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					                                                                  ADVICE SUMMARY
                              APPLICATION FOR VARIATION OF A REGISTERED CHEMICAL PRODUCT

Product name:               CERENIA 160MG TABLETS FOR DOGS
Applicant:                  PFIZER ANIMAL HEALTH A DIV OF PFIZER AUSTRALIA PTY LTD
Product number:             62421
Application number:         50739

Purpose of Application and Description of Use:       Variation to registration and label approval to add a claim for prevention of nausea.

Active Constituent(s):      MAROPITANT AS MAROPITANT CITRATE
Gilbertttatata
Regulatory Decision:
To grant the application subject to the following conditions:

STANDARD CONDITIONS OF LABEL APPROVAL
    1.   Label must contain an Expiry Date and Batch Number
For full conditions, refer to http://www.apvma.gov.au/advice_summaries/adv_summaries.shtml.

Non-Standard Conditions of Approval

    2.    The Marketed Product Label (MPL) must comply with the relevant APVMA Labelling Code or Labelling Standard, whichever is in force at the time.
    3.   The Marketed Product Label (MPL) must comply with any conditions prescribed by the regulations (whether or not the conditions are prescribed at the
         time the label is approved).




«appl_num»                                                                  Page 1 of 6                                              KP25S_F40 Version: 2 Issued: 10/08/2007
ADVICE

External Efficacy Reviewer
An external efficacy and safety reviewer has evaluated data to support the proposed variation to the label claim for the product Cerenia 160mg Tablets for
Dogs (62421), and three secondary products Cerenia 60mg Tablets for Dogs (62422), Cerenia 24mg Tablets for Dogs (62423) and Cerenia 16mg Tablets for
Dogs (62424). The applicant has proposed to include a claim for the prevention of nausea, in addition to the claim for prevention of emesis in dogs. While
vomiting occurs at a certain threshold and may be completely eliminated, nausea is a graded response. As such, medicines that inhibit vomiting may only partly
reduce nausea and this may vary greatly between individuals, and relate at the subconscious level to previous experience.

To support a claim for anti-nausea properties, the applicant measured a variety of subjective behavioural signs (depression, lethargy, salivation, excessive or
exaggerated swallowing, lip licking and restlessness) and produced a composite score using a visual analogue scale (VAS). Several studies were conducted to
evaluate nausea using VAS scores, comparing a Cerenia treatment group, and a negative control group. Not all studies showed statistical improvement for all
behavioural signs related to nausea, however a positive effect was generally indicated, if not a complete effect on nausea. Analysis of the data presented by the
applicant, as well as the supportive literature supports the conclusion that the product delivered orally will be useful for the prevention of acute nausea due to
chemical stimuli at 2mg/kg. The safety profile is no different at the approved dose rate and regimen to that already approved for prevention of emesis.

Based on the advice of the external reviewer and the relied on data, the APVMA determines that use of the product in accordance with 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
                                                                                                                                                                                          Inherited
Data         Data            Author(s)                              Title                                Date          Data Type           Data Sub-type              Authorising        Application
No           Source*                                                                                                                                                    Party                No.
45181        S         Alan D. Miller,       Brain areas essential or non-essential for emesis         22        Efficacy and Safety   Efficacy                    Public
                       Satoshi Nonaka, Jan                                                             Februar
                       Jakus                                                                           y 1994
45183        S         Eric Prommer          Aprepitant (EMEND): The role of substance P               02/12/0   Efficacy and Safety   Efficacy                    Public
                                             in nausea and vomiting                                    5




