle Otic Gel by K. Fischer Titration
Study date
16 December 2010
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268572
Title
Analytical Method Transfer Report
Study date
02 September 2014
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268573
Title
Validation of the current European Pharmacopoeia 9.4 and USP 40 (Harmonised methods) Test Method for Total Counts (pour plate) and Detection of Specified Organisms in: Otis
Study date
13 August 2018
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268574
Title
Validation Report: Determination of Assay of Terbinafine, Bethametason acetate, Florfenicol and Butylated hydroxytoluene (BHT) in Auricle otic gel by HPLC
Study date
29 July 2010
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268575
Title
Validation Report: Determination of related substances of Terbinafine, Betamethasone acetate and Florfenicol in Auricle otic gel by HPLC
Study date
24 September 2010
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268576
Title
Validation Report Addendum 01: Determination of Assay of Terbinafine, Betamethasone acetate, Florfenicol and Butylated hydroxytoluene (BHT) in Auricle otic gel by HPLC
Study date
08 November 2010
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268558
Title
Certificates of Analysis / Certificates of Manufacture
Study date
01 April 2021
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268543
Title
Certificate of GMP Compliance of a Manufacturer
Study date
18 January 2022
Auth party contact address
-
Data no
268544
Title
Certificate of GMP Compliance of a Manufacturer
Study date
17 February 2020
Auth party contact address
-
Data no
268545
Title
MHRA GMP Search Page
Study date
23 January 2024
Auth party contact address
-
Data no
268546
Title
Licence to manufacture veterinary chemical products
Study date
11 October 2023
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268577
Title
Tube Otis 1ml
Study date
15 March 2021
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268578
Title
Quality Inspection Certificate TUBE Dechra (OSURNIA) 1 ML blank w .eye mark
Study date
12 November 2020
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268554
Title
Process Validation Protocol
Study date
26 July 2021
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268555
Title
Process Validation Interim Report
Study date
08 February 2022
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268556
Title
Forced Degradation Study Report
Study date
29 April 2013
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268557
Title
Otis Lab Batch DC Report
Study date
04 May 2021
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268541
Title
Module 2.3 - Chemistry and Manufacture
Study date
March 2024
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268542
Title
Development Pharmaceutics
Study date
13 May 2013
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268579
Title
Container Closure System: Finished Product
Study date
24 April 2013
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268580
Title
USP test reports general monographs 661 and 671
Study date
14 February 2013
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268581
Title
Sorption of drugs from Auricle formulation into Laminate (Polyfoil) Tube
Study date
12 April 2010
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268582
Title
Study Report: Evaluation of the nominal content extraction from the tube
Study date
19 July 2012
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268551
Title
Compendial monographs and certificates of analysis (excipients)
Study date
17 January 2024
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268552
Title
Exipient methods
Study date
March 2024
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268553
Title
Exipient methods
Study date
March 2024
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268559
Title
Stability Testing Programme Protocols number VT3186, VT3187, VT3188
Study date
18 March 2021
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268560
Title
Stability Testing Programme Protocol number VT3189
Study date
22 March 2021
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268561
Title
Stability Testing Programme Protocol number VT3332
Study date
18 August 2021
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268562
Title
Stability tables 25C 60 per cent RH
Study date
19 May 2023
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268563
Title
Stability tables 5C
Study date
31 August 2023
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268564
Title
Stability tables 30C 65 and 75 per cent RH
Study date
13 June 2023
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268565
Title
Stability tables 40C 75 per cent RH
Study date
06 December 2021
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268566
Title
Photostability tables
Study date
04 October 2021
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268567
Title
Freeze thaw stability tables
Study date
17 March 2022
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268584
Title
A pivotal field study to evaluate the efficacy and safety of DP02270 in the treatment of yeast-related canine otitis externa
Study date
21 July 2023
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268585
Title
Summary Final Laboratory Report - A pivotal field study to evaluate the efficacy and safety of DP02270 in the treatment of yeastrelated canine otitis externa
Study date
10 July 2023
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
268586
Title
Azole and terbinafine susceptibility testing of Malassezia pachydermatis in Japan
Study date
2 February 2023
Auth party contact address
-
Data no
268587
Title
In vitro effects of omeprazole in combination with antifungal compounds against Malassezia pachydermatis
Study date
2023
Auth party contact address
-
Data no
268588
Title
Antifungal Resistance Regarding Malassezia pachydermatis: Where Are We Now?
Study date
25 June 2020
Auth party contact address
-
Data no
268583
Title
Module 8.2 - Efficacy and Safety
Study date
March 2024
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
282514
Title
Determination of Minimum Inhibitory Concentration (MIC) of florfenicol and terbinafine against bacterial and fungal strains from clinical otitis cases.
Study date
2014
Data no
284095
Title
Memorandum - VMD Authority Inspection Date
Study date
08 January 2025
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
271640
Title
Certificate of GMP Compliance of a Manufacturer
Study date
16 June 2023
Auth party contact address
-
Data no
271641
Title
Good Manufacturing Practice (GMP) Inspection Report
Study date
June 2023
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Date
Application Date
Application No
Application Number
143096
Product/Active constituent Name
Application Product Name
Titan Fluroxypyr 333 EC Herbicide
Application Date
Application Number
143096
Application Product Name
Titan Fluroxypyr 333 EC Herbicide
Application details
Product name:
Titan Fluroxypyr 333 EC Herbicide
Product number:
88496
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration to add a formulation and formulation sites to the product's registration details.
To vary the label to change the solvent statement to agree with the new formulation, and to add spray drift restraints.
Reference details:
68005 - TITAN FLUROXYPYR 400 HERBICIDE
88496 - Titan Fluroxypyr 333 EC Herbicide
Active constituents:
Active constituent name
49139 - FLUROXYPYR-MEPTYL
Description of data provided:
Data no
267702
Title
Chemistry and manufacture Titan Fluroxypyr 333 EC
Study date
28 February 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267700
Title
Manufacturers' specifications for the non-active constituents of Titan Fluroxypyr 333 EC Herbicide
Study date
2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267701
Title
Part 2 chemistry and manufacture
Study date
3 March 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267703
Title
Storage stability of Titan Fluroxypyr 333 EC
Study date
29 February 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
267699
Title
88496 AA letter
Study date
1 March 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
143073
Product/Active constituent Name
Application Product Name
Tessie 0.3 mg/mL Oral Solution For Dogs
Application Date
Application Number
143073
Application Product Name
Tessie 0.3 mg/mL Oral Solution For Dogs
Application details
Product name:
Tessie 0.3 mg/mL Oral Solution For Dogs
Product number:
94643
Applicant Name:
MAVLAB ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 0.3 mg/mL tasipimidine sulfate oral solution product for the short term alleviation of situational anxiety and fear in dogs triggered by noise or owner departure, in conjunction with approval of tasipimidine sulfate.
