For many applications, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required to publish a summary of the application once the applicant has been notified that the application has been accepted for assessment. The summary will be removed once the application is finalised.
The types of applications requiring an application summary include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change in the use, supply or disposal of the product.
The summaries include details of the applications as specified in Divisions 2.1 and 2.2 of the regulations.
Please remember to follow the guidance for preparing information lists when preparing your application to avoid sensitive information being published.
For more information, please see the questions and answers.
Use the filter and links below to find and view application summaries.
Date
Application Date
Application No
Application Number
131144
Product/Active constituent Name
Application Product Name
S-methoprene
Application Date
Application Number
131144
Application Product Name
S-methoprene
Application details
Product name:
S-methoprene
Active name:
S-methoprene
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of (S)-methoprene for use in agricultural and veterinary chemical products.
Description of data provided:
Data no
219697
Title
Qualitative and Quantitative Analysis of S-(+)-METHOPRENE Technical
Study date
9 April 2021
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
219698
Title
New source of S-(+)-Methoprene technical
Study date
10 May 2021
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
219699
Title
S-methoprene - DoC
Study date
28 April 2021
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
233591
Title
Quantitative Analysis of Cis-methoprene in S-(+)-methoprene Tech.
Study date
15 December 2021
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
233592
Title
Response to APVMA Queries
Study date
15 December 2021
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
238038
Title
Explanation - 2022-05-09
Study date
16 May 2022
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date
Application Date
Application No
Application Number
106073
Product/Active constituent Name
Application Product Name
SOMETRIBOVE ZINC
Application Date
Application Number
106073
Application Product Name
SOMETRIBOVE ZINC
Application details
Product name:
SOMETRIBOVE ZINC
Product number:
82564
Applicant Name:
ELANCO ANIMAL HEALTH A DIV OF ELI LILLY AUST PTY LTD
Reference details:
70120 - ELANCO POSILAC
Date
Application Date
Application No
Application Number
62556
Product/Active constituent Name
Application Product Name
ELANCO POSILAC
Application Date
Application Number
62556
Application Product Name
ELANCO POSILAC
Application details
Product name:
ELANCO POSILAC
Product number:
70120
Applicant Name:
ELANCO ANIMAL HEALTH A DIV OF ELI LILLY AUST PTY LTD
Application purpose and description of use:
Registration of a 500 mg/syringe sometribove zinc injection product for increased milk production in lactating dairy cows, in conjunction with approval of sometribove zinc [HASBZ/70120].
Description of data provided:
Data no
95783
Title
Determination of the appearance of sometribove zinc powder
Study date
2009
Data no
95784
Title
Electrophoretic Profile Gel Densitometry (SDS-PAGE/reduced)
Study date
2010
Data no
95785
Title
Aqueous size exclusion HPLC assay
Study date
2009
Data no
95786
Title
Kinetic LAL assay of sometribove zinc (ZnbST) bulk powder
Study date
2009
Data no
95787
Title
Determination of the water content in sometribove zinc bulk powder
Study date
2009
Data no
95788
Title
Zinc determination in unbuffered, lyophilized sometribove zinc (ZnbST) by atomic absorption
Study date
2008
Data no
95789
Title
Reduced RP-HPLC assay for bST process streams
Study date
2008
Data no
95790
Title
Tryptic Map Analysis of Sometribove Zinc Bulk Powder by RP-HPLC
Study date
2009
Data no
95791
Title
Determination of N-Formyl-BST and Norleucyl 123-BST in Bulk ZnBST Powder by Reversed-Phase HPLC
Study date
2008
Data no
95792
Title
Spectrophotometric determination of urea in bulk ZnbST or bST
Study date
2009
Data no
95793
Title
Modified USP Sterility Testing for Sterile ZnBST Bulk Powder
Study date
2009
Data no
95794
Title
Certificate of Analysis - Sometribove Zinc Bulk Powder
Study date
7 Nov 2011
Data no
95795
Title
Certificate of Analysis - Sometribove Zinc Bulk Powder
Study date
7 Nov 2011
Data no
95796
Title
Certificate of Analysis - Sometribove Zinc Bulk Powder
Study date
7 Nov 2011
Data no
95797
Title
Examination of the manufacturers working cell bank for purity
Study date
2009
Data no
95798
Title
Adventitious organism screening of recombinant E. coli fermentation samples
Study date
2010
Data no
95799
Title
Stability Data Summary for Sometribove Zinc bulk powder at -15oC.
