4107 results
Keyword vaccination Remove keyword
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Veterinary medicine European public assessment report (EPAR): Bovilis Blue-8
bluetongue virus vaccine, serotype 8 (inactivated), Cattle; Sheep
Date of authorisation: 21/11/2017, Revision: 4, Authorised, Last updated: 20/12/2021bluetongue virus vaccine (inactivated) serotype 8 … Blue-8 bluetongue virus vaccine, serotype 8 (inactivated … for? Bovilis Blue-8 is a vaccine used in cattle and sheep … -
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Veterinary medicine European public assessment report (EPAR): Coxevac
inactivated Coxiella burnetii vaccine, strain Nine Mile, Goats; Cattle
Date of authorisation: 30/09/2010, Revision: 7, Authorised, Last updated: 21/07/2020inactivated Coxiella burnetii vaccine … Inactivated Coxiella burnetii vaccine This document is a summary … Coxevac is a veterinary vaccine that contains inactivated … -
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Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013,
, 
, Revision: 23, Authorised, Last updated: 22/12/2022
Mixtures Biological Products Vaccines Viral Vaccines Monkeypox Smallpox Vaccine Monkeypox virus … rised smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara) Overview Imvanex … Ankara) Overview Imvanex is a vaccine used to protect against smallpox … -
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Veterinary medicine European public assessment report (EPAR): Bovilis BTV8
bluetongue virus vaccine, serotype 8 (inactivated), Sheep; Cattle
Date of authorisation: 06/09/2010, Revision: 4, Withdrawn, Last updated: 27/07/2022BTV8 Inactivated adjuvanted vaccine against bluetongue virus … BTV8? Bovilis BTV8 is a vaccine that contains an inactivated … Bovilis BTV8 is serotype 8. The vaccine is used to prevent viraemia … -
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Human medicine European public assessment report (EPAR): Rotarix
human rotavirus, live attenuated, Immunization; Rotavirus Infections
Date of authorisation: 21/02/2006, Revision: 40, Authorised, Last updated: 29/06/2022Authorised rotavirus vaccine, live Overview This is a summary … is Rotarix? Rotarix is a vaccine that is given by mouth. It … official recommendations. The vaccine can only be obtained with … -
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Herbal medicinal product: Vaccinii macrocarpi fructus
Vaccinium macrocarpon Aiton, Cranberry, F: Assessment finalised, Last updated: 29/11/2022Vaccinii macrocarpi fructus … this information. Key facts Vaccinii macrocarpi fructusCranberryVaccinium … Union herbal monograph on Vaccinium macrocarpon Aiton, fructus … -
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Referral: Preflucel
influenza vaccine, purified antigen, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 10/12/2012, Last updated: 20/07/2012of the seasonal influenza vaccine Preflucel, following an increase … Preflucel? Preflucel is a vaccine used to prevent seasonal … a study to show that the vaccine produced by the revised process … -
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Referral: Engerix B
hepatitis B recombinant vaccine, adsorbed, Article 30 referrals
Status: European Commission final decision, opinion/position date: 13/04/2000, EC decision date: 28/08/2000, Last updated: 28/08/2000SmithKline Beecham, for Engerix B vaccine in all 15 EU Member States … Name: recombinant hepatitis B vaccine: Background information an … Bhepatitis B recombinant vaccine, adsorbedAbout this procedureCPMP/1493/01 … -
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Human medicine European public assessment report (EPAR): Celvapan
Whole virion influenza vaccine, inactivated containing antigen of strain A/California/07/2009 (H1N1)v, Disease Outbreaks; Influenza, Human; Immunization
Date of authorisation: 04/03/2009, Revision: 11, Withdrawn, Last updated: 21/12/2016Withdrawn influenza vaccine (H1N1)v (whole virion, Vero … gt;CelvapanEMEA/H/C/000982Whole virion influenza vaccine, inactivated containing antigen … A/California/07/2009 (H1N1)vinfluenza vaccine (H1N1)v (whole virion, Vero … -
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,
, , Revision: 25, Authorised, Last updated: 30/11/2022
xzevria (previously COVID-19 Vaccine AstraZeneca) Myelitis Respiratory … xzevria (previously COVID-19 Vaccine AstraZeneca … events (SMQ) with COVID-19 Vaccine (ChAdOx1-S [recombinant … -
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Human medicine European public assessment report (EPAR): Vaxneuvance
pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections
Date of authorisation: 13/12/2021,, Revision: 3, Authorised, Last updated: 29/11/2022
polysaccharide conjugate vaccine (adsorbed) Overview Vaxneuvance … Overview Vaxneuvance is a vaccine used to protect against three … polysaccharide conjugate vaccine, 15-valent, adsorbed) An … -
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Human medicine European public assessment report (EPAR): Vaxchora
vibrio cholerae, strain cvd 103-hgr, live, Cholera
Date of authorisation: 01/04/2020,, Revision: 6, Authorised, Last updated: 27/09/2022
Authorised cholera vaccine, oral, live Overview Vaxchora … live Overview Vaxchora is a vaccine to prevent cholera disease … causes severe diarrhoea. The vaccine contains a weakened form … -