Description of data provided:
Data no
267847
Title
Response to D180 LoOI: Appendix 52
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268197
Title
3.2.P.4.2 Analytical procedures
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268198
Title
Analytical method 113966
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268199
Title
Analytical method 114025
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268200
Title
Analytical method 114026
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268201
Title
Analytical method 120503
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268202
Title
Analytical method 120535
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268203
Title
3.2.P.4.3 Validation of analytical procedures
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268213
Title
3.2.P 5.2 Analytical procedures
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268214
Title
Analytical method 122424
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268215
Title
Analytical method 122425
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268216
Title
Analytical method 123885
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268217
Title
3.2.P.5.3 Validation of analytical procedures
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268218
Title
Suitability study report
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268219
Title
Validation report ID
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268220
Title
Validation report UHPLC
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268221
Title
3.2.P.5.4 Batch analyses
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268222
Title
3.2.P.5.5 Characterisation of Impurities
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268223
Title
3.2.P.5.6 Justification of specifications
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268212
Title
3.2.P.5.1 Specifications
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268204
Title
3.2.P.4.4 Justification of specifications
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268205
Title
Excipient CoA (1)
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268206
Title
Excipient CoA (2)
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268207
Title
Excipient CoA (3)
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268208
Title
Excipient CoA (4)
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268209
Title
Excipient CoA (5)
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268187
Title
3.2.P.2.3 Manufacturing process development
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268192
Title
3.2.P.3.2 Batch formula
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268193
Title
3.2.P.3.3 Description of manufacturing processes and controls
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268194
Title
3.2.P.3.4 Control of critical steps and intermediates
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268195
Title
3.2.P.3.5 Process validation and/or evaluation
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268196
Title
3.2.P.4.1 Specifications
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268145
Title
3-2-r-1-process-validation-scheme-product
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268146
Title
3-2-r-4-materials-of-animal-and/or-origin-not-applic
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268181
Title
2.3 Quality Overall Summary-introduction
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268182
Title
2.3.P Drug Product
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268184
Title
3.2.P.1 Description and composition of drug product
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268185
Title
3.2.P.2.1 Components of drug product
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268186
Title
3.2.P.2.2 Drug Product
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268188
Title
3.2.P.2.4 Container closure system
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268189
Title
3.2.P 2.5 Microbiological attributes
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268190
Title
3.2.P.2.6 Compatibility
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268191
Title
3.2.P.3.1 Manufacturers
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268210
Title
3.2.P.4.5 Excipients of human or animal origin
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268211
Title
3.2.P.4.6 Novel excipients
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267844
Title
Response to D180 LoOI: Appendix 46
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267845
Title
Response to D180 LoOI: Appendix 48-1
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267846
Title
Response to D180 LoOI: Appendix 48-2
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267839
Title
Response to D180 LoOI: Appendix 8-1
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268224
Title
3.2.P.7 Container closure system
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268225
Title
Packaging compliance certificate 1
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268226
Title
Compliance certificate packaging 2
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268227
Title
Compliance certificate packaging 3
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268228
Title
Compliance certificate packaging 4
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268229
Title
3.2.P.8.1 Stability summary & conclusions
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268230
Title
3.2.P.8.2 Post-approval stability protocol & committment
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268231
Title
3.2.P.8.3 Stability data
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268232
Title
Stability results (1)
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268233
Title
Stability results (2)
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268234
Title
Stability results (3)
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268235
Title
Stability results -freeze-thaw
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268236
Title
Stability results -photostability
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268237
Title
Stability results -in-use
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268252
Title
Short term excursions
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268138
Title
Phasic vs Sustained Fear in Rats and Humans: Role of the Extended Amygdala in Fear vs Anxiety
Study date
2010
Auth party contact address
-
Data no
267851
Title
Preventing travel anxiety using dexmedetomidine hydrochloride oromucosal gel
Study date
2018
Auth party contact address
-
Data no
267848
Title
Erratum 2 to v3110006
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267849
Title
Ethogram
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267853
Title
Signalment factors, comorbidity, and trends in behavior diagnoses in dogs: 1,644 cases (1991-2001)
Study date
2006
Auth party contact address
-
Data no
267854
Title
Locus coeruleus-norepinephrine: basic functions and insights into Parkinson's disease
Study date
2020
Auth party contact address
-
Data no
267855
Title
Effects of alpha-casozepine (Zylkene) versus selegiline hydrochloride (Selgian, Anipryl) on anxiety disorders in dogs
Study date
2007
Auth party contact address
-
Data no
267856
Title
Noradrenergic alpha-2 receptor agonists reverse working memory deficits induced by the anxiogenic drug, FG7142, in rats
Study date
2000
Auth party contact address
-
Data no
267862
Title
Caregiver placebo effect for dogs with lameness from osteoarthritis
Study date
2012
Auth party contact address
-
Data no
267863
Title
A double-blind placebo-controlled study into the efficacy of a homeopathic remedy for fear of firework noises in the dog (Canis familiaris)
Study date
2008
Auth party contact address
-
Data no
267866
Title
Characteristics of Relinquished Dogs and Their Owners at 14 Rehoming Centers in the United Kingdom
Study date
2010
Auth party contact address
-
Data no
267874
Title
Current perspectives of the roles of the central norepinephrine system in anxiety and depression
Study date
2010
Auth party contact address
-
Data no
267875
Title
Use of trazodone as an adjunctive agent in the treatment of canine anxiety disorders: 56 cases (1995-2007)
Study date
2008
Auth party contact address
-
Data no
267880
Title
Breaking the human-companion animal bond
Study date
1996
Auth party contact address
-
Data no
267883
Title
Development and validation of a canine travel anxiety model
Study date
2018
Auth party contact address
-
Data no
267889
Title
Stress: Its Effects on Health and Behavior: A Guide for Practitioners
Study date
2014
Auth party contact address
-
Data no
267890
Title
Role of brain norepinephrine in the behavioral response to stress
