Public Chemical Registration Information System - PUBCRIS
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General Details
Product No 59865 Category Veterinary Medicine Product Type ENDOCRINE SYSTEM
Formulation PARENTERAL LIQUID/SOLUTION/SUSPENSION Poison Schedule 4 Reg. Status R
Reg. Date 01-Jul-2009 Expiry Date 30-Jun-2010  
Name LIFETIDE SW 5 INJECTABLE PLASMID ENCODING PORCINE GHRH
Registrant VGX ANIMAL HEALTH, INC.
 
Constituents
Constituent Name Chemical Group Amount Units
SYNTHETIC PORCINE GHRH ENCODING PLASMID HORMONE-GONADOTROPHIN 2.5 mg/mL
 
States
State Reg. Status 1st Registered Date
ACT R 04-Jan-2008
NSW R 04-Jan-2008
NT R 04-Jan-2008
QLD R 04-Jan-2008
SA R 04-Jan-2008
TAS R 04-Jan-2008
VIC R 04-Jan-2008
WA R 04-Jan-2008
 
Label Details
Label No Date
0108 04-Jan-2008
 
Pack Sizes
Pack Size Information
#2mL
#dose vial
#single
10mL
20mL
50mL
^100mL
^multidose
^vial
 
Withholding Periods
Withholding Period Details
WHP: MEAT-NIL
ESI: NOT REQUIRED
 
Protected Data Details
Appl. Data Ref.     Study      
No No Product Author Title Date Data Type End Date Auth. Party
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 1524 N/A A Perez Single Dose Tolerance and Safety Study of ADViSYS, Inc HV Plasmid in Beagle Dogs 11/11/2002 Toxicology (Acute Oral Studies, Active) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 1525 N/A A Perez Multiple Dose Tolerance and Safety Study of ADViSYS, Inc Plasmid Lot #paV0125.98158 in Beagle Dogs 29/01/2003 Toxicology (Short-term Studies) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 1550 N/A RC Person Effects of ADViSYS GHRH plasmid treatment of sows and progeny 14/04/2005 Efficacy and Safety (Efficacy) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 1551 N/A RC Person Effects of GHRH plasmid treatment in sows. 14/04/2005 Efficacy and Safety (Efficacy) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 1552 N/A Holtkamp D Summary of reported adverse reactions related to anaesthesia and plasmid treatment of swine. 12-Mar Efficacy and Safety (Target Animal Safety Studies) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 5764 N/A Davis R Correspondence containing additional efficacy data for Lifetide SW 5 2006 Efficacy and Safety (Efficacy) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 6206 N/A Gammon R Sample assay for bacteriophages/prophage 2003 Efficacy and Safety (Other Information) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 8123 N/A Anon Supplemental Analysis to Study 1551 Large Scale Efficacy Study (applicant reference 03PO79C) 1/8/06 Efficacy and Safety (Efficacy) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 8142 N/A Various Chemistry data received in conjunction with an application made between 01/01/2005 and 31/08/2005. Various Chemistry and Manufacture (Product, Other Information) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 9213 N/A Draghia-Akli R Discussion on the safety of LifeTide SW 5 following inadvertent administration to humans 09/06 Toxicology (Other Information) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 12028 N/A Davis R Correspondence reporting two in vivo mouse batch release optimisation experiments March 2007 Chemistry and Manufacture (Product, Batch Analysis) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 12029 N/A Anon Batch release Mouse In vivo Efficacy Testing March 2007 Chemistry and Manufacture (Product, Batch Analysis) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 12030 N/A Anon Batch release Mouse In vivo Efficacy Testing Form March 2007 Chemistry and Manufacture (Product, Batch Analysis) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 12031 N/A Anon ADP0002 Release Testing - Serial and Subserials March 2007 Chemistry and Manufacture (Product, Batch Analysis) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 12032 N/A Anon Batch in vivo safety testing March 2007 Chemistry and Manufacture (Product, Batch Analysis) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 12033 N/A Anon Out of specification Investigation procedure Nov 2006 Chemistry and Manufacture (Product, Batch Analysis) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA
36936An Advice summary may not be available.

The APVMA is required to publish an advice summary where, in making a decision to grant an application, it relied on advice received from a person, body or government it consulted. The APVMA may not need to consult external parties.		 12034 N/A Anon Investigations July 2006 Chemistry and Manufacture (Product, Other Information) 04-Jan-2016 Registrant / SUITE 180, 2700 RESERCH FOREST DR. THE WOODLANDS, TEXAS 77381 USA