For many applications, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required to publish a summary of the application once the applicant has been notified that the application has been accepted for assessment. The summary will be removed once the application is finalised.
The types of applications requiring an application summary include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change in the use, supply or disposal of the product.
The summaries include details of the applications as specified in Divisions 2.1 and 2.2 of the regulations.
Please remember to follow the guidance for preparing information lists when preparing your application to avoid sensitive information being published.
For more information, please see the questions and answers.
Use the filter and links below to find and view application summaries.
Date
Application Date
Application No
Application Number
138135
Product/Active constituent Name
Application Product Name
AviPro Salmonella Duo Live Vaccine
Application Date
Application Number
138135
Application Product Name
AviPro Salmonella Duo Live Vaccine
Application details
Product name:
AviPro Salmonella Duo Live Vaccine
Product number:
93162
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.
Description of data provided:
Data no
248321
Title
Study no.: 148/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248298
Title
Study no.: 67/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248275
Title
Study no.: 279/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248252
Title
Batch record-200312-2c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248229
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261812
Title
Impact of maternal antibodies on the efficacy of immunisation of chicks with live Salmonella vaccines
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291295
Title
Import permit
Study date
20DEC2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248244
Title
Product development
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248292
Title
Report on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248304
Title
PSUR Vac E
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248338
Title
Oral Administration of the Salmonella Typhimurium Vaccine Strain NaI2/Rif9/Rtt to Laying Hens at Day of Hatch Reduces Shedding and Caecal Colonization of Salmonella 4, 12:i:-, the Monophasic Variant of Salmonella Typhimurium
Study date
2015
Auth party contact address
-
Data no
254982
Title
Minireview: Antibiotic-supersusceptible mutants of Escherichia coli and Salmonella Typhimurium.
Study date
1993
Auth party contact address
-
Data no
248344
Title
Salmonella infections: immune and non-immune protection with vaccines
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248238
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248261
Title
Study no.: 13/06
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261806
Title
Protocol vials and stoppers
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248212
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270319
Title
ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Duo Live Vaccine
Study date
30 Jan 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248281
Title
Study no.: 521/94 A
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248355
Title
Report(s) on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248232
Title
Validation report 0-0060-VR-92637
Study date
04 May 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248361
Title
Study no.: 97/06
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278657
Title
13835-93162 e-label Version 3
Study date
September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248375
Title
PSUR Vac E
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291298
Title
Rapid real-time PCR methods to distinguish Salmonella Enteritidis wildtype field isolates from vaccine strains Salmovac SE/Gallivac SE and AviPro SALMONELLA VAC E
Study date
March 2015
Auth party contact address
-
Data no
248318
Title
Study no.: 294/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248324
Title
Studies of contamination of three broiler breeder houses with Salmonella enteritidis before and after cleansing and disinfection
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261800
Title
Specification cap
Study date
30 June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289185
Title
Response App 2-3c batch-record Salm VacT English language
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248218
Title
0-0062-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248367
Title
Study no.: 66/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254985
Title
2023-06-19 Elanco Salmonella Resp to s159 notice
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291292
Title
Vacuum testing procedure Engligh language
Study date
14DEC2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254979
Title
Common themes among bacteriophage-encoded virulence factors and diversity among the bacteriophages involved.
Study date
2002
Auth party contact address
-
Data no
261809
Title
SPF-certification relating to Study 85/01
Study date
7 March 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248255
Title
Study no.: 85/01
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248301
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270322
Title
138135-93162 e-label version 2
Study date
8 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248241
Title
Quality Certificate
Study date
October 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248341
Title
Review article: Vaccination and early protection against non-host-specific Salmonella serotypes in poultry: exploitation of innate immunity and microbial activity
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248347
Title
Part 6 overview AviPro Salmonella Duo
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248295
Title
Study no.: 399/05
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261803
Title
Sealing procedure
Study date
30 May 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248215
Title
Expert report
Study date
16 December 2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248264
Title
Study no.: 372/01
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248235
Title
Starting materials of biological origin
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248335
Title
Oral Vaccination with a Live Salmonella Enteritidis/Typhimurium Bivalent Vaccine in Layers Induces Cross-protection Against Caecal and Internal Organ Colonization by a Salmonella Infantis Strain
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248284
Title
Study no.: 525/94
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248358
Title
Study no.: H 01/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248209
Title
Master seed S.T.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248258
Title
Study no.: 147/05
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248307
Title
Study no.: 244/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270316
Title
Ph. Eur. 2521E
Study date
2013
Auth party contact address
-
Data no
248315
Title
Study no.: 97/06
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248327
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289188
Title
Response App 2-3f Homogenous mixing English language
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248278
Title
Study no.: LAH2001-1
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248364
Title
Diagnostic, epidemiology and prevention of Salmonella Typhimurium and Salmonella Enteritidis infections in ducks considering in particular the immunoprophylaxis with live vaccines
Study date
18 August 1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291301
Title
138146-93168 e-label version 4
Study date
19 June 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248272
Title
PDV/5101-ER/2011-05-04
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248221
Title
0-0110-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248250
Title
Stress stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291293
Title
GMP Certificate
Study date
19JUN2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248273
Title
Study no.: 37/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248227
Title
GMP certificate
Study date
15 November 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248256
Title
Study no.: 262/02
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254980
Title
Vaccination against Salmonella Enteritidis in Dutch commercial layer flocks with a vaccine based on a live Salmonella Gallinarum 9R strain: evaluation of efficacy, safety, and performance of serologic Salmonella tests.
Study date
2001
Auth party contact address
-
Data no
248290
Title
Communications from Robert H Davies, Weybridge
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248350
Title
PSUR Vac T
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248342
Title
Review: The long view: Salmonella - the last forty years
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261818
Title
Monograph 2521
Study date
04/2013
Auth party contact address
-
Data no
248296
Title
Study no.: 97/06
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270317
Title
ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Vac T Live Vaccine
Study date
24 Jan 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248310
Title
Expert report on the safety of a Salmonella vaccine strain for calves and piglets
Study date
1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261804
Title
Homogenous mixing
Study date
20 August 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248216
Title
0-0115-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248287
Title
Diagnostic, epidemiology and prevention of Salmonella Typhimurium and Salmonella Enteritidis infections in ducks considering in particular the immunoprophylaxis with live vaccines.
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248259
Title
Study no.: 148/05
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248330
Title
Clonal Structure and Variation in Virulence of Salmonella Enteritidis Isolated from Mice, Chickens, and Humans
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248336
Title
Salmonella enterica Serotype Typhimurium and its Host-Adapted Variants
Study date
2002
Auth party contact address
-
Data no
248236
Title
In process control tests
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248353
Title
Report: Communications from Robert H Davies, Weybridge
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248359
Title
Expert report on the safety of a Salmonella vaccine strain for calves and piglets
Study date
1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248210
Title
Working seed S.E.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248267
Title
Study no.: 60/96
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248279
Title
Study no.: 188/11
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248316
Title
Study no.: 521/94 A
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261798
Title
Specification vial
Study date
5 January 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248373
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248224
Title
Batch record-200312-2c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289189
Title
20231129 Salmonella vaccines-response cover letter
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261815
Title
Testing Standard 0-0171-TS-BA.01
Study date
20 January 2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248322
Title
Study no.: 67/01B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248299
Title
Infection model of Salmonella Enteritidis and S. Typhimurium in Pekin ducks (Anas playrhynchos)
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248276
Title
Study no.: 294/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289183
Title
Response App 2-3a Batch-record Salm Duo English language
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248253
Title
Batch record-200401-3c
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291296
Title
20250704 Response doc
Study date
July 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248230
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278655
Title
20240923 Response doc-Sept 2024
Study date
23 September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248339
Title
Salmonella Infections: Immune and Non-immune Protection with Vaccines
Study date
2007
Auth party contact address
-
Data no
248247
Title
Long term stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248293
Title
Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella enteritidis isolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248333
Title
Advances in typing and identification of foodborne pathogens
Study date
2021
Auth party contact address
-
Data no
248213
Title
Development of S.E. strain
Study date
March 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248239
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261801
Title
Batch-record Salm Duo
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270314
Title
Response App 2-12 G-A
Study date
20 March 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248233
Title
Starting materials listed in pharmacopoeias
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248356
Title
Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella enteritidis isolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261807
Title
Chem & Manuf response to s159(1)(a) Notice of 25 July 2023
Study date
October 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248313
Title
Study no.: 0-0197-TS-BA.01
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248362
Title
Study no.: 244/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278658
Title
13846-93168 e-label Version 3
Study date
September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289186
Title
Response App 2-3d Filling-closing procedure English language
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248370
Title
Ducks Safety 2005
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248270
Title
Part 8 Overview AviPro Salmonella Duo
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248319
Title
Study: Gantois et al., 2006
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261816
Title
5.2.6. Evaluation of Safety of Veterinary Vaccines and Immunosera
Study date
04/2024
Auth party contact address
-
Data no
248225
Title
Batch record-b052600-03
Study date
13 February 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289184
Title
Response App 2-3b batch-record Salm VacE English language
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278656
Title
13835-93162 e-label Version 3
Study date
September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248254
Title
Batch record-9475400
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248231
Title
Validation report 0-0063-VR-111-01
Study date
23 November 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248208
Title
Master seed S.E.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291291
Title
Vacuum testing procedure
Study date
14DEC2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270323
Title
138146-93168 e-label version 2
Study date
8 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261810
Title
Wird die Wirksamkeit der Immunisierung von K ? ken mit Salmonella-Lebendimpfstoffen durch maternale Anik?rper beeinflusst?