Study date
2005
Auth party contact address
-
Data no
267895
Title
Placebo Effect in Canine Epilepsy Trials
Study date
2010
Auth party contact address
-
Data no
267899
Title
Human and animal factors related to the relinguishment of dogs and cats in 12 selected animal shelters in the United States
Study date
1998
Auth party contact address
-
Data no
267900
Title
Prevalence, comorbidity, and breed differences in canine anxiety in 13,700 Finnish pet dogs
Study date
2020
Auth party contact address
-
Data no
268140
Title
The use of clonidine in the treatment of fear-based behavior problems in dogs: An open trial
Study date
2011
Auth party contact address
-
Data no
268141
Title
Understanding the genetic basis of canine anxiety: phenotyping dogs for behavioral, neurochemical, and genetic assessment
Study date
2006
Auth party contact address
-
Data no
268142
Title
The neurobiology of stress: from serendipity to clinical relevance
Study date
2000
Auth party contact address
-
Data no
268143
Title
Frequency of nonspecific clinical signs in dogs with separation anxiety, thunderstorm phobia, and noise phobia, alone or in combination
Study date
2001
Auth party contact address
-
Data no
268144
Title
Prevalence, comorbidity, and behavioral variation in canine anxiety
Study date
2016
Auth party contact address
-
Data no
268123
Title
Reliability and validity of a questionnaire survey in canineanxiety research
Study date
2014
Auth party contact address
-
Data no
268124
Title
Neuronal circuits for fear and anxiety
Study date
2015
Auth party contact address
-
Data no
268125
Title
Behavioural testing of dogs in animal shelters to predict problem behaviour
Study date
1991
Auth party contact address
-
Data no
268126
Title
Manifestations of chronic and acute stress in dogs
Study date
1997
Auth party contact address
-
Data no
268127
Title
Behavioural, saliva cortisol and heart rate responses to different types of stimuli in dogs
Study date
1998
Auth party contact address
-
Data no
268128
Title
Use of clomipramine, alprazolam, and behavior modification for treatment of storm phobia in dogs
Study date
2003
Auth party contact address
-
Data no
268129
Title
Demographics and comorbidity of behavior problems in dogs
Study date
2019
Auth party contact address
-
Data no
268130
Title
The effects of fear and anxiety on health and lifespan in pet dogs
Study date
2010
Auth party contact address
-
Data no
268131
Title
Sensitive Periods in Affective Development: Nonlinear Maturation of Fear Learning
Study date
2015
Auth party contact address
-
Data no
268132
Title
Physiological reactions to fear provocation in dogs
Study date
2004
Auth party contact address
-
Data no
268133
Title
Dogs predisposed to anxiety disorders and related factors in Japan
Study date
2017
Auth party contact address
-
Data no
268134
Title
Assessing stress in dogs during a visit to the veterinary clinic: Correlations between dog behavior in standardized tests and assessments by veterinary staff and owners
Study date
2017
Auth party contact address
-
Data no
268135
Title
Fear responses to noises in domestic dogs: Prevalence, risk factors and co-occurrence with other fear related behaviour
Study date
2013
Auth party contact address
-
Data no
268079
Title
Human and Animal Factors Related to the Relinquishment of Dogs and Cats in 12 Selected Animal Shelters in the United States
Study date
1998
Auth party contact address
-
Data no
268080
Title
High-dose dexmedetomidine sedation for pediatric MRI
Study date
2011
Auth party contact address
-
Data no
268084
Title
Molecular Pharmacology of a2-adrenoceptor Subtypes
Study date
1995
Auth party contact address
-
Data no
268085
Title
Perioperative Stress Response in the Dog: Effect of Pre-Emptive Administration of Medetomidine
Study date
2000
Auth party contact address
-
Data no
268086
Title
Diagnosis and Treatment of Separation-Related Behavior Problems in Dogs
Study date
1982
Auth party contact address
-
Data no
268087
Title
An epidemiology study on travel anxiety and motion sickness
Study date
2010
Auth party contact address
-
Data no
268088
Title
Video analysis of dogs suffering from anxiety when left home alone and treated with clomipramine
Study date
2014
Auth party contact address
-
Data no
268089
Title
Alpha-Adrenoceptors Subtypes
Study date
2001
Auth party contact address
-
Data no
268090
Title
Fear-related behaviour of dogs in veterinary practice
Study date
2009
Auth party contact address
-
Data no
268091
Title
Unerwunschtes Verhalten von Hunden beim Autofahren - Prophylaxe und Therapie
Study date
2004
Auth party contact address
-
Data no
268092
Title
Fearful Fido: Investigating dog experience in the veterinary context in an effort to reduce distress
Study date
2019
Auth party contact address
-
Data no
268093
Title
Placebo-controlled double-blind clomipramine trial for the treatment of anxiety or fear in beagles during ground transport
Study date
2006
Auth party contact address
-
Data no
268095
Title
Signs of travel-related problems in dogs and their response to treatment with dog-appeasing pheromone
Study date
2006
Auth party contact address
-
Data no
268096
Title
Evaluation of the quality of the recovery after administration of propofol or alfaxalone for induction of anaesthesia in dogs anaesthetized for magnetic resonance imaging
Study date
2012
Auth party contact address
-
Data no
268097
Title
Comparison of blood pressure measurements obtained in dogs by use of indirect oscillometry in a veterinary clinic versus at home
Study date
1997
Auth party contact address
-
Data no
268098
Title
The effect of a pressure wrap (ThunderShirt) on heart rate and behavior in canines diagnosed with anxiety disorder
Study date
2014
Auth party contact address
-
Data no
268099
Title
Treatment of separation anxiety in dogs with clomipramine: results from a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial
Study date
2000
Auth party contact address
-
Data no
268100
Title
Dexmedetomidine oromucosal gel for noiseassociated acute anxiety and fear in dogs - a randomised, double-blind, placebo-controlled clinical study
Study date
2000
Auth party contact address
-
Data no
268101
Title
The distribution of canine behavior cases at three behavior referral practices
Study date
1991
Auth party contact address
-
Data no
268102
Title
Minimising Stress for Patients in the Veterinary Hospital: Why It Is Important and What Can Be Done about It
Study date
2017
Auth party contact address
-
Data no
268103
Title
Behaviour patterns and time course of activity in dogs with separation problems
Study date
1999
Auth party contact address
-
Data no
268104
Title
Diagnostic Criteria for Separation Anxiety in the Dog
Study date
1999
Auth party contact address
-
Data no
268105
Title
S18616, a Highly Potent Spiroimidazoline Agonist at a2-Adrenoceptors: II. Influence on Monoaminergic Transmission, Motor Function, and Anxiety in Comparison with Dexmedetomidine and Clonidine
Study date
2000
Auth party contact address
-
Data no
268106
Title
A triple blind placebo-controlled investigation into the assessment of the effect of Dog Appeasing Pheromone (DAP) on anxiety related behaviour of problem dogs in the veterinary clinic
Study date
2006
Auth party contact address
-
Data no
268107
Title
a2-Adrenoceptor subtypes involved in the regulation of catecolamine release from the adrenal medulla of mice
Study date
2006
Auth party contact address
-
Data no
268108
Title
Video analysis of dogs with separation-related behaviors
Study date
2010
Auth party contact address
-
Data no
268109
Title
Effects of exercise-induced stress and dexamethasone on plasma hormone and glucose concentrations and sedation in dogs treated with dexmedetomidine
Study date
2005
Auth party contact address
-
Data no
268110
Title
Evaluation of dog-appeasing pheromone as a potential treatment for dogs fearful of fireworks
Study date
2003
Auth party contact address
-
Data no
268111
Title
Canine Anxieties and Phobias: An Update on Separation Anxiety and Noise Aversions
Study date
2008
Auth party contact address
-
Data no
268112
Title
Advances in the Understanding and Treatment of Noise Phobias
Study date
1991
Auth party contact address
-
Data no
268113
Title
Evaluation of the perioperative stress response in dogs administered medetomidine or acepromazine as part of the preanesthetic medication
Study date
2002
Auth party contact address
-
Data no
268114
Title
Pre-operative stress in dogs - a preliminary investigation of behavior and heart rate variability in healthy hospitalized dogs
Study date
2005
Auth party contact address
-
Data no
268115
Title
Using an owner-based questionnaire to phenotype dogs with separation-related distress: Do owners know what their dogs do when they are absent?