Study date
2009
Data no
95800
Title
Determination of Zinc in Posilac Syringes
Study date
2008
Data no
95801
Title
Particle Size Determination of Sometribove Zinc Suspension
Study date
2009
Data no
95802
Title
Viscosity Measurement of Sometribove Zinc Formulated Product by Means of Large-Cone Rotation Viscometry
Study date
2009
Data no
95803
Title
In Vitro Dissolution of Sometribove Zinc Suspension According to the Disk Method
Study date
2008
Data no
95804
Title
Non-reduced assay (RP-HPLC) for in process, ZnbST bulk powder and sometribove zinc suspension samples
Study date
2008
Data no
95805
Title
Determination of the Appearance of Sometribove Zinc Suspension
Study date
2008
Data no
95806
Title
Analytical Technology Reference Guide to Summary of Validation Activity
Study date
7 Mar 2005
Data no
95807
Title
Dissolution of ZnBST SO/ALMS formulation using a paddle over Teflon device
Study date
23 June 1994
Data no
95977
Title
Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
23-Aug-1995
Data no
95979
Title
Appendix H Stability Summary: Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
23 Aug 1995
Data no
95980
Title
Appendix J Freeze/Thaw Stability: Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
18 Jul 1994
Data no
95982
Title
3140.301 RP-HPLC Assay for ZnBST Bulk Powder, Bulk Posilac (r) and Posilac (r) S
Study date
24-Jun-2000
Data no
95983
Title
Validation Report for Analytical Method 3140.301
Study date
19-Jan-2001
Data no
95984
Title
Protocol: Supplement to the Validation Protocol for Monsanto Analytical Method No. 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
15 Mar 1994
Data no
95808
Title
Batch 2009600033 Formulation / Filling production batch record
Study date
2009
Data no
95809
Title
Certificate of Analysis - POSILAC 500 mg/unit dose
Study date
1 Nov 2011
Data no
95810
Title
Certificate of Analysis - POSILAC 500 mg/unit dose
Study date
1 Nov 2011
Data no
95811
Title
Certificate of Analysis - POSILAC 500 mg/unit dose
Study date
1 Nov 2011
Data no
95812
Title
Determination of Content Uniformity and Uniformity of Fill of Sometribove Zinc Suspension Disposable Syringes
Study date
2009
Data no
95813
Title
Modified USP Sterility Testing for Posilac (Sterile Sometribove Zinc Suspension) Syringes
Study date
2009
Data no
95976
Title
Validation Addendum Protocol: Validation Addendum to Method 2-32-403: RP-HPLC for In-Process, ZnbST Bulk Powder and Sometribove Zinc Suspension Syringes
Study date
10-Dec-2012
Data no
95981
Title
Appendix A: Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
23 Aug 1995
Data no
95978
Title
Figure 8 Accuracy- Weighted Analysis of Variance: Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
07-Jun-1994
Data no
95814
Title
Stability data summary for process qualification
Study date
2007
Data no
95841
Title
A meta-analysis review of the effects of recombinant bovine somatotropin 1. Methodology and effects on production
Study date
2003
Auth party contact address
-
Data no
95842
Title
A meta-analysis review of the effects of recombinant bovine somatotropin 2. Effects on animal health, reproductive performance, and culling
Study date
2003
Auth party contact address
-
Data no
95843
Title
Production and health effects of sometribove zinc suspension (recombinant bovine somatotropin) in lactating dairy cows
Study date
2014
Auth party contact address
-
Data no
95844
Title
Comparison of New Zealand and Australian production systems, mastitis prevalence, incidence and bacterial pathogens
Study date
2011
Data no
95845
Title
Bovine somatotropin: review of an emerging animal technology
Study date
1992
Auth party contact address
-
Data no
95846
Title
Responses by lactating cows in commercial dairy herds to recombinant bovine somatotropin
Study date
1991
Auth party contact address
-
Data no
95847
Title
Production responses to bovine somatotropin in northeast dairy herds
Study date
1999
Auth party contact address
-
Data no
95848
Title
Production response of multiparous Holstein cows treated with bovine somatotropin and fed n-3 fatty acids in early lactation
Study date
2009
Auth party contact address
-
Data no
95849
Title
Effect of a Prolonged-Release Formulation of N-Methionyl Bovine Somatotropin (Sometribove) on Milk Fat
Study date
1992
Auth party contact address
-
Data no
95850
Title
Factors affecting response of cows to biweekly injections of sometribove
Study date
1992
Auth party contact address
-
Data no
95851
Title
Effect of increased milking frequency in early lactation with or without recombinant bovine somatotropin
Study date
2005
Auth party contact address
-
Data no
95852
Title
Southeastern pasture-based dairy systems: housing, Posilac, and supplemental silage effects on cow performance
Study date
2002
Auth party contact address
-
Data no
95853
Title
