Application summaries

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

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

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

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

For more information, please see the questions and answers.

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

Date

11 May 2023

Application No

139403

Product/Active constituent Name

SA WATER COPPER SULPHATE ALGICIDE

Application details

Product name:

SA WATER COPPER SULPHATE ALGICIDE

Product number:

51854

Applicant Name:

SOUTH AUSTRALIAN WATER CORPORATION

Application purpose and description of use:

Variation of product registration and/or label approval to update label statements and include additional reservoir.

Description of data provided:

Data no

262146

Author

Joel Bowes for JBS&G Australia Pty Ltd

Title

Wirrina Water Treatment Plant – Local Catchment Environmental Assessment

Study date

24 August 2023

Authorising party

Applicant

Auth party contact address

LEVEL 4, 250 VIC SQUARE ADELAIDE Australia

Data no

262155

Author

Tanya Cabella for SA Water

Title

Wirrina WTP – Catchment Barrier Status Report

Study date

17 February 2023

Authorising party

Applicant

Auth party contact address

LEVEL 4, 250 VIC SQUARE ADELAIDE Australia

Data no

264220

Author

John Winter

Title

Wirrina Catchment Golf Course Dam

Study date

23/9/19 and 17/10/19

Authorising party

Applicant

Auth party contact address

LEVEL 4, 250 VIC SQUARE ADELAIDE Australia

Data no

298742

Author

Peter Hobson

Title

Raw Data_Figure 2A and Figure 3

Study date

19 November 2025

Authorising party

Applicant

Auth party contact address

LEVEL 4, 250 VIC SQUARE ADELAIDE Australia

Data no

298743

Author

Peter Hobson and Tony Frasca

Title

SA Water Response to the Outcome of the APVMA Environmental Assessment Module

Study date

24 October 2025

Authorising party

Applicant

Auth party contact address

LEVEL 4, 250 VIC SQUARE ADELAIDE Australia

Date

20 Mar 2023

Application No

138676

Product/Active constituent Name

Nufarm Galaxy Herbicide

Application details

Product name:

Nufarm Galaxy Herbicide

Product number:

92149

Applicant Name:

NUFARM AUSTRALIA LIMITED

Application purpose and description of use:

Variation of product label approval to include aerial application for the same crops, weeds controlled, application rates and tank mixes as currently registered for ground boom application.

Active constituents:

91686 - Pyrasulfotole

Description of data provided:

Data no

250060

Author

APVMA

Title

Environmental Technical Report for Application no. 131089, Permit 91161

Study date

1 June 2022

Authorising party

Applicant

Auth party contact address

103-105 PIPE RD LAVERTON NORTH Australia

Data no

250061

Author

C Kelly

Title

Nufarm Galaxy Herbicide Executive Summary

Study date

14 Feb 2023

Authorising party

Applicant

Auth party contact address

103-105 PIPE RD LAVERTON NORTH Australia

Data no

250062

Author

C Kelly

Title

Nufarm Galaxy Herbicide draft label marked up 14022023

Study date

13 Feb 2023

Authorising party

Applicant

Auth party contact address

103-105 PIPE RD LAVERTON NORTH Australia

Data no

257005

Author

C Kelly

Title

92149/138676 Nufarm Galaxy Herbicide - Response to S159 Notice of 28 June 2023

Study date

11 July 2023

Authorising party

Applicant

Auth party contact address

103-105 PIPE RD LAVERTON NORTH Australia

Date

3 Feb 2023

Application No

138134

Product/Active constituent Name

Salmonella Enterica ser. Enteritidis

Application details

Product name:

Salmonella Enterica ser. Enteritidis

Product number:

93161

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.

Date

3 Feb 2023

Application No

138136

Product/Active constituent Name

Salmonella Enterica ser. Typhimurium

Application details

Product name:

Salmonella Enterica ser. Typhimurium

Product number:

93163

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.

Date

3 Feb 2023

Application No

138135

Product/Active constituent 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

248208

Author

Elanco Animal Health

Title

Master seed S.E.

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248209

Author

Elanco Animal Health

Title

Master seed S.T.

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248210

Author

Elanco Animal Health

Title

Working seed S.E.

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248211

Author

Elanco Animal Health

Title

Working seed S.T.

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248212

Author

Linde, K., Fthenakis, G., and Fichtner, A.

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248213

Author

Elanco Animal Health

Title

Development of S.E. strain

Study date

March 2019

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248214

Author

Elanco Animal Health

Title

Development of S.T. strain

Study date

May 2018

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248215

Author

Heisig, P.

Title

Expert report

Study date

16 December 2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248216

Author

Elanco Animal Health

Title

0-0115-TS-BA

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248217

Author

Elanco Animal Health

Title

0-0061-TS-BA

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248218

Author

Elanco Animal Health

Title

0-0062-TS-BA

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248219

Author

Elanco Animal Health

Title

0-0060-TS-BA

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248220

Author

Elanco Animal Health

Title

0-0063-TS-BA

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248221

Author

Elanco Animal Health

Title

0-0110-TS-BA

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248222

Author

Elanco Animal Health

Title

Batch to batch consistency

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248223

Author

Rebeski, D.

Title

Batch record-200308-1c03

Study date

29 March 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248224

Author

Rebeski, D.

Title

Batch record-200312-2c03

Study date

29 March 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248225

Author

Rebeski, D.

Title

Batch record-b052600-03

Study date

13 February 2012

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248226

Author

Vogel, P.

