Download Advice Summary - Product No. 67201, Application No. 55445

ADVICE SUMMARY
APPLICATION FOR REGISTRATION OF A CHEMICAL PRODUCT
Product name:
VETMEDIN 0.75 MG/ML INJECTABLE SOLUTION FOR DOGS
Applicant:
BOEHRINGER INGELHEIM PTY LIMITED, VETMEDICA DIVISION
Product number:
67201
Application number:
55445
Purpose of Application and Description of Use: Registration of a pimobendan 0.75 mg/mL injectable solution product for the initiation of treatment of
congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid regurgitation) in
dogs.
Active Constituent(s):
PIMOBENDAN
Regulatory Decision:
To grant the application subject to the following conditions:
Standard Conditions of Registration/Approval
1.
2.
3.
4.
Containers must meet AgVet Code Regulation 18
Product must not be supplied without meeting GMP Requirements
Label must contain an Expiry Date and Batch Number
Product Label (MPL) must comply with Labelling Standard / Code
For full conditions, refer to Standard Conditions for Applications on the APVMA website.
55445
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ADVICE
External Efficacy Reviewer
An external reviewer has evaluated data submitted by the applicant to support the efficacy and target animal safety of the proposed product Vetmedin 0.75 mg/mL Injectable
Solution For Dogs (67201), containing the active constituent pimobendan. The proposed product is to be used for the initiation of treatment of congestive heart failure
originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid regurgitation) in dogs.
The submitted data included published literature supporting the safety, efficacy and pharmacology of the active constituent, target animal safety studies,
bioequivalence/pharmacology studies, pharmacovigilance data and a confirmatory field efficacy and safety study.
Based on the advice of the external reviewer and the relied on data, the APVMA determines that the use of the product in accordance with the label instructions would not be
likely to have an adverse effect on the safety of target animals and that use of the product in accordance with the recommendations for its use that the APVMA approves
would be effective.
Data relied on to provide the advice
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Party
65103
S
Prof Adrian Boswood
Detailed and Critical Summary - Vetmedin 0.75 mg/mL
solution for injection for dogs. Efficacy Documentation.
Expert Report
4 March 2011
Efficacy and Safety
Efficacy
Applicant
65108
S
U Langbein
Vetmedin 1.25mg, 2.5 mg and 5 mg chewable tablets
for dogs. Periodic safety update report. August 1 2008
until January 31 2009
2009
Efficacy and Safety
Efficacy
Applicant
65104
S
Professor Herve Pouliquen
Detailed Critical Summary - Vetmedin 0.75 mg/mL
solution for injection for dogs - Safety Documentation Expert Report
9 March 2011
Efficacy and Safety
Efficacy
Applicant
65092
S
M Markert
Comparison of the effect of single, therapeutic doses of
Vetmedin chewable tablets and Vetmedin injectable on
hemodynamic and electrocardiogrphic parameters in
conscious dogs
2008
Efficacy and Safety
Efficacy
Applicant
55445
Page 2 of 7
Inherited
Application
No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Party
65087
S
M Market
Comparison of the effect of single therapeutic doses of
Vetmedin capsules and Vetmedin chewable tablets on
hemodynamic and electrocardiographic parameters in
conscious dogs
2006
Efficacy and Safety
Efficacy
Applicant
65098
S
CW Lombard, O Jons, CM
Bussadori
Clinical efficacy of pimobendan versus benazepril for
the treatment of acquired atrioventricular valvular
disease in dogs
2006
Efficacy and Safety
Other Information
Public
65112
S
BN Bonnett, A Egenvall, A
Hedhammar et al
Mortality in over 350,000 insured Swedish dogs 19952000: I Breed-, gender-, age- and cause-specific rates
2005
Efficacy and Safety
Other Information
Public
65113
S
JW Buchanan
Prevalence of Cardiovascular Disorders
1999
Efficacy and Safety
Other Information
Public
65114
S
MA Oyama
Neurohormal activation in canine degenerative mitral
valve disease: implications on pathophysiology and
treatment
2009
Efficacy and Safety
Other Information
Public
65115
S
RLStepien, A Boswood
Cardiovascular emergencies. In: King LG, Boag A, eds,
2007
Efficacy and Safety
Other Information
Public
65110
S
U Langbein
Vetmedin 1.25 mg, 2.5 mg and 5 mg capsules for dogs.