Milk response to bovine somatotropin of high producing dairy cows with three different feeding systems combining pasture and total mixed rations
Study date
2003
Auth party contact address
-
Data no
95854
Title
Effects of exogenous bovine somatotropin on lactation
Study date
1993
Auth party contact address
-
Data no
95855
Title
Report MSL 6532: Preliminary Dose Determination for Weekly Administration of the CP115099 Prolonged Release Formulation in Lactating Dairy Cows
Study date
27 April 1987
Data no
95856
Title
Report MSL 4936: A preliminary range finding study to determine the dose response profile of the standard CP115099 prolonged release formulation, 40% ZnMBS / 5% ALMS/SO in lactating dairy cows
Study date
25 February 1986
Data no
95857
Title
Report MSL 7051: Initial dose determination of CP115099-F in lactating dairy cows - terminated after seven 14-day treatment cycles
Study date
15 September 1987
Data no
95858
Title
Report MSL 8140: Assessment of the effective range of CP115099-F in lactating primiparous and multiparous dairy cows
Study date
2 September 1988
Data no
95859
Title
Report MSL 8140 (Supplement): Assessment of the effective range of CP115099-F in lactating primiparous and multiparous dairy cows - additional health analyses
Study date
18 January 1990
Data no
95860
Title
Evaluation of Sometribove in a Prolonged-Release system in lactating dairy cows - production responses
Study date
1991
Auth party contact address
-
Data no
95861
Title
Report MSL 9607: Response of Cows Throughout Lactation to Sometribove, in a Prolonged Release System. A Dose Titration Study, conducted at four US sites
Study date
18 January 1991
Data no
95862
Title
Report MSL 7183: Long term evaluation of zinc methionyl bovine somatotropin treatment in a prolonged release system for lactating cows at four US clinical trial sites - 252 days of treatment
Study date
30 September 1987
Data no
95863
Title
Report MSL 8193: Long term evaluation of Zinc Treatment in a Prolonged Release System for Lactating Primaparous Cows at Four U.S. Clinical Trial Sites
Study date
1 August 1988
Data no
95864
Title
Supplement to MSL 8193: Long term evaluation of Zinc Treatment in a Prolonged Release System for Lactating Primaparous Cows at Four U.S. Clinical Trial Sites
Study date
21 June 1989
Data no
95865
Title
Report MSL 9664: Long Term Evaluation of Zinc Methionyl Bovine Somatotropin Treatment in a Prolonged Release System for Lactating Multiparous Cows at Four U.S. Clinical Trial Sites
Study date
15 December 1989
Data no
95866
Title
Report MSL 6594: Galactopoietic response and injection site resolution of CP115099-F administered intramuscularly or subcutaneously to lactating Holstein cows
Study date
27 March 1987
Data no
95867
Title
Report MSL 7118: Assessment of the effective range of CP115099-F in lactating primiparous and multiparous dairy cows: report covering 312 days of lactation
Study date
23 September 1987
Data no
95868
Title
Report MSL 9646: Comparison of the effectiveness of intramuscular and subcutaneous administration of CP115099-F
Study date
22 January 1990
Data no
95869
Title
Report MSL 8734: Long Term Evaluation of Zinc Methionyl Bovine Somatotropin Treatment in a Prolonged Release System for Lactation Jersey Cows
Study date
5 January 1985
Data no
95870
Title
Study T4UME0702: Lactation performance of dairy cows treated at different dose and injection interval of bovine somatotropin (Lactropina and Lactropina Plus)
Study date
2002
Data no
95871
Title
Report MLL 90376: Efficacy and Safety of CP115099-F in Dairy Cows. Report on lactations 1 and 2 of the French Clinical Trials performed at Sanders Experimental Centre, Saint Symphorien
Study date
29 July 1988
Data no
95872
Title
Report MLL 90329: Efficacy and safety of CP115099-F in dairy cows. Report on UK clinical trial performed under Animal Test Certificate No 5997/0001
Study date
10 July 1987
Data no
95873
Title
Report MLL 90413: Efficacy and safety of CP115099-F (Sometribove) in dairy cows through three consecutive lactations of treatment in the UK. Report on the clinical trial performed under Animal Test Certificate NO. 5997/0001
Study date
May 1989
Data no
95874
Title
Report MLL 90330: Efficacy and safety of CP115099-F in dairy cows. Report on German clinical trial (one lactation) performed at the Bundesforschungsanstalt fur Milcherzeugung
Study date
10 July 1987
Data no
95875
Title
Report MLL 90406: Safety and Efficacy of CP115099-F (sometribove) in dairy cows through three consecutive lactations of treatment. Report on the German Clinical Trial performed at Bundesanstalt fur Milchforschung, Kiel
Study date
19 April 1989
Data no
95876
Title
Report MLL 90328: Efficacy and safety of CP115099-F in dairy cows. Report on Netherlands clinical trial performed at Instituut voor Veevoedingsonderzoek (I.V.V.O.)