Title

Batch record-g039700-01

Study date

29 December 2016

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248227

Author

Not Identified

Title

GMP certificate

Study date

15 November 2019

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248228

Author

Elanco Animal Health

Title

Manufacturing flow chart

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248229

Author

Elanco Animal Health

Title

Manufacturing description

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248230

Author

Elanco Animal Health

Title

Manufacturing validation summary

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248231

Author

Elanco Animal Health

Title

Validation report 0-0063-VR-111-01

Study date

23 November 2018

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248232

Author

Lohmann Animal Health

Title

Validation report 0-0060-VR-92637

Study date

04 May 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248233

Author

Elanco Animal Health

Title

Starting materials listed in pharmacopoeias

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248234

Author

Elanco Animal Health

Title

Starting materials of non-biological origin

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248235

Author

Elanco Animal Health

Title

Starting materials of biological origin

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248236

Author

Elanco Animal Health

Title

In process control tests

Study date

July 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248237

Author

Elanco Animal Health

Title

Control tests on the finished product

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248238

Author

Elanco Australasia Pty Ltd

Title

Part 2 Overview

Study date

December 2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248239

Author

Elanco Animal Health

Title

Particulars

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248240

Author

Elanco Animal Health

Title

Vial

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248241

Author

Nipro Pharmapackaging

Title

Quality Certificate

Study date

October 2017

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248242

Author

Elanco Animal Health

Title

Closure

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248243

Author

West Pharmaceuticals

Title

Quality Certificate

Study date

November 2017

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248244

Author

Elanco Animal Health

Title

Product development

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248245

Author

Elanco Animal Health

Title

Stability overview and conclusion

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248246

Author

Elanco Animal Health

Title

Frozen storage stability report

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248247

Author

Elanco Animal Health

Title

Long term stability report

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248248

Author

Elanco Animal Health

Title

Relocation stability report

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248249

Author

Elanco Animal Health

Title

In use stability report

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248250

Author

Elanco Animal Health

Title

Stress stability report

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248251

Author

Rebeski, D.

Title

Batch record 200308-1c03

Study date

29 March 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248252

Author

Rebeski, D.

Title

Batch record-200312-2c03

Study date

29 March 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248253

Author

Rebeski, D.

Title

Batch record-200401-3c

Study date

29 March 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248254

Author

Rebeski, D.

Title

Batch record-9475400

Study date

29 March 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248255

Author

Dr Ilka Shroder

Title

Study no.: 85/01

Study date

2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248256

Author

Dr Ilka Shroder

Title

Study no.: 262/02

Study date

2002

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248257

Author

Dr Ilka Shroder

Title

Study no.: 278/02

Study date

2002

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248258

Author

Dr Ilka Shroder

Title

Study no.: 147/05

Study date

2007

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248259

Author

Dr Ilka Shroder

Title

Study no.: 148/05

Study date

2007

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248260

Author

Dr Ilka Shroder

Title

Study no.: 147/06

Study date

2007

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248261

Author

Dr Ilka Shroder

Title

Study no.: 13/06

Study date

2007

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248262

Author

Dr Daniel Windhorst

Title

Study no.: Gantois et al.

Study date

2006

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248263

Author

Dr Ilka Hahn

Title

Study no.: 485/99

Study date

2000

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248264

Author

Dr Ilka Shroder

Title

Study no.: 372/01

Study date

2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248265

Author

Dr. Frank Fehler

Title

Study no.: 152/99

Study date

1999

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248266

Author

Dr Ilka Shroder

Title

Study no.: 250/93

Study date

2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248267

Author

Dr Ilka Hahn

Title

Study no.: 60/96

Study date

2000

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248268

Author

Dr M. Voss

Title

M. Voss, 1996 (Study: Lohmann Information 3/96)

Study date

1996

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248269

Author

Dr. Nathalie Desloges

Title

Study: Salm 01/05

Study date

2008

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248270

Author

Elanco Australasia Pty Ltd

Title

Part 8 Overview AviPro Salmonella Duo

Study date

2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248271

Author

Prof. Dr. Peter Heisig

Title

Expert report on the possible transferability of plasmids between cells of Salmonella VacE and Salmonella VacT during co-cultivation

Study date

2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248272

Author

Dr. Daniel Windhorst

Title

PDV/5101-ER/2011-05-04

Study date

2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248273

Author

Dr Ilka Shroder

Title

Study no.: 37/05

Study date

2005

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248274

Author

Dr Ilka Shroder

Title

Study no.: Ducks Safety 2005

Study date

2009

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248275

Author

Dr Ilka Shroder

Title

Study no.: 279/05

Study date

2005

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248276

Author

Dr Ilka Shroder

Title

Study no.: 294/05

Study date

2005

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248277

Author

Prof. Dr. Bernd Kaspers

Title

Study no.: Salmonella 101

Study date

2000

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248278

Author

Prof. Dr. Bernd Kaspers

Title

Study no.: LAH2001-1

Study date

2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248279

Author

Dr. Petra Regenhard, Georg Wohlmuth, Heinz Kramer

Title

Study no.: 188/11

Study date

2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248280

Author

Prof. Dr. Bernd Kaspers

Title

Study no.: V2011/07

Study date

2012

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248281

Author

Dr. Ilka Hahn

Title

Study no.: 521/94 A

Study date

2000

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248282

Author

Dr Ilka Shroder

Title

Study no.: 66/01 B

Study date

2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248283

Author

Dr. Ilka Hahn

Title

Study no.: 244/99

Study date

1999

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248284

Author

Dr. Ilka Hahn

Title

Study no.: 525/94

Study date

1995

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248285

Author

Prof. Dr. J Varga

Title

Study no.: 01/99

Study date

1999

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248286

Author

Dr. Th. Blaha

Title

Study: Hannover Veterinary College (Expert report on the safety of a Salmonella vaccine strain for calves and piglets)