Study date
2002
Auth party contact address
-
Data no
248302
Title
Study: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248348
Title
Study no.: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248242
Title
Closure
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248248
Title
Relocation stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248294
Title
Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella Typhimuriumisolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248357
Title
Report on the fourth semester of monitoring Salmonella Typhimurium isolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248285
Title
Study no.: 01/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248334
Title
Protection Conferred by a Live Salmonella Enteritidis Vaccine Against Fowl Typhoid in Laying Hens
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261802
Title
Filling-closing procedure
Study date
30 September 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248234
Title
Starting materials of non-biological origin
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248308
Title
Study no.: 525/94
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278659
Title
Expert Report 4/6/2024
Study date
4 June 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248328
Title
PAA - Salmonella Vaccines Registration in Australia
Study date
2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248314
Title
PSUR Vac T
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248265
Title
Study no.: 152/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248271
Title
Expert report on the possible transferability of plasmids between cells of Salmonella VacE and Salmonella VacT during co-cultivation
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291302
Title
Design and Validation of RT-PCR Assays to Differentiate Salmonella Vaccine Strains from Wild-Type Field Isolates
Study date
2024
Auth party contact address
-
Data no
248365
Title
Study no.: 0-0197-TS-BA.01
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248371
Title
Study no.: 148/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248222
Title
Batch to batch consistency
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261796
Title
Salmonella Enteritidis WSB _ CoA
Study date
11 December 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289187
Title
Response App 2-3e Sealing procedure English language
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248274
Title
Study no.: Ducks Safety 2005
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248345
Title
PAA - APVMA Written assistance
Study date
2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248228
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248251
Title
Batch record 200308-1c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261813
Title
Safety & Efficacy response to s159(1)(a) Notice of 25 July 2023
Study date
Oct 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248351
Title
Expert Report for the occurrences in Germany of Salmonella strains in humans, which correspond to the live vaccines TAD Salmonella vac T and TAD Salmonella vac
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248291
Title
Report on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248337
Title
Genome Variation and Molecular Epidemiology of Salmonella enterica Serovar Typhimurium Pathovariants
Study date
2018
Auth party contact address
-
Data no
248245
Title
Stability overview and conclusion
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254983
Title
Alterations in outer membrane permeability.
Study date
1984
Auth party contact address
-
Data no
261819
Title
Cover letter for response to s159(1)(a) Notice of 25 July 2023
Study date
Oct 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248262
Title
Study no.: Gantois et al.
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248311
Title
Diagnostic, epidemiology and prevention of Salmonella Typhimurium and Salmonella Enteritidis infections in ducks considering in particular the immunoprophylaxis with live vaccines
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248288
Title
Expert Report for the occurrences in Germany of Salmonella strains in humans, which correspond to the live vaccines TAD Salmonella vac T and TAD Salmonella vac E.
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248354
Title
Report(s) on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270320
Title
20240411 Cover letter Salmonella vaccines
Study date
11 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248211
Title
Working seed S.T.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248305
Title
PSUR Vac T
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248282
Title
Study no.: 66/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248331
Title
The Transformation of Reference Microbiology Methods and Surveillance for Salmonella With the Use of Whole Genome Sequencing in England and Wales
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248268
Title
M. Voss, 1996 (Study: Lohmann Information 3/96)
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291299
Title
13835-93162 e-label version 4
Study date
19 June 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261799
Title
Specification stopper
Study date
30 June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248325
Title
Study no.: 399/05
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248374
Title
Studies of contamination of three broiler breeder houses with Salmonella enteritidis before and after cleansing and disinfection
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248219
Title
0-0060-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248317
Title
Study no.: 66/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248368
Title
Study no.: 294/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248369
Title
Study No.: Gantois et al.
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248346
Title
Pre-application Assistance: APVMA Written Assistance
Study date
2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248323
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261814
Title
Vaccines for Veterinary Use (Supplement 7.7)
Study date
September 2021
Auth party contact address
-
Data no
248300
Title
Salmonella infection in a commercial line of ducks; Experimental studies on virulence, intestinal colonization and immune protection
Study date
1999
Auth party contact address
-
Data no
248277
Title
Study no.: Salmonella 101
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248340
Title
Vaccination and Early Protection Against Non-host-specific Salmonella Serotypes in Poultry: Exploitation of Innate Immunity and Microbial Activity
Study date
2005
Auth party contact address
-
Data no
248352
Title
Expert Report on the incidence of Salmonella strains in humans in Germany which correspond to the live vaccines AviPro Salmonella vac T and AviPro Salmonella vac E
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270321
Title
20240411 Response doc-April 2024
Study date
11 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248246
Title
Frozen storage stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254984
Title
Stable Salmonella live vaccine strains with two or more attenuating mutations and any desired level of attenuation
Study date
1990
Auth party contact address
-
Data no
248240
Title
Vial
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248214
Title
Development of S.T. strain
Study date
May 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248263
Title
Study no.: 485/99
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248312
Title
Study no.: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248283
Title
Study no.: 244/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248332
Title
What WGS Reveals about Salmonella enterica subsp. Enterica in Wildlife in Germany
Study date
2021
Auth party contact address
-
Data no
261808
Title
Study No. 92/92
Study date
19 June 1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248257
Title
Study no.: 278/02
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248306
Title
Part 7 Overview AviPro Salmonella Duo
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270315
Title
Ph. Eur. 2520E
Study date
2013
Auth party contact address
-
Data no
248363
Title
Study no.:525/94
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291300
Title
138142-93166 e-label version 4
Study date
19 June 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248326
Title
Part 1 Application Overview
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248320
Title
Study: no.: Ducks Safety 2005
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248220
Title
0-0063-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248269
Title
Study: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248297
Title
Study no.: 148/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291294
Title
20250729 CMC Response document
Study date
July 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248249
Title
In use stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248226
Title
Batch record-g039700-01
Study date
29 December 2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248303
Title
Duck-Tec Bruterei GmbH (Administration of AviPro Salmonella Vac E and AviPro Salmonella Vac T to Peking ducks under field conditions
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270324
Title
138142-93166 e-label version 2
Study date
8 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261811
Title
Successful vaccination of layer pullets during the first days of life using a bivalent live vaccine against Salmonella Enteritidis and Salmonella Typhimurium
Study date
September 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248349
Title
PSUR Vac E
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248289
Title
Expert Report on the incidence of Salmonella strains in humans in Germany which correspond to the live vaccines AviPro Salmonella vac T and AviPro Salmonella vac E
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248243
Title
Quality Certificate
Study date
November 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254981
Title
Development of live Salmonella vaccines optimally attenuated for chickens.
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261817
Title
Monograph 2520
Study date
04/2013
Auth party contact address
-
Data no
248343
Title
Salmonella in Domestic Animals (2nd edition
Study date
2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248286
Title
Study: Hannover Veterinary College (Expert report on the safety of a Salmonella vaccine strain for calves and piglets)
Study date
1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248309
Title
Study no.: 01/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270318
Title
ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Vac E Live Vaccine
Study date
25 Jan 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248237
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248360
Title
Study no.: 399/05
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248260
Title
Study no.: 147/06
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248329
Title
Response to: Pre-Application Assistance APVMA Written Assistance Report, questions from pages 6 to 7
Study date
September 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261805
Title
Residual moisture VR Salm Duo
Study date
November 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248280
Title
Study no.: V2011/07
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261797
Title
Salmonella Typhimurium WSB _ CoA
Study date
14 April 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291297
Title
Technical Bulletin: A real-time PCR-based method to distinguish the live AviPro? SALMONELLA VAC E, AviPro? SALMONELLA VAC T and AviPro? SALMONELLA DUO vaccine strains from S. Enteritidis and S. Typhimurium field strains
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248366
Title
Study no.: 521/94 A
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248372
Title
Study no.: 67/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248217
Title
0-0061-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248223
Title
Batch record-200308-1c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248266
Title
Study no.: 250/93
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138142
Product/Active constituent Name
Application Product Name
AviPro Salmonella Vac E Live Vaccine
Application Date
Application Number
138142
Application Product Name
AviPro Salmonella Vac E Live Vaccine
Application details
Product name:
AviPro Salmonella Vac E Live Vaccine
Product number:
93166
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction
with approval of an active constituent.
