869 results
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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,
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, Revision: 40, Authorised, Last updated: 28/09/2023
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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: 44, Authorised, Last updated: 28/09/2023
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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: 27/09/2023
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
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): Paxlovid (updated)
nirmatrelvir, ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022, Revision: 13, Authorised, Last updated: 21/09/2023 -
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Human medicine European public assessment report (EPAR): Xevudy (updated)
Sotrovimab, COVID-19 virus infection
Date of authorisation: 17/12/2021,, Revision: 9, Authorised, 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): Regkirona
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 8, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Nuvaxovid
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, Revision: 10, Authorised, Last updated: 24/08/2023
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Human medicine European public assessment report (EPAR): Veklury
remdesivir, COVID-19 virus infection
Date of authorisation: 03/07/2020,, Revision: 21, Authorised, Last updated: 24/08/2023
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Human medicine European public assessment report (EPAR): Evusheld
tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022,, Revision: 3, Authorised, Last updated: 18/08/2023
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Human medicine European public assessment report (EPAR): Kineret
anakinra, Arthritis, Rheumatoid; COVID-19 virus infection
Date of authorisation: 08/03/2002, Revision: 34, Authorised, Last updated: 17/07/2023 -
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Human medicine European public assessment report (EPAR): Ronapreve
casirivimab, imdevimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 5, Authorised, Last updated: 10/07/2023
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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: 04/07/2023
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Human medicine European public assessment report (EPAR): RoActemra
tocilizumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Cytokine Release Syndrome; Giant Cell Arteritis; COVID-19 virus infection
Date of authorisation: 15/01/2009, Revision: 41, Authorised, Last updated: 04/04/2023 -
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Human medicine European public assessment report (EPAR): VidPrevtyn Beta
SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain), COVID-19 virus infection
Date of authorisation: 10/11/2022,, Authorised, Last updated: 30/11/2022
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Withdrawn application: Lagevrio
molnupiravir, date of withdrawal: 21/06/2023, Initial authorisation, Last updated: 09/08/2023 -
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Withdrawal from the rolling review process: CureVac’s COVID-19 vaccine (CVnCoV)
COVID-19 mRNA vaccine, date of withdrawal: 11/10/2021, Initial authorisation, Last updated: 21/10/2021 -
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Withdrawal from the rolling review process: Bamlanivimab and etesevimab for COVID-19
date of withdrawal: 02/11/2021, Initial authorisation, Last updated: 02/11/2021 -
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Withdrawn application: Skycovion (new)
GBP510, date of withdrawal: 01/09/2023, Initial authorisation, Last updated: 15/09/2023 -
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Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 26/04/2021 -
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Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE)
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 13/10/2021 -
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Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: Contraindication in individuals with previous capillary leak syndrome and update on thrombosis with thrombocytopenia syndrome
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 19/07/2021 -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders
Active substance: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), DHPC type: Safety signal, Last updated: 24/03/2021 -
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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: 13/04/2021