Study date

1992

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248287

Author

B. Kohler et al.

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248288

Author

H. Tschape and W. Rabsch

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248289

Author

A. Flieger and W. Rabsch

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248290

Author

R. H. Davies

Title

Communications from Robert H Davies, Weybridge

Study date

2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248291

Author

Dr. Ida Luzzi

Title

Report on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium

Study date

2009

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248292

Author

Dr. Ida Luzzi

Title

Report on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium

Study date

2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248293

Author

A. Ricci

Title

Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella enteritidis isolates

Study date

2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248294

Author

A. Ricci

Title

Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella Typhimuriumisolates

Study date

2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248295

Author

Dr. Ilka Schroder

Title

Study no.: 399/05

Study date

2006

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248296

Author

Dr. Ilka Schroder

Title

Study no.: 97/06

Study date

2006

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248297

Author

Dr. Ilka Schroder

Title

Study no.: 148/99

Study date

1999

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248298

Author

Dr. Ilka Schroder

Title

Study no.: 67/01 B

Study date

2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248299

Author

I. Schroder, W. Oellrich, D.E. Rebeski and G. Glinder

Title

Infection model of Salmonella Enteritidis and S. Typhimurium in Pekin ducks (Anas playrhynchos)

Study date

2006

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248300

Author

P.A. Barrow, M.A. Lovell, C.K. Murphy and K. Page

Title

Salmonella infection in a commercial line of ducks; Experimental studies on virulence, intestinal colonization and immune protection

Study date

1999

Authorising party

Public

Auth party contact address

Data no

248301

Author

K. Linde, G.C. Fthenakis, A. Fichtner

Title

Study date

1998

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248302

Author

Dr. Nathalie Desloges

Title

Study: Salm 01/05

Study date

2008

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248303

Author

Dr. C. Ahlers

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248304

Author

Dr. Rita Weber

Title

PSUR Vac E

Study date

2009

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248305

Author

Dr. Cornelia Malz

Title

PSUR Vac T

Study date

2008

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248306

Author

Elanco Australasia Pty Ltd

Title

Part 7 Overview AviPro Salmonella Duo

Study date

December 2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248307

Author

Dr Ilka Hahn

Title

Study no.: 244/99

Study date

1999

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248308

Author

Dr Ilka Hahn

Title

Study no.: 525/94

Study date

1995

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248309

Author

Prof. Dr. J. Varga

Title

Study no.: 01/99

Study date

1999

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248310

Author

Dr Th. Blaha

Title

Expert report on the safety of a Salmonella vaccine strain for calves and piglets

Study date

1992

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248311

Author

B. Kohler, G. Reetz, K. Albrecht and W. Rabsch

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248312

Author

Dr Nathalie Deslogies

Title

Study no.: Salm 01/05

Study date

2008

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248313

Author

M. Meinhard

Title

Study no.: 0-0197-TS-BA.01

Study date

2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248314

Author

Dr. Cornelia Malz

Title

PSUR Vac T

Study date

2008

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248315

Author

Dr. Ilka Schroder

Title

Study no.: 97/06

Study date

2006

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248316

Author

Dr. Ilka Hahan

Title

Study no.: 521/94 A

Study date

2000

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248317

Author

Dr. Ilka Schroder

Title

Study no.: 66/01 B

Study date

2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248318

Author

Dr. Ilka Schroder

Title

Study no.: 294/05

Study date

2005

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248319

Author

Dr. Daniel Windhorst

Title

Study: Gantois et al., 2006

Study date

2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248320

Author

Dr. Ilka Schroder

Title

Study: no.: Ducks Safety 2005

Study date

2009

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248321

Author

Dr. Ilka Hahn

Title

Study no.: 148/99

Study date

1999

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248322

Author

Dr. Ilka Schroder

Title

Study no.: 67/01B

Study date

2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248323

Author

K. Linde, G.C. Fthenakis, A. Fichtner

Title

Study date

1998

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248324

Author

R.H. Davies and C. Wray

Title

Studies of contamination of three broiler breeder houses with Salmonella enteritidis before and after cleansing and disinfection

Study date

1996

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248325

Author

Dr. Ilka Schroder

Title

Study no.: 399/05

Study date

2006

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248326

Author

Elanco Australasia Pty Ltd

Title

Part 1 Application Overview

Study date

2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248327

Author

Elanco Australasia Pty Ltd

Title

Permit Application ID 0003267036

Study date

2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248328

Author

Elanco Australasia Pty Ltd

Title

PAA - Salmonella Vaccines Registration in Australia

Study date

2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248329

Author

Elanco Australasia Pty Ltd (prepared by Dr Octavi Panyella and Dr Doris Mueller-Doblies)

Title

Response to: Pre-Application Assistance APVMA Written Assistance Report, questions from pages 6 to 7

Study date

September 2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248330

Author

Mahdi Saeed A., Walk S.T., Arshad M., Whittam T.S.

Title

Clonal Structure and Variation in Virulence of Salmonella Enteritidis Isolated from Mice, Chickens, and Humans

Study date

2006

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248331

Author

Chattaway M., Dallman T.J., Larkin L. et al.

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248332

Author

Uelze L., Block A., Borowiak M, et al

Title

What WGS Reveals about Salmonella enterica subsp. Enterica in Wildlife in Germany

Study date

2021

Authorising party

Public

Auth party contact address

Data no

248333

Author

Wei X. & Zhao X.

Title

Advances in typing and identification of foodborne pathogens

Study date

2021

Authorising party

Public

Auth party contact address

Data no

248334

Author

Chacana P.A. & Terzolo H.R.

Title

Protection Conferred by a Live Salmonella Enteritidis Vaccine Against Fowl Typhoid in Laying Hens

Study date

2006

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248335

Author

Eeckhaut V., Haesebrouck F., Ducatelle R., Van Immerseel F.

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248336

Author

Rabsch W., Andrews H.L., Kingsley R.A. et al.

Title

Salmonella enterica Serotype Typhimurium and its Host-Adapted Variants

Study date

2002

Authorising party

Public

Auth party contact address

Data no

248337

Author

Branchu P., Bawn M., Kingsley R.A.

Title

Genome Variation and Molecular Epidemiology of Salmonella enterica Serovar Typhimurium Pathovariants

Study date

2018

Authorising party

Public

Auth party contact address

Data no

248338

Author

Kilroy S., Raspoet R., Devloo R. et al.

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

Authorising party

Public

Auth party contact address

Data no

248339

Author

Barrow P.A.

