200 results
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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,
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, Revision: 4, Authorised, Last updated: 15/04/2021
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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: 5, Authorised, Last updated: 15/04/2021
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Human medicine European public assessment report (EPAR): 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,, , Revision: 1, Authorised, Last updated: 30/03/2021
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Human medicine European public assessment report (EPAR): 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,, , Authorised, Last updated: 19/03/2021
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Human medicine European public assessment report (EPAR): Veklury
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, , Revision: 4, Authorised, Last updated: 22/12/2020
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Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
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): highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2)
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-002861-PIP02-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 27/11/2020, Last updated: 18/12/2020, 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 (ChAdOx1-S [recombinant]) (AZD1222)
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-002862-PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 05/01/2021, Last updated: 05/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib
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-001220-PIP07-20, Route(s) of administration: Gastric use, Oral use, Pharmaceutical form(s): Tablet and powder for oral solution, Oral suspension for use in drinking water
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): 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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COVID-19: latest updates (updated)
Last updated: 15/04/2021 -
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COVID-19 vaccines: Article 5(3) reviews (updated)
Last updated: 15/04/2021 -
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COVID-19 vaccines: authorised (updated)
Last updated: 14/04/2021 -
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COVID-19 vaccines (updated)
Last updated: 14/04/2021 -
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Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU (updated)
Virtual meeting, 13:00 - 15:15 (CET), 26/03/2021, Last updated: 14/04/2021 -
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COVID-19 treatments: Article 5(3) reviews (updated)
Last updated: 26/03/2021 -
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Public-health advice during COVID-19 pandemic (updated)
Last updated: 22/03/2021 -
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Press briefing on the conclusion of the investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events by the Pharmacovigilance Risk Assessment Committee (PRAC) (updated)
Virtual meeting, 18/03/2021, Last updated: 19/03/2021 -
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News: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets (updated)
PRAC, Last updated: 19/03/2021 -
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COVID-19 vaccines: research and development (updated)
Last updated: 17/03/2021 -
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COVID-19 treatments: research and development (updated)
Last updated: 17/03/2021 -
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COVID-19 vaccines: under evaluation
Last updated: 16/03/2021 -
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COVID-19 guidance: evaluation and marketing authorisation
Last updated: 15/03/2021