«appl_num»                                                                               Page 2 of 6                                                       KP25S_F40 Version: 2 Issued: 10/08/2007
                                                                                                                                                                                            Inherited
Data         Data             Author(s)                               Title                                Date          Data Type           Data Sub-type              Authorising        Application
No           Source*                                                                                                                                                      Party                No.
45179        S         mark G.Kris, Richard    Improved Control of Cisplatin-Induced emesis              January   Efficacy and Safety   Efficacy                    Public
                       J. Gralla, Leslie B.    with High-Dose Metoclopramide and with                    30,
                       Tyson, Rebecca A.       Combinations of metoclopramide,                           1984
                       Clark, David P.         dexamethasone and Diphenhydramine
                       kelsen, Laura K.
                       Reilly, Susan
                       Groshen, George J.
                       Bosl and Leonard A.
                       Kalm
45180        S         Makau Lee, Mark         Nausea and Vomiting                                       1993      Efficacy and Safety   Efficacy                    Public
                       Feldman
45165        S         A. McLoughlin           Confirmation of the dose of CJ-11,972 (oral               26 May    Efficacy and Safety   Efficacy                    PFIZER
                                               tablet formulation) required for the prevention of        2003                                                        ANIMAL
                                               emesis and nausea caused by motion sickness in                                                                        HEALTH A
                                               dogs. (Summary)                                                                                                       DIV OF
                                                                                                                                                                     PFIZER
                                                                                                                                                                     AUSTRALIA
                                                                                                                                                                     PTY LTD
45160        S         Anon                    Cerenia (maropitant citrate) Tablets and                  October   Efficacy and Safety   Efficacy                    Applicant
                                               Injectable Solution - Supplemental International          2009
                                               Registration Dossier to add a new claim.
45171        S         Jonathan Elliot         Expert Report Extension of the efficacy claim             19        Efficacy and Safety   Efficacy                    Applicant
                                               for Maropitant (Cerenia) A neurokinin-1                   Novem
                                               receptor antagonist for the treatment and                 ber
                                               prevention of nausea and vomiting in the dog.             2008
45162        S         S. Mhedhbi, V de la     Preliminary Dose-selection Study of CJ-11,972             30 Oct    Efficacy and Safety   Efficacy                    PFIZER
                       Puente-Redondo, RG      (Oral Formulation) for the Prevention of Emesis           2002                                                        ANIMAL
                       Clemence                and Nausea in Dogs, using a Cisplatin-induced                                                                         HEALTH A
                                               Emesis Model. (Summary)                                                                                               DIV OF
                                                                                                                                                                     PFIZER
                                                                                                                                                                     AUSTRALIA
                                                                                                                                                                     PTY LTD
45173        S         T.Endo, M. Minami,      Neurochemistry and neuropharmacology of                   2000      Efficacy and Safety   Efficacy                    Public
                       M.Hirafuji, T. Ogawa,   emesis - the role of serotonin.
                       K.Akita, M.Nemoto,
                       H.Saito, M.Yoshioka,
                       S.H. Parvez



«appl_num»                                                                                 Page 3 of 6                                                       KP25S_F40 Version: 2 Issued: 10/08/2007
                                                                                                                                                                                         Inherited
Data         Data            Author(s)                              Title                               Date          Data Type           Data Sub-type              Authorising        Application
No           Source*                                                                                                                                                   Party                No.
45184        S         Abhay R. Shelke,       The Pathophysiology of Treatment - related              Februar   Efficacy and Safety   Efficacy                    Public
                       Karen M. Mustian,      nausea and vomiting in cancer patients: Current         y 9,
                       Gary R. Morrow         models                                                  2004
45175        S         Pamela J.Hornby        Central neurocircuitry Associated with emesis.          Decemb    Efficacy and Safety   Efficacy                    Public
                                                                                                      er 3,
                                                                                                      2001
45185        S         Todd R. Tams           Vomiting, Regurgitation and Dysphagia                   1995      Efficacy and Safety   Efficacy                    Public
45177        S         Karen Jenns            Importance of nausea                                    May 12,   Efficacy and Safety   Efficacy                    Public
                                                                                                      1994
45186        S         M.R. Tramer            A rational approach to the control of                   2001      Efficacy and Safety   Efficacy                    Public
                                              postoperative nausea and vomiting: evidence
                                              from systematic reviews. Part 1. Efficacy and
                                              harm of antiemetic interventions, and
                                              methodological issues.
45166        S         Sheerin Mathur, G A    Field effectiveness and safety of oral CJ-11,972        12 Jan    Efficacy and Safety   Efficacy                    PFIZER
                       Conder                 for the prevention of cisplatin-induced emesis          2005                                                        ANIMAL
                                              and nausea in canine cancer patients. (Summary)                                                                     HEALTH A
                                                                                                                                                                  DIV OF
                                                                                                                                                                  PFIZER
                                                                                                                                                                  AUSTRALIA
                                                                                                                                                                  PTY LTD
45187        S         Robert J. Washabau,    Antiemetic Therapy                                      1995      Efficacy and Safety   Efficacy                    Public
                       Marcs S. Elie
45163        S         Michael C. Savides     Dose confirmation of the efficacy of CJ-11, 972         17 Aug    Efficacy and Safety   Efficacy                    PFIZER
                                              for syrup of ipecac (Ipecacuanha) induced               2004                                                        ANIMAL
                                              emesis in dogs. (Summary)                                                                                           HEALTH A
                                                                                                                                                                  DIV OF
                                                                                                                                                                  PFIZER
                                                                                                                                                                  AUSTRALIA
                                                                                                                                                                  PTY LTD
45188        S         Mehernoor F. Watcha,   Postoperative Nausea and Vomiting                       1992      Efficacy and Safety   Efficacy                    Public
                       Paul F. White
45176        S         E.C.Huskisson          Measurement of Pain                                     9,1974    Efficacy and Safety   Efficacy                    Public