Title

Salmonella Infections: Immune and Non-immune Protection with Vaccines

Study date

2007

Authorising party

Public

Auth party contact address

Data no

248340

Author

Van Immerseel F., Methner U., Rychlik I. et al.

Title

Vaccination and Early Protection Against Non-host-specific Salmonella Serotypes in Poultry: Exploitation of Innate Immunity and Microbial Activity

Study date

2005

Authorising party

Public

Auth party contact address

Data no

248341

Author

F. Van Immerseel, U. Methner, I. Rychlik et al.

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248342

Author

P.A. Barrow, M.A. Jones, A.L. Smith and P. Wigley

Title

Review: The long view: Salmonella - the last forty years

Study date

2012

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248343

Author

P.A. Barrow and U. Methner (editors)

Title

Salmonella in Domestic Animals (2nd edition

Study date

2013

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248344

Author

P. A. Barrow

Title

Salmonella infections: immune and non-immune protection with vaccines

Study date

2007

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248345

Author

APVMA

Title

PAA - APVMA Written assistance

Study date

2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248346

Author

APVMA

Title

Pre-application Assistance: APVMA Written Assistance

Study date

2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248347

Author

Elanco Australasia Pty Ltd

Title

Part 6 overview AviPro Salmonella Duo

Study date

December 2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248348

Author

Dr. Nathalie Desloges

Title

Study no.: Salm 01/05

Study date

2008

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248349

Author

Dr Rita Weber

Title

PSUR Vac E

Study date

2009

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248350

Author

Dr. Cornelia Malz

Title

PSUR Vac T

Study date

2008

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248351

Author

H. Tschape and W. Rabsch

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248352

Author

A. Flieger and W. Rabsch

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248353

Author

R. H. Davis

Title

Report: Communications from Robert H Davies, Weybridge

Study date

2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248354

Author

I. Luzzi

Title

Report(s) on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium

Study date

2009

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248355

Author

I. Luzzi

Title

Report(s) on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium

Study date

2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248356

Author

A. Ricci

Title

Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella enteritidis isolates

Study date

2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248357

Author

A. Ricci

Title

Report on the fourth semester of monitoring Salmonella Typhimurium isolates

Study date

2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248358

Author

D.J. Varga

Title

Study no.: H 01/99

Study date

1999

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248359

Author

Hannover Veterinary College

Title

Expert report on the safety of a Salmonella vaccine strain for calves and piglets

Study date

1992

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248360

Author

Dr Ilka Schroder

Title

Study no.: 399/05

Study date

2006

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248361

Author

Dr Ilka Schroder

Title

Study no.: 97/06

Study date

2006

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248362

Author

Dr Ilka Hahn

Title

Study no.: 244/99

Study date

1999

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248363

Author

Dr Hahn

Title

Study no.:525/94

Study date

1995

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248364

Author

B. Kohler et al.,

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248365

Author

M. Meinhard

Title

Study no.: 0-0197-TS-BA.01

Study date

2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248366

Author

Dr Ilka Hahn

Title

Study no.: 521/94 A

Study date

2000

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248367

Author

Dr Ilka Schroder

Title

Study no.: 66/01 B

Study date

2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248368

Author

Dr Ilka Schroder

Title

Study no.: 294/05

Study date

2005

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248369

Author

Dr. Daniel Windhorst

Title

Study No.: Gantois et al.

Study date

2006

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248370

Author

Dr Ilka Schroder

Title

Ducks Safety 2005

Study date

2009

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248371

Author

Dr. Ilka Hahn

Title

Study no.: 148/99

Study date

1999

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248372

Author

Dr Ilka Schroder

Title

Study no.: 67/01 B

Study date

2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248373

Author

K. Linde, G.C. Fthenakis, A. Fichtner

Title

Study date

1998

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248374

Author

R.H. Davies, C. Wray

Title

Studies of contamination of three broiler breeder houses with Salmonella enteritidis before and after cleansing and disinfection

Study date

1996

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248375

Author

Dr. Rita Weber

Title

PSUR Vac E

Study date

2009

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

254979

Author

Boyd E.F, Brussow H.

Title

Common themes among bacteriophage-encoded virulence factors and diversity among the bacteriophages involved.

Study date

2002

Authorising party

Public

Auth party contact address

Data no

254980

Author

Feberwee A., de Vries T.S., Hartman E.G., de Wit J.J., Elbers A.R.W., de Jong W.A.

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

Authorising party

Public

Auth party contact address

Data no

254981

Author

Linde K., Hahn I., Vielitz E.

Title

Development of live Salmonella vaccines optimally attenuated for chickens.

Study date

1997

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

254982

Author

Vaara M.

Title

Minireview: Antibiotic-supersusceptible mutants of Escherichia coli and Salmonella Typhimurium.

Study date

1993

Authorising party

Public

Auth party contact address

Data no

254983

Author

Hancock R.E.W.

Title

Alterations in outer membrane permeability.

Study date

1984

Authorising party

Public

Auth party contact address

Data no

254984

Author

Linde K., Beer J., Bondarenko V.

