76 results
Keyword ronapreve 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: 30/05/2023adapted BA.4-5 vaccine • Ronapreve (casirivimab / imdevimab …
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List of medicines under additional monitoring (updated)
Last updated: 30/05/2023 -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023 (updated)
CHMP, Last updated: 26/05/2023Ronapreve … -
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COVID-19: latest updates (updated)
Last updated: 25/05/2023a disease. indication for Ronapreve to include people aged 12 …
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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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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 February 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 06/02/2023 to 09/02/2023, Last updated: 17/05/2023 -
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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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News: EMA annual report 2022 published (new)
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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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
Ronapreve Respiratory Tract Infections Coronaviridae … Ronapreve … EMA/629738/2021 EMEA/H/C005814 Ronapreve (casirivimab and imdevimab … -
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Summary of opinion: Ronapreve
casirivimab, imdevimab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023Ronapreve: Pending EC decision … opinion1 (post authorisation) Ronapreve casirivimab / imdevimab … for the medicinal product Ronapreve. The marketing authorisation … -
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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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Committee for Medicinal Products for Human Use (CHMP): 24-26 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 24/04/2023 to 26/04/2023, Last updated: 24/04/2023 -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Ronapreve, Imdevimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002965-PIP01-21-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 03/02/2022, Last updated: 17/04/2023, Compliance check: XInvented name Ronapreve Active substance Imdevimab … investigation plan for imdevimab (Ronapreve), (EMEA-002965-PIP01-21-M01 … investigation plan for imdevimab (Ronapreve), (EMEA-002965-PIP01-21-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ronapreve, Casirivimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002964-PIP01-21-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 03/02/2022, Last updated: 17/04/2023, Compliance check: XInvented name Ronapreve Active substance Casirivimab … investigation plan for casirivimab (Ronapreve), (EMEA-002964-PIP01-21-M01 … investigation plan for casirivimab (Ronapreve), (EMEA-002964-PIP01-21-M01 … -
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Committee for Medicinal Products for Human Use (CHMP): 23-26 January 2023
European Medicines Agency, Amsterdam, the Netherlands, from 23/01/2023 to 26/01/2023, Last updated: 14/04/2023