Description of data provided:
Data no
248722
Title
In-use stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248699
Title
Appendix 1-0 Part 1 overview AviPro Salmonella Vac E
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248710
Title
Starting materials of biological origin
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248716
Title
Batch record-A059400
Study date
09 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248702
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261823
Title
Residual moisture VR Salm VacE
Study date
March 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248719
Title
Stability overview and conclusion
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248713
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248708
Title
Validation report 0-0060-vr-ba01
Study date
03 Jan 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248714
Title
Batch to batch consistency
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248725
Title
Batch record-6093700
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248705
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248717
Title
Batch record-A059500
Study date
10 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248711
Title
Master seed S.E.
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248703
Title
Product development
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248726
Title
Appendix 8-0 Part 8 overview Salmonella Vac E
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261822
Title
Batch record Salm VacE
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248720
Title
Long term stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248706
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248712
Title
Working seed S.E.
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248723
Title
Stress stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248700
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248709
Title
Validation report 0-0060-vr-91998-01
Study date
25 April 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248701
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248724
Title
Batch record-6093500
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248718
Title
Batch record-G033600
Study date
29 November 2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248704
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248721
Title
Relocation stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248707
Title
Validation report 0-0063-vr-110-01-01
Study date
21 March 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248715
Title
Batch record-5062300
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138146
Product/Active constituent Name
Application Product Name
AviPro Salmonella Vac T Live Vaccine
Application Date
Application Number
138146
Application Product Name
AviPro Salmonella Vac T Live Vaccine
Application details
Product name:
AviPro Salmonella Vac T Live Vaccine
Product number:
93168
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of an active constituent (secondary application).
Description of data provided:
Data no
248676
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248693
Title
Batch record-5077000
Study date
11 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248667
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248673
Title
Starting materials of biological origin
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248679
Title
Batch record-9101100
Study date
9 May 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248687
Title
Stress stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248690
Title
Batch record-B031700
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248670
Title
Validation report 0-0060-vr-92059-01
Study date
25 April 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248674
Title
Master seed S.T.
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248682
Title
Batch record-B031700
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261824
Title
Residual moisture VR Salm VacT
Study date
March 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248691
Title
Batch record-5076600
Study date
1 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248688
Title
Batch record-B017800
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248665
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248671
Title
Validation report 0-0060-vr-ba01
Study date
03 January 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248694
Title
Part 8 overview AviPro Salmonella Vac T
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248685
Title
Intermediate storage stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248662
Title
Part 1 application overview AviPro Salmonella Vac T
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248668
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248680
Title
Batch record-B017800
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248686
Title
In-use stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248669
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248663
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248677
Title
Batch to batch consistency
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248683
Title
Stability overview and conclusion
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248692
Title
Batch record-5076800
Study date
11 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248689
Title
Batch record-B024100
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248666
Title
Product development
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248678
Title
Batch record-6005400
Study date
26 April 2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248684
Title
Long term stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261825
Title
Batch-record Salm VacT
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248675
Title
Working see S.T.
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248681
Title
Batch record-B024100
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248672
Title
Validation report 0-0063-vr-111-01
Study date
29 March 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248664
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138155
Product/Active constituent Name
Application Product Name
Bacillus amyloliquefaciens strain FZB24
Application Date
Application Number
138155
Application Product Name
Bacillus amyloliquefaciens strain FZB24
Application details
Product name:
Bacillus amyloliquefaciens strain FZB24
Product number:
93174
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 130 g/kg Bacillus amyloliquefaciens strain FZB24 wettable powder product for disease control in grapes, in conjunction with approval of Bacillus amyloliquefaciens strain FZB24.
Description of data provided:
Data no
301683
Title
Multi-locus sequence analysis (MLSA) of Bacillus subtilis var. amyloliquefaciens strain FZB24, the active ingredient in Taegro
Study date
2019
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301680
Title
Final Storage Stability Study for Taegro Technical (70127-6)
Study date
2012
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301686
Title
Bacillus velezensis sp. nov., a surfactant-producing bacterium isolated from the river Velez in Malaga, southern Spain
Study date
2005
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301689
Title
High throughput ANI analysis of 90K prokaryotic genomes reveals clear species boundaries
Study date
2018
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301681
Title
Composition Taegro Technical and Quality Specifications for Taegro Technical
Study date
2022
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301692
Title
Draft Assessment Report Bacillus amyloliquefaciens strain FZB24 Volume 3 Annex B2 Biological, physical, chemical and technical properties
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301693
Title
Draft Assessment Report Bacillus amyloliquefaciens strain FZB24 Volume 3 Annex B5 Analytical methods
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301687
Title
DNA-DNA hybridisation values and their relationship to whole-genome sequence similarities
Study date
2007
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301690
Title
Relationship of Bacillus amyloliquefaciens clades associated with strains DSM 7T and FZB42T: a proposal for Bacillus amyloliquefaciens subsp. amyloliquefaciens subsp. nov. and Bacillus amyloliquefaciens subsp. plantarum subsp. nov. based on complete genome sequence comparisons
Study date
2011
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301684
Title
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedures - International Form
Study date
2009
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301691
Title
Taxonomic placement of the Bacillus strain FZB24 in Taegro
Study date
2022
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301685
Title
Bacillus velezensis is not a later heterotypic synonym of Bacillus amyloliquefaciens; Bacillus methylotrophicus, Bacillus amyloliquefaciens subsp. plantarum and ???Bacillus oryzicola??? are later heterotypic synonyms of Bacillus velezensis based on phylogenomics
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301679
Title
Taegro Technical Product Chemistry
Study date
2012
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301688
Title
Genomic insights that advance the species definition for prokaryotes
Study date
2004
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
301682
Title
Draft Assessment Report Bacillus amyloliquefaciens strain FZB24 Volume 3 Annex B1 Identity
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Date
Application Date
Application No
Application Number
136797
Product/Active constituent Name
Application Product Name
IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE
Application Date
Application Number
136797
Application Product Name
IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE
Application details
Product name:
IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE
Product number:
92822
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 72g/L ABAMECTIN + 180g/L PIPERONYL BUTOXIDE emulsifiable concentrate product for the control of certain Mites and Insect Pests on a variety of crops along with Native Budworm and Bollworm on Cotton as as specified in the Directions for Use table.
Reference details:
53325 - IMTRADE ABACHEM 18 MITICIDE/INSECTICIDE
53695 - PUPPET INSECTICIDE SYNERGIST
67524 - VANTAL UPGRADE MITICIDE/INSECTICIDE
Active constituents:
Active constituent name
53333 - ABAMECTIN
Active constituent name
65954 - PIPERONYL BUTOXIDE
Description of data provided:
Data no
242934
Title
Investigation into the bio-efficacy of IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE compared to IMTRADE ABACHEM 18 MITICIDE/INSECTICIDE for the control of Two Spotted Mite in Strawberries. One Trial, Kuitpo, South Australia.
Study date
30/11/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242928
Title
Abamectin 72 + Piperonyl Butoxide 180 EC Method Validation Sep 2021
Study date
16/09/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242945
Title
Comments to support Efficacy and Host Crop Safety data submitted
Study date
25/08/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242937
Title
Investigation into the Host Crop Safety of IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE compared to IMTRADE ABACHEM 18 MITICIDE/INSECTICIDE on Lettuce. One Trial, Kwinana, Western Australia.
Study date
15/09/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252446
Title
Acute Eye Irritation/Serious Eye Damage Study of Imtrade MYRIAD RMR Miticide (Abamectin 72g/L & Piperonyl Butoxide 180g/L) in New Zealand White Rabbits
Study date
13/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242931
Title
CoA Piperonyl Butoxide
Study date
25/05/2020
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
256067
Title
s.159 Residues Response - Abamectin + PBO Product
Study date
19/07/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242925
Title
Method of Manufacture - Abamectin 72 + Piperonyl Butoxide 180 EC Miticide_Insecticide
Study date
22/09/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252443
Title
Acute Dermal Toxicity Study of Imtrade MYRIAD RMR Miticide (Abamectin 72g/L & Piperonyl Butoxide 180g/L) in Wistar Rats
Study date
10/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242940
Title
Investigation into the Host Crop Safety of IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE compared to IMTRADE ABACHEM 18 MITICIDE/INSECTICIDE on Snow Pea cv. Oregon Dwarf. One Trial, Kwinana, Western Australia.
Study date
15/11/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242932
Title
Argument Against Residues Work for Registration of Abamectin 72g/L + PBO 180g/L Product
Study date
22/09/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242926
Title
Formulation and Stability Report - Abamectin 72 + Piperonyl Butoxide 180 EC Miticide_Insecticide
Study date
22/09/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242943
Title
Investigation into the Bio-efficacy of IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE compared to ABACHEM 18 MITICIDE/INSECTICIDE for the control of Two Spotted Mite and Native Budworm in Cotton cv. Sicot 606B3FBA. One Trial, Forest Hill, Queensland.