Title

Stable Salmonella live vaccine strains with two or more attenuating mutations and any desired level of attenuation

Study date

1990

Authorising party

Public

Auth party contact address

Data no

254985

Author

Elanco Australasia Pty Lts

Title

2023-06-19 Elanco Salmonella Resp to s159 notice

Study date

2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261796

Author

Elanco Animal Health

Title

Salmonella Enteritidis WSB _ CoA

Study date

11 December 2012

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261797

Author

Elanco Animal Health

Title

Salmonella Typhimurium WSB _ CoA

Study date

14 April 2015

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261798

Author

Elanco Animal Health

Title

Specification vial

Study date

5 January 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261799

Author

Elanco Animal Health

Title

Specification stopper

Study date

30 June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261800

Author

Elanco Animal Health

Title

Specification cap

Study date

30 June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261801

Author

Elanco Animal Health

Title

Batch-record Salm Duo

Study date

14 February 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261802

Author

Elanco Animal Health

Title

Filling-closing procedure

Study date

30 September 2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261803

Author

Elanco Animal Health

Title

Sealing procedure

Study date

30 May 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261804

Author

Lohmann Animal Health

Title

Homogenous mixing

Study date

20 August 2015

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261805

Author

Elanco Animal Health

Title

Residual moisture VR Salm Duo

Study date

November 2018

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261806

Author

Elanco Animal Health

Title

Protocol vials and stoppers

Study date

2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261807

Author

Elanco Australasia Pty Ltd

Title

Chem & Manuf response to s159(1)(a) Notice of 25 July 2023

Study date

October 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261808

Author

Ilka Shroder

Title

Study No. 92/92

Study date

19 June 1992

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261809

Author

Lohmann Animal Health

Title

SPF-certification relating to Study 85/01

Study date

7 March 2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261810

Author

U. Methner, S. Keiling, B. Kreutzer and P. Schweinitz

Title

Wird die Wirksamkeit der Immunisierung von K ? ken mit Salmonella-Lebendimpfstoffen durch maternale Anik?rper beeinflusst?

Study date

2002

Authorising party

Public

Auth party contact address

Data no

261811

Author

S.A. Cawthraw, L. Chiverton, T. Huby, A. Goddard, D. Mueller-Doblies

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261812

Author

U. Methner

Title

Impact of maternal antibodies on the efficacy of immunisation of chicks with live Salmonella vaccines

Study date

2002

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261813

Author

Elanco Australasia Pty Ltd

Title

Safety & Efficacy response to s159(1)(a) Notice of 25 July 2023

Study date

Oct 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261814

Author

EDQM Council of Europe

Title

Vaccines for Veterinary Use (Supplement 7.7)

Study date

September 2021

Authorising party

Public

Auth party contact address

Data no

261815

Author

Lohmann Animal Health

Title

Testing Standard 0-0171-TS-BA.01

Study date

20 January 2010

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261816

Author

EDQM Council of Europe

Title

5.2.6. Evaluation of Safety of Veterinary Vaccines and Immunosera

Study date

04/2024

Authorising party

Public

Auth party contact address

Data no

261817

Author

EDQM Council of Europe

Title

Monograph 2520

Study date

04/2013

Authorising party

Public

Auth party contact address

Data no

261818

Author

EDQM Council of Europe

Title

Monograph 2521

Study date

04/2013

Authorising party

Public

Auth party contact address

Data no

261819

Author

Elanco Australasia Pty Ltd

Title

Cover letter for response to s159(1)(a) Notice of 25 July 2023

Study date

Oct 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

270314

Author

Elanco Australasia Pty Ltd

Title

Response App 2-12 G-A

Study date

20 March 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

270315

Author

European Pharmacopoeia

Title

Ph. Eur. 2520E

Study date

2013

Authorising party

Public

Auth party contact address

Data no

270316

Author

European Pharmacopoeia

Title

Ph. Eur. 2521E

Study date

2013

Authorising party

Public

Auth party contact address

Data no

270317

Author

Elanco Australasia Pty Ltd

Title

ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Vac T Live Vaccine

Study date

24 Jan 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

270318

Author

Elanco Australasia Pty Ltd

Title

ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Vac E Live Vaccine

Study date

25 Jan 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

270319

Author

Elanco Australasia Pty Ltd

Title

ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Duo Live Vaccine

Study date

30 Jan 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

270320

Author

Elanco Australasia Pty Ltd

Title

20240411 Cover letter Salmonella vaccines

Study date

11 April 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

270321

Author

Elanco Australasia Pty Ltd

Title

20240411 Response doc-April 2024

Study date

11 April 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

270322

Author

Elanco Australasia Pty Ltd

Title

138135-93162 e-label version 2

Study date

8 April 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

270323

Author

Elanco Australasia Pty Ltd

Title

138146-93168 e-label version 2

Study date

8 April 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

270324

Author

Elanco Australasia Pty Ltd

Title

138142-93166 e-label version 2

Study date

8 April 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

278655

Author

Elanco Australasia Pty Ltd

Title

20240923 Response doc-Sept 2024

Study date

23 September 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

278656

Author

Elanco Australasia Pty Ltd

Title

13835-93162 e-label Version 3

Study date

September 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

278657

Author

Elanco Australasia Pty Lts

Title

13835-93162 e-label Version 3

Study date

September 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

278658

Author

Elanco Australasia Pty Ltd

Title

13846-93168 e-label Version 3

Study date

September 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

278659

Author

Anon

Title

Expert Report 4/6/2024

Study date

4 June 2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

289183

Author

Elanco Animal Health

Title

Response App 2-3a Batch-record Salm Duo English language

Study date

29 Nov 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

289184

Author

Elanco Animal Health

Title

Response App 2-3b batch-record Salm VacE English language

Study date

29 Nov 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

289185

Author

Enaco Animal Health

Title

Response App 2-3c batch-record Salm VacT English language

Study date

29 Nov 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

289186

Author

Elanco Animal Health

Title

Response App 2-3d Filling-closing procedure English language

Study date

29 Nov 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

289187

Author

Elanco Animal Health

Title

Response App 2-3e Sealing procedure English language

Study date

29 Nov 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

289188

Author

Elanco Animal Health

Title

Response App 2-3f Homogenous mixing English language

Study date

29 Nov 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

289189

Author

Elanco Australasia Pty Ltd

Title

20231129 Salmonella vaccines-response cover letter

Study date

29 Nov 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

291291

Author

Elanco

Title

Vacuum testing procedure

Study date

14DEC2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

291292

Author

Elanco

Title

Vacuum testing procedure Engligh language

Study date

14DEC2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

291293

Author

Dr. Lehmann

Title

GMP Certificate

Study date

19JUN2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

291294

Author

Elanco Australasia

Title

20250729 CMC Response document

Study date

July 2025

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

291295

Author

Department of Agriculture, Fisheries and Forestry

Title

Import permit

Study date

20DEC2024

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

291296

Author

Elanco Australasia

Title

20250704 Response doc

Study date

July 2025

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

291297

Author

Elanco Animal Health

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

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

291298

Author

Maurischat S., Szabo I., Baumann B., Malorny B.

