For many applications, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required to publish a summary of the application once the applicant has been notified that the application has been accepted for assessment. The summary will be removed once the application is finalised.

The types of applications requiring an application summary include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change in the use, supply or disposal of the product.

The summaries include details of the applications as specified in Divisions 2.1 and 2.2 of the regulations.

Please remember to follow the guidance for preparing information lists when preparing your application to avoid sensitive information being published.

For more information, please see the questions and answers.

Use the filter and links below to find and view application summaries.

Date
Application No
153402
 Product/Active constituent Name
Pyrocam 20 mg/mL Solution for Injection

Application details

Product name:

Pyrocam 20 mg/mL Solution for Injection

Product number:

97547

Applicant Name:

Huvepharma EOOD

Application purpose and description of use:

Registration of a 20 mg/ mL meloxicam solution for injection, a non-steroidal anti-inflammatory, analgesic, and antipyretic injection for use in cattle, sheep, pigs and horses.

Reference details:

54061 - METACAM 20MG/ML SOLUTION FOR INJECTION

Description of data provided:

Data no
305782
Author
Anonymous
Title
Manufacturing information
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305793
Author
Anonymous
Title
Rel sub validation report
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305762
Author
Anonymous
Title
Pyrocam chemistry and manufacture dossier
Study date
25/05/2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305785
Author
Anonymous
Title
Validation report
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305796
Author
Anonymous
Title
Sterility validation report
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305773
Author
Anon
Title
Pharmaceutical equivalence - Part 3 of 4
Study date
25/5/2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305765
Author
British Pharmacopoeia
Title
Meloxicam injection monograph
Study date
07/05/2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305788
Author
Anonymous
Title
Additional packaging information
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305774
Author
Anon
Title
Pharmaceutical equivalence - Part 4 of 4
Study date
25/5/2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305768
Author
Anonymous
Title
Batch analysis 2
Study date
jan 2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305791
Author
Anonymous
Title
Methods
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305771
Author
Anon
Title
Pharmaceutical equivalence - Part 1 of 4
Study date
25/5/2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305794
Author
Anonymous
Title
Excipient validation report
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305786
Author
Anonymous
Title
Excipient certificates of analysis and specifications
Study date
2025
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305792
Author
Anonymous
Title
Assay validation report
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305795
Author
Anonymous
Title
Endotoxin validation report
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305772
Author
Anon
Title
Pharmaceutical equivalence - Part 2 of 4
Study date
25/5/2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305766
Author
Anonymous
Title
Calculation of endotoxin limit
Study date
01/03/2024
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305783
Author
Anonymous
Title
Calculation of endotoxin limit
Study date
01/03/2024
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305789
Author
Anonymous
Title
Stability study
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305769
Author
Anonymous
Title
Batch analysis 3
Study date
Nov 2025
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305763
Author
EUROPEAN PHARMACOPOEIA
Title
Meloxicam EP monograph
Study date
01/01/2017
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305784
Author
Anonymous
Title
Primary packaging
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305790
Author
Anonymous
Title
Stability supporting documents
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305770
Author
G. Pippia
Title
Product shelf life - Pyrocam 20
Study date
25/5/2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305764
Author
Anonymous
Title
Certificate of GMP compliance of a manufacturer
Study date
3/11/2025
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305781
Author
Anonymous
Title
Meloxicam certificate of analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305787
Author
Anonymous
Title
Manufacturing Process Validation
Study date
2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305767
Author
Anonymous
Title
Batch analysis 1
Study date
jan 2026
Authorising party
Applicant
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Date
Application No
153850
 Product/Active constituent Name
ADAMA 2,4-D AMINE 625 HERBICIDE C

Application details

Product name:

ADAMA 2,4-D AMINE 625 HERBICIDE C

Applicant Name:

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a 625 g/L 2,4-D Soluble Concentrate (SL) product for use as described in the directions for use.
Date
Application No
154113
 Product/Active constituent Name
SMART TRIFLURALIN 480 EC HERBICIDE (Label B)

Application details

Product name:

SMART TRIFLURALIN 480 EC HERBICIDE (Label B)

Applicant Name:

CROP SMART PTY LTD

Application purpose and description of use:

Registration of a 480 g/L Trifluralin emulsifiable concentrate product for control of a pre-emergence herbicide for the control of annual grasses and certain broadleaf weeds in certain horticultural and agricultural crops as listed in the Directions for Use table.
Date
Application No
154142
 Product/Active constituent Name
SpinoSec 240 SC Insecticide

Application details

Product name:

SpinoSec 240 SC Insecticide

Applicant Name:

ANOVITECH PTY LTD

Application purpose and description of use:

Registration of a 240 g/L suspension concentrate formulation for the control of certain insect pests in fruit, ornamentals, vegetables and forestry (Eucalyptus spp. and Tea Tree) as specified in the Directions for Use.
Date
Application No
154106
 Product/Active constituent Name
Transocean Optima Antifouling 2.32 Blue

Application details

Product name:

Transocean Optima Antifouling 2.32 Blue

Applicant Name:

WAGON PAINTS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 479 g/L cuprous oxide antifouling paint product for the prevention of marine biofouling on vessel hulls
Date
Application No
153839
 Product/Active constituent Name
PROLECTUS SC FUNGICIDE

Application details

Product name:

PROLECTUS SC FUNGICIDE

Applicant Name:

SUMITOMO CHEMICAL AUSTRALIA PTY. LIMITED

Application purpose and description of use:

Registration of a 400 g/L FENPYRAZAMINE SC product for control of Grey mould in wine grapes.
Date
Application No
154035
 Product/Active constituent Name
Titan CC & Dry OTT Gly 700 Herbicide B

Application details

Product name:

Titan CC & Dry OTT Gly 700 Herbicide B

Applicant Name:

TITAN AG PTY LTD

Application purpose and description of use:

Registration of a 700 g/kg Glyphosate present as the mono-ammunium salt product for the control of annual and perennial weeds in Roundup Ready Flex cotton crops, Roundup Ready canola crops, TruFlex canola crops and for the control of annual and perennial weeds in agricultural areas, tree and vine crops, pasture, commercial, industrial and public service areas as per the Directions for Use.
Date
Application No
154133
 Product/Active constituent Name
Tenet 500 SC Herbicide - B

Application details

Product name:

Tenet 500 SC Herbicide - B

Applicant Name:

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a 500 g/L Metazachlor SC product for use as proposed in the directions for use
Date
Application No
153484
 Product/Active constituent Name
ilium Gentam 100 Injectable Gentamicin Solution

Application details

Product name:

ilium Gentam 100 Injectable Gentamicin Solution

Product number:

46373

Applicant Name:

TROY LABORATORIES PTY LTD

Application purpose and description of use:

Update label to align with current VLC

Active constituents:

85639 - GENTAMICIN SULPHATE

Description of data provided:

Data no
305885
Author
Troy Lab
Title
Attachment - 1
Study date
2025
Authorising party
Applicant
Auth party contact address
37 GLENDENNING ROAD GLENDENNING Australia
Date
Application No
153824
 Product/Active constituent Name
SpinoSec 240 SC Insecticide B

Application details

Product name:

SpinoSec 240 SC Insecticide B

Applicant Name:

ANOVITECH PTY LTD

Application purpose and description of use:

Registration of a 240 g/L suspension concentrate formulation for the control of certain insect pests in fruit, ornamentals, vegetables and forestry (Eucalyptus spp. and Tea Tree) as specified in the Directions for Use.
Date
Application No
152220
 Product/Active constituent Name
Gabapentin

Application details

Product name:

Gabapentin

Product number:

97191

Applicant Name:

INVETRO PTY LTD

Application purpose and description of use:

Registration of a gabapentin tablet product for anxiety and analgesia in cats, in conjunction with approval of the active constituent gabapentin.

Description of data provided:

Data no
302238
Author
Anon
Title
Gabapentin DMF Part 4
Study date
2025
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302235
Author
Anon
Title
Gabapentin DMF Part 1
Study date
2025
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302236
Author
Anon
Title
Gabapentin DMF Part 2
Study date
2025
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302239
Author
Anon
Title
Gabapentin DMF Part 5
Study date
2025
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302234
Author
Anon
Title
CoA Gabapentin
Study date
2025
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302237
Author
Anon
Title
Gabapentin DMF Part 3
Study date
2025
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Date
Application No
152221
 Product/Active constituent Name
Gabacalm 100 mg

Application details

Product name:

Gabacalm 100 mg

Product number:

97192

Applicant Name:

INVETRO PTY LTD

Application purpose and description of use:

Registration of a gabapentin tablet product for anxiety and analgesia in cats, in conjunction with approval of the active constituent gabapentin.