Study date
2017
Auth party contact address
-
Data no
268116
Title
Classification of Behavior Problems in Dogs: Distributions of Age, Breed, Sex and Reproductive Status
Study date
1987
Auth party contact address
-
Data no
268117
Title
The contextual brain: implications for fear conditioning, extinction and psychopathology
Study date
2013
Auth party contact address
-
Data no
268118
Title
Perception of dogs - stress by their owners
Study date
2012
Auth party contact address
-
Data no
268119
Title
S18616, a Highly Potent Spiroimidazoline Agonist at a2-Adrenoceptors: II. Influence on Monoaminergic Transmission, Motor Function, and Anxiety in Comparison with Dexmedetomidine and Clonidine
Study date
2000
Auth party contact address
-
Data no
268120
Title
Phenotypic determination of noise reactivity in 3 breeds of working dogs: A cautionary tale of age, breed, behavioral assessment, and genetics
Study date
2016
Auth party contact address
-
Data no
268121
Title
Fear of noises affects canine problem solving behavior and locomotion in standardized cognitive tests
Study date
2019
Auth party contact address
-
Data no
268010
Title
Efficacy Report No. V3110002
Study date
2015
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268011
Title
Efficacy Report No. V3110003
Study date
2015
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268012
Title
Efficacy Report No. V3110004
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268013
Title
Efficacy Report No. V3110005
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268014
Title
Efficacy Report No. V3110006
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268015
Title
Efficacy Report No. V3110007
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268072
Title
Stress: Its Effects on Health and Behavior: A Guide for Practitioners
Study date
2014
Auth party contact address
-
Data no
268073
Title
Clinical Scenarios
Study date
2013
Auth party contact address
-
Data no
268074
Title
A simple practice guide for dose conversion between animals and human
Study date
2016
Auth party contact address
-
Data no
268075
Title
Dexmedetomidine overdosage: An unusual presentation
Study date
2013
Auth party contact address
-
Data no
268081
Title
Ophthalmological and Pharmacological Studies after Administration of Clonidine in Rats
Study date
1978
Auth party contact address
-
Data no
267916
Title
Tessie - response template D120
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267917
Title
Characterisation of a2-adrenoceptor subtypes involved in gastric emptying, gastric motility and gastric mucosal defence
Study date
2005
Data no
267979
Title
Development of resistance
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267922
Title
Detailed and Critical Summary on Safety
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267923
Title
Expert CV
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267924
Title
Tabular formats for safety critical summary
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267925
Title
Detailed and Critical Summary on Efficacy
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267926
Title
Expert signature
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267927
Title
Tabular summaries
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267928
Title
Glutamate neurotransmission is affected in prenatally stressed offspring
Study date
2015
Auth party contact address
-
Data no
267929
Title
Development and validation of a novel laboratory model of sound-induced fear and anxiety in Beagle dogs
Study date
2013
Auth party contact address
-
Data no
267930
Title
Schutz von Hunden und Katzen in der tierarztlichen Kleintierpraxis: Empfehlungen zur Optimierung der Ausstattung und des Managements sowie des Umgangs mit Patienten unter Tierschutzaspekten
Study date
2017
Auth party contact address
-
Data no
267931
Title
Separation, Confinement, or Noises: What Is Scaring That Dog?
Study date
2018
Auth party contact address
-
Data no
267932
Title
Periods of Early Development and the Effects of Stimulation and Social Experiences in the Canine
Study date
2009
Auth party contact address
-
Data no
267933
Title
Comparison of the effectiveness of a purported anti-static cape (the Storm Defender) vs. a placebo cape in the treatment of canine thunderstorm phobia as assessed by owners reports
Study date
2009
Auth party contact address
-
Data no
267934
Title
An evaluation of owner expectation on apparent treatment effect in a blinded comparison of 2 homeopathic remedies for firework noise sensitivity in dogs
Study date
2011
Auth party contact address
-
Data no
267935
Title
Acute stress selectively impairs learning to act
Study date
2016
Auth party contact address
-
Data no
267936
Title
The importance of early life experiences for the development of behavioural disorders in domestic dogs
Study date
2018
Auth party contact address
-
Data no
267937
Title
Communication between domestic dogs (Canis familiaris) and humans: Dogs are good learners
Study date
2009
Auth party contact address
-
Data no
267938
Title
Noise sensitivities in Dogs: An exploration of signs in Dogs with and without Musculoskeletal Pain Using Qualitative content Analysis
Study date
2018
Auth party contact address
-
Data no
267939
Title
The role of context specificity in learning: the effects of training context on explosives detection in dogs
Study date
2005
Auth party contact address
-
Data no
267940
Title
Effects of early gentling and early environment on emotional development of puppies
Study date
2008
Auth party contact address
-
Data no
267941
Title
Puppy behavior at the veterinary clinic: A pilot study
Study date
2007
Auth party contact address
-
Data no
267942
Title
The role of environmental and owner-provided consequences in canine stereotypy and compulsive behavior
Study date
2015
Auth party contact address
-
Data no
267943
Title
Retrospective evaluation of the effects of diazepam in dogs with anxiety-related behavior problems
Study date
2008
Auth party contact address
-
Data no
267944
Title
Dog training methods: Their use, effectiveness and interaction with behaviour and welfare
Study date
2004
Auth party contact address
-
Data no
267945
Title
The Importance of the Secure Base Effect for Domestic Dogs - Evidence from a Manipulative Problem-Solving Task
Study date
2004
Auth party contact address
-
Data no
267946
Title
Disambiguating the 'guilty look': Salient prompts to a familiar dog behaviour
Study date
2009
Auth party contact address
-
Data no
267947
Title
Genetic Characterisation of Dog Personality Traits
Study date
2017
Auth party contact address
-
Data no
267948
Title
Dual-transmitter systems regulating arousal, attention, learning and memory
Study date
2018
Auth party contact address
-
Data no
267949
Title
Learning about stress: neural, endocrine and behavioral adaptations
Study date
2018
Auth party contact address
-
Data no
267950
Title
Thunderstorm phobia in dogs: An internet survey of 69 cases
Study date
2001
Auth party contact address
-
Data no
267951
Title
Behavioral and psychological outcomes for dogs sold as puppies through pet stores and/or born in commercial breeding establishments: Current knowledge and putative causes
Study date
2017
Auth party contact address
-
Data no
267952
Title
The use of imepitoin (Pexion) on fear and anxiety related problems in dogs - a case series
Study date
2017
Auth party contact address
-
Data no
267953
Title
Placebo Effect in Canine Epilepsy Trials
Study date
2010
Auth party contact address
-
Data no
267954
Title
Stress enhances model-free reinforcement learning only after negative outcome
Study date
2010
Auth party contact address
-
Data no
267955
Title