Study date
10 July 1987
Data no
95877
Title
Report MLL 90402: Safety and Efficacy of CP115099-F (Sometribove) in Dairy Cows through Three Consecutive Lactations of Treatment. Report on the Netherlands Clinical Trial performed at INstituut voor Veevoedingsonderzoek (I.V.V.O.)
Study date
20 March 1989
Data no
95878
Title
Effects of sustained release bovine somatotropin (Sometribove) on animal health in commercial dairy herds
Study date
2001
Auth party contact address
-
Data no
95879
Title
Administration of recombinant bovine somatotropin to dairy cows for four consecutive lactations
Study date
1997
Auth party contact address
-
Data no
95880
Title
Effect of acute challenge with an extreme dose of somatotropin in a prolonged release formulation on milk production and health of dairy cattle
Study date
1990
Auth party contact address
-
Data no
95884
Title
Response of dairy cows to high doses of a sustained - release bovine somatotropin administered during two lactations. 1. Production response
Study date
1991
Auth party contact address
-
Data no
95885
Title
Response of dairy cows to high doses of a sustained - release bovine somatotropin administered during two lactations. 2. Health and Reproduction
Study date
1992
Auth party contact address
-
Data no
95886
Title
Effect of high doses of a sustained-release bovine somatotropin on antibody formation in dairy cows
Study date
1992
Auth party contact address
-
Data no
95895
Title
Effect of dietary energy and previous bovine somatotropin on milk yield, mastitis, and reproduction in dairy cows
Study date
1992
Auth party contact address
-
Data no
95903
Title
Study GN4AU090012: Confirmation of lactation performance and animal safety of dairy cows treated with a lactation enhancer
Study date
December 2012
Data no
95904
Title
Report MLL 90336: Efficacy and safety of CP115099-F in dairy cows. Report on the French clinical trial performed at Sanders Experimental Centre, Saint Symphorien
Study date
30 September 1987
Data no
95905
Title
Report MSL 12207: Evaluation of the galactopoietics response of bovine somatotropin (sometribove (CP115099-F), 500 mg and CP115400-P, 260 mg) when administered subcutaneously to lactating jersey cows in a commercial dairy herd
Study date
8 September 1992
Data no
95906
Title
Galactopoiesis. Effect of treatment with somatotropin
Study date
2011
Auth party contact address
-
Data no
95907
Title
Effects of bovine somatotropin on dry matter intake, milk yield, and body temperature in Holstein and Jersey cows during heat stress
Study date
1990
Auth party contact address
-
Data no
95908
Title
Freedom of Information Summary: Posilac 1Step
Study date
27 Dec 2001
Auth party contact address
-
Data no
95896
Title
Recombinant bovine somatotropin and clinical mastitis: Incidence, discarded milk following therapy and culling
Study date
1997
Auth party contact address
-
Data no
95897
Title
Effect of recombinantly-derived bovine somatotropin on reproductive performance of dairy cattle
Study date
1991
Auth party contact address
-
Data no
95839
Title
Freedom of Information Summary 1: Posilac
Study date
5 Nov 1993
Auth party contact address
-
Data no
95840
Title
Freedom of Information Summary, Supplemental New Animal Drug Application: Posilac
Study date
11 Nov 2003
Auth party contact address
-
Data no
95889
Title
Final response to Citizens Petition. CVM, FDA
Study date
2000
Auth party contact address
-
Data no
95956
Title
Survey of retail milk composition as affected by label claims regarding farm-management practices.
Study date
2008
Auth party contact address
-
Data no
95957
Title
Effect of exogenous growth hormone in early and late lactation on lactational performance of dairy cows.
Study date
1983
Auth party contact address
-
Data no
95958
Title
Effect of dose of bovine growth hormone on milk composition: Alpha-lactalbumin, fatty acids and mineral elements.
Study date
1985
Auth party contact address
-
Data no
95959
Title
Blood and milk lipid responses induced by growth hormone administration to lactating cows.
Study date
1984
Auth party contact address
-
Data no
95960
Title
Effect of exogenous growth hormone on lactational performance in the high yielding dairy cow.
Study date
1981
Auth party contact address
-
Data no
95961
Title
Endocrine control of energy metabolism in the cow: The effect on milk yield and levels of some blood constituents of injecting growth hormone and growth hormone fragments.
Study date
1980
Auth party contact address
-
Data no
95962
Title
Effect of dose of bovine growth hormone on lactation of dairy cows.
Study date
1985
Auth party contact address
-
Data no
95963
Title
Comparison of different patterns of exogenous growth hormone administration on milk production in Holstein cows.
Study date
1983
Auth party contact address
-
Data no
95964
Title
Lactational response to exogenous growth hormone and abomasal infusion of a glucose-sodium caseinate mixture in high-yielding dairy cows.