Description of data provided:

Data no
302178
Author
Guedes, A.G.P.; Meadows, J.M.; Pypendop, B.H.; Johnson, E.G.; Zaffarano, B.
Title
Assessment of the effects of gabapentin on activity levels and owner-perceived mobility impairment and quality of life in osteoarthritic geriatric cats. .
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
302201
Author
Siao KT, Pypendop BH, Ilkiw JE.
Title
Pharmacokinetics of gabapentin in cats.
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
302155
Author
Torres-Bernal, F., Martínez-Burnes, J., Hernández-Avalos, I., Olmos-Hernández, A., Domínguez-Oliva, A., Reyes-Sotelo, B., González-López, C., Villanueva-Pereyra, D., & Mota-Rojas, D.
Title
Infrared thermography and physiological variables as methods for recognizing fear in domestic cats (Felis catus) using three pharmacological models: Cannabidiol, gabapentin, and synthetic facial pheromones.
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302195
Author
Liu Gangyi, Jia Jingying, Liu Haiming, et al. [J].
Title
Determination of gabapentin in human serum by liquid chromatography-tandem mass spectrometry
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
302212
Author
Tucker, L. E., Sanchez, A., Valverde, A., Blois, S., Monteith, G., Longworth, P., Downie, A., Gu, Y., & Johnson, R.
Title
Evaluation of the sedative properties of oral trazodone, gabapentin or their combination in healthy cats.
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
302161
Author
Allen ME, LeBlanc NL, Scollan KF.
Title
Hemodynamic, Echocardiographic, and Sedative Effects of Oral Gabapentin in Healthy Cats.
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
302218
Author
Xia S, You Z, Wu X, Yang J, Wang S, Li N, Dai J, Dong Y, Chen L, Yan M, Shen S, Xie Z, Mao J.
Title
Long-term gabapentin treatment impairs cognitive function in aged mice via tau hyperphosphorylation.
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302175
Author
Veronezi, T.M.; Lopes, D.J.; Zardo, I.L.; Ferronatto, J.V.; Trojan, M.M.; Franck, K.R.; de Azevedo, A.F.; Spiering, A.G.; Nunes, L.N.; Fadel, L.; et al.
Title
Evaluation of the effects of gabapentin on the physiologic and echocardiographic variables of healthy cats: A prospective, randomized and blinded study.
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
302224
Author
Mattson CL, Chowdhury F, Gilson TP.
Title
Notes from the Field: Trends in Gabapentin Detection and Involvement in Drug Overdose Deaths - 23 States and the District of Columbia, 2019???2020.
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
302227
Author
Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn.
Title
Handbook of Pharmaceutical Excipients c
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
302204
Author
Radulovic, L L et al.
Title
Disposition of gabapentin (neurontin) in mice, rats, dogs, and monkeys.
Study date
1995
Authorising party
Public
Auth party contact address
-
Data no
302181
Author
Downing, D. R.
Title
Retrospective Study of 240 Dogs Receiving Gabapentin for Chronic Pain Relief.
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
302158
Author
Papageorgiou, V.; Ververidis, C.; Mylonakis, M.E.; Savvas, I.; Kazakos, G.
Title
Use of Gabapentin or Alprazolam in Cats during Postoperative, Short-Term Hospitalization. .
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
302152
Author
Eagan, B. H., van Haaften, K., & Protopopova, A.
Title
Daily gabapentin improved behavior modification progress and decreased stress in shelter cats from hoarding environments in a double-blind randomized placebo-controlled clinical trial.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302198
Author
Adrian, D., Papich, M. G., Baynes, R., Stafford, E., & Lascelles, B. D. X.
Title
The pharmacokinetics of gabapentin in cats.
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
302215
Author
McCune, S.
Title
The impact of paternity and early socialisation on the development of cats' behaviour to people and novel objects.
Study date
1995
Authorising party
Public
Auth party contact address
-
Data no
302192
Author
ClinCalc DrugStats
Title
Gabapentin - Drug usage statistics
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302164
Author
Miranda-Cortés, A. E., Prado-Ochoa, M. G., Díaz-Torres, R., Pérez-Sánchez, A. P., Del Río-García, J. C., Mota-Rojas, D., & Hernández-Avalos, I.
Title
Comparison of the anxiolytic and analgesic effects of gabapentin and pregabalin in cats: A systematic review.
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302172
Author
Papageorgiou, V.; Ververidis, C.; Mylonakis, M.E.; Savvas, I.; Kazakos, G.
Title
Orally administered gabapentin and alprazolam induce comparable levels of anxiolysis and sedation in cats.
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
302184
Author
Varadi Gyula
Title
Mechanism of Analgesia by Gabapentinoid Drugs: Involvement of Modulation of Synaptogenesis and Trafficking of Glutamate-Gated Ion Channels,