Study date
25/02/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242929
Title
Safety Data Sheets for other Constituents
Study date
22/09/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286707
Title
Review of APVMA Environment Technical Report with respect to Birds and Mammals; and Aquatic Spray Drift
Study date
17/12/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242938
Title
Investigation into the Host Crop Safety of IMTRADE MYRIAD RMRMITICIDE/INSECTICIDE compared to IMTRADE ABACHEM 18 MITICIDE/INSECTICIDE on Tomato cv. Roma. One Trial, Kwinana, Western Australia.
Study date
30/09/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252447
Title
Skin Sensitisation Potential of Imtrade MYRIAD RMR Miticide (Abamectin 72g/L & Piperonyl Butoxide 180g/L) in Guinea Pigs
Study date
25/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242944
Title
Investigation into the Bio-efficacy of IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE compared to ABACHEM 18 MITICIDE/INSECTICIDE for the control of Two Spotted Mite and Native Budworm in Cotton cv. Sicot 606B3FBA. One Trial, Forest Hill, Queensland.
Study date
16/08/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252444
Title
Acute Inhalation Toxicity Study of Imtrade MYRIAD RMR Miticide (Abamectin 72g/L & Piperonyl Butoxide 180g/L) in Wistar Rats
Study date
14/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242941
Title
Investigation into the Efficacy of IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE against IMTRADE ABACHEM 18 MITICIDE/INSECTICIDE for the control of Two Spotted Mite in Strawberry. One Trial, Glass House Mountains, Queensland.
Study date
24/11/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242935
Title
Investigation into the bio-efficacy of IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE compared to IMTRADE ABACHEM 18 MITICIDE/INSECTICIDE for the control of Two Spotted Mite in Strawberries. One Trial, Kuitpo, South Australia.
Study date
16/12/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242927
Title
Abamectin 72 + Piperonyl Butoxide 180 EC 1 Batch Analysis Sep 2021
Study date
16/09/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242942
Title
Investigation into the Bio-efficacy of IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE when compared to ABACHEM 18 MITICIDE/INSECTICIDE for the control of Two Spotted Mites in Sweetcorn. One Trial, Kuitpo, South Australia.
Study date
11/05/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242930
Title
CoA Abamectin Tech
Study date
09/07/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242936
Title
Investigation into the Host Crop Safety of IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE compared to IMTRADE ABACHEM 18 MITICIDE/INSECTICIDE for the control of Mites in Citrus. One Trial, Waikerie, South Australia
Study date
30/11/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252442
Title
Acute Oral Toxicity Study of Imtrade MYRIAD RMR Miticide (Abamectin 72g/L & Piperonyl Butoxide 180g/L) in Wistar Rats
Study date
04/04/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242939
Title
Investigation into the Host Crop Safety of IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE compared to IMTRADE ABACHEM 18 MITICIDE/INSECTICIDE on Cucumber cv. Lebanese. - One Trial, Kwinana, Western Australia.
Study date
20/10/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
242933
Title
OH and S Report - IMTRADE MYRIAD RMR Miticide/Insecticide
Study date
24/08/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252445
Title
Acute Dermal Irritation/Corrosion Study of Imtrade MYRIAD RMR Miticide (Abamectin 72g/L & Piperonyl Butoxide 180g/L) in New Zealand White Rabbits
Study date
10/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
134834
Product/Active constituent Name
Application Product Name
Royal Canin Recovery Liquid Canine Feline
Application Date
Application Number
134834
Application Product Name
Royal Canin Recovery Liquid Canine Feline
Application details
Product name:
Royal Canin Recovery Liquid Canine Feline
Product number:
92202
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Recovery Liquid Canine Feline', indicated for 'vet only' use in a critical care environment for dogs and cats.
Description of data provided:
Data no
234945
Title
Finished product batch analysis
Study date
September 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246306
Title
Claim substantiation - Renal Feline
Study date
2016
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234936
Title
Certificates of Analysis_exempt active constituents
Study date
2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246309
Title
Claim substantiation - Recovery
Study date
2016
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234942
Title
In-process controls
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246303
Title
Kerry Inc. potable water source
Study date
October 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234933
Title
Critical care liquid diets product guide
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234953
Title
Scientific Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234939
Title
Certificates of Analysis_excipients
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246300
Title
Recovery 15 month stability
Study date
November 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234928
Title
Release & expiry specifications
Study date
January 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234934
Title
Certificate of Analysis_finished product
Study date
October 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234940
Title
GMP evidence
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246301
Title
Gastrointestinal 14.5 month stability
Study date
April 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234948
Title
Product verification testing
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234931
Title
MPL artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234951
Title
ICU Product Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246312
Title
Ingredient classification outcome
Study date
May 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234937
Title
Certificates of Analysis_pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234949
Title
Target Animal Safety & Efficacy summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234932
Title
Nutritional protocol guidelines
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246313
Title
Silliker site certification
Study date
July 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234952
Title
Critical Care Guidelines
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234946
Title
Analytical procedures
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246307
Title
Vet education webinar
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234935
Title
Chemistry & Manufacture summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234929
Title
PAA written correspondence
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246310
Title
Claim substantiation - Gastrointestinal
Study date
2016
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234943
Title
Packaging specifications
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246304
Title
Lutein CoA documentation
Study date
2018
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234947
Title
Stability data
Study date
August 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246308
Title
GIT tract scientific presentation
Study date
April 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234930
Title
IMPL cluster artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246299
Title
Renal Canine 15.25 month stability
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246311
Title
PAA advice - DCPAA2-07426157A
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234938
Title
Certificates of Analysis_non-pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234944
Title
Quality control documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246305
Title
Claim substantiation - Renal Canine
Study date
2016
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234950
Title
AAFCO 2020 Nutritional Profiles
Study date
2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234941
Title
Manufacturing flowchart
Study date
December 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246302
Title
Appendix 2-11 replacement documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Date
Application Date
Application No
Application Number
134836
Product/Active constituent Name
Application Product Name
Royal Canin Gastrointestinal Low Fat Liquid Canine
Application Date
Application Number
134836
Application Product Name
Royal Canin Gastrointestinal Low Fat Liquid Canine
Application details
Product name:
Royal Canin Gastrointestinal Low Fat Liquid Canine
Product number:
92204
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Gastrointestinal Low Fat Liquid Canine', indicated for 'vet only' use in a critical care environment for dogs.
Description of data provided:
Data no
235005
Title
Packaging specifications
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234999
Title
Certificates of Analysis_pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235002
Title
GMP evidence
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235008
Title
Analytical procedures
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234996
Title
Certificate of Analysis_finished product
Study date
June 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235014
Title
Critical Care Guidelines
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235003
Title
Manufacturing flowchart
Study date
December 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234997
Title
Chemistry & Manufacture summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234991
Title
PAA written correspondence
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234994
Title
Nutritional protocol guidelines
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235011
Title
Target Animal Safety & Efficacy summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235000
Title
Certificates of Analysis_non-pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234995
Title
Critical care liquid diets product guide
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235012
Title
AAFCO 2020 Nutritional Profiles
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235009
Title
Stability data
Study date
March 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235015
Title
Scientific Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235006
Title
Quality control documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234998
Title
Certificates of Analysis_exempt active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234992
Title
IMPL cluster artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234993
Title
MPL artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235010
Title
Product verification testing
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235007
Title
Finished product batch analysis
Study date
April 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235001
Title
Certificates of Analysis_excipients
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235013
Title
ICU Product Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235004
Title
In-process controls
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234990
Title
Release and expiry specifications
Study date
January 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Date
Application Date
Application No
Application Number
134837
Product/Active constituent Name
Application Product Name
Royal Canin Renal Support Liquid Canine
Application Date
Application Number
134837
Application Product Name
Royal Canin Renal Support Liquid Canine
Application details
Product name:
Royal Canin Renal Support Liquid Canine
Product number:
92205
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Renal Support Liquid Canine', indicated for 'vet only' use in a critical care environment for dogs.