Study date
1982
Auth party contact address
-
Data no
95965
Title
Responses of high-producing dairy cows to long-term treatment with pituitary somatotropin and recombinant somatotropin.
Study date
1985
Auth party contact address
-
Data no
95966
Title
The effects of long-term administration of bovine growth hormone on the lactational performance of identical twin dairy cows.
Study date
1985
Auth party contact address
-
Data no
95967
Title
Report MSL 542: Sensory and chemical evaluation of milk produced from cows treated with CP115099 in a prolonged release system - a preliminary study.
Study date
10 February 1986
Data no
95968
Title
Survey of the fatty acid composition of retail milk differing in label claims based on production management practices.
Study date
2010
Auth party contact address
-
Data no
95969
Title
Effect of long-term bovine somatotropin (sometribove) treatment on nitrogen (protein) distribution in Jersey milk.
Study date
1991
Auth party contact address
-
Data no
95970
Title
Report MSL 6600: Somatotropin and antibodies in milk from cows on study no. 100-DDC-COW-PJE-010 (Toxicity Study): First lactation study final report.
Study date
11 May 1987
Data no
95971
Title
Responses of dairy cows to exogenous bovine growth hormone administered during early lactation.
Study date
1985
Auth party contact address
-
Data no
95972
Title
Report MLL 90311: Composition and processing characteristics of milk from cows in the French Clinical trial.
Study date
2 February 1987
Data no
95973
Title
Report MSL 7031: Evaluation of vitamins in milk produced from cows treated with placebo and CP115099 in a prolonged release system.
Study date
29 May 1987
Data no
95974
Title
Report MLL 90310: The influence of the treatment of lactating cows with methionyl bovine somatotropin on milk properties.
Study date
29 January 1987
Data no
95975
Title
CVM ADE Comprehensive Clinical Detail Report Listing: Cumulative Date Range: 01/01/1987 -thru- 12/31/2012. Drug Listing: N;O;P;Q;R;S. pages 388-398
Study date
2013
Auth party contact address
-
Data no
95933
Title
Report MSL 6578: Characterisation of the pharmacokinetic parameters of CP104301 in lactating cows.
Study date
31 March 1987
Data no
95934
Title
Report MSL 6603: Characterisation of the pharmacological parameters of MBS AlaVal and AlaValHis in lactating cows.
Study date
31 March 1987
Data no
95935
Title
Report MSL 6610: Determination of somatotropin release kinetics in dairy cows administered several doses of CP115099 prolonged release formulation.
Study date
31 March 1987
Data no
95936
Title
Report MSL 6611: Evaluation of BST metabolic pathways in dairy cows after intramuscular administration of BST-formulation.
Study date
25 March 1987
Data no
95937
Title
Report MSL 6749: Comparison of bovine pituitary and recombinant somatotropins by in vitro degradation with proteases: thrombin, trypsin and leukocyte elastase.
Study date
21 May 1987
Data no
95938
Title
Peptide hormones and their analogues: Distribution, clearance from the circulation and inactivation in vivo.
Study date
1979
Auth party contact address
-
Data no
95939
Title
Estimates of the kinetic parameters of growth hormone metabolism in fed and fasted calves and sheep.
Study date
1976
Auth party contact address
-
Data no
95940
Title
Changes in growth hormone status related to body weights of growing cattle.
Study date
1977
Auth party contact address
-
Data no
95941
Title
The search for the active core of pituitary growth hormone.
Study date
1974
Auth party contact address
-
Data no
95942
Title
Action of thrombin on ovine, bovine and human pituitary growth hormones.
Study date
1976
Auth party contact address
-
Data no
95943
Title
Fate of injected human growth hormone in the female rat liver in vivo.
Study date
1982
Auth party contact address
-
Data no
95944
Title
The uptake and degradation of growth hormone fragments by isolated rat hepatocytes.
Study date
1978
Auth party contact address
-
Data no
95945
Title
The intriguing nature of the multiple actions of growth hormone.
Study date
1979
Auth party contact address
-
Data no
95946
Title
Distribution of tritium labelled human growth hormone in rats and guinea pigs.
Study date
1966
Auth party contact address
-
Data no
95947
Title
Early localisation of 125I-labelled human growth hormone in adrenals and other organs of immature hypophysectomised rats.
Study date
1971
Auth party contact address
-
Data no
95948
Title
The fate of 131I-labelled human growth hormone in the rabbit.
Study date
1962
Auth party contact address
-
Data no
95949
Title
The distribution of radioactivity in the administration of radioactive growth hormone preparations.
Study date
1954
Auth party contact address
-
Data no
95950
Title
Autoradiographic demonstration of glomerular filtration and proximal tubular absorption of 125I-labelled growth hormone in the mouse.