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302221
Author
INVETRO PTY LTD
Title
Item 2 Gabacalm - Executive Summary
Study date
2026
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302153
Author
Rusbridge, C.
Title
Neuropathic pain in cats: Mechanisms and multimodal management
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
302159
Author
Versteg, N., Dias, T. P., de Freitas, V. R., das Neves, V. B., Gomes, M. R., Meinerz, A. R. M., Jorge, S., Rondelli, M. C. H., & Cleff, M. B.
Title
A comparative study between integrative practices and preappointment gabapentin on serum cortisol in cats.
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
302207
Author
Shanghai Archives of Psychiatry.
Title
Gabapentin: A review of its pharmacology and clinical use.
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
302193
Author
Anon
Title
Announcement No. 1247
Study date
2009
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302199
Author
Zhao, F., Lin, C., Wu, Y., Luo, X., Han, N., Xiong, W., & Zeng, Z.
Title
Development and validation of an LC-MS/MS method for quantifying gabapentin in plasma: Application to a pharmacokinetic study in cats.
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
302147
Author
Anon
Title
Process Validation Report
Study date
2025
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302167
Author
DuPont A, Zidan N, Lueck LC, Cameron S.
Title
Evaluation of gabapentin administration on neurologic examination in 2 different age groups of healthy cats.
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
302216
Author
Fan Hua, Ho Jiewen.
Title
Pharmacological effects and clinical application progress of gabapentin.
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
302187
Author
Anon
Title
Effect of gabapentin tablets on the prevention and treatment of stress in cats - Phase II clinical trials (Report No. SCAU 202306 HYE01)
Study date
2023
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302210
Author
Quimby, J. M., Lorbach, S. K., Saffire, A., Kennedy, A., Wittenburg, L. A., Aarnes, T. K., Creighton, K. J., Jones, S. E., Paschall, R. E., King, E. M., Bruner, C. E., Wallinger, J. N., & van Haaften, K. A.
Title
Serum concentrations of gabapentin in cats with chronic kidney disease.
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
302230
Author
Chan AYL, Yuen ASC, Tsai DHT, et al.
Title
Gabapentinoid consumption in 65 countries and regions from 2008 to 2018: a longitudinal trend study.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302173
Author
Spano, V.; Springer, C.M.; Christensen, E.L.; Albright, J.D.
Title
Effects of transdermal mirtazapine and oral gabapentin as pre-veterinary visit pharmaceuticals for shelter Cats.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302222
Author
INVETRO PTY LTD
Title
Item 2 Gabacalm - Health Dossier
Study date
2026
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302156
Author
Pankratz, K. E., Ferris, K. K., Griffith, E. H., & Sherman, B. L. J.
Title
Use of single-dose oral gabapentin to attenuate fear responses in cage-trap confined community cats: A double-blind, placebo-controlled field trial.
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
302179
Author
Chen H, Yang H, Li M, Peng H, Guo W, Li M.
Title
Effect of oral administration of gabapentin on the minimum alveolar concentration of isoflurane in cats. .
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302196
Author
Vet Practice Magazine
Title
Tools of the Trade: Gabapentin.
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
302150
Author
Reader, B.
Title
Use of Gabapentin in Veterinary Medicine.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302190
Author
INVETRO PTY LTD
Title
Item 2 Gabacalm - Safety and Efficacy Dossier
Study date
2026
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302213
Author
Tucker, L. E., Sanchez, A., Valverde, A., Blois, S., Monteith, G., Longworth, P., Downie, A., Gu, Y., & Johnson, R.
Title
Supplemental material for Evaluation of the sedative properties of oral trazodone, gabapentin or their combination in healthy cats. Feline multiparametric sedation score (FMSS) for Study presented in Appendix 8.24
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
307549
Author
Not Identified
Title
GMP certificates, Certificates of Analysis non-active ingredients and related monographs
Study date
2026
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302233
Author
FDA
Title
FDA. Neurontin. NDA #021397.
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
302219
Author
Anon
Title
Safety test of gabapentin tablets in cats (Report No. SCAU 202306 HYE07)
Study date
2023
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302170
Author
Kruszka, M.; Graff, E.; Medam, T.; Masson, S.
Title
Clinical evaluation of the effects of a single oral dose of gabapentin on fear-based aggressive behaviors in cats during veterinary examinations.
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
302176
Author
