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Keyword Paxlovid Remove keyword
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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: 21/09/2023Paxlovid Pneumonia, Viral Respiratory … nirmatrelvirritonavir Overview Paxlovid is a medicine used for treating … disease becoming severe. Paxlovid contains two The substance … -
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News: COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
CHMP, PRAC, Last updated: 28/01/2022marketing authorisation for Paxlovid … marketing authorisation for Paxlovid … THE MEDICINAL PRODUCT Paxlovid 150 mg + 100 mg film-coated … -
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News: EMA starts review of Paxlovid for treating patients with COVID-19
CHMP, Last updated: 19/11/2021EMA starts review of Paxlovid for treating patients with … EMA starts review of Paxlovid for treating patients with … -
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News: EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
CHMP, PRAC, Last updated: 10/01/2022marketing authorisation for Paxlovid (PF-07321332 and ritonavir … marketing authorisation for Paxlovid (PF-07321332 and ritonavir … -
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News: EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19: rolling review starts in parallel
CHMP, Last updated: 16/12/2021EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir … EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir … -
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News: ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2
Last updated: 09/12/2022Antiviral treatments such as Paxlovid (nirmatrelvir / ritonavir … treating COVID-19, including Paxlovid and Veklury, is available … Nirmatrelvir/Ritonavir (Paxlovid)15 and Remdesivir (Veklury)16 … -
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Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 19 November 2021
Online, 19/11/2021, Last updated: 25/10/2021Lagevrio (molnupiravir) and Paxlovid (PF-07321332 / ritonavir … (19/11/2021) EMA starts review of Paxlovid for treating patients with … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 2022
CHMP, Last updated: 05/07/2022Paxlovid … -
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Opinion/decision on a Paediatric investigation plan (PIP): (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: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-003081-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 21/12/2021, Last updated: 07/01/2021, Compliance check: Xmarketing authorisation for Paxlovid (PF-07321332 and ritonavir … -
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National expert: Istvan Varkonyi MD, National Center for Public Health and Pharmacy (updated)
- Declaration of interests - 40.69 KB | PDF
- Curriculum Vitae - 23.02 KB | PDF
indication Past 06-06- 2021 15-08- 2022 Pfizer paxlovid covid19 Past 12-01- 2022 26-12- 2022 MSD … -
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National expert: Carolina Garcia-Vidal, European Medicines Agency (updated)
- Declaration of interests - 41.86 KB | PDF
- Curriculum Vitae - 58.23 KB | PDF
candidiasis Past 01-12- 2021 31-12- 2021 Pfizer Individual product related paxlovid covid19 Past 01-03- 2021 30-03- 2021 Janssen Individual … -
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National expert: Francisco López-Medrano, European Medicines Agency (updated)
- Declaration of interests - 42.41 KB | PDF
- Curriculum Vitae - 21.44 KB | PDF
deficit Current 01-03- 2020 Pfizer Individual product related Paxlovid Treatment of early stages … -
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COVID-19 medicines: Article 18 and Article 5(3) reviews
Last updated: 06/06/2023Treatment Status More information Paxlovid (PF-07321332 / ritonavir … EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir …
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
CHMP, Last updated: 17/12/2021COVID-19: Advice on use of Paxlovid for treating COVID-19 The … -
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Article 5(3) opinions on any scientific matter: human medicines
Last updated: 22/06/2023Use of Paxlovid (PF-07321332 and ritonavir … 726/2004 Invented name: Paxlovid INN/active substance: PF-07321332/ritonavir …
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023
CHMP, Last updated: 27/01/2023Paxlovid … -
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COVID-19: latest updates (archive)
Last updated: 05/06/2023marketing authorisation for Paxlovid to standard The approval to … States. marketing authorisation Paxlovid 26/01/2023 EMA published … information for COVID-19 treatment Paxlovid, with an increase in its approved …
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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): 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): 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): 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): 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): 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): 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: 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