«appl_num»                                                                              Page 4 of 6                                                       KP25S_F40 Version: 2 Issued: 10/08/2007
                                                                                                                                                                                           Inherited
Data         Data             Author(s)                              Title                                Date          Data Type           Data Sub-type              Authorising        Application
No           Source*                                                                                                                                                     Party                No.
45161        S         M.Murphy, V de la     Preliminary study to select the dose of                    09 Feb    Efficacy and Safety   Efficacy                    PFIZER
                       Puente-Redondo. R G   maropitant required for the prevention of emesis           2005                                                        ANIMAL
                       Clemence              and nausea in dogs (summary)                                                                                           HEALTH A
                                                                                                                                                                    DIV OF
                                                                                                                                                                    PFIZER
                                                                                                                                                                    AUSTRALIA
                                                                                                                                                                    PTY LTD
45174        S         Jorn Herrstedt        Antiemetics: an update and the MASCC                       22 Aug    Efficacy and Safety   Efficacy                    Public
                                             guidelines applied in clinical practce                     2007
45178        S         Kenneth L.Koch        Approach to the Patient With Nausea and                    1995      Efficacy and Safety   Efficacy                    Public
                                             Vomiting
45164        S         Michael C.Savides     Dose confirmation of the efficacy of CJ-11,972             17 Aug    Efficacy and Safety   Efficacy                    PFIZER
                                             for apomorphine-induced emesis in dogs.                    2004                                                        ANIMAL
                                             (Summary)                                                                                                              HEALTH A
                                                                                                                                                                    DIV OF
                                                                                                                                                                    PFIZER
                                                                                                                                                                    AUSTRALIA
                                                                                                                                                                    PTY LTD
45190        S         John A. Rudd and      Mechanism of Acute, delayed, and anticipatory              2005      Efficacy and Safety   Efficacy                    Public
                       Paul L.R. Andrews     emesis induced by anticancer therapies.
45191        S         William C.            Complications of Cancer and Its treatment                  2001      Efficacy and Safety   Efficacy                    Public
                       Kisseberth, E.
                       Gregory MacEwen
45170        S         G. Dranitsaris, P.    Implementing evidence based antiemetic                     5 July    Efficacy and Safety   Other Information           Public
                       Leung, D. Warr        guidelines in the oncology setting: results of a 4-        2001
                                             month prospective intervention study.
45167        S         Paul.L.R. Andrews,    Signals of nausea and emesis: Implications for             14        Efficacy and Safety   Other Information           Public
                       Charles.C. Horn       models of upper gastrointestinal diseases                  January
                                                                                                        2006
45189        S         Elizabeth M. Welsh,   Comparison of visual analogue scale and a                  1993      Efficacy and Safety   Other Information           Public
                       George Gettinby,      numerical rating scale for assessment of
                       Andrea M.Nolan        lameness, using sheep as a model.




«appl_num»                                                                                Page 5 of 6                                                       KP25S_F40 Version: 2 Issued: 10/08/2007
                                                                                                                                                                                          Inherited
Data         Data            Author(s)                               Title                               Date          Data Type           Data Sub-type              Authorising        Application
No           Source*                                                                                                                                                    Party                No.
45169        S         Alan Coates, Suzanne   On the Receiving end - Patient Perception of the         20        Efficacy and Safety   Other Information           Public
                       Abraham, S.B.Kaye,     Side-effects of Cancer Chemotherapy                      August
                       Timothy Sowerbutts,                                                             1982
                       Cheryl Frewin,
                       R.M.Fox, M.H.N.
                       Tattersall
45168        S         J.G. Boogaerts, E.     Assessment of postoperative nausea using a               23 Sept   Efficacy and Safety   Other Information           Public
                       Vanacker, L. Seidel,   visual analogue scale.                                   1999
                       A. Albert and F.M.
                       Bardiau
45172        S         Anon                   EMEND (aprepitant) CAPSULES                              April     Efficacy and Safety   Pharmacological             MERCK&CO,
                                                                                                       2008                            Data/Studies                INC




* S = Data submitted with the application
 I = Data inherited (that is, referenced) from another application




«appl_num»                                                                               Page 6 of 6                                                       KP25S_F40 Version: 2 Issued: 10/08/2007

				
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