Raucourt, L.; Masson, S.
Title
The Effect of Gabapentin on the Efficiency of a Desensitization-Counter-Conditioning Claw-Trimming Protocol for Cats with Healthcare Phobias: A Double-Blind, Placebo-Controlled Crossover Trial. .
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302228
Author
Davis JL, Posner LP, Elce Y.
Title
Gabapentin for the treatment of neuropathic pain in a pregnant horse.
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
302205
Author
Di Cesare F, Negro V, Ravasio G, Villa R, Draghi S, Cagnardi P.
Title
Gabapentin: Clinical Use and Pharmacokinetics in Dogs, Cats, and Horses.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302182
Author
Gold, J. R., Grubb, T. L., Cox, S., Malavasi, L., & Villarino, N. L.
Title
Pharmacokinetics and pharmacodynamics of repeat dosing of gabapentin in adult horses.
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
302151
Author
Laguardia, M. V., Polvere, M., Piemontese, C., Gernone, F., & Staffieri, F.
Title
A systematic review of the sedative, behavioral, analgesic and cardiovascular effects of gabapentin in cats.
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302214
Author
Buckley, C., Griffin, C., Anderson, H., & Moore, S. A.
Title
Presumed gabapentin-induced myoclonus in two cats.
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
302165
Author
de Azevedo AF, Veronezi TM, Zardo IL, et al.
Title
Does preappointment gabapentin affect neurological examination findings? A prospective, randomized and blinded study in healthy cats.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302191
Author
Athavale A, Murnion B.
Title
Gabapentinoids: a therapeutic review.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302185
Author
Amelia Erickson, Kaylin Harbin, Justine MacPherson, Kate Rundle, Karen L. Overall September 2021
Title
A review of pre-appointment medications to reduce fear and anxiety in dogs and cats at veterinary visits.
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
302171
Author
De Lombaert MC, Lourenço BN, Coleman AE, Arne AM, Berghaus RD, Schmiedt CW.
Title
Effect of gabapentin on ambulatory, direct, systemic arterial blood pressure in apparently healthy cats in the at-home and in-clinic environments.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302202
Author
BenchChem Technical Support Team.
Title
Application notes: Gabapentin administration for in vivo animal studies.
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302225
Author
Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn.
Title
Handbook of Pharmaceutical Excipients a
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
302154
Author
Rusbridge, C.
Title
Neuropathic pain in cats: Mechanisms and multimodal management
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
302208
Author
Jafarbeglou, M.; Arkan, P. Res.
Title
Retrospective evaluation of preanesthetic oral gabapentin in cats receiving total injectable anesthesia in a high-quality, high-volume spay-neuter setting.
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302194
Author
Anon
Title
Technical Guidelines for Validation of Methods for Quantitative Analysis of Biological Samples
Study date
2022
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302148
Author
Anon
Title
Item 2 Gabacalm - Chemistry Dossier
Study date
2026
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302168
Author
Gurney M, Gower L.
Title
Randomised clinical trial evaluating the effect of a single preappointment dose of gabapentin on signs of stress in hyperthyroid cats.
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
302211
Author
Tucker, L. E., Sanchez, A., Valverde, A., Blois, S., Uccello, O., Rutherford, A., Monteith, G., Reinhart, J. M., Keating, S., Gu, Y., & Johnson, R.
Title
Pharmacokinetic, sedative, and physiological effects of oral compounded formulations of trazodone alone or in combination with gabapentin in male cats.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302188
Author
Anon
Title
Effect of gabapentin tablets on the prevention and treatment of stress in cats - Phase III clinical trial (Report No. SCAU 202306 HYE02)
Study date
2023
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302162
Author
Fantinati, M., Trnka, J., Signor, A., Dumond, S., Jourdan, G., Verwaerde, P., & Priymenko, N.
Title
Appetite stimulating effect of gabapentin vs mirtazapine in healthy cats post ovariectomy.
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
302231
Author
TGA
Title
Australian Product Information Neurontin® (gabapentin) tablets and capsules,
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302174
Author
Spano, V.; Springer, C.M.; Christensen, E.L.; Albright, J.D.
Title
Appendix A. Supplementary material Effects of transdermal mirtazapine and oral gabapentin as pre-veterinary visit pharmaceuticals for shelter Cats.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302226
Author
Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn.
Title
