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Guidance documents
Last updated: 20/04/2020Guidance documents … Agency's general guidance documents relating to veterinary medici … of a question and answer document, is intended to clarify how …
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Product information: Reference documents and guidelines
Last updated: 31/12/2020oduct information: Reference documents and guidelines … This page lists the reference documents and guidelines on the quality … vaccines Quality Review of Documents (QRD) group 1. Introduction …
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Working Group on Quality Review of Documents
Group on Quality Review of Documents … Group on Quality Review of Documents … Group on Quality Review of Documents …
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Veterinary medicine European public assessment report (EPAR): Palladia (updated)
toceranib, Dogs
Date of authorisation: 23/09/2009, Revision: 10, Authorised, Last updated: 30/03/2021CVMP) on the basis of the documentation provided, led to the recommendations … leaflet or the label to the doctor. For more information, see … outer package. Summary documents Palladia : EPAR - Summary … -
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Veterinary medicine European public assessment report (EPAR): Syvazul BTV (updated)
Inactivated bluetongue virus, serotype 1, strain ALG2006/01 E1, Inactivated bluetongue virus, serotype 4, strain BTV-4/SPA-1/2004, Inactivated bluetongue virus, serotype 8, strain BEL2006/01, Cattle, Sheep
Date of authorisation: 09/01/2019, Revision: 2, Authorised, Last updated: 08/04/2021been included in the A document describing the properties … leaflet or label shown to the doctor. What is the withdrawal period … on 9 January 2019. Summary documents Syvazul BTV : EPAR - Medicine … -
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Veterinary medicine European public assessment report (EPAR): Fortekor Plus (updated)
benazepril hydrochloride, pimobendan, Dogs
Date of authorisation: 08/09/2015, Revision: 4, Authorised, Last updated: 23/03/2021a person, the advice of a doctor should be sought immediately … leaflet or label shown to the doctor. Pregnant women should take … veterinarian or pharmacist. Summary documents Fortekor Plus : EPAR - Summary … -
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Veterinary medicine European public assessment report (EPAR): Equioxx (updated)
firocoxib, Horses
Date of authorisation: 25/06/2008, Revision: 10, Authorised, Last updated: 22/03/2021themselves, the advice of a doctor should be sought immediately … leaflet or label shown to the doctor. What is the withdrawal period … veterinarian or pharmacist. Summary documents Equioxx : EPAR - Summary … -
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Veterinary medicine European public assessment report (EPAR): Comfortis (updated)
spinosad, Dogs, Cats
Date of authorisation: 11/02/2011, Revision: 9, Authorised, Last updated: 18/03/2021CVMP) on the basis of the documentation provided, led to the recommendations … or the label shown to the doctor. Why has Comfortis been approved … label/outer package. Summary documents Comfortis : EPAR - Summary … -
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Veterinary medicine European public assessment report (EPAR): Zolvix (updated)
monepantel, Sheep
Date of authorisation: 04/11/2009, Revision: 14, Authorised, Last updated: 18/03/2021CVMP) on the basis of the documentation provided, led to the recommendations … or the label shown to the doctor. The user must not eat, drink … label/outer package. Summary documents Zolvix : EPAR - Summary for … -
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Veterinary medicine European public assessment report (EPAR): Nobivac Myxo-RHD (updated)
live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009, Rabbits
Date of authorisation: 07/09/2011, Revision: 4, Authorised, Last updated: 25/03/2021CVMP) on the basis of the documentation provided, led to the recommendations … outer package. Summary documents Nobivac Myxo-RHD : EPAR … RHD virus strain 009 This document is a summary of the European … -
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Veterinary medicine European public assessment report (EPAR): Coliprotec F4/F18
Live non-pathogenic Escherichia coli O141:K94 (F18ac) and O8:K87 (F4ac), Pigs
Date of authorisation: 09/01/2017, Revision: 3, Authorised, Last updated: 01/03/2021leaflet or label shown to the doctor. In case of spillage onto … leaflet or label shown to the doctor. What is the withdrawal period … veterinarian or pharmacist. Summary documents Coliprotec F4/F18 : EPAR … -
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Veterinary medicine European public assessment report (EPAR): Purevax RCPCh
attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain), attenuated feline panleucopenia virus (PLI IV), Cats
Date of authorisation: 23/02/2005, Revision: 16, Authorised, Last updated: 09/03/2021or the label shown to the doctor. The vaccine should not be … in these people, tell the doctor that self-injection with … 23 February 2005. Summary documents Purevax RCPCh : EPAR - Medicine … -
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Veterinary medicine European public assessment report (EPAR): Spironolactone Ceva
spironolactone, Dogs
Date of authorisation: 20/06/2007, Revision: 7, Authorised, Last updated: 24/02/2021a person, the advice of a doctor should be sought immediately … leaflet or label shown to the doctor. Why is Spironolactone Ceva … 25 November 2016. Summary documents Prilactone : EPAR - Medicine … -