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

Authorising party

Public

Auth party contact address

Data no

291299

Author

Elanco Australasia

Title

13835-93162 e-label version 4

Study date

19 June 2025

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

291300

Author

Elanco Australasia

Title

138142-93166 e-label version 4

Study date

19 June 2025

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

291301

Author

Elanco Australasia

Title

138146-93168 e-label version 4

Study date

19 June 2025

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

291302

Author

Ceyssens, P.-J., Mueller-Doblies, D., Mattheus,W.

Title

Design and Validation of RT-PCR Assays to Differentiate Salmonella Vaccine Strains from Wild-Type Field Isolates

Study date

2024

Authorising party

Public

Auth party contact address

Date

3 Feb 2023

Application No

138142

Product/Active constituent 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

248699

Author

Elanco Australasia Pty Ltd

Title

Appendix 1-0 Part 1 overview AviPro Salmonella Vac E

Study date

2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248700

Author

Elanco Australasia Pty Ltd

Title

Permit Application ID 0003267036

Study date

2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248701

Author

Elanco Australasia Pty Ltd

Title

Part 2 Overview

Study date

December 2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248702

Author

Elanco Animal Health

Title

Particulars

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248703

Author

Elanco Animal Health

Title

Product development

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248704

Author

Elanco Animal Health

Title

Manufacturing flow chart

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248705

Author

Elanco Animal Health

Title

Manufacturing description

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248706

Author

Elanco Animal Health

Title

Manufacturing validation summary

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248707

Author

Lohmann Animal Health

Title

Validation report 0-0063-vr-110-01-01

Study date

21 March 2019

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248708

Author

Lohmann Animal Health

Title

Validation report 0-0060-vr-ba01

Study date

03 Jan 2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248709

Author

Lohmann Animal Health

Title

Validation report 0-0060-vr-91998-01

Study date

25 April 2012

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248710

Author

Elanco Animal Health

Title

Starting materials of biological origin

Study date

July 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248711

Author

Elanco Animal Health

Title

Master seed S.E.

Study date

July 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248712

Author

Elanco Animal Health

Title

Working seed S.E.

Study date

July 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248713

Author

Elanco Animal Health

Title

Control tests on the finished product

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248714

Author

Elanco Animal Health

Title

Batch to batch consistency

Study date

July 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248715

Author

Elanco Animal Health

Title

Batch record-5062300

Study date

May 2019

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248716

Author

Rebeski, D.

Title

Batch record-A059400

Study date

09 March 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248717

Author

Rebeski, D.

Title

Batch record-A059500

Study date

10 March 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248718

Author

Christmann, L.

Title

Batch record-G033600

Study date

29 November 2016

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248719

Author

Elanco Animal Health

Title

Stability overview and conclusion

Study date

July 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248720

Author

Elanco Animal Health

Title

Long term stability report

Study date

July 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248721

Author

Elanco Animal Health

Title

Relocation stability report

Study date

July 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248722

Author

Elanco Animal Health

Title

In-use stability report

Study date

July 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248723

Author

Elanco Animal Health

Title

Stress stability report

Study date

July 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248724

Author

Elanco Animal Health

Title

Batch record-6093500

Study date

May 2019

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248725

Author

Elanco Animal Health

Title

Batch record-6093700

Study date

May 2019

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248726

Author

Elanco Australasia Pty Ltd

Title

Appendix 8-0 Part 8 overview Salmonella Vac E

Study date

2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261822

Author

Elanco Animal Health

Title

Batch record Salm VacE

Study date

14 February 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261823

Author

Elanco Animal Health

Title

Residual moisture VR Salm VacE

Study date

March 2017

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Date

3 Feb 2023

Application No

138146

Product/Active constituent 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

248662

Author

Elanco Australasia Pty Ltd

Title

Part 1 application overview AviPro Salmonella Vac T

Study date

2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248663

Author

Elanco Australasia Pty Ltd

Title

Permit Application ID 0003267036

Study date

2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248664

Author

Elanco Australasia Pty Ltd

Title

Part 2 Overview

Study date

December 2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248665

Author

Elanco Animal Health

Title

Particulars

Study date

January 2020

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248666

Author

Elanco Animal Health

Title

Product development

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248667

Author

Elanco Animal Health

Title

Manufacturing flow chart

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248668

Author

Elanco Animal Health

Title

Manufacturing description

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248669

Author

Elanco Animal Health

Title

Manufacturing validation summary

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248670

Author

Rebeski, D.

Title

Validation report 0-0060-vr-92059-01

Study date

25 April 2012

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248671

Author

Wietheger, M.

Title

Validation report 0-0060-vr-ba01

Study date

03 January 2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248672

Author

Urban, C.

Title

Validation report 0-0063-vr-111-01

Study date

29 March 2018

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248673

Author

Elanco Animal Health

Title

Starting materials of biological origin

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248674

Author

Elanco Animal Health

Title

Master seed S.T.

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248675

Author

Elanco Animal Health

Title

Working see S.T.

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248676

Author

Elanco Animal Health

Title

Control tests on the finished product

Study date

June 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248677

Author

Elanco Animal Health

Title

Batch to batch consistency

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248678

Author

Lohmann Animal Health

Title

Batch record-6005400

Study date

26 April 2006

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248679

Author

Lohmann Animal Health

Title

Batch record-9101100

Study date

9 May 2001

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248680

Author

Rebeski, D.

Title

Batch record-B017800

Study date

24 October 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248681

Author

Rebeski, D.

Title

Batch record-B024100

Study date

24 October 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248682

Author

Rebeski, D.