Handbook of Pharmaceutical Excipients f
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
302180
Author
Stollar, O. O., Moore, G. E., Mukhopadhyay, A., Gwin, W., & Ogata, N.
Title
Effects of a single dose of orally administered gabapentin in dogs during a veterinary visit: a double-blinded, placebo-controlled study.
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
302203
Author
Rat Guide
Title
Rat Guide. Gabapentin. Central nervous system drugs: Anticonvulsants
Study date
2026 Jan 15
Authorising party
Public
Auth party contact address
-
Data no
302157
Author
Van Haaften, K. A., Eichstadt Forsythe, L. R., Stelow, E. A., & Bain, M. J.
Title
Effects of a single preappointment dose of gabapentin on signs of stress in cats during transportation and veterinary examination.
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
302149
Author
Alicia Mack, PharmD
Title
Examination of the Evidence for Off-Label Use of Gabapentin
Study date
2003
Authorising party
Public
Auth party contact address
-
Data no
302197
Author
Sofía Municio, Sergio Mato, José L. Alonso, Elena R. Alonso, and Iker León
Title
New Molecular Insights on Gabapentin
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302189
Author
Pypendop B H, Siao K T, Ilkiw J E.
Title
Thermal antinociceptive effect of orally administered gabapentin in healthy cats[J].
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
302163
Author
Slovak, J. E., & Costa, A. P.
Title
A pilot study of transdermal gabapentin in cats.
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
302220
Author
INVETRO PTY LTD
Title
Item 2 Gabacalm- Environment Dossier
Study date
2026
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302232
Author
Athavale A, Murnion B.
Title
Gabapentinoids: a therapeutic review.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
302169
Author
Hudec CP, Griffin CE.
Title
Changes in the stress markers cortisol and glucose before and during intradermal testing in cats after single administration of pre-appointment gabapentin.
Study date
2019
Authorising party
Public
Auth party contact address
-
Data no
302177
Author
Rabbani, A.H.; Ullah, Q.; Naseer, O.; Gardezi, F.H.; Shahid, M.; Hussain, K.; Saleem, T.; Ali, A.; Khan, Y.R.; Waheed,
Title
A Comparative Multimodal Palliative efficacy of gabapentin and tramadol by Using Two Pain Scoring Systems in Cats Undergoing Ovariohysterectomy. .
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
302229
Author
PubChem
Title
PubChem Compound Summary for CID 3446, Gabapentin. National Center for Biotechnology Information (NCBI).
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302206
Author
Al-Zubaydi, F., Wassef, A., Kagan, L., & Brunetti, L.
Title
Development of a Population Pharmacokinetic Gabapentin Model Leveraging Therapeutic Drug Monitoring Concentrations.
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
302183
Author
Vettorato E, Corletto F.
Title
Gabapentin as part of multi-modal analgesia in two cats suffering multiple injuries.
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
302160
Author
Steagall, P. V., Benito, J., Monteiro, B. P., Doodnaught, G. M., Beauchamp, G., & Evangelista, M. C.
Title
Analgesic effects of gabapentin and buprenorphine in cats undergoing ovariohysterectomy using two pain-scoring systems: a randomized clinical trial.
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
302146
Author
Anon
Title
Analytical Methods Validation Report
Study date
2025
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302200
Author
Anon
Title
Pharmacokinetics of gabapentin tablets in cats: Kinetic test (Summary Report) (Report No. SCAU-202306-HYE05)
Study date
2023
Authorising party
Applicant
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302166
Author
Crowe, Y. C., Groth, A. D., Billson, F. M., White, J., Coall, S. M., Yates, K. L., & Premont, J. E.
Title
Gabapentin reduces stress and does not affect ocular parameters in clinically normal cats.
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
302186
Author
Lorenz ND, Comerford EJ, Iff I.
Title
Long-term use of gabapentin for musculoskeletal disease and trauma in three cats.
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
302209
Author
Ruviaro Tuleski, G. L., Silveira, M. F., Bastos, R. F., Pscheidt, M. J. G. R., Prieto, W. S., & Sousa, M. G.
Title
Behavioral and cardiovascular effects of a single dose of gabapentin or melatonin in cats: a randomized, double blind, placebo controlled trial.
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
302217
Author
Quimby JM, Jones SE, Saffire A, et al.
Title
Assessment of the effect of gabapentin on blood pressure in cats with and without chronic kidney disease.
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
302223
Author
DEA
Title
Gabapentin (Drug & Chemical Evaluation Section Report).
Study date
2025
Authorising party
Public
Auth party contact address
-
Date
Application No
152222
 Product/Active constituent Name
Gabacalm 50 mg

