379 results
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Human medicine European public assessment report (EPAR): Prevenar 13 (updated)
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal Infections; Immunization
Date of authorisation: 09/12/2009, Revision: 45, Authorised, Last updated: 27/11/2023 -
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Human medicine European public assessment report (EPAR): Zabdeno (updated)
Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,
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, Revision: 5, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Mvabea (updated)
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,, , Revision: 4, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
Single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 06/01/2021,
, , Revision: 41, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS CoV-2 (Original) recombinant spike protein, SARS-CoV-2 (Omicron XBB.1.5) recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, Revision: 11, Authorised, Last updated: 08/11/2023
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Human medicine European public assessment report (EPAR): VidPrevtyn Beta (updated)
SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain), COVID-19 virus infection
Date of authorisation: 10/11/2022,, Revision: 1, Authorised, Last updated: 08/11/2023
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Human medicine European public assessment report (EPAR): PreHevbri (updated)
hepatitis B surface antigen, Hepatitis B
Date of authorisation: 25/04/2022,, Revision: 2, Authorised, Last updated: 07/11/2023
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, , Revision: 45, Authorised, Last updated: 31/10/2023
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva (updated)
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,, Revision: 6, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Trumenba
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B, Meningitis, Meningococcal
Date of authorisation: 24/05/2017, Revision: 15, Authorised, Last updated: 20/10/2023 -
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, Revision: 30, Authorised, Last updated: 10/10/2023
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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: 7, Authorised, Last updated: 06/10/2023
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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: 13, Authorised, Last updated: 03/10/2023
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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: 5, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Infanrix Hexa
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis B surface antigen, poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)), Haemophilus influenzae type b polysaccharide, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 23/10/2000, Revision: 47, Authorised, Last updated: 21/09/2023 -
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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: 30, Authorised, Last updated: 21/09/2023
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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, Withdrawn, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Bimervax
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains, COVID-19 virus infection
Date of authorisation: 30/03/2023,, Revision: 2, Authorised, Last updated: 01/09/2023
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Human medicine European public assessment report (EPAR): Dengvaxia
chimeric yellow fever dengue virus serotype 1 (live, attenuated), chimeric yellow fever dengue virus serotype 2 (live, attenuated), chimeric yellow fever dengue virus serotype 3 (live, attenuated), chimeric yellow fever dengue virus serotype 4 (live, attenuated), Dengue
Date of authorisation: 12/12/2018, Revision: 5, Authorised, Last updated: 23/08/2023 -
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Human medicine European public assessment report (EPAR): Ervebo
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019,, Revision: 8, Authorised, Last updated: 23/08/2023
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Human medicine European public assessment report (EPAR): Fluenz Tetra
A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) / A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) / B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) / B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444), Influenza, Human
Date of authorisation: 04/12/2013, Revision: 24, Authorised, Last updated: 07/08/2023 -
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Human medicine European public assessment report (EPAR): Flucelvax Tetra
A/Darwin/6/2021(H3N2)-like strain (A/Darwin/11/2021, wild type) / A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022 CVR-167) / B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021) / B/Phuket/3073/2013-like virus (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 14, Authorised, Last updated: 07/08/2023
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Human medicine European public assessment report (EPAR): Fluad Tetra
A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/6/2021, IVR-227) / A/Victoria/4897/2022 (H1N1) pdm09-like strain (A/Victoria/4897/2022, IVR-238) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) / Influenza virus B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26), Influenza, Human
Date of authorisation: 20/05/2020,, Revision: 7, Authorised, Last updated: 04/08/2023
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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: 41, Authorised, Last updated: 31/07/2023 -
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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: 3, Authorised, Last updated: 26/07/2023