Study date
1973
Auth party contact address
-
Data no
95951
Title
Adsorption of 125I-labelled sheep growth hormone in single proximal tubules of the rat kidney.
Study date
1976
Auth party contact address
-
Data no
95952
Title
Studies on human growth hormone. II. Physiological disposition and metabolic fate of human growth hormone in man.
Study date
1962
Auth party contact address
-
Data no
95953
Title
Biology of somatotropin in growth and lactation of domestic animals.
Study date
1998
Auth party contact address
-
Data no
95954
Title
Report MSL 9672: Effect of sometribove on blood clinical chemistries and hormones in dairy cattle.
Study date
9 January 1990
Data no
95955
Title
Effect of somatotropin on the plasminogen and plasmin system in the mammary gland: Proposed mechanism of action for somatotropin on the mammary gland.
Study date
1990
Auth party contact address
-
Data no
95891
Title
Report MSL 11545: A histological evaluation of injection sites with visual scores of 2 and 3 following chronic subcutaneous administration of sometribove prolonged release formulation
Study date
25 November 1991
Data no
95892
Title
Report MSL 11509: A histopathological evaluation of persistent local inflammatory lesions following tailhead (ischiorectal fossa) injection of rbST in dairy cows (study 100-DDC-COW-PJE-91-068)
Study date
21 November 1991
Data no
95893
Title
Supplement to Report 6757: Long Term Evaluation of Zinc Methionyl Bovine Somatotropin Treatment in a Prolonged Release System for Lactation Cows producing high fat and high protein milk Summary report: injection site swellings
Study date
August 1988
Data no
95894
Title
Report MSL 9012: Injection site and carcass evaluation following subcutaneous administration of sometribove prolonged release formulation
Study date
24 May 1989
Data no
95909
Title
Effect of a single growth hormone (rbST) treatment at breeding on conception rates and pregnancy retention in dairy and beef cattle
Study date
2006
Auth party contact address
-
Data no
95910
Title
Effect of recombinant bovine somatotropin on superovulatory response and recipient pregnancy rates in a commercial embryo transfer program
Study date
2003
Auth party contact address
-
Data no
95899
Title
The effect of a depot injection of recombinant bovine somatotropin on follicular development and embryo yield in superovulated Holstein heifers
Study date
1993
Auth party contact address
-
Data no
95900
Title
Follicular function in lactating dairy cows treated with sustained-release bovine somatotropin
Study date
1997
Auth party contact address
-
Data no
95901
Title
Supplement to Report MSL 9012: Evaluation of injection sites and carcass quality following subcutaneous administration of sometribove in a prolonged release formulation in jersey cows
Study date
8 December 1989
Data no
95902
Title
Report MSL 11476: Injection site evaluation following subcutaneous administration of somatotropin prolonged release formulation
Study date
21 October 1991
Data no
95911
Title
Effect of pretreatment with bovine somatotropin (bST) and/or gonadotropin-releasing homone (GnRH) on conception rate of dairy cows with ovarian cysts subjected to synchronisation of ovulation and timed insemination.
Study date
2003
Auth party contact address
-
Data no
95912
Title
Effects of presynchronisation and bovine somatotropin on pregnancy rates to a timed artificial insemination protocol in lactating dairy cows.
Study date
2001
Auth party contact address
-
Data no
95913
Title
Effect of bST and Reproductive Management on Reproductive Performance of Holstein Dairy Cows.
Study date
2004
Auth party contact address
-
Data no
95914
Title
Effect of bovine somatotropin (500mg) administered at ten-day intervals on ovulatory responses, expression of estrus, and fertility in dairy cows.
Study date
2010
Auth party contact address
-
Data no
95915
Title
Effect of short-term treatment with bovine somatotropin at estrus on conception rate and luteal function of repeat-breeding dairy cows.
Study date
2001
Auth party contact address
-
Data no
95916
Title
l (2002) Bovine somatotropin increases embryonic development in superovulated cows and improves post-transfer pregnancy rates when given to lactating recipient cows.
Study date
2002
Auth party contact address
-
Data no
95917
Title
Fertility of lactating dairy cows administered recombinant bovine somatotropin during heat stress.
Study date
2007
Auth party contact address
-
Data no
95918
Title
Report MSL 12026: Effect of sometribove treatment of dairy cows on the incidence of clinical signs and birth abnormalities in the resultant offspring.
Study date
16 September 1992
Data no
95919
Title
Health, welfare and fertility implications of the use of bovine somatotropin in dairy cattle.
Study date
1988
Auth party contact address
-
Data no
95920
Title
Somatotropin treatment for a second consecutive lactation.
Study date
1990
Auth party contact address
-
Data no
95921
Title
Overall efficacy of chronically administered recombinant bovine somatotropin to lactating dairy cows.
Study date
1990
Auth party contact address
-
Data no
95922
Title
Use of recombinant bovine somatotropin for up to two consecutive lactations on dairy production traits.
Study date
1990
Auth party contact address
-
Data no
95923
Title
Lactation response and body composition of cows receiving somatotropin and three ratios of forage to concentrate.
Study date
1991
Auth party contact address
-
Data no
95924
Title
Effect on production of the use of recombinant bovine somatotropin for up to three consecutive lactations.
Study date
1992
Auth party contact address
-
Data no
95925
Title
Effects of recombinant bovine somatotropin under conditions of high production and heat stress.
Study date
1993
Auth party contact address
-
Data no
95926
Title
Slow release somatotropin in dairy heifers and cows fed two levels of energy concentrate. 1. Performance and body condition.
Study date
1991
Auth party contact address
-
Data no
95927
Title
Effects of recombinant bovine somatotropin on milk production, body composition and physiological parameters.
Study date
1988
Auth party contact address
-
Data no
95928
Title
Recombinant bovine somatotropin with lactating cows fed diets differing in energy density.
Study date
1991
Auth party contact address
-
Data no
95929
Title
Effect of the use of bovine somatotropin on culling practices in thirty-two dairy herds in Indiana, Michigan and Ohio.
Study date
1998
Auth party contact address
-
Data no
95930
Title
Report MSL 11838: Effect of sometribove on incidence of clinical signs in dairy cows.
Study date
1 May 1992
Data no
95931
Title
Clinical mastitis in cows treated with sometribove (recombinant bovine somatotropin) and its relationship to milk yield.
Study date
1994
Auth party contact address
-
Data no
95932
Title
Effect of long-term administration of a prolonged release formulation of bovine somatotropin (sometribove) on clinical lameness in dairy cows.
Study date
1995
Auth party contact address
-
Data no
95898
Title
Reproductive performance of Holstein cows receiving somatotropin
Study date
2000
Auth party contact address
-
Data no
95890
Title
Effects of recombinant growth hormone on fertility: Dependence upon seasonal variations, dosage differences and lactational status
Study date
2009
Data no
95887
Title
Report MSL 7119: Effect of CP115099-F treatment of the dam on the subsequent health and reproductive performance of first generation heifers; interim report from birth through 4 months of life
Study date
18 September 1987
Data no
95888
Title
Report MSL 9639: Effect of sometribove on health of dairy cattle
Study date
18 January 1991
Data no
95881
Title
Report MSL 8133: Toxicity of CP115099 in a prolonged release system in lactating cows through two lactations of treatment: final report
Study date
2 September 1988
Data no
95882
Title
Report MSL 9671: Toxicity of CP115099 in a prolonged release system in lactating cows through two lactations of treatment: additional analyses
Study date
10 January 1990
Data no
95883
Title
Report MSL 9671 - Amendment: Toxicity of CP115099 in a prolonged release system in lactating cows through two lactations of treatment: additional analyses
Study date
21 April 1993
Data no
95815
Title
Discussion of Overseas Registration Submissions for POSILAC
Study date
March 2013
Data no
95816
Title
The regulation of rBST: The European case.
Study date
2000
Auth party contact address
-
Data no
95817
Title
Final response to citizens petition.
Study date
2000
Auth party contact address
-
Data no
95818
Title
Recombinant bovine somatotropin (rbST).
Study date
1998, revised 1999
Auth party contact address
-
Data no
95819
Title
CVM Update: FDA Analysis of DGXXIV Report on Public Health Aspects of BST.
Study date
April 13, 1999
Auth party contact address
-
Data no
95820
Title
rbST and the Drug Approval Process, Interim Report. March 1999.
Study date
March 1999
Auth party contact address
-
Data no
95821
Title
Recombinant Bovine Somatotropin: Challenging Canadas Science-based Regulatory System and the Emergence of Post-Normal Science.
Study date
2005
Auth party contact address
-
Data no
95822
Title
Primary dermal irritation study in rabbits, Bio/dynamics project No. 6578-86, Monsanto reference No. BD-86-132
Study date
1986
Data no
95823
Title
JECFA (2000) WHO Food Additives Series 43: Porcine Somatotropins
Study date
2000
Auth party contact address
-
Data no
95824
Title
Primary dermal irritation study in rabbits, Bio/dynamics project No. 6582-86, Monsanto reference No. BD-86-131
Study date
1986
Data no
95825
Title
The acute oral and dermal toxicity and primary ocular and dermal irritation of EL-349 parental injection. Unpublished report on studies R-0-155-86. R-0-154-86. 8-D-120-86 and 8-E-100-86.
Study date
1987
Data no
95826
Title
Primary dermal irritation study in rabbits, Bio/dynamics project No. 6579-86, Monsanto reference No. BD-86-132
Study date
1986
Data no
95827
Title
Skin and eye irritation and dermal sensitization attributed to sometribove zinc formulation.
