382 results
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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: 22, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 2, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , Revision: 19, Authorised, Last updated: 12/05/2022
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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: 25, Authorised, Last updated: 12/05/2022
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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: 20, Authorised, Last updated: 12/05/2022
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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: 1, Authorised, Last updated: 06/05/2022
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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,, Authorised, Last updated: 05/05/2022
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Human medicine European public assessment report (EPAR): Paxlovid (updated)
(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 [PF-07321332], ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022,, Revision: 1, Authorised, Last updated: 29/04/2022
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Human medicine European public assessment report (EPAR): RoActemra (updated)
tocilizumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Cytokine Release Syndrome; Giant Cell Arteritis; COVID-19 virus infection
Date of authorisation: 15/01/2009, Revision: 38, Authorised, Last updated: 26/04/2022 -
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Human medicine European public assessment report (EPAR): Regkirona
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 2, Authorised, Last updated: 13/04/2022
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Human medicine European public assessment report (EPAR): Veklury
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, , Revision: 10, Authorised, Last updated: 28/03/2022
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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: 1, Authorised, Last updated: 18/03/2022
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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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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): Vaxzevria/COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination with thrombocytopenia - Updated information
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Type II variation, Last updated: 02/06/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Zorecimeran
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-002986-PIP01-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate and solvent for dispersion for injection
Decision date: 17/05/2021, Last updated: 11/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Powder for concentrate for solution for infusion
Decision date: 09/08/2021, Last updated: 19/08/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002862-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 07/07/2021, Last updated: 19/08/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Comirnaty, highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002861-PIP02-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 23/04/2021, Last updated: 19/05/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): mRNA that encodes for the pre-fusion stabilized spike glycoprotein of SARS-CoV-2 (mRNA-1273)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-002893- PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 30/11/2020, Last updated: 18/12/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): COVID-19 vaccine (Ad26.COV2-S (recombinant))
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-002880-PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in cartridge
Decision date: 05/02/2021, Last updated: 16/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) / matrix-M1 adjuvant
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-002941-PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 15/03/2021, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): SARS-CoV2 prefusion Spike delta TM (CoV-2 preS dTM) adjuvanted with AS03
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-002915-PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution and emulsion for emulsion for injection
Decision date: 10/05/2021, Last updated: 19/05/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tixagevimab (AZD8895)
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-002900-PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 08/06/2021, Last updated: 17/06/2021, Compliance check: X