83 results
Keyword sotrovimab Remove keyword
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 31/05/2023 -
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
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,
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, Revision: 37, Authorised, Last updated: 31/05/2023
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Newsletters (updated)
Last updated: 30/05/2023 -
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List of medicines under additional monitoring (updated)
Last updated: 30/05/2023 -
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COVID-19: latest updates (updated)
Last updated: 25/05/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 27-30 March 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 27/03/2023 to 30/03/2023, Last updated: 22/05/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 May 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 22/05/2023 to 25/05/2023, Last updated: 22/05/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/05/2023 -
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Annual reports and work programmes (updated)
Last updated: 15/05/2023 -
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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: 28, Authorised, Last updated: 12/05/2023
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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
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Paediatric Committee (PDCO): 28-31 March 2023 (updated)
Virtual meeting, from 28/03/2023 to 31/03/2023, Last updated: 11/05/2023 -
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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): Paxlovid
nirmatrelvir, ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022, Revision: 11, Authorised, Last updated: 03/05/2023 -
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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: 4, Authorised, Last updated: 28/04/2023
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Committee for Medicinal Products for Human Use (CHMP): 20-23 February 2023
European Medicines Agency, Amsterdam, the Netherlands, from 20/02/2023 to 23/02/2023, Last updated: 24/04/2023 -
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Paediatric Committee (PDCO): 24-26 April 2023
Virtual meeting, from 24/04/2023 to 26/04/2023, Last updated: 24/04/2023 -
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PDCO: Agendas, minutes and reports
Last updated: 24/04/2023 -
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Human medicine European public assessment report (EPAR): Regkirona
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 7, Authorised, Last updated: 21/04/2023
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Exemptions to labelling and package-leaflet obligations
Last updated: 19/04/2023 -
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Availability of medicines during COVID-19 pandemic
Last updated: 19/04/2023 -
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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): 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): 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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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023
PRAC, Last updated: 17/03/2023