Human-directed social behaviour in dogs shows significant heritability
Study date
2015
Auth party contact address
-
Data no
267956
Title
From the individual to the population - and back again: Emphasising the role of the individual in animal welfare science
Study date
2019
Auth party contact address
-
Data no
267957
Title
Canine behaviour problems: discussions between veterinarians and dog owners during annual booster consultations
Study date
2013
Auth party contact address
-
Data no
267958
Title
Use of clomipramine in treatment of obsessive-compulsive disorder, separation anxiety and noise phobia in dogs: a preliminary, clinical study
Study date
2001
Auth party contact address
-
Data no
267959
Title
Noise sensitivity in 17 dog breeds: Prevalence, breed risk andcorrelation with fear in other situations
Study date
2015
Auth party contact address
-
Data no
267960
Title
Early Life Experiences and Exercise Associate with Canine Anxieties
Study date
2015
Auth party contact address
-
Data no
267961
Title
Environmental Effects on Compulsive Tail Chasing in Dogs
Study date
2012
Auth party contact address
-
Data no
267962
Title
Unpredictable chronic mild stress differentially impairs social and contextual discrimination learning in two inbred mouse strains
Study date
2017
Auth party contact address
-
Data no
267963
Title
In Defense of Case Reports and Case Series
Study date
2001
Auth party contact address
-
Data no
267964
Title
From Pavlov to PTSD: The extinction of conditioned fear in rodents, humans, and in anxiety disorders
Study date
2014
Auth party contact address
-
Data no
267965
Title
Information Loss over Time Defines the Memory Defect of Propofol: A Comparative Response with Thiopental and Dexmedetomidine
Study date
2014
Auth party contact address
-
Data no
267966
Title
Brain activity associated with illusory correlations in animal phobia
Study date
2015
Auth party contact address
-
Data no
267967
Title
Quality of life and animal behaviour
Study date
2016
Auth party contact address
-
Data no
267872
Title
BORIS: a free, versatile open-source event-logging software for video/audio coding and live observations
Study date
2016
Auth party contact address
-
Data no
267879
Title
The use of oral transmucosal detomidine hydrochloride gel to facilitate handling in dogs
Study date
2013
Auth party contact address
-
Data no
268238
Title
Concomittant medications with tasipimidine
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268239
Title
Concomittant use clomipramidine with tasipimidine
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268240
Title
Concomittant use fluoxetine with tasipimidine
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268241
Title
Pharmacology Report No. R210070
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268242
Title
Pharmacology Report No. R220079
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268243
Title
Summary document
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268244
Title
Adverse events
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268139
Title
a2-Adrenoceptor subtypes-mediated physiological, pharmacological actions
Study date
2009
Auth party contact address
-
Data no
268246
Title
dog-master-study-protocol-v-1
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268247
Title
ref-no-4-bioanalyt-qualif-report
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268248
Title
Sensitivity in vivo of Central a2- and Opiate Receptors After Chronic Treatment with Various Antidepressant
Study date
1982
Auth party contact address
-
Data no
267876
Title
Diverse Tissue Expression of Rat a2-Adrenergic Receptor Genes
Study date
1993
Auth party contact address
-
Data no
267877
Title
The effect of alpha 2 agonists and antagonists on the lower urinary tract of the rat
Study date
1993
Auth party contact address
-
Data no
267878
Title
Effects of alpha adrenoceptor blockade on renal nerve stimulation-induced norepinephrine release and vasoconstriction in the dog kidney
Study date
1989
Auth party contact address
-
Data no
267868
Title
Renal effects of infusion of rilmenidine and guanabenz in conscious dogs: contribution of peripheral and central nervous system alpha 2-adrenoceptors
Study date
1995
Auth party contact address
-
Data no
267869
Title
Characterization of binding sites for [3H]-idazoxan, [3H]-P-aminoclonidine and [3H]-rauwolscine in the kidney of the dog
Study date
1994
Auth party contact address
-
Data no
267870
Title
Altered glucose homeostasis in a2A-adrenoceptor knockout mice
Study date
2004
Auth party contact address
-
Data no
267871
Title
a2-Adrenoceptor Regulation of Blood Glucose Homeostasis
Study date
2011
Auth party contact address
-
Data no
267896
Title
Inhibition of insulin secretion via distinct signaling pathways in a2-adrenoceptor knockout mice
Study date
2003
Auth party contact address
-
Data no
267897
Title
Plasma glucose, insulin, free fatty acids, lactate and cortisol concentrations in dexmedetomidine-sedated dogs with or without MK-467: A peripheral a-2 adrenoceptor antagonist
Study date
2012
Auth party contact address
-
Data no
267898
Title
Involvement of a2-Adrenoceptor Subtypes A and C in Glucose Homeostasis and Adrenaline-Induced Hyperglycaemia
Study date
2012
Auth party contact address
-
Data no
267892
Title
Involvement of the opioid system in the central antisecretory action of alpha-2 adrenoceptor agonists in rat
Study date
2001
Auth party contact address
-
Data no
267893
Title
Involvement of central KATP channels in the gastric antisecretory action of a2-adrenoceptor agonists and b-endorphin in rats
Study date
2002
Auth party contact address
-
Data no
267894
Title
Angiotensin II and aldosterone regulation
Study date
1999
Auth party contact address
-
Data no
267885
Title
Characterization of a2-adrenoceptors mediating contraction of dog saphenous vein: identity with the human a2A subtype
Study date
1997
Auth party contact address
-
Data no
267886
Title
Effects of medetomidine on intestinal and colonic motility in the dog
Study date
1994
Auth party contact address
-
Data no
267887
Title
Xylazine-induced prolongation of gastrointestinal transit in dogs: Reversal by yohimbine and potentiation by doxapram
Study date
1984
Auth party contact address
-
Data no
267888
Title
Patterns of messenger RNA expression for adrenergic receptor subtypes in the rat kidney
Study date
1994
Auth party contact address
-
Data no
267857
Title
Characterization of a2-adrenoceptor subtypes involved in the modulation of gastric acid secretion
Study date
1995
Auth party contact address
-
Data no
267858
Title
Imidazoline Receptor System: The Past, the Present, and the Future
Study date
2020
Auth party contact address
-
Data no
267859
Title
The Water Diuretic Effect of the Alpha-2 Adrenoceptor Agonist
Study date
1991
Auth party contact address
-
Data no
267860
Title
Modulation of vasopressin antidiuretic action by alpha 2-adrenoceptors is species specific
Study date
1991
Auth party contact address
-
Data no
267861
Title
Effects of medetomidine on serum insulin and plasma glucose concentrations in clinically normal dogs
Study date
1997
Auth party contact address
-
Data no
267850
Title
Alpha2A adrenergic receptor genetic variation contributes to hyperglycemia after myocardial infarction
Study date
2016
Auth party contact address
-
Data no
267852
Title
Involvement of Alpha-2 Adrenergic Receptor Subtypes in Hyperglycemia
Study date
1990
Auth party contact address
-
Data no
267920
Title
Development and validation of a simple, sensitive and accurate LC-MS/MS method for the determination of guanfacine, a selective a2A-adrenergicreceptor agonist, in plasma and its application to a pharmacokinetic study
Study date