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Veterinary medicine European public assessment report (EPAR): Purevax RCP FeLV
attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), Cats
Date of authorisation: 23/02/2005, Revision: 14, Authorised, Last updated: 10/03/2021CVMP) on the basis of the documentation provided, led to the recommendations … the conditions of use. This document cannot replace a face-to-face … or the label shown to the doctor. Why has Purevax RCP FeLV … -
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Veterinary medicine European public assessment report (EPAR): Aivlosin (updated)
tylvalosin, Pheasants, Chicken, Turkeys, Pigs
Date of authorisation: 09/09/2004, Revision: 33, Authorised, Last updated: 29/03/2021leaflet or label shown to the doctor. What is the withdrawal period … 9 September 2004. Summary documents Aivlosin : EPAR - Medicine … -
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Veterinary medicine European public assessment report (EPAR): Meloxoral
meloxicam, Dogs, Cats
Date of authorisation: 19/11/2010,
, Revision: 7, Authorised, Last updated: 12/03/2021
CVMP) on the basis of the documentation provided, led to the recommendations … a person, the advice of a doctor should be sought immediately … label of the carton. Summary documents Meloxoral : EPAR - Summary … -
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Veterinary medicine European public assessment report (EPAR): Purevax RC
attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), Cats
Date of authorisation: 23/02/2005, Revision: 15, Authorised, Last updated: 10/03/2021or the label shown to the doctor. Why is Purevax RC authorised … February 2005. Summary documents Purevax RC : EPAR - Medicine … or the label shown to the doctor. Why is Purevax RC authorised … -
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N2 (updated)
inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), Chicken
Date of authorisation: 01/09/2006,
, Revision: 8, Authorised, Last updated: 25/03/2021
CVMP) on the basis of the documentation provided, led to the recommendations … 1 September 2006. Summary documents Nobilis Influenza H5N2 … and/or distribution of this document is authorised for non commercial … -
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Veterinary medicine European public assessment report (EPAR): Cortavance
hydrocortisone aceponate, Dogs
Date of authorisation: 09/01/2007, Revision: 8, Authorised, Last updated: 25/02/2021leaflet or the label to the doctor. Spray preferably in a well … on 9 January 2007. Summary documents Cortavance : EPAR - Medicine … leaflet or the label to the doctor. Spray preferably in a well … -
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Veterinary medicine European public assessment report (EPAR): Easotic
gentamicin sulfate, hydrocortisone aceponate, miconazole nitrate, Dogs
Date of authorisation: 19/11/2008, Revision: 9, Authorised, Last updated: 24/02/2021leaflet or the label to a doctor. Why is Easotic authorised … 20 November 2008. Summary documents Easotic : EPAR - Medicine … leaflet or the label to a doctor. Why is Easotic authorised … -
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Veterinary medicine European public assessment report (EPAR): Purevax RCP
attenuated feline panleucopenia virus (PLI IV), Cats
Date of authorisation: 23/02/2005, Revision: 16, Authorised, Last updated: 08/03/2021or the label shown to the doctor. Why is Purevax RCP authorised … 23 February 2005. Summary documents Purevax RCP : EPAR - Medicine … or the label shown to the doctor. Why is Purevax RCP authorised … -
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Veterinary medicine European public assessment report (EPAR): Posatex
orbifloxacin, Mometasone furoate, posaconazole, Dogs
Date of authorisation: 23/06/2008, Revision: 9, Authorised, Last updated: 23/02/2021leaflet or the label to a doctor. If accidental skin contact … on 23 June 2008. Summary documents Posatex : EPAR - Medicine … leaflet or the label to a doctor. If accidental skin contact … -
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Veterinary medicine European public assessment report (EPAR): Purevax RCPCh FeLV
attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), attenuated Chlamydophila felis (905 strain), Cats
Date of authorisation: 23/02/2005, Revision: 14, Authorised, Last updated: 08/03/2021or the label shown to the doctor. The vaccine should not be … occur in these people, the doctor should be told that self-injection … 23 February 2005. Summary documents Purevax RCPCh FeLV : EPAR … -
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Veterinary medicine European public assessment report (EPAR): Purevax FeLV
feline leukaemia virus recombinant canarypox virus (vCP97), Cats
Date of authorisation: 13/04/2000, Revision: 12, Authorised, Last updated: 05/03/2021leaflet or the label to the doctor. Why is Purevax FeLV authorised … on 18 April 2005. Summary documents Purevax FeLV : EPAR - Medicine … leaflet or the label to the doctor. Why is Purevax FeLV authorised … -
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Veterinary medicine European public assessment report (EPAR): Gumbohatch
live attenuated infectious bursal disease virus (IBDV), strain 1052, Chicken, Embryonated chicken eggs
Date of authorisation: 12/11/2019, Revision: 2, Authorised, Last updated: 05/03/2021leaflet or label shown to the doctor. What is the withdrawal period … November 2019. Summary documents Gumbohatch : EPAR - Medicine …