Description of data provided:
Data no
235022
Title
Certificate of Analysis_finished product
Study date
June 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235016
Title
Release and expiry specifications
Study date
January 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235028
Title
GMP evidence
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235036
Title
Product verification testing
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235019
Title
MPL artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235025
Title
Certificates of Analysis_pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235039
Title
ICU Product Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235020
Title
Nutritional protocol guidelines
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235034
Title
Analytical procedures
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235040
Title
Critical Care Guidelines
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235017
Title
PAA written correspondence
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235023
Title
Chemistry & Manufacture summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235031
Title
Packaging specifications
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235037
Title
Target Animal Safety & Efficacy summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235018
Title
IMPL cluster artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235026
Title
Certificates of Analysis_non-pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235032
Title
Quality control documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235038
Title
AAFCO 2020 Nutritional Profiles
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235029
Title
Manufacturing flowchart
Study date
December 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235035
Title
Stability data
Study date
April 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235041
Title
Scientific Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235024
Title
Certificates of Analysis_exempt active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235030
Title
In-process controls
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235021
Title
Critical care liquid diets product guide
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235027
Title
Certificates of Analysis_excipients
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235033
Title
Finished product batch analysis
Study date
March 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Date
Application Date
Application No
Application Number
134838
Product/Active constituent Name
Application Product Name
Royal Canin Renal Support Liquid Feline
Application Date
Application Number
134838
Application Product Name
Royal Canin Renal Support Liquid Feline
Application details
Product name:
Royal Canin Renal Support Liquid Feline
Product number:
92206
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Renal Support Liquid Feline', indicated for 'vet only' use in a critical care environment for cats.
Description of data provided:
Data no
235062
Title
Product verification testing
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235056
Title
In-process controls
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235048
Title
Certificate of Analysis_finished product
Study date
June 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235042
Title
Release & expiry specifications
Study date
January 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235059
Title
Finished product batch analysis
Study date
March 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235065
Title
ICU Product Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235045
Title
MPL artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235060
Title
Analytical procedures
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235066
Title
Critical Care Guidelines
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235054
Title
GMP evidence
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235057
Title
Packaging specifications
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235063
Title
Target Animal Safety & Efficacy summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235051
Title
Certificates of Analysis_pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235043
Title
PAA written correspondence
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235058
Title
Quality control documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235052
Title
Certificates of Analysis_non-pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235046
Title
Nutritional protocol guidelines
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235061
Title
Stability data
Study date
October 2018
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235049
Title
Chemistry & Manufacture summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235055
Title
Manufacturing flowchart
Study date
December 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235064
Title
AAFCO 2020 Nutritional Profiles
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235050
Title
Certificates of Analysis_exempt active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235044
Title
IMPL cluster artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235067
Title
Scientific Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235053
Title
Certificates of Analysis_excipients
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235047
Title
Critical care liquid diets product information
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Date
Application Date
Application No
Application Number
106073
Product/Active constituent Name
Application Product Name
SOMETRIBOVE ZINC
Application Date
Application Number
106073
Application Product Name
SOMETRIBOVE ZINC
Application details
Product name:
SOMETRIBOVE ZINC
Product number:
82564
Applicant Name:
ELANCO ANIMAL HEALTH A DIV OF ELI LILLY AUST PTY LTD
Reference details:
70120 - ELANCO POSILAC
Date
Application Date
Application No
Application Number
62556
Product/Active constituent Name
Application Product Name
ELANCO POSILAC
Application Date
Application Number
62556
Application Product Name
ELANCO POSILAC
Application details
Product name:
ELANCO POSILAC
Product number:
70120
Applicant Name:
ELANCO ANIMAL HEALTH A DIV OF ELI LILLY AUST PTY LTD
Application purpose and description of use:
Registration of a 500 mg/syringe sometribove zinc injection product for increased milk production in lactating dairy cows, in conjunction with approval of sometribove zinc [HASBZ/70120].
Description of data provided:
Data no
95783
Title
Determination of the appearance of sometribove zinc powder
Study date
2009
Data no
95784
Title
Electrophoretic Profile Gel Densitometry (SDS-PAGE/reduced)
Study date
2010
Data no
95785
Title
Aqueous size exclusion HPLC assay
Study date
2009
Data no
95786
Title
Kinetic LAL assay of sometribove zinc (ZnbST) bulk powder
Study date
2009
Data no
95787
Title
Determination of the water content in sometribove zinc bulk powder
Study date
2009
Data no
95788
Title
Zinc determination in unbuffered, lyophilized sometribove zinc (ZnbST) by atomic absorption
Study date
2008
Data no
95789
Title
Reduced RP-HPLC assay for bST process streams
Study date
2008
Data no
95790
Title
Tryptic Map Analysis of Sometribove Zinc Bulk Powder by RP-HPLC
Study date
2009
Data no
95791
Title
Determination of N-Formyl-BST and Norleucyl 123-BST in Bulk ZnBST Powder by Reversed-Phase HPLC
Study date
2008
Data no
95792
Title
Spectrophotometric determination of urea in bulk ZnbST or bST
Study date
2009
Data no
95793
Title
Modified USP Sterility Testing for Sterile ZnBST Bulk Powder
Study date
2009
Data no
95794
Title
Certificate of Analysis - Sometribove Zinc Bulk Powder
Study date
7 Nov 2011
Data no
95795
Title
Certificate of Analysis - Sometribove Zinc Bulk Powder
Study date
7 Nov 2011
Data no
95796
Title
Certificate of Analysis - Sometribove Zinc Bulk Powder
Study date
7 Nov 2011
Data no
95797
Title
Examination of the manufacturers working cell bank for purity
Study date
2009
Data no
95798
Title
Adventitious organism screening of recombinant E. coli fermentation samples
Study date
2010
Data no
95799
Title
Stability Data Summary for Sometribove Zinc bulk powder at -15oC.
Study date
2009
Data no
95800
Title
Determination of Zinc in Posilac Syringes
Study date
2008
Data no
95801
Title
Particle Size Determination of Sometribove Zinc Suspension
Study date
2009
Data no
95802
Title
Viscosity Measurement of Sometribove Zinc Formulated Product by Means of Large-Cone Rotation Viscometry
Study date
2009
Data no
95803
Title
In Vitro Dissolution of Sometribove Zinc Suspension According to the Disk Method
Study date
2008
Data no
95804
Title
Non-reduced assay (RP-HPLC) for in process, ZnbST bulk powder and sometribove zinc suspension samples
Study date
2008
Data no
95805
Title
Determination of the Appearance of Sometribove Zinc Suspension
Study date
2008
Data no
95806
Title
Analytical Technology Reference Guide to Summary of Validation Activity
Study date
7 Mar 2005
Data no
95807
Title
Dissolution of ZnBST SO/ALMS formulation using a paddle over Teflon device
Study date
23 June 1994
Data no
95977
Title
Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
23-Aug-1995
Data no
95979
Title
Appendix H Stability Summary: Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
23 Aug 1995
Data no
95980
Title
Appendix J Freeze/Thaw Stability: Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
18 Jul 1994
Data no
95982
Title
3140.301 RP-HPLC Assay for ZnBST Bulk Powder, Bulk Posilac (r) and Posilac (r) S
Study date
24-Jun-2000
Data no
95983
Title
Validation Report for Analytical Method 3140.301
Study date
19-Jan-2001
Data no
95984
Title
Protocol: Supplement to the Validation Protocol for Monsanto Analytical Method No. 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
15 Mar 1994
Data no
95808
Title
Batch 2009600033 Formulation / Filling production batch record
Study date
2009
Data no
95809
Title
Certificate of Analysis - POSILAC 500 mg/unit dose
Study date
1 Nov 2011
Data no
95810
Title
Certificate of Analysis - POSILAC 500 mg/unit dose
Study date
1 Nov 2011
Data no
95811
Title
Certificate of Analysis - POSILAC 500 mg/unit dose
Study date
1 Nov 2011
Data no
95812
Title
Determination of Content Uniformity and Uniformity of Fill of Sometribove Zinc Suspension Disposable Syringes
Study date
2009
Data no
95813
Title
Modified USP Sterility Testing for Posilac (Sterile Sometribove Zinc Suspension) Syringes
Study date
2009
Data no
95976
Title
Validation Addendum Protocol: Validation Addendum to Method 2-32-403: RP-HPLC for In-Process, ZnbST Bulk Powder and Sometribove Zinc Suspension Syringes