Title

Batch record-B031700

Study date

24 October 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248683

Author

Elanco Animal Health

Title

Stability overview and conclusion

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248684

Author

Elanco Animal Health

Title

Long term stability report

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248685

Author

Elanco Animal Health

Title

Intermediate storage stability report

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248686

Author

Elanco Animal Health

Title

In-use stability report

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248687

Author

Elanco Animal Health

Title

Stress stability report

Study date

August 2021

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248688

Author

Rebeski, D.

Title

Batch record-B017800

Study date

24 October 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248689

Author

Rebeski, D.

Title

Batch record-B024100

Study date

24 October 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248690

Author

Rebeski, D.

Title

Batch record-B031700

Study date

24 October 2011

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248691

Author

Elanco Animal Health

Title

Batch record-5076600

Study date

1 March 2013

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248692

Author

Elanco Animal Health

Title

Batch record-5076800

Study date

11 March 2013

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248693

Author

Elanco Animal Health

Title

Batch record-5077000

Study date

11 March 2013

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

248694

Author

Elanco Australasia Pty Ltd

Title

Part 8 overview AviPro Salmonella Vac T

Study date

2022

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261824

Author

Elanco Animal Health

Title

Residual moisture VR Salm VacT

Study date

March 2017

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Data no

261825

Author

Elanco Animal Health

Title

Batch-record Salm VacT

Study date

14 February 2023

Authorising party

Applicant

Auth party contact address

7 Eden Park Drive MACQUARIE PARK Australia

Date

6 Apr 2022

Application No

134834

Product/Active constituent 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

Author

Anon

Title

Finished product batch analysis

Study date

September 2019

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246306

Author

Royal Canin

Title

Claim substantiation - Renal Feline

Study date

2016

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234936

Author

Anon

Title

Certificates of Analysis_exempt active constituents

Study date

2019

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246309

Author

Royal Canin

Title

Claim substantiation - Recovery

Study date

2016

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234942

Author

Anon

Title

In-process controls

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246303

Author

Anon

Title

Kerry Inc. potable water source

Study date

October 2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234933

Author

Anon

Title

Critical care liquid diets product guide

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234953

Author

Anon

Title

Scientific Guide

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234939

Author

Anon

Title

Certificates of Analysis_excipients

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246300

Author

Anon

Title

Recovery 15 month stability

Study date

November 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234928

Author

Anon

Title

Release & expiry specifications

Study date

January 2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234934

Author

Anon

Title

Certificate of Analysis_finished product

Study date

October 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234940

Author

Anon

Title

GMP evidence

Study date

October 2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246301

Author

Anon

Title

Gastrointestinal 14.5 month stability

Study date

April 2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234948

Author

Anon

Title

Product verification testing

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234931

Author

Anon

Title

MPL artwork

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234951

Author

Anon

Title

ICU Product Guide

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246312

Author

Anon

Title

Ingredient classification outcome

Study date

May 2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234937

Author

Anon

Title

Certificates of Analysis_pharmacopoeial grade active constituents

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234949

Author

Anon

Title

Target Animal Safety & Efficacy summary

Study date

March 2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234932

Author

Anon

Title

Nutritional protocol guidelines

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246313

Author

Anon

Title

Silliker site certification

Study date

July 2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234952

Author

Anon

Title

Critical Care Guidelines

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234946

Author

Anon

Title

Analytical procedures

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246307

Author

Royal Canin

Title

Vet education webinar

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234935

Author

Anon

Title

Chemistry & Manufacture summary

Study date

March 2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234929

Author

Anon

Title

PAA written correspondence

Study date

August 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246310

Author

Royal Canin

Title

Claim substantiation - Gastrointestinal

Study date

2016

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234943

Author

Anon

Title

Packaging specifications

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246304

Author

Anon

Title

Lutein CoA documentation

Study date

2018

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234947

Author

Anon

Title

Stability data

Study date

August 2019

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246308

Author

Royal Canin

Title

GIT tract scientific presentation

Study date

April 2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234930

Author

Anon

Title

IMPL cluster artwork

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246299

Author

Anon

Title

Renal Canine 15.25 month stability

Study date

October 2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246311

Author

Anon

Title

PAA advice - DCPAA2-07426157A

Study date

August 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234938

Author

Anon

Title

Certificates of Analysis_non-pharmacopoeial grade active constituents

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234944

Author

Anon

Title

Quality control documentation

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246305

Author

Royal Canin

Title

Claim substantiation - Renal Canine

Study date

2016

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234950

Author

Anon

Title

AAFCO 2020 Nutritional Profiles

Study date

2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234941

Author

Anon

Title

Manufacturing flowchart

Study date

December 2019

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

246302

Author

Anon

Title

Appendix 2-11 replacement documentation

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Date

6 Apr 2022

Application No

134836

Product/Active constituent 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

Author

Anon

Title

Packaging specifications

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234999

Author

Anon

Title

Certificates of Analysis_pharmacopoeial grade active constituents

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235002

Author

Anon

Title

GMP evidence

Study date

October 2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235008

Author

Anon

Title

Analytical procedures

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234996

Author

Anon

Title

Certificate of Analysis_finished product

Study date

June 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235014

Author

Anon

Title

Critical Care Guidelines

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235003

Author

Anon

Title

Manufacturing flowchart

Study date

December 2019

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234997

Author

Anon

Title

Chemistry & Manufacture summary

Study date

March 2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234991

Author

Anon

Title

PAA written correspondence

Study date

August 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234994

Author

Anon

Title

Nutritional protocol guidelines

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235011

Author

Anon

Title

Target Animal Safety & Efficacy summary

Study date

March 2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235000

Author

Anon

Title

Certificates of Analysis_non-pharmacopoeial grade active constituents

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234995

Author

Anon

Title

Critical care liquid diets product guide

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235012

Author

Anon

Title

AAFCO 2020 Nutritional Profiles

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235009

Author

Anon

Title

Stability data

Study date

March 2019

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235015

Author

Anon

Title

Scientific Guide

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235006

Author

Anon

Title