Periodic safety update report. February 1 2008 until July
31 2008
2009
Efficacy and Safety
Other Information
Applicant
65117
S
JE Tisdale, R Patel, CR
Webb et al
Electrophysiologic and proarrhythmic effects of
intravenous inotropic agents
1995
Efficacy and Safety
Other Information
Public
65119
S
V Luis Fuentes
Use of pimobendan in the management of heart failure
2004
Efficacy and Safety
Other Information
Public
65097
S
J Haggstrom, A Boswood,
M O'Grady et al
Effect of pimobendan or benazepril hydrochloride on
survival times in dogs with congestive heart failure
caused by naturally occurring myxomatous mitral valve
disease: the QUEST study
2008
Efficacy and Safety
Other Information
Public
55445
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Inherited
Application
No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Party
65121
S
C Atkins, J Bonagura, S
Ettinger et al
Guidelines for the Diagnosis and Treatment of Canine
Chronic Valvular Heart Disease
2009
Efficacy and Safety
Other Information
Public
65122
S
MR O'Grady, SL Minors,
ML O'Sullivan et al
Effect of pimobendan on case fatality rate in doberman
pinschers with congestive heart failure caused by
dilated cardiomyopathy
2008
Efficacy and Safety
Other Information
Public
65109
S
Boehringer Ingelheim
Periodic Safety Update Report Vetmedin 1.25 mg, 2.5
mg and 5 mg capsules. Time Period October 1 2007
until January 31 2008
March 2008
Efficacy and Safety
Other Information
Applicant
65107
S
U Langbein
Vetmedin 1.25mg, 2.5 mg and 5 mg chewable tablets
for dogs. Periodic safety update report. December 1
2007 until July 31 2008
2008
Efficacy and Safety
Other Information
Applicant
65094
S
BI
Periodic Safety Update Report for Vetmedin 1.25 mg,
2.5 mg and 5 mg chewable tablets for dogs
2009
Efficacy and Safety
Other Information
Applicant
65093
S
JN Matthews, DG Altman,
MJ Campbell et al
Analysis of serial measurements in medical research
1990
Efficacy and Safety
Other Information
Public
65106
S
A Hirsch
Vetmedin 1.25mg, 2.5mg and 5 mg chewable tablets for
dogs. Periodic Safety update report; June 1 2006 until
Novmber 30 2007
2008
Efficacy and Safety
Other Information
Applicant
65091
S
H Pouleur, C Hanet, E
Schroder et al
Effects of pimobendan (UD-CG 115BS) on left
ventricular inotropic state in conscious dogs and in
patients with heart failure
1989
Efficacy and Safety
Other Information
Public
71534
S
Markert et al
The value added by measuring myocardial contractility
in vivo in safety pharmocological profiling of drug
candidates
2007
Efficacy and Safety
Other Information
Public
71535
S
Meyners and Markert
Correcting the QT Interval for Changes in HR in PreClinical Drug Development
2004
Efficacy and Safety
Other Information
Public
55445
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Inherited
Application
No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Party
65105
S
HG Vogel, Franz jakob
Hock, Jochen Maas, Dieter
Mayer
Drug Discovery and Evaluation: safety and
pharmacokinetic assays
2006
Efficacy and Safety
Other Information
Public
65102
S
HS Bender
Veterinary Laboratory Medicine, Clinical Pathology,
fourth edition. Chapter: muscle
2003
Efficacy and Safety
Other Information
Public
65100
S
A Klumpp, T Trautmann,
M Markert et al
Optimizing the experimental environment for dog
telemetry studies
2006
Efficacy and Safety
Other Information
Public
65116
S
MR Vasko, DB Cartwright,
JP Knochel et al
Furosemide absorption altered in decompensated
congestive heart failure
1985
Efficacy and Safety
Other Information
Public
75723
S
N.Mohren
Addendum to the detailed and critical summary on the
efficacy documentation (Document No vr 00075471)
21 May 2013
Efficacy and Safety
Other Information
Applicant
65099
S
V Luis Fuentes, B
Corcoran, A French et al
A double-blind, randomised, placebo-controlled study of
pimobendan in dogs with dilated cardiomyopathy
2002
Efficacy and Safety
Other Information
Public
65086
S
J Dammgen
Addendum to Clinical Expert Report
2008
Efficacy and Safety
Other Information
Applicant
65085
S
J Dammgen
Addendum to Clinical Expert Report
2004
Efficacy and Safety
Other Information
Applicant
65111
S
U Langbein
Vetmedin 1.25 mg, 2.5 mg and 5 mg capsules for dogs.