Study date
10-Dec-2012
Data no
95981
Title
Appendix A: Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
23 Aug 1995
Data no
95978
Title
Figure 8 Accuracy- Weighted Analysis of Variance: Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
07-Jun-1994
Data no
95814
Title
Stability data summary for process qualification
Study date
2007
Data no
95841
Title
A meta-analysis review of the effects of recombinant bovine somatotropin 1. Methodology and effects on production
Study date
2003
Auth party contact address
-
Data no
95842
Title
A meta-analysis review of the effects of recombinant bovine somatotropin 2. Effects on animal health, reproductive performance, and culling
Study date
2003
Auth party contact address
-
Data no
95843
Title
Production and health effects of sometribove zinc suspension (recombinant bovine somatotropin) in lactating dairy cows
Study date
2014
Auth party contact address
-
Data no
95844
Title
Comparison of New Zealand and Australian production systems, mastitis prevalence, incidence and bacterial pathogens
Study date
2011
Data no
95845
Title
Bovine somatotropin: review of an emerging animal technology
Study date
1992
Auth party contact address
-
Data no
95846
Title
Responses by lactating cows in commercial dairy herds to recombinant bovine somatotropin
Study date
1991
Auth party contact address
-
Data no
95847
Title
Production responses to bovine somatotropin in northeast dairy herds
Study date
1999
Auth party contact address
-
Data no
95848
Title
Production response of multiparous Holstein cows treated with bovine somatotropin and fed n-3 fatty acids in early lactation
Study date
2009
Auth party contact address
-
Data no
95849
Title
Effect of a Prolonged-Release Formulation of N-Methionyl Bovine Somatotropin (Sometribove) on Milk Fat
Study date
1992
Auth party contact address
-
Data no
95850
Title
Factors affecting response of cows to biweekly injections of sometribove
Study date
1992
Auth party contact address
-
Data no
95851
Title
Effect of increased milking frequency in early lactation with or without recombinant bovine somatotropin
Study date
2005
Auth party contact address
-
Data no
95852
Title
Southeastern pasture-based dairy systems: housing, Posilac, and supplemental silage effects on cow performance
Study date
2002
Auth party contact address
-
Data no
95853
Title
Milk response to bovine somatotropin of high producing dairy cows with three different feeding systems combining pasture and total mixed rations
Study date
2003
Auth party contact address
-
Data no
95854
Title
Effects of exogenous bovine somatotropin on lactation
Study date
1993
Auth party contact address
-
Data no
95855
Title
Report MSL 6532: Preliminary Dose Determination for Weekly Administration of the CP115099 Prolonged Release Formulation in Lactating Dairy Cows
Study date
27 April 1987
Data no
95856
Title
Report MSL 4936: A preliminary range finding study to determine the dose response profile of the standard CP115099 prolonged release formulation, 40% ZnMBS / 5% ALMS/SO in lactating dairy cows
Study date
25 February 1986
Data no
95857
Title
Report MSL 7051: Initial dose determination of CP115099-F in lactating dairy cows - terminated after seven 14-day treatment cycles
Study date
15 September 1987
Data no
95858
Title
Report MSL 8140: Assessment of the effective range of CP115099-F in lactating primiparous and multiparous dairy cows
Study date
2 September 1988
Data no
95859
Title
Report MSL 8140 (Supplement): Assessment of the effective range of CP115099-F in lactating primiparous and multiparous dairy cows - additional health analyses
Study date
18 January 1990
Data no
95860
Title
Evaluation of Sometribove in a Prolonged-Release system in lactating dairy cows - production responses
Study date
1991
Auth party contact address
-
Data no
95861
Title
Report MSL 9607: Response of Cows Throughout Lactation to Sometribove, in a Prolonged Release System. A Dose Titration Study, conducted at four US sites
Study date
18 January 1991
Data no
95862
Title
Report MSL 7183: Long term evaluation of zinc methionyl bovine somatotropin treatment in a prolonged release system for lactating cows at four US clinical trial sites - 252 days of treatment
Study date
30 September 1987
Data no
95863
Title
Report MSL 8193: Long term evaluation of Zinc Treatment in a Prolonged Release System for Lactating Primaparous Cows at Four U.S. Clinical Trial Sites
Study date
1 August 1988
Data no
95864
Title
Supplement to MSL 8193: Long term evaluation of Zinc Treatment in a Prolonged Release System for Lactating Primaparous Cows at Four U.S. Clinical Trial Sites
Study date
21 June 1989
Data no
95865
Title
Report MSL 9664: Long Term Evaluation of Zinc Methionyl Bovine Somatotropin Treatment in a Prolonged Release System for Lactating Multiparous Cows at Four U.S. Clinical Trial Sites
Study date
15 December 1989
Data no
95866
Title
Report MSL 6594: Galactopoietic response and injection site resolution of CP115099-F administered intramuscularly or subcutaneously to lactating Holstein cows
Study date
27 March 1987
Data no
95867
Title
Report MSL 7118: Assessment of the effective range of CP115099-F in lactating primiparous and multiparous dairy cows: report covering 312 days of lactation
Study date
23 September 1987
Data no
95868
Title
Report MSL 9646: Comparison of the effectiveness of intramuscular and subcutaneous administration of CP115099-F
Study date
22 January 1990
Data no
95869
Title
Report MSL 8734: Long Term Evaluation of Zinc Methionyl Bovine Somatotropin Treatment in a Prolonged Release System for Lactation Jersey Cows
Study date
5 January 1985
Data no
95870
Title
Study T4UME0702: Lactation performance of dairy cows treated at different dose and injection interval of bovine somatotropin (Lactropina and Lactropina Plus)
Study date
2002
Data no
95871
Title
Report MLL 90376: Efficacy and Safety of CP115099-F in Dairy Cows. Report on lactations 1 and 2 of the French Clinical Trials performed at Sanders Experimental Centre, Saint Symphorien
Study date
29 July 1988
Data no
95872
Title
Report MLL 90329: Efficacy and safety of CP115099-F in dairy cows. Report on UK clinical trial performed under Animal Test Certificate No 5997/0001
Study date
10 July 1987
Data no
95873
Title
Report MLL 90413: Efficacy and safety of CP115099-F (Sometribove) in dairy cows through three consecutive lactations of treatment in the UK. Report on the clinical trial performed under Animal Test Certificate NO. 5997/0001
Study date
May 1989
Data no
95874
Title
Report MLL 90330: Efficacy and safety of CP115099-F in dairy cows. Report on German clinical trial (one lactation) performed at the Bundesforschungsanstalt fur Milcherzeugung
Study date
10 July 1987
Data no
95875
Title
Report MLL 90406: Safety and Efficacy of CP115099-F (sometribove) in dairy cows through three consecutive lactations of treatment. Report on the German Clinical Trial performed at Bundesanstalt fur Milchforschung, Kiel
Study date
19 April 1989
Data no
95876
Title
Report MLL 90328: Efficacy and safety of CP115099-F in dairy cows. Report on Netherlands clinical trial performed at Instituut voor Veevoedingsonderzoek (I.V.V.O.)
Study date
10 July 1987
Data no
95877
Title
Report MLL 90402: Safety and Efficacy of CP115099-F (Sometribove) in Dairy Cows through Three Consecutive Lactations of Treatment. Report on the Netherlands Clinical Trial performed at INstituut voor Veevoedingsonderzoek (I.V.V.O.)
Study date
20 March 1989
Data no
95878
Title
Effects of sustained release bovine somatotropin (Sometribove) on animal health in commercial dairy herds
Study date
2001
Auth party contact address
-
Data no
95879
Title
Administration of recombinant bovine somatotropin to dairy cows for four consecutive lactations
Study date
1997
Auth party contact address
-
Data no
95880
Title
Effect of acute challenge with an extreme dose of somatotropin in a prolonged release formulation on milk production and health of dairy cattle
Study date
1990
Auth party contact address
-
Data no
95884
Title
Response of dairy cows to high doses of a sustained - release bovine somatotropin administered during two lactations. 1. Production response
Study date
1991
Auth party contact address
-
Data no
95885
Title
Response of dairy cows to high doses of a sustained - release bovine somatotropin administered during two lactations. 2. Health and Reproduction
Study date
1992
Auth party contact address
-
Data no
95886
Title
Effect of high doses of a sustained-release bovine somatotropin on antibody formation in dairy cows
Study date
1992
Auth party contact address
-
Data no
95895
Title
Effect of dietary energy and previous bovine somatotropin on milk yield, mastitis, and reproduction in dairy cows
Study date
1992
Auth party contact address
-
Data no
95903
Title
Study GN4AU090012: Confirmation of lactation performance and animal safety of dairy cows treated with a lactation enhancer
Study date
December 2012
Data no
95904
Title
Report MLL 90336: Efficacy and safety of CP115099-F in dairy cows. Report on the French clinical trial performed at Sanders Experimental Centre, Saint Symphorien
Study date
30 September 1987
Data no
95905
Title
Report MSL 12207: Evaluation of the galactopoietics response of bovine somatotropin (sometribove (CP115099-F), 500 mg and CP115400-P, 260 mg) when administered subcutaneously to lactating jersey cows in a commercial dairy herd
Study date
8 September 1992
Data no
95906
Title
Galactopoiesis. Effect of treatment with somatotropin
Study date
2011
Auth party contact address
-
Data no
95907
Title
Effects of bovine somatotropin on dry matter intake, milk yield, and body temperature in Holstein and Jersey cows during heat stress
Study date
1990
Auth party contact address
-
Data no
95908
Title
Freedom of Information Summary: Posilac 1Step
Study date
27 Dec 2001
Auth party contact address
-
Data no
95896
Title
Recombinant bovine somatotropin and clinical mastitis: Incidence, discarded milk following therapy and culling
Study date
1997
Auth party contact address
-
Data no
95897
Title
Effect of recombinantly-derived bovine somatotropin on reproductive performance of dairy cattle
Study date
1991
Auth party contact address
-
Data no
95839
Title
Freedom of Information Summary 1: Posilac
Study date
5 Nov 1993
Auth party contact address
-
Data no
95840
Title
Freedom of Information Summary, Supplemental New Animal Drug Application: Posilac
Study date
11 Nov 2003
Auth party contact address
-
Data no
95889
Title
Final response to Citizens Petition. CVM, FDA
Study date
2000
Auth party contact address
-
Data no
95956
Title
Survey of retail milk composition as affected by label claims regarding farm-management practices.