Study date
2010
Data no
95828
Title
Primary dermal irritation study in rabbits, Bio/dynamics project No. 6583-86, Monsanto reference No. BD-86-131
Study date
1986
Data no
95829
Title
Potential for Posilac (recombinant bovine somatotropin, rbST) to stimulate hormonal activity in Humans
Study date
2011
Data no
95830
Title
Use of Bovine Somatotropin in Dairy Production
Study date
2010
Data no
95831
Title
Cline, 2007. Assessing the Mammary Gland of Nonhuman Primates: Effects of Endogenous Hormones and Exogenous Hormonal Agents and Growth Factors.
Study date
2007
Auth party contact address
-
Data no
95832
Title
Factors effecting insulin-like growth factor -1 concentration in bovine milk.
Study date
1991
Auth party contact address
-
Data no
95833
Title
Bioactivity of milk from bst-treated cows.
Study date
1990
Auth party contact address
-
Data no
95834
Title
Episodic evolution of growth hormone in primates and emergence of the species specificity of human growth hormone receptor.
Study date
2001
Auth party contact address
-
Data no
95835
Title
Parodi, 2005. Dairy Product consumption and the risk of breast cancer.
Study date
2005
Auth party contact address
-
Data no
95836
Title
Recombinat Bovine Somatotropin (rbST): A safety Assessment
Study date
2010
Data no
95837
Title
WHO Food Additive Series 31: Bovine somatotropins
Study date
1993
Auth party contact address
-
Data no
95838
Title
Survey of retail milk composition as affected by label claims regarding farm-management practices
Study date
2008
Auth party contact address
-
Date
Application No
Application Number
147467
Product/Active constituent Name
Application Product Name
hypochlorous acid (super-oxidised solution)
Application Number
147467
Application Product Name
hypochlorous acid (super-oxidised solution)
Application details
Product name:
hypochlorous acid (super-oxidised solution)
Product number:
95889
Applicant Name:
MEDIMARK SYNERGY PTY LTD
Application purpose and description of use:
Registration of a hypochlorous acid in liquid formulated for use in livestock farms.
Date
Application No
Application Number
150391
Product/Active constituent Name
Application Product Name
Thursday Plantation Walkabout Insect Repellent
Application Number
150391
Application Product Name
Thursday Plantation Walkabout Insect Repellent
Application details
Product name:
Thursday Plantation Walkabout Insect Repellent
Product number:
96682
Applicant Name:
HOMART WELLNESS AUST PTY LTD
Application purpose and description of use:
Registration of a (concentration/active) household insecticide product containing Tea Tree Oil (Melaleuca Oil), Lemon scented Tea Tree Oil (Leptospermum Petersonii Leaf Oil) and Citronellal for personal protection against biting insects and flies.
Reference details:
46146 - THURSDAY PLANTATION AUSTRALIA'S ORIGINAL WALKABOUT INSECT REPELLENT
Description of data provided:
Data no
294553
Title
Batch 409334 Certificate of Analysis
Study date
2025
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294556
Title
Packaging Work Order
Study date
2025
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294552
Title
Finished Product Specification
Study date
2025
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294557
Title
Holder Transfer Notice
Study date
2025
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294554
Title
Product Label
Study date
2025
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294555
Title
Safety Data Sheet
Study date
2025
Auth party contact address
59 Kirby St RYDALMERE Australia
Date
Application No
Application Number
149719
Product/Active constituent Name
Application Product Name
Planterra GoldPrime Vegetable Oil Concentrate
Application Number
149719
Application Product Name
Planterra GoldPrime Vegetable Oil Concentrate
Application details
Product name:
Planterra GoldPrime Vegetable Oil Concentrate
Product number:
96540
Applicant Name:
PLANTERRA PTY LTD
Application purpose and description of use:
Registration of an 835 g/L emulsifiable Vegetable Oil Concentrate product for increasing droplet spread, chemical uptake and
rainfastness, improves drift control, reduces foam generation, assists with odour reduction and evaporation of various agricultural and horticultural sprays.
Reference details:
55994 - CHEMAG EXTEND VEGETABLE OIL CONCENTRATE
Description of data provided:
Data no
291369
Title
Registration Dossier
Study date
2025
Auth party contact address
82 Holzwart Road Emerald Australia
Data no
294310
Title
Part 2 Chemistry and Manufacturer
Study date
2025
Auth party contact address
82 Holzwart Road Emerald Australia
Data no
291370
Title
eLabel - Planterra GoldPrime Vegetable Oil Concentrate - Draft DFU Label
Study date
2025
Auth party contact address
82 Holzwart Road Emerald Australia