1955 results
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Veterinary medicine European public assessment report (EPAR): Respiporc Flu3
inactivated influenza-A virus / swine, Pigs
Date of authorisation: 14/01/2010, Revision: 5, Authorised, Last updated: 16/02/2021inactivated influenza-A virus / swine … Respiporc FLU3 (inactivated influenza-A virus / swine) An overview … different strains of swine influenza A virus which have been inactivated … -
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Veterinary medicine European public assessment report (EPAR): Gripovac 3
inactivated influenza-A virus, swine, Pigs
Date of authorisation: 14/01/2010, Revision: 1, Withdrawn, Last updated: 04/09/2018Withdrawn inactivated influenza-A virusswine Overview The marketing … 3EMEA/V/C/000157inactivated influenza-A virusswineinactivated influenza-A virusswinePigsQI09AA03 Publication … different strains of swine influenza A virus which have been … -
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Human medicine European public assessment report (EPAR): Supemtek
Influenza A virus subtype H1N1 haemagglutinin, recombinant, Influenza A virus subtype H3N2 haemagglutinin, recombinant, Influenza B virus Victoria lineage haemagglutinin, recombinant, Influenza B virus Yamagata lineage haemagglutinin, recombinant, Influenza, Human
Date of authorisation: 16/11/2020,
, Revision: 2, Authorised, Last updated: 28/07/2022
Infections Orthomyxoviridae Infections Influenza, Human … Quadrivalent influenza vaccine (recombinant, prepared … syringe Quadrivalent Influenza Vaccine (recombinant, prepared … -
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Veterinary medicine European public assessment report (EPAR): Equilis Prequenza
equine influenza-virus strains: A/equine-2/South Africa/4/03, A/equine-2/Newmarket/2/93, Horses
Date of authorisation: 08/07/2005, Revision: 9, Authorised, Last updated: 16/12/2020rised vaccine against equine influenza in horses Overview This document … whole virus of two equine influenza (flu) strains (‘A/equine-2/South … months of age against equine influenza. Equine … -
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Veterinary medicine European public assessment report (EPAR): Equilis Prequenza Te
equine influenza-virus strains: A/equine-2/South Africa/4/03, A/equine-2/Newmarket/2/93, tetanus toxoid, Horses
Date of authorisation: 08/07/2005, Revision: 10, Authorised, Last updated: 10/12/2020rised vaccine against equine influenza and tetanus in horses Overview … whole virus of two equine influenza (flu) strains (‘A/equine-2/South … months of age against equine influenza and tetanus. The vaccine … -
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Human medicine European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human
Date of authorisation: 20/05/2016,, 
, Revision: 9, Authorised, Last updated: 06/10/2022
Pandemic influenza vaccine H5N1 AstraZeneca … AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) Respiratory … Infections Orthomyxoviridae Infections Influenza, Human … -
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Opinion/decision on a Paediatric investigation plan (PIP): A/California/7/2009 influenza-like virus strain
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000663-PIP01-09-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 30/07/2010, Last updated: 26/08/2010, Compliance check: XKey facts A/California/7/2009 influenza-like virus strain VaccinesP/146/2010EMEA-000663-PIP01-09-M03 … Suspension for injection Influenza Intramuscular use Novartis … plan for A/California/7/2009 influenza-like virus strain (EMEA-000663-PIP01-09-M03 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza Virus Type A, H3N2Influenza Virus Type A, H1N1Influenza Virus Type B
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Vaccines
PIP number: EMEA-000249-PIP01-08, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray suspension
Decision date: 03/11/2008, Last updated: 07/01/2009, Compliance check: XKey facts Influenza Virus Type A, H3N2 Influenza Virus Type A, H1N1 Influenza Virus Type B VaccinesP/101/2008EMEA-000249-PIP01-08 … Microsoft Word - Decision influenza virus EMEA-000249-PIP01-08 … product specific waiver for influenza virus type A, H3N2 influenza virus type A, H1N1 influenza virus type B (EMEA-000249-PIP01-08 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype), Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype), Recombinant Influenza Hemagglutinin-strain B (Victoria lineage), Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage) (RIV4)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002418-PIP01-18-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 17/06/2019, Last updated: 08/11/2019, Compliance check: XKey facts Recombinant Influenza Hemagglutinin-strain A (H1N1 … H1N1 subtype) Recombinant Influenza Hemagglutinin-strain A (H3N2 … H3N2 subtype) Recombinant Influenza Hemagglutinin-strain B (Victoria … -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus H1 haemagglutinin, influenza virus haemagglutinin from strain B Yamagata lineage (expressed as virus-like particle [VLP]), influenza virus H3 haemagglutinin, influenza virus haemagglutinin from strain B Victoria lineage
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-002220-PIP01-17, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 11/04/2018, Last updated: 26/07/2018, Compliance check: XKey facts Influenza virus H1 haemagglutinin influenza virus haemagglutinin from … virus-like particle [VLP]) influenza virus H3 haemagglutinin influenza virus haemagglutinin from … granting of a waiver for influenza virus H1 haemagglutinin influenza virus H3 haemagglutinin influenza virus haemagglutinin from … -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus type A, H1N1, influenza virus type A, H3N2, influenza virus type B, Yamagata lineage, influenza virus type B, Victoria lineage
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001051-PIP01-10-M03, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray
Decision date: 12/10/2012, Last updated: 26/11/2012, Compliance check: V, 14/06/2013Key facts Influenza virus type A, H1N1 influenza virus type A, H3N2 influenza virus type B, Yamagata lineage … paediatric investigation plan for Influenza Virus Type A, H1N1 Influenza Virus Type A, H3N2 Influenza Virus Type B, Yamagata lineage … -