2013
Data no
267921
Title
Physiological significance of a2-adrenergic receptor subtype diversity: one receptor is not enough
Study date
2002
Data no
267978
Title
Pharmacology
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267985
Title
Pharmacology Report No. 499682
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267986
Title
Pharmacology Report No. 499683
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267990
Title
Pharmacology Report No. 504069
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267991
Title
Pharmacology Report No. 504070
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267918
Title
Identification and characterization of platelet a2-adrenoceptors and imidazoline receptors in rats, rabbits, cats, dogs, cattle, and horses
Study date
2013
Data no
267913
Title
Effects of Dexmedetomidine on Renal System and on Vasopressin Plasma Levels. Experimental Study in Dogs
Study date
2005
Auth party contact address
-
Data no
267914
Title
Pre- and postsynaptic mechanisms in the clonidine and oxymetazoline-induced inhibition of gastric motility in the rat
Study date
2007
Auth party contact address
-
Data no
267902
Title
Effects of alpha-2-adrenoceptor agonists on induced diuresis in rats
Study date
1993
Auth party contact address
-
Data no
267903
Title
Molecular and pharmacological characterization of the canine brainstem alpha-2A adrenergic receptor
Study date
1999
Auth party contact address
-
Data no
267905
Title
A review of the physiological effects of a2-agonists related to the clinical use of medetomidine in small animal practice
Study date
2003
Auth party contact address
-
Data no
267906
Title
Evidence for two opposite effects of clonidine on gastric acid secretion in the dog
Study date
1984
Auth party contact address
-
Data no
267907
Title
Renal effects of the antihypertensive, guanabenz, in the dog
Study date
1982
Auth party contact address
-
Data no
267908
Title
Antagonistic effects of atipamezole and yohimbine on medetomidine-induced diuresis in healthy dogs
Study date
2009
Auth party contact address
-
Data no
267909
Title
Diuretic effects of medetomidine compared with xylazine in healthy dogs
Study date
2009
Auth party contact address
-
Data no
268078
Title
A Phase I, Two-center Study of the Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Children
Study date
2006
Auth party contact address
-
Data no
268122
Title
Noradrenaline systems in the hypothalamus, amygdala and locus coeruleus are involved in the provocation of anxiety: basic studies
Study date
2000
Auth party contact address
-
Data no
268136
Title
Interferences of the autonomic nervous system with drug induced QT prolongation: A point to consider in non-clinical safety studies
Study date
2010
Auth party contact address
-
Data no
268137
Title
High-frequency autonomic modulation: a new model for analysis of autonomic cardiac control
Study date
2018
Auth party contact address
-
Data no
268016
Title
Pharmacology Report No. 090017ff815b54c1
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268017
Title
Pharmacology Report No. 130307.DCC
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268018
Title
Pharmacology Report No. 498078
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268019
Title
Pharmacology Report No. 498319
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268001
Title
Pharmacology Report No. 11000358
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268002
Title
Pharmacology Report No. 12000025
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268003
Title
Pharmacology Report No. 12000156
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268004
Title
Pharmacology Report No. 12000191
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268005
Title
Pharmacology Report No. 12000294
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268006
Title
Pharmacology Report No. 13000003
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268007
Title
Pharmacology Report No. 13000022
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268008
Title
Pharmacology Report No. 13000169
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268021
Title
Pharmacology Report No. 509760
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268022
Title
Pharmacology Report No. 514553
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268023
Title
Pharmacology Report No. 8160276
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268024
Title
Pharmacology Report No. 8160279
Study date
2011
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268025
Title
Pharmacology Report No. 8160282
Study date
2011
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268026
Title
Pharmacology Report No. 11000231
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268027
Title
Pharmacology Report No. 12000041
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268028
Title
Pharmacology Report No. 12000151
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268029
Title
Pharmacology Report No. 12000252
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268030
Title
Pharmacology Report No. 12000257
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268031
Title
Pharmacology Report No. 12000296
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268032
Title
Pharmacology Report No. 12000313
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268033
Title
Pharmacology Report No. 13000027
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268034
Title
Pharmacology Report No. 13000162
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268035
Title
Pharmacology Report No. 13000183
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268036
Title
Pharmacology Report No. 20120065SPEP
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268037
Title
Pharmacology Report No. 20120066PCCP
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268038
Title
Pharmacology Report No. 20130030SPE
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268039
Title
Pharmacology Report No. 20130031SPE
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268040
Title
Pharmacology Report No. 100004045
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268041
Title
Pharmacology Report No. 100005326
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268042
Title
Pharmacology Report No. 100005327
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268043
Title
Pharmacology Report No. 100007356
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268044
Title
Pharmacology Report No. 100008367
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268045
Title
Pharmacology Report No. AB13355
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268046
Title
Pharmacology Report No. AB18170
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268047
Title
Pharmacology Report No. AB18254
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268048
Title
Pharmacology Report No. ADM-11-091b
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268049
Title
Pharmacology Report No. ORN001-01
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268050
Title
Pharmacology Report No. ORN-03
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268051
Title
Pharmacology Report No. PR013000156
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268052
Title
Pharmacology Report No. R140284
Study date
2015
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268053
Title
Pharmacology Report No. R160213
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268020
Title
Pharmacology Report No. 499681
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268094
Title
Repeat - Dose Toxicity Studies
Study date
2010
Auth party contact address
-
Data no
267901
Title