Periodic safety report. August 1 2008 until Novmber 30
2008
2009
Efficacy and Safety
Other Information
Applicant
65084
S
G Le Bobbinec, W
Diederen
Clinical expert report on Vetmedin Capsules (2.5 and 5
mg) (Pimobendan)
1996
Efficacy and Safety
Other Information
Applicant
55445
Page 5 of 7
Inherited
Application
No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Party
65120
S
W Diederen, W roth, H
Lehmann et al
Vetmedin (pimobendan) capsules and chewable tablets
for dogs
2008
Efficacy and Safety
Pharmacological
Data/Studies
Applicant
65088
S
W Roth, W Diederen
Plasma level profile, positive inotropic activity and tissue
distribution after intravenous administration of UD-CG
115 BS and UD-CG 212 in dogs
1987
Efficacy and Safety
Pharmacological
Data/Studies
Applicant
65096
S
L Lutzen, A Eckenfield, M
Bauer et al
Subacute toxicity study on the substance UD-CG115 BS
with intravenous administration of dogs for 4 weeks
1986
Efficacy and Safety
Pharmacological
Data/Studies
Applicant
65095
S
R Serbedija, A Eckenfels,
M Bauer et al
Subacute toxicity study with substance UD-CG 115 BS
in dogs after intravenous administration for 4 weeks
1985
Efficacy and Safety
Pharmacological
Data/Studies
Applicant
65090
S
A Greischel
Pharmacokinetics of UDCG 115 BS after oral and
intravenous administration of 0.5 mg/kg of (14C)-UDCG
115 BS in dogs
1989
Efficacy and Safety
Pharmacological
Data/Studies
Applicant
65089
S
W Roth
Supporting the rationale to apply pharmacodynamic
endpoints instead of pharmacokinetic analysis for
assessing the bioequivalence of the Vetmedin chewable
tablet versus the marketed Vetmedin capsule
information
2006
Efficacy and Safety
Pharmacological
Data/Studies
Applicant
65101
S
P Clausing, S Mueller
Subcutaneous and intravenous local tolerance study in
the beagle dog
2007
Efficacy and Safety
Target Animal
Safety Studies
Applicant
75724
S
BI
Periodic Safety Update Report. Vetmedin solution for
injection
21 May 2013
Efficacy and Safety
Target Animal
Safety Studies
Applicant
75725
S
N.Mohren
Vetmedin 0.75mg/ml solution for injection for initiation of
treatment for congestive heart failure in dogs with
acquired cardiac disease. (Document No VU-07500)
26 September 2012
Efficacy and Safety
Target Animal
Safety Studies
Applicant
55445
Page 6 of 7
Inherited
Application
No.
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Data
No
71536
Data
Source*
S
Author(s)
P. Clausing and S. Muller
Title
Pimobendan ( UD-CG 115 BS): Subcutaneous and
intravenous local tolerance study in beagle dogs. Doc
No U07-1096
Date
Data Type
Data Sub-type
Authorising
Party
2007
Efficacy and Safety
Target Animal
Safety Studies
Applicant
Inherited
Application
No.
* S = Data submitted with the application
I = Data inherited (that is, referenced) from another application
55445
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