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Human medicine European public assessment report (EPAR): RotaTeq
rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1, Immunization; Rotavirus Infections
Date of authorisation: 26/06/2006, Revision: 34, Authorised, Last updated: 16/08/2022rotavirus vaccine, live … RotaTeq, INN-Rotavirus vaccine, live 30 Churchill … public RotaTeq rotavirus vaccine, live This document is a … -
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Veterinary medicine European public assessment report (EPAR): Suvaxyn Circo
porcine circovirus vaccine (inactivated, recombinant), Pigs (for fattening)
Date of authorisation: 07/02/2018, Revision: 2, Authorised, Last updated: 30/10/2020porcine circovirus vaccine (inactivated, recombinant … Circo porcine circovirus vaccine (inactivated) This is a … Suvaxyn Circo is a veterinary vaccine used to protect pigs over … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002862-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: XEMEA-002862-PIP01-20-M01 Vaccines … Vaxzevria (previously COVID-19 Vaccine AstraZeneca) Active substance … Active substance COVID-19 vaccine (ChAdOx1-S [recombinant … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vaxchora, Cholera vaccine, live attenuated, oral (strain CVD 103-HgR)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001490-PIP01-13-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension, Age-appropriate oral liquid dosage form
Decision date: 22/12/2020, Last updated: 22/09/2021, Compliance check: XEMEA-001490-PIP01-13-M02 Vaccines … Active substance Cholera vaccine, live attenuated, oral (strain … 103-HgR) Therapeutic area Vaccines Decision number P/0509/2020 … -
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Human medicine European public assessment report (EPAR): Menveo (updated)
meningococcal group A, C, W-135 and Y conjugate vaccine, Immunization; Meningitis, Meningococcal
Date of authorisation: 15/03/2010,
Date of refusal: 17/12/2009, Revision: 32, Authorised, Last updated: 30/01/2023C, W-135 and Y conjugate vaccine … is Menveo? Menveo is a vaccine that contains parts of the … blood infection). The vaccine should be given according … -
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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 (previously … previously Pandemic influenza vaccine H5N1 Medimmune) Respiratory … Authorised pandemic influenza vaccine (H5N1) (live attenuated … -
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Veterinary medicine European public assessment report (EPAR): Suiseng Diff/A
Clostridioides difficile toxoid A, Clostridioides difficile toxoid B, Clostridium perfringens, type A, alpha toxoid, Pigs
Date of authorisation: 07/12/2021, Authorised, Last updated: 24/01/2022clostridium perfringens vaccine, inactivated … Clostridium perfringens vaccine, inactivated) An overview … Suiseng Diff/A is a veterinary vaccine given to sows (female pigs … -
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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: 7, Authorised, Last updated: 26/04/2022
Pandemic Influenza Vaccine H5N1 Baxter AG Respiratory … Authorised pandemic influenza vaccine (H5N1) (whole virion, inactivated … What is Pandemic Influenza Vaccine H5N1 Baxter AG? Pandemic … -
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Veterinary medicine European public assessment report (EPAR): Rabitec
attenuated live rabies vaccine virus, strain SPBN GASGAS, Red foxes (Vulpes vulpes); Raccoon dogs (Nyctereutes procyonoides)
Date of authorisation: 01/12/2017, Revision: 3, Authorised, Last updated: 07/01/2021Rabies vaccine (live, oral) for foxes and … Bait: PE sleeve 800 vaccinal baits (1 x 800) Not … Bait: PE sleeve 800 vaccinal baits (4 x 200) Not … -
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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 … inactivated, adjuvanted) Novartis Vaccines and Diagnostics Influenza … hdrawn prepandemic influenza vaccine (H5N1) (surface antigen … -
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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
Withdrawn pandemic influenza vaccine (H5N1) (split virion, inactivated … gt;PumarixEMEA/H/C/001212pandemic influenza vaccine (H5N1) (split virion, inactivated … adjuvanted) pandemic influenza vaccine (H5N1) (split virion, inactivated … -
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Veterinary medicine European public assessment report (EPAR): Innovax-ND-ILT
Cell-associated live recombinant turkey herpesvirus (strain HVT/NDV/ILT) expressing the fusion protein of newcastle disease virus and the glycoproteins gD and gI of infectious laryngotracheitis virus, Embryonated chicken eggs; Chicken
Date of authorisation: 16/09/2020, Revision: 1, Authorised, Last updated: 24/03/2021Marek's disease vaccine, Newcastle disease vaccine & infectious laryngotracheitis … infectious laryngotracheitis vaccine (live recombinant … Innovax-ND-ILT (Marek's disease vaccine, Newcastle disease vaccine and infectious laryngotracheitis … -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/04/2021xzevria (previously COVID-19 Vaccine AstraZeneca): link between … AstraZeneca): link between the vaccine and the occurrence of thrombosis … xzevria (previously COVID-19 Vaccine AstraZeneca): link between …