Reasons for Relinquishment of Companion Animals in U.S. Animal Shelters: Selected Health and Personal Issues
Study date
1999
Auth party contact address
-
Data no
267882
Title
Dogs predisposed to anxiety disorders and related factors in Japan
Study date
2017
Auth party contact address
-
Data no
267980
Title
Tolerance in target animal species
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267981
Title
Clinical
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267867
Title
Risk Factors for Dog Relinquishment to a Los Angeles Municipal Animal Shelter
Study date
2015
Auth party contact address
-
Data no
268250
Title
20319819 amendment 1
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268251
Title
20319819 report
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268249
Title
Response
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268245
Title
Response to list of questions
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267818
Title
2024-01-24 - Project Plan signed by both parties - 141934
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267824
Title
Tessie - International Documentation Summary
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267825
Title
Tessie - Cross-reference Table
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267826
Title
GMP certificates
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267828
Title
Tessie - PAA wrritten assistance - 141934
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267819
Title
D120 Tessie - Scientific overview and LoQ
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267820
Title
D180 Tessie - Scientific overview and LoOI
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267821
Title
D210 Tessie - CVMP AR
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267822
Title
Tessie VRA-0001 - CVMP AR
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267823
Title
Tessie SPC - ema-combined-v5427-tessie-vra-0001-en
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267912
Title
Dexmedetomidine-lnduced Ocular Hypotension in Rabbits With Normal or Elevated Intraocular Pressures
Study date
1992
Auth party contact address
-
Data no
267996
Title
Toxicology Report No. 514878
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267983
Title
Toxicokinetic Report No. 498317
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268083
Title
OECD 439
Study date
2015
Auth party contact address
-
Data no
267993
Title
Toxicology Report No. 514874
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267992
Title
Toxicology Report No. 514873
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267911
Title
Maternal and preterm fetal sheep responses to dexmedetomidine
Study date
2012
Auth party contact address
-
Data no
267904
Title
The in vitro effects of clonidine and dexmedetomidine on human myometrium
Study date
2005
Auth party contact address
-
Data no
267865
Title
Bone development in laboratory mammals used in developmental toxicity studies
Study date
2018
Auth party contact address
-
Data no
267873
Title
Different roles of a2-adrenoceptor subtypes in non-pregnant and late-pregnant uterine contractility in vitro in the rat
Study date
2007
Auth party contact address
-
Data no
267884
Title
Effects of Altered Food Intake during Pubertal Development in Male and Female Wistar Rats
Study date
2007
Auth party contact address
-
Data no
267994
Title
Toxicology Report No. 514875
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267995
Title
Toxicology Report No. 514876
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267997
Title
Toxicology Report No. 780070
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267998
Title
Toxicology Report No. 1494101
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267999
Title
Toxicology Report No. 1494102
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267829
Title
In Vitro Micronucleus Assay
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267910
Title
Report of the IWGT working group on strategies and interpretation of regulatory in vivo tests I. Increases in micronucleated bone marrow cells in rodents that do not indicate genotoxic hazards
Study date
2007
Auth party contact address
-
Data no
267987
Title
Toxicology Report No. 500502
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267982
Title
Toxicology Report No. 13ORIOP2
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267968
Title
Precise ident of prod and active subs
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267969
Title
Pharmacology
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267970
Title
Toxicology
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267971
Title
Other requirements
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267972
Title
User risk assessment
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267973
Title
Environ impact assess
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267974
Title
Residue tests
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267975
Title
Identif of product
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267976
Title
Metabolism and residue kinetics
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267977
Title
Residue analyt method
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267830
Title
Chromosome Aberration Assay
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267832
Title
The Pharmacokinetics of Dexmedetomidine in Volunteers with Severe Renal Impairment
Study date
2001
Auth party contact address
-
Data no
267833
Title
Dexmedetomidine and Mannitol for Awake Craniotomy in a Pregnant Patient
Study date
2015
Auth party contact address
-
Data no
267834
Title
Postoperative management with dexmedetomidine in a pregnant patient who underwent AVM nidus removal: a case report
Study date
2017
Auth party contact address
-
Data no
267835
Title
Dexmedetomidine for awake fiberoptic intubation in a parturient with spinal muscular atrophy type III for cesarean delivery
Study date
2009
Auth party contact address
-
Data no
267836
Title
Intravenous dexmedetomidine as an adjunct for labor analgesia and cesarean delivery anesthesia in a parturient with a tethered spinal cord
Study date
2009
Auth party contact address
-
Data no
267837
Title
Effect and Placental Transfer of Dexmedetomidine During Caesarean Section Under General Anaesthesia
Study date
2015
Auth party contact address
-
Data no
267840
Title
Tessie - D180 LoOI Responses
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267841
Title
Heterogeneity of a2-adrenoceptors in human and rat myometrium and differential expression during pregnancy
Study date
1997
Data no
267842
Title
Response to D180 LoOI: Appendix 9
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268000
Title
Toxicology Report No. 08000278
Study date
2008
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268076
Title
Handbook of Pharmaceutical Excipients 4
Study date
2003
Auth party contact address
-
Data no
268077
Title
Subtype-specific stimulation of [35S]GTPgS binding by recombinant a2-adrenoceptors
Study date
1998
Auth party contact address
-
Data no
268064
Title
Neurogenesis in adulthood: a possible role in learning
Study date
1999
Auth party contact address
-
Data no
268065
Title
Atipamezole as an emergency treatment for overdose from highly concentrated alpha-2 agonists used in zoo and wildlife anesthesia
Study date
2017
Auth party contact address
-
Data no
268066
Title
Sedative, Amnestic, and Analgesic Properties of Small-Dose Dexmedetomidine Infusions
Study date
2000
Auth party contact address
-
Data no
268067
Title
Can light absorption and photostability data be used to assess the photosafety risks in patients for a new drug molecule?