Application details

Product name:

Gabacalm 50 mg

Product number:

97193

Applicant Name:

INVETRO PTY LTD

Application purpose and description of use:

Registration of a gabapentin tablet product for anxiety and analgesia in cats, in conjunction with approval of the active constituent gabapentin.
Date
Application No
154018
 Product/Active constituent Name
Hempaguard X7 89900 Fouling Defence Coating Part A 89909 59161 Red

Application details

Product name:

Hempaguard X7 89900 Fouling Defence Coating Part A 89909 59161 Red

Applicant Name:

HEMPEL (WATTYL) AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 77 g/L Copper Pyrithione antifouling paint for the prevention of marine biofouling on vessel hulls
Date
Application No
154019
 Product/Active constituent Name
Hempaguard X7 89900 Fouling Defence Coating Part A 89909 19740 Black

Application details

Product name:

Hempaguard X7 89900 Fouling Defence Coating Part A 89909 19740 Black

Applicant Name:

HEMPEL (WATTYL) AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 87 g/L copper pyrithione antifouling paint for prevention of marine biofouling on vessel hulls.
Date
Application No
154046
 Product/Active constituent Name
Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Red

Application details

Product name:

Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Red

Applicant Name:

AKZO NOBEL PTY LIMITED

Application purpose and description of use:

Registration of Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Red Active Constituents: 830 g/L COPPER PRESENT AS CUPROUS OXIDE 64 g/L COPPER PYRITHIONE Use as an antifouling paint to control marine growth below the waterline on vessels.
Date
Application No
154048
 Product/Active constituent Name
Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Black

Application details

Product name:

Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Black

Applicant Name:

AKZO NOBEL PTY LIMITED

Application purpose and description of use:

Registration of Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Black Active Constituents 830 g/L COPPER PRESENT AS CUPROUS OXIDE 64 g/L COPPER PYRITHIONE Use as an antifouling paint to control marine growth below the waterline on vessels.
Date
Application No
154052
 Product/Active constituent Name
Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Brown

Application details

Product name:

Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Brown

Applicant Name:

AKZO NOBEL PTY LIMITED

Application purpose and description of use:

Registration of Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Brown Active Constituents: 824 g/L COPPER PRESENT AS CUPROUS OXIDE 64 g/L COPPER PYRITHIONE Use as an antifouling paint to control marine growth below the waterline on vessels.
Date
Application No
154128
 Product/Active constituent Name
Intersmooth 7460HS SPC Antifouling Black

Application details

Product name:

Intersmooth 7460HS SPC Antifouling Black

Applicant Name:

AKZO NOBEL PTY LIMITED

Application purpose and description of use:

Registration of Intersmooth 7460HS SPC Antifouling Black. ACTIVE CONSTITUENTS 801 g/L COPPER PRESENT AS CUPROUS OXIDE 84 g/L COPPER PYRITHIONE
Date
Application No
154129
 Product/Active constituent Name
Intersmooth 7460HS SPC Antifouling Red

Application details

Product name:

Intersmooth 7460HS SPC Antifouling Red

Applicant Name:

AKZO NOBEL PTY LIMITED

Application purpose and description of use:

Registration of Intersmooth 7460HS SPC Antifouling Red Active Constituents: 806 g/L COPPER PRESENT AS CUPROUS OXIDE 84 g/L COPPER PYRITHIONE Use as an antifouling paint to control marine growth