Study date
2008
Auth party contact address
-
Data no
95957
Title
Effect of exogenous growth hormone in early and late lactation on lactational performance of dairy cows.
Study date
1983
Auth party contact address
-
Data no
95958
Title
Effect of dose of bovine growth hormone on milk composition: Alpha-lactalbumin, fatty acids and mineral elements.
Study date
1985
Auth party contact address
-
Data no
95959
Title
Blood and milk lipid responses induced by growth hormone administration to lactating cows.
Study date
1984
Auth party contact address
-
Data no
95960
Title
Effect of exogenous growth hormone on lactational performance in the high yielding dairy cow.
Study date
1981
Auth party contact address
-
Data no
95961
Title
Endocrine control of energy metabolism in the cow: The effect on milk yield and levels of some blood constituents of injecting growth hormone and growth hormone fragments.
Study date
1980
Auth party contact address
-
Data no
95962
Title
Effect of dose of bovine growth hormone on lactation of dairy cows.
Study date
1985
Auth party contact address
-
Data no
95963
Title
Comparison of different patterns of exogenous growth hormone administration on milk production in Holstein cows.
Study date
1983
Auth party contact address
-
Data no
95964
Title
Lactational response to exogenous growth hormone and abomasal infusion of a glucose-sodium caseinate mixture in high-yielding dairy cows.
Study date
1982
Auth party contact address
-
Data no
95965
Title
Responses of high-producing dairy cows to long-term treatment with pituitary somatotropin and recombinant somatotropin.
Study date
1985
Auth party contact address
-
Data no
95966
Title
The effects of long-term administration of bovine growth hormone on the lactational performance of identical twin dairy cows.
Study date
1985
Auth party contact address
-
Data no
95967
Title
Report MSL 542: Sensory and chemical evaluation of milk produced from cows treated with CP115099 in a prolonged release system - a preliminary study.
Study date
10 February 1986
Data no
95968
Title
Survey of the fatty acid composition of retail milk differing in label claims based on production management practices.
Study date
2010
Auth party contact address
-
Data no
95969
Title
Effect of long-term bovine somatotropin (sometribove) treatment on nitrogen (protein) distribution in Jersey milk.
Study date
1991
Auth party contact address
-
Data no
95970
Title
Report MSL 6600: Somatotropin and antibodies in milk from cows on study no. 100-DDC-COW-PJE-010 (Toxicity Study): First lactation study final report.
Study date
11 May 1987
Data no
95971
Title
Responses of dairy cows to exogenous bovine growth hormone administered during early lactation.
Study date
1985
Auth party contact address
-
Data no
95972
Title
Report MLL 90311: Composition and processing characteristics of milk from cows in the French Clinical trial.
Study date
2 February 1987
Data no
95973
Title
Report MSL 7031: Evaluation of vitamins in milk produced from cows treated with placebo and CP115099 in a prolonged release system.
Study date
29 May 1987
Data no
95974
Title
Report MLL 90310: The influence of the treatment of lactating cows with methionyl bovine somatotropin on milk properties.
Study date
29 January 1987
Data no
95975
Title
CVM ADE Comprehensive Clinical Detail Report Listing: Cumulative Date Range: 01/01/1987 -thru- 12/31/2012. Drug Listing: N;O;P;Q;R;S. pages 388-398
Study date
2013
Auth party contact address
-
Data no
95933
Title
Report MSL 6578: Characterisation of the pharmacokinetic parameters of CP104301 in lactating cows.
Study date
31 March 1987
Data no
95934
Title
Report MSL 6603: Characterisation of the pharmacological parameters of MBS AlaVal and AlaValHis in lactating cows.
Study date
31 March 1987
Data no
95935
Title
Report MSL 6610: Determination of somatotropin release kinetics in dairy cows administered several doses of CP115099 prolonged release formulation.
Study date
31 March 1987
Data no
95936
Title
Report MSL 6611: Evaluation of BST metabolic pathways in dairy cows after intramuscular administration of BST-formulation.
Study date
25 March 1987
Data no
95937
Title
Report MSL 6749: Comparison of bovine pituitary and recombinant somatotropins by in vitro degradation with proteases: thrombin, trypsin and leukocyte elastase.
Study date
21 May 1987
Data no
95938
Title
Peptide hormones and their analogues: Distribution, clearance from the circulation and inactivation in vivo.
Study date
1979
Auth party contact address
-
Data no
95939
Title
Estimates of the kinetic parameters of growth hormone metabolism in fed and fasted calves and sheep.
Study date
1976
Auth party contact address
-
Data no
95940
Title
Changes in growth hormone status related to body weights of growing cattle.
Study date
1977
Auth party contact address
-
Data no
95941
Title
The search for the active core of pituitary growth hormone.
Study date
1974
Auth party contact address
-
Data no
95942
Title
Action of thrombin on ovine, bovine and human pituitary growth hormones.
Study date
1976
Auth party contact address
-
Data no
95943
Title
Fate of injected human growth hormone in the female rat liver in vivo.
Study date
1982
Auth party contact address
-
Data no
95944
Title
The uptake and degradation of growth hormone fragments by isolated rat hepatocytes.
Study date
1978
Auth party contact address
-
Data no
95945
Title
The intriguing nature of the multiple actions of growth hormone.
Study date
1979
Auth party contact address
-
Data no
95946
Title
Distribution of tritium labelled human growth hormone in rats and guinea pigs.
Study date
1966
Auth party contact address
-
Data no
95947
Title
Early localisation of 125I-labelled human growth hormone in adrenals and other organs of immature hypophysectomised rats.
Study date
1971
Auth party contact address
-
Data no
95948
Title
The fate of 131I-labelled human growth hormone in the rabbit.
Study date
1962
Auth party contact address
-
Data no
95949
Title
The distribution of radioactivity in the administration of radioactive growth hormone preparations.
Study date
1954
Auth party contact address
-
Data no
95950
Title
Autoradiographic demonstration of glomerular filtration and proximal tubular absorption of 125I-labelled growth hormone in the mouse.
Study date
1973
Auth party contact address
-
Data no
95951
Title
Adsorption of 125I-labelled sheep growth hormone in single proximal tubules of the rat kidney.
Study date
1976
Auth party contact address
-
Data no
95952
Title
Studies on human growth hormone. II. Physiological disposition and metabolic fate of human growth hormone in man.
Study date
1962
Auth party contact address
-
Data no
95953
Title
Biology of somatotropin in growth and lactation of domestic animals.
Study date
1998
Auth party contact address
-
Data no
95954
Title
Report MSL 9672: Effect of sometribove on blood clinical chemistries and hormones in dairy cattle.
Study date
9 January 1990
Data no
95955
Title
Effect of somatotropin on the plasminogen and plasmin system in the mammary gland: Proposed mechanism of action for somatotropin on the mammary gland.
Study date
1990
Auth party contact address
-
Data no
95891
Title
Report MSL 11545: A histological evaluation of injection sites with visual scores of 2 and 3 following chronic subcutaneous administration of sometribove prolonged release formulation
Study date
25 November 1991
Data no
95892
Title
Report MSL 11509: A histopathological evaluation of persistent local inflammatory lesions following tailhead (ischiorectal fossa) injection of rbST in dairy cows (study 100-DDC-COW-PJE-91-068)
Study date
21 November 1991
Data no
95893
Title
Supplement to Report 6757: Long Term Evaluation of Zinc Methionyl Bovine Somatotropin Treatment in a Prolonged Release System for Lactation Cows producing high fat and high protein milk Summary report: injection site swellings
Study date
August 1988
Data no
95894
Title
Report MSL 9012: Injection site and carcass evaluation following subcutaneous administration of sometribove prolonged release formulation
Study date
24 May 1989
Data no
95909
Title
Effect of a single growth hormone (rbST) treatment at breeding on conception rates and pregnancy retention in dairy and beef cattle
Study date
2006
Auth party contact address
-
Data no
95910
Title
Effect of recombinant bovine somatotropin on superovulatory response and recipient pregnancy rates in a commercial embryo transfer program
Study date
2003
Auth party contact address
-
Data no
95899
Title
The effect of a depot injection of recombinant bovine somatotropin on follicular development and embryo yield in superovulated Holstein heifers
Study date
1993
Auth party contact address
-
Data no
95900
Title
Follicular function in lactating dairy cows treated with sustained-release bovine somatotropin
Study date
1997
Auth party contact address
-
Data no
95901
Title
Supplement to Report MSL 9012: Evaluation of injection sites and carcass quality following subcutaneous administration of sometribove in a prolonged release formulation in jersey cows
Study date
8 December 1989
Data no
95902
Title
Report MSL 11476: Injection site evaluation following subcutaneous administration of somatotropin prolonged release formulation
Study date
21 October 1991
Data no
95911
Title
Effect of pretreatment with bovine somatotropin (bST) and/or gonadotropin-releasing homone (GnRH) on conception rate of dairy cows with ovarian cysts subjected to synchronisation of ovulation and timed insemination.
