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Keyword Evusheld Remove keyword
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Human medicine European public assessment report (EPAR): Evusheld (updated)
tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022,, Revision: 2, Authorised, Last updated: 12/05/2023
Evusheld Pneumonia, Viral Pneumonia Respiratory … tixagevimabcilgavimab Overview Evusheld is a medicine used to prevent … disease becoming severe. Evusheld contains two The substance … -
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News: EMA recommends authorisation of COVID-19 medicine Evusheld
CHMP, Last updated: 24/03/2022authorisation of COVID-19 medicine Evusheld … marketing authorisation for Evusheld, developed by AstraZeneca … to the SARS-CoV-2 virus. Evusheld is made of the The substance … -
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News: EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
CHMP, Last updated: 14/10/2021EMA starts rolling review of Evusheld (tixagevimab and cilgavimab … EMA starts rolling review of Evusheld (tixagevimab and cilgavimab … -
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News: ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2
Last updated: 09/12/2022body’s cells. These are Evusheld (tixagevimab / cilgavimab … course. References: 1: Evusheld EPAR Evusheld | European Medicines Agency … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 March 2022
CHMP, Last updated: 25/03/2022Evusheld … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022
CHMP, Last updated: 19/09/2022Evusheld … -
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COVID-19 treatments: authorised
Last updated: 12/08/2022Treatment Status More information Evusheld (tixagevimab / cilgavimab …
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COVID-19 treatments
Last updated: 14/10/2021Evusheld …
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National expert: Robin Vos, European Medicines Agency (updated)
- Declaration of interests - 44.25 KB | PDF
- Curriculum Vitae - 35.03 KB | PDF
activity Past 01-06- 2022 01-06- 2022 AstraZeneca Individual product related Evusheld COVID_19 null Past 01-11- 2017 01-11- 2017 Shire Individual … -
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Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants
Online, 13:00 - 17:00 Amsterdam time (CET), 15/12/2022, Last updated: 10/02/2023Modeling During COVID-19_Evusheld and Points to Consider (PDF/1.58 … -
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National expert: Saul Faust, European Medicines Agency (updated)
- Declaration of interests - 51.43 KB | PDF
- Curriculum Vitae - 106.52 KB | PDF
indication Current 01-01- 2022 22-03- 2023 AstraZeneca Evusheld Paediatric use 1.6 Investigator Time … -
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva
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: 04/04/2023
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Human medicine European public assessment report (EPAR): Veklury (updated)
remdesivir, COVID-19 virus infection
Date of authorisation: 03/07/2020,, Revision: 18, Authorised, Last updated: 11/05/2023
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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: 8, Authorised, Last updated: 27/03/2023
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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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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: 28, Authorised, Last updated: 12/05/2023
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National expert: Christophe Richez, European Medicines Agency (updated)
- Declaration of interests - 60.86 KB | PDF
- Curriculum Vitae - 29.16 KB | PDF
ZENECA Individual product related Evusheld Covid_19 null Current 01-10- 2022 22-03- 2023 GSK Cross … -
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna)
CX-024414 (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: 36, Authorised, Last updated: 12/04/2023
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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: 28, Authorised, Last updated: 17/02/2023
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Human medicine European public assessment report (EPAR): Comirnaty
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: 41, Authorised, Last updated: 24/03/2023
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COVID-19: latest updates (updated)
Last updated: 25/05/2023published clinical data for Evusheld supporting its use to treat … published clinical data for Evusheld supporting its use to prevent …
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Withdrawn application: Olumiant
baricitinib, date of withdrawal: 07/12/2022, Post-authorisation, Last updated: 02/02/2023 -
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Exemptions to labelling and package-leaflet obligations
Last updated: 19/04/2023 -
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Management Board meeting: 16 March 2023
European Medicines Agency, Amsterdam, the Netherlands, 16/03/2023, Last updated: 04/04/2023 -
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List of medicines under additional monitoring
Last updated: 26/04/2023