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Veterinary medicine European public assessment report (EPAR): Poulvac Flufend H5N3 RG
recombinant inactivated avian influenza virus, Chicken; Ducks
Date of authorisation: 01/09/2006,
, 
, Revision: 8, Withdrawn, Last updated: 07/05/2012
recombinant inactivated avian influenza virus Overview The marketing … RGEMEA/V/C/000117recombinant inactivated avian influenza virusrecombinant inactivated … virusrecombinant inactivated avian influenza virusChickenDucksQI01AA23 … -
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009,, Revision: 8, Authorised, Last updated: 06/02/2023
Pandemic Influenza Vaccine H5N1 Baxter AG Respiratory … Prevention Public Health Practice Influenza, Human Immunization Disease … Pandemic Influenza Vaccine H5N1 Baxter AG … -
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Human medicine European public assessment report (EPAR): Foclivia
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 18/10/2009,, Revision: 12, Authorised, Last updated: 06/04/2022
Prevention Public Health Practice Influenza, Human Immunization Disease … Authorised pandemic influenza vaccine (H5N1) (surface antigen … parts of inactivated (killed) influenza (flu) virus. It contains … -
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Human medicine European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 10/10/2009,, Revision: 11, Authorised, Last updated: 08/06/2022
upanrix (previously Pandemic influenza vaccine (H5N1) (split virion … Prevention Public Health Practice Influenza, Human Immunization Disease … Authorised pandemic influenza vaccine (H5N1) (split virion … -
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Human medicine European public assessment report (EPAR): Pumarix
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) , Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 04/03/2011,, Revision: 4, Withdrawn, Last updated: 17/03/2015
Pumarix Influenza, Human Immunization Disease … Withdrawn pandemic influenza vaccine (H5N1) (split virion … gt;PumarixEMEA/H/C/001212pandemic influenza vaccine (H5N1) (split virion … -
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Veterinary medicine European public assessment report (EPAR): Respiporc FLUpan H1N1
Influenza A virus/human strain: A/Jena/VI5258/2009 (H1N1)pdm09, inactivated, Pigs
Date of authorisation: 17/05/2017, Revision: 6, Authorised, Last updated: 21/03/2022Authorised Porcine influenza vaccine (inactivated) Overview … weeks of age against swine influenza caused by pandemic subtype … pandemic subtype H1N1. Swine influenza or swine flu is a disease … -
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N2
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
Nobilis Influenza H5N2 … inactivated vaccine against avian influenza virus type A, subtype H5 … the EPAR). What is Nobilis Influenza H5N2? Nobilis Influenza H5N2 is a vaccine containing … -
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Human medicine European public assessment report (EPAR): Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 29/11/2010, Revision: 2, Withdrawn, Last updated: 07/03/2016Prepandemic influenza vaccine (H5N1) (surface antigen … Vaccines and Diagnostics Influenza, Human Immunization Disease … Withdrawn prepandemic influenza vaccine (H5N1) (surface antigen … -
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Human medicine European public assessment report (EPAR): Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 26/09/2008, Revision: 3, Withdrawn, Last updated: 21/03/2012Prepandemic Influenza Vaccine (H5N1) (Split Virion … GlaxoSmithKline Biologicals Influenza, Human Immunization Disease … Withdrawn prepandemic influenza vaccine (H5N1) (split virion … -
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H7N1
inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), Chicken; Ducks
Date of authorisation: 14/05/2007,, , Revision: 2, Withdrawn, Last updated: 26/07/2010
Nobilis Influenza H7N1 … inactivated vaccine against avian influenza virus type A, subtype H7 … authorisation for Nobilis Influenza H7N1 has been withdrawn at … -
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N6
inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84), Chicken
Date of authorisation: 31/01/2008,, , Revision: 1, Withdrawn, Last updated: 26/07/2010
Nobilis Influenza H5N6 … inactivated vaccine against avian influenza virus type A, subtype H5 … authorisation for Nobilis Influenza H5N6 has been withdrawn at … -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin) of strain A (H1N1), influenza virus surface antigens (haemagglutinin) of strain A (H3N2), influenza virus surface antigens (haemagglutinin) of strain B (Victoria lineage), influenza virus surface antigens (haemagglutinin) of strain B (Yamagata lineage)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002027-PIP02-17-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 10/09/2019, Last updated: 26/03/2020, Compliance check: XKey facts Influenza virus surface antigens (haemagglutinin … haemagglutinin) of strain A (H1N1) influenza virus surface antigens (haemagglutinin … haemagglutinin) of strain A (H3N2) influenza virus surface antigens (haemagglutinin … -
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Opinion/decision on a Paediatric investigation plan (PIP): Purified antigen fractions of inactivated split virion influenza virus type A, H1N1, influenza virus type A, H3N2, influenza virus type B, Victoria lineage, influenza virus type B, Yamagata lineage
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000817-PIP02-11-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 30/07/2013, Last updated: 19/01/2012, Compliance check: V, 21/04/2017inactivated split virion influenza virus type A, H1N1 influenza virus type A, H3N2 influenza virus type B, Victoria lineage … inactivated split virion Influenza virus type A, H1N1 Influenza virus type A, H3N2 Influenza virus type B, Victoria lineage … -
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Human medicine European public assessment report (EPAR): Aflunov
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 28/11/2010, Revision: 15, Authorised, Last updated: 03/10/2022Prevention Public Health Practice Influenza, Human Immunization Disease … Authorised zoonotic influenza vaccine (H5N1) (surface antigen … ‘bird flu’) strain of the influenza A virus. Aflunov contains …