Study date
2003
Auth party contact address
-
Data no
95912
Title
Effects of presynchronisation and bovine somatotropin on pregnancy rates to a timed artificial insemination protocol in lactating dairy cows.
Study date
2001
Auth party contact address
-
Data no
95913
Title
Effect of bST and Reproductive Management on Reproductive Performance of Holstein Dairy Cows.
Study date
2004
Auth party contact address
-
Data no
95914
Title
Effect of bovine somatotropin (500mg) administered at ten-day intervals on ovulatory responses, expression of estrus, and fertility in dairy cows.
Study date
2010
Auth party contact address
-
Data no
95915
Title
Effect of short-term treatment with bovine somatotropin at estrus on conception rate and luteal function of repeat-breeding dairy cows.
Study date
2001
Auth party contact address
-
Data no
95916
Title
l (2002) Bovine somatotropin increases embryonic development in superovulated cows and improves post-transfer pregnancy rates when given to lactating recipient cows.
Study date
2002
Auth party contact address
-
Data no
95917
Title
Fertility of lactating dairy cows administered recombinant bovine somatotropin during heat stress.
Study date
2007
Auth party contact address
-
Data no
95918
Title
Report MSL 12026: Effect of sometribove treatment of dairy cows on the incidence of clinical signs and birth abnormalities in the resultant offspring.
Study date
16 September 1992
Data no
95919
Title
Health, welfare and fertility implications of the use of bovine somatotropin in dairy cattle.
Study date
1988
Auth party contact address
-
Data no
95920
Title
Somatotropin treatment for a second consecutive lactation.
Study date
1990
Auth party contact address
-
Data no
95921
Title
Overall efficacy of chronically administered recombinant bovine somatotropin to lactating dairy cows.
Study date
1990
Auth party contact address
-
Data no
95922
Title
Use of recombinant bovine somatotropin for up to two consecutive lactations on dairy production traits.
Study date
1990
Auth party contact address
-
Data no
95923
Title
Lactation response and body composition of cows receiving somatotropin and three ratios of forage to concentrate.
Study date
1991
Auth party contact address
-
Data no
95924
Title
Effect on production of the use of recombinant bovine somatotropin for up to three consecutive lactations.
Study date
1992
Auth party contact address
-
Data no
95925
Title
Effects of recombinant bovine somatotropin under conditions of high production and heat stress.
Study date
1993
Auth party contact address
-
Data no
95926
Title
Slow release somatotropin in dairy heifers and cows fed two levels of energy concentrate. 1. Performance and body condition.
Study date
1991
Auth party contact address
-
Data no
95927
Title
Effects of recombinant bovine somatotropin on milk production, body composition and physiological parameters.
Study date
1988
Auth party contact address
-
Data no
95928
Title
Recombinant bovine somatotropin with lactating cows fed diets differing in energy density.
Study date
1991
Auth party contact address
-
Data no
95929
Title
Effect of the use of bovine somatotropin on culling practices in thirty-two dairy herds in Indiana, Michigan and Ohio.
Study date
1998
Auth party contact address
-
Data no
95930
Title
Report MSL 11838: Effect of sometribove on incidence of clinical signs in dairy cows.
Study date
1 May 1992
Data no
95931
Title
Clinical mastitis in cows treated with sometribove (recombinant bovine somatotropin) and its relationship to milk yield.
Study date
1994
Auth party contact address
-
Data no
95932
Title
Effect of long-term administration of a prolonged release formulation of bovine somatotropin (sometribove) on clinical lameness in dairy cows.
Study date
1995
Auth party contact address
-
Data no
95898
Title
Reproductive performance of Holstein cows receiving somatotropin
Study date
2000
Auth party contact address
-
Data no
95890
Title
Effects of recombinant growth hormone on fertility: Dependence upon seasonal variations, dosage differences and lactational status
Study date
2009
Data no
95887
Title
Report MSL 7119: Effect of CP115099-F treatment of the dam on the subsequent health and reproductive performance of first generation heifers; interim report from birth through 4 months of life
Study date
18 September 1987
Data no
95888
Title
Report MSL 9639: Effect of sometribove on health of dairy cattle
Study date
18 January 1991
Data no
95881
Title
Report MSL 8133: Toxicity of CP115099 in a prolonged release system in lactating cows through two lactations of treatment: final report
Study date
2 September 1988
Data no
95882
Title
Report MSL 9671: Toxicity of CP115099 in a prolonged release system in lactating cows through two lactations of treatment: additional analyses
Study date
10 January 1990
Data no
95883
Title
Report MSL 9671 - Amendment: Toxicity of CP115099 in a prolonged release system in lactating cows through two lactations of treatment: additional analyses
Study date
21 April 1993
Data no
95815
Title
Discussion of Overseas Registration Submissions for POSILAC
Study date
March 2013
Data no
95816
Title
The regulation of rBST: The European case.
Study date
2000
Auth party contact address
-
Data no
95817
Title
Final response to citizens petition.
Study date
2000
Auth party contact address
-
Data no
95818
Title
Recombinant bovine somatotropin (rbST).
Study date
1998, revised 1999
Auth party contact address
-
Data no
95819
Title
CVM Update: FDA Analysis of DGXXIV Report on Public Health Aspects of BST.
Study date
April 13, 1999
Auth party contact address
-
Data no
95820
Title
rbST and the Drug Approval Process, Interim Report. March 1999.
Study date
March 1999
Auth party contact address
-
Data no
95821
Title
Recombinant Bovine Somatotropin: Challenging Canadas Science-based Regulatory System and the Emergence of Post-Normal Science.
Study date
2005
Auth party contact address
-
Data no
95822
Title
Primary dermal irritation study in rabbits, Bio/dynamics project No. 6578-86, Monsanto reference No. BD-86-132
Study date
1986
Data no
95823
Title
JECFA (2000) WHO Food Additives Series 43: Porcine Somatotropins
Study date
2000
Auth party contact address
-
Data no
95824
Title
Primary dermal irritation study in rabbits, Bio/dynamics project No. 6582-86, Monsanto reference No. BD-86-131
Study date
1986
Data no
95825
Title
The acute oral and dermal toxicity and primary ocular and dermal irritation of EL-349 parental injection. Unpublished report on studies R-0-155-86. R-0-154-86. 8-D-120-86 and 8-E-100-86.
Study date
1987
Data no
95826
Title
Primary dermal irritation study in rabbits, Bio/dynamics project No. 6579-86, Monsanto reference No. BD-86-132
Study date
1986
Data no
95827
Title
Skin and eye irritation and dermal sensitization attributed to sometribove zinc formulation.
Study date
2010
Data no
95828
Title
Primary dermal irritation study in rabbits, Bio/dynamics project No. 6583-86, Monsanto reference No. BD-86-131
Study date
1986
Data no
95829
Title
Potential for Posilac (recombinant bovine somatotropin, rbST) to stimulate hormonal activity in Humans
Study date
2011
Data no
95830
Title
Use of Bovine Somatotropin in Dairy Production
Study date
2010
Data no
95831
Title
Cline, 2007. Assessing the Mammary Gland of Nonhuman Primates: Effects of Endogenous Hormones and Exogenous Hormonal Agents and Growth Factors.
Study date
2007
Auth party contact address
-
Data no
95832
Title
Factors effecting insulin-like growth factor -1 concentration in bovine milk.
Study date
1991
Auth party contact address
-
Data no
95833
Title
Bioactivity of milk from bst-treated cows.
Study date
1990
Auth party contact address
-
Data no
95834
Title
Episodic evolution of growth hormone in primates and emergence of the species specificity of human growth hormone receptor.
Study date
2001
Auth party contact address
-
Data no
95835
Title
Parodi, 2005. Dairy Product consumption and the risk of breast cancer.
Study date
2005
Auth party contact address
-
Data no
95836
Title
Recombinat Bovine Somatotropin (rbST): A safety Assessment
Study date
2010
Data no
95837
Title
WHO Food Additive Series 31: Bovine somatotropins
Study date
1993
Auth party contact address
-
Data no
95838
Title
Survey of retail milk composition as affected by label claims regarding farm-management practices
Study date
2008
Auth party contact address
-