101 results
Keyword paxlovid Remove keyword
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List of medicines under additional monitoring (updated)
Last updated: 29/11/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 27/11/2023 -
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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: 5, Authorised, Last updated: 22/11/2023
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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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CHMP: Agendas, minutes and highlights (updated)
Last updated: 10/11/2023 -
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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): 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
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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Pharmacovigilance Risk Assessment Committee (PRAC): 28-31 August 2023
European Medicines Agency, Amsterdam, the Netherlands, from 28/08/2023 to 31/08/2023, Last updated: 27/10/2023 -
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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: 15, Authorised, Last updated: 19/10/2023Paxlovid Pneumonia, Viral Respiratory … nirmatrelvirritonavir Overview Paxlovid is a medicine used for treating … disease becoming severe. Paxlovid contains two The substance … -
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Opinion/decision on a Paediatric investigation plan (PIP): Paxlovid, (1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2- trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-003081-PIP01-21-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 01/12/2022, Last updated: 13/10/2023, Compliance check: XInvented name Paxlovid Active substance (1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2 … 1R,2S,5S)-N- ((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2- trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide / ritonavir (Paxlovid), (EMEA-003081-PIP01-21-M02 … -
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Newsletters
Last updated: 11/10/2023 -
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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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Public data from Article 57 database
Last updated: 09/10/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 17-20 July 2023
European Medicines Agency, Amsterdam, the Netherlands, from 17/07/2023 to 20/07/2023, Last updated: 06/10/2023 -
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10th anniversary of European Medicines Agency (EMA) Healthcare Professionals' (HCPWP) Working Party meeting
Amsterdam, 27/06/2023, Last updated: 21/09/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 July 2023
European Medicines Agency, Amsterdam, the Netherlands, from 03/07/2023 to 06/07/2023, Last updated: 21/09/2023 -
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COVID-19 medicines
Last updated: 15/09/2023granted: 17/12/2021 Latest news Paxlovid (PF-07321332 / ritonavir …
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Committee for Medicinal Products for Human Use (CHMP): 11-14 September 2023
European Medicines Agency, Amsterdam, the Netherlands, from 11/09/2023 to 14/09/2023, Last updated: 14/09/2023 -
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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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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 August 2023
PRAC, Last updated: 01/09/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-12 May 2023
European Medicines Agency, Amsterdam, the Netherlands, from 10/05/2023 to 12/05/2023, Last updated: 31/08/2023 -
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Safety of COVID-19 vaccines
Last updated: 14/08/2023 -
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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