Study date
2009
Auth party contact address
-
Data no
268068
Title
Sedation with Dexmedetomidine or Propofol Impairs Hypoxic Control of Breathing in Healthy Male Volunteers: A Nonblinded, Randomized Crossover Study
Study date
2016
Auth party contact address
-
Data no
268069
Title
Upper Airway Collapsibility during Dexmedetomidine and Propofol Sedation in Healthy Volunteers: A Nonblinded Randomized Crossover Study
Study date
2019
Auth party contact address
-
Data no
268070
Title
High dose dexmedetomidine as the sole sedative for pediatric MRI
Study date
2008
Auth party contact address
-
Data no
268071
Title
Extended Infusion of Dexmedetomidine to an Infant at Sixty Times the Intended Rate
Study date
2010
Auth party contact address
-
Data no
268009
Title
Toxicology Report No. UVVIS
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268054
Title
Benefit-Risk assessment tasipimidine
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268055
Title
Handbook of Pharmaceutical Excipients 1
Study date
2003
Auth party contact address
-
Data no
268056
Title
Handbook of Pharmaceutical Excipients 2
Study date
2003
Auth party contact address
-
Data no
268057
Title
Effects of Intravenous Dexmedetomidine in Humans. I. Sedation, Ventilation, and Metabolic Rate
Study date
1992
Auth party contact address
-
Data no
268058
Title
Hypoglycemia associated with dexmedetomidine overdose in a child
Study date
2009
Auth party contact address
-
Data no
268059
Title
Effects of Intravenous Dexmedetomidine in Humans. II. Hemodynamic Changes
Study date
1992
Auth party contact address
-
Data no
268060
Title
The Effects of Increasing Plasma Concentrations of Dexmedetomidine in Humans
Study date
2000
Auth party contact address
-
Data no
268061
Title
Handbook of Pharmaceutical Excipients 3
Study date
2003
Auth party contact address
-
Data no
268062
Title
Effect of Dexmedotomidine, an a2-Adrenergic Agonist, in the Isolated Heart
Study date
1992
Auth party contact address
-
Data no
268063
Title
Structural Changes in the Rat Bladder after Acute Outlet Obstruction
Study date
1999
Auth party contact address
-
Data no
268082
Title
The contextual brain: implications for fear conditioning, extinction and psychopathology
Study date
2013
Auth party contact address
-
Data no
267881
Title
Comprehensive Observational Assessment: Ia. A Systematic, Quantitative Procedure for Assessing the Behavioral and Physiologic State of the Mouse
Study date
1968
Auth party contact address
-
Data no
267891
Title
Functional Assays for Neurotoxicity Testing
Study date
2011
Auth party contact address
-
Data no
267864
Title
Fear-potentiated startle: a neural and pharmacological analysis
Study date
1993
Auth party contact address
-
Data no
267988
Title
Toxicology Report No. 501808
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267989
Title
Toxicology Report No. 501809
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267984
Title
Toxicology Report No. 499680
Study date
2012
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
267915
Title
Volume 6B Notice to applicants
Study date
2015
Auth party contact address
-
Data no
267919
Title
Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD
Study date
2018
Date
Application Date
Application No
Application Number
143223
Product/Active constituent Name
Application Product Name
GAUCHO 600 RED FLOWABLE SEED TREATMENT INSECTICIDE
Application Date
Application Number
143223
Application Product Name
GAUCHO 600 RED FLOWABLE SEED TREATMENT INSECTICIDE
Application details
Product name:
GAUCHO 600 RED FLOWABLE SEED TREATMENT INSECTICIDE
Product number:
52320
Applicant Name:
BAYER CROPSCIENCE PTY LTD
Application purpose and description of use:
Variation of product registration to add an alternative formulation.
Active constituents:
Active constituent name
49016 - IMIDACLOPRID
Description of data provided:
Data no
268898
Title
Validation of HPLC-method 2001-0050605-05.
Study date
27 March 2008
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268899
Title
Determination of imidacloprid in formulations.
Study date
5 July 2005
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268897
Title
Manufacturing procedure.
Study date
13 March 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268900
Title
Gaucho 600 Red Flowable Seed Treatment Insecticide.
Study date
14 March 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268894
Title
Module 2 - Chemistry data: Gaucho 600 Red Flowable Seed Treatment Insecticide.
Study date
14 March 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268895
Title
Gaucho 600 Red Flowable Seed Treatment Insecticide - SDS compilation.
Study date
14 March 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268896
Title
Storage stability at elevated temperature and cold stability of imidacloprid FS 600 (600 g/L).
Study date
20 December 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268884
Title
Microcosm trial comparing the efficacy of two Gaucho formulations against green peach aphids on canola.
Study date
24 January 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268885
Title
Microcosm trial comparing the efficacy of two Gaucho formulations against pea aphids on faba beans.
Study date
24 January 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268886
Title
Microcosm trial comparing the efficacy of two Gaucho formulations against bluegreen aphids on lentils.
Study date
24 January 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268887
Title
Microcosm trial comparing the efficacy of two Gaucho formulations against oat aphids on wheat.
Study date
24 January 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268888
Title
Field evaluation of Gaucho Red FS600 versus modified formulation, Gaucho Red 111, for crop establishment, vigour and for insect control in winter cereal.
Study date
22 January 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268889
Title
Field evaluation of Gaucho Red FS600 versus modified formulation, Gaucho Red 111, for crop establishment, vigour and for insect control in winter cereal.
Study date
22 January 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268890
Title
Field evaluation of Gaucho Red FS600 versus modified formulation, Gaucho Red 111, for crop establishment, vigour and for insect control in winter cereal.
Study date
22 January 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268891
Title
Evaluation of Gaucho Red FS600 and a modified formulation, Gaucho Red 111, in the lab for standard seed germination & vigour tests on a range of crops.
Study date
22 January 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268892
Title
Evaluation of Gaucho Red FS600 and a modified formulation, Gaucho Red 111, in the lab for standard seed germination & vigour tests on wheat and barley, tested at T0 and T12 (12 months later).
Study date
22 January 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
268893
Title
Approval of an alternative formulation for Gaucho 600 Red Flowable Seed Treatment Insecticide - bioequivalence and crop safety data.
Study date
29 February 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Date
Application Date
Application No
Application Number
143084
Product/Active constituent Name
Application Product Name
DORAMECTIN
Application Date
Application Number
143084
Application Product Name
DORAMECTIN
Application details
Product name:
DORAMECTIN
Active name:
DORAMECTIN
Applicant Name:
THE HUNTER RIVER COMPANY PTY LIMITED
Application purpose and description of use:
Approval of doramectin for use in veterinary chemical products.
Description of data provided:
Data no
268539
Title
Consent letter
Study date
2024
Auth party contact address
74-76 Drummond Road SHEPPARTON Australia
Data no
267673
Title
Correspondence
Study date
2024
Auth party contact address
74-76 Drummond Road SHEPPARTON Australia