Quality control documentation

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234998

Author

Anon

Title

Certificates of Analysis_exempt active constituents

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234992

Author

Anon

Title

IMPL cluster artwork

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234993

Author

Anon

Title

MPL artwork

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235010

Author

Anon

Title

Product verification testing

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235007

Author

Anon

Title

Finished product batch analysis

Study date

April 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235001

Author

Anon

Title

Certificates of Analysis_excipients

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235013

Author

Anon

Title

ICU Product Guide

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235004

Author

Anon

Title

In-process controls

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

234990

Author

Anon

Title

Release and expiry specifications

Study date

January 2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Date

6 Apr 2022

Application No

134837

Product/Active constituent 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

Author

Anon

Title

Certificate of Analysis_finished product

Study date

June 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235016

Author

Anon

Title

Release and expiry specifications

Study date

January 2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235028

Author

Anon

Title

GMP evidence

Study date

October 2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235036

Author

Anon

Title

Product verification testing

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235019

Author

Anon

Title

MPL artwork

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235025

Author

Anon

Title

Certificates of Analysis_pharmacopoeial grade active constituents

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235039

Author

Anon

Title

ICU Product Guide

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235020

Author

Anon

Title

Nutritional protocol guidelines

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235034

Author

Anon

Title

Analytical procedures

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235040

Author

Anon

Title

Critical Care Guidelines

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235017

Author

Anon

Title

PAA written correspondence

Study date

August 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235023

Author

Anon

Title

Chemistry & Manufacture summary

Study date

March 2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235031

Author

Anon

Title

Packaging specifications

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235037

Author

Anon

Title

Target Animal Safety & Efficacy summary

Study date

March 2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235018

Author

Anon

Title

IMPL cluster artwork

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235026

Author

Anon

Title

Certificates of Analysis_non-pharmacopoeial grade active constituents

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235032

Author

Anon

Title

Quality control documentation

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235038

Author

Anon

Title

AAFCO 2020 Nutritional Profiles

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235029

Author

Anon

Title

Manufacturing flowchart

Study date

December 2019

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235035

Author

Anon

Title

Stability data

Study date

April 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235041

Author

Anon

Title

Scientific Guide

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235024

Author

Anon

Title

Certificates of Analysis_exempt active constituents

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235030

Author

Anon

Title

In-process controls

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235021

Author

Anon

Title

Critical care liquid diets product guide

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235027

Author

Anon

Title

Certificates of Analysis_excipients

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235033

Author

Anon

Title

Finished product batch analysis

Study date

March 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Date

6 Apr 2022

Application No

134838

Product/Active constituent 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

Author

Anon

Title

Product verification testing

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235056

Author

Anon

Title

In-process controls

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235048

Author

Anon

Title

Certificate of Analysis_finished product

Study date

June 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235042

Author

Anon

Title

Release & expiry specifications

Study date

January 2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235059

Author

Anon

Title

Finished product batch analysis

Study date

March 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235065

Author

Anon

Title

ICU Product Guide

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235045

Author

Anon

Title

MPL artwork

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235060

Author

Anon

Title

Analytical procedures

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235066

Author

Anon

Title

Critical Care Guidelines

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235054

Author

Anon

Title

GMP evidence

Study date

October 2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235057

Author

Anon

Title

Packaging specifications

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235063

Author

Anon

Title

Target Animal Safety & Efficacy summary

Study date

March 2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235051

Author

Anon

Title

Certificates of Analysis_pharmacopoeial grade active constituents

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235043

Author

Anon

Title

PAA written correspondence

Study date

August 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235058

Author

Anon

Title

Quality control documentation

Study date

December 2020

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235052

Author

Anon

Title

Certificates of Analysis_non-pharmacopoeial grade active constituents

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235046

Author

Anon

Title

Nutritional protocol guidelines

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235061

Author

Anon

Title

Stability data

Study date

October 2018

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235049

Author

Anon

Title

Chemistry & Manufacture summary

Study date

March 2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235055

Author

Anon

Title

Manufacturing flowchart

Study date

December 2019

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235064

Author

Anon

Title

AAFCO 2020 Nutritional Profiles

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235050

Author

Anon

Title

Certificates of Analysis_exempt active constituents

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235044

Author

Anon

Title

IMPL cluster artwork

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235067

Author

Anon

Title

Scientific Guide

Study date

2021

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235053

Author

Anon

Title

Certificates of Analysis_excipients

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Data no

235047

Author

Anon

Title

Critical care liquid diets product information

Study date

2022

Authorising party

Applicant

Auth party contact address

Level 23 727 Collins Street Melbourne Australia

Application summaries

Application Date

Application Number

Application Product Name

Application details

Product name:

Product number:

Applicant Name:

Application purpose and description of use:

Description of data provided:

Application Date

Application Number

Application Product Name

Application details

Product name:

Product number:

Applicant Name:

Application purpose and description of use:

Active constituents:

Description of data provided:

Application Date

Application Number

Application Product Name

Application details

Product name:

Product number:

Applicant Name:

Application purpose and description of use:

Application Date

Application Number

Application Product Name

Application details

Product name:

Product number:

Applicant Name:

Application purpose and description of use:

Application Date

Application Number

Application Product Name

Application details

Product name:

Product number:

Applicant Name:

Application purpose and description of use:

Description of data provided:

Application Date

Application Number

Application Product Name

Application details

Product name:

Product number:

Applicant Name:

Application purpose and description of use:

Description of data provided:

Application Date

Application Number

Application Product Name

Application details

Product name:

Product number:

Applicant Name:

Application purpose and description of use:

Description of data provided:

Application Date

Application Number

Application Product Name

Application details

Product name:

Product number:

Applicant Name:

Application purpose and description of use:

Description of data provided:

Application Date

Application Number

Application Product Name

Application details

Product name:

Product number:

Applicant Name:

Application purpose and description of use: