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Keyword ronapreve Remove keyword
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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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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-M02, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 10/08/2022, Last updated: 31/08/2023, Compliance check: XKey facts Ronapreve Imdevimab Infectious diseasesP/0343/2022EMEA-002965-PIP01-21-M02 … investigation plan for imdevimab (Ronapreve) (EMEA-002965-PIP01-21-M02 … 31/08/2023 EMA/638306/2022 Generic Ronapreve: EPAR … -
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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-M02, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 10/08/2022, Last updated: 31/08/2023, Compliance check: XKey facts Ronapreve Casirivimab Infectious diseasesP/0300/2022EMEA-002964-PIP01-21-M02 … investigation plan for casirivimab (Ronapreve) (EMEA-002964-PIP01-21-M02 … 31/08/2023 EMA/638305/2022 Generic Ronapreve: EPAR … -
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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
Ronapreve Respiratory Tract Infections Coronaviridae … casirivimabimdevimab Overview Ronapreve is a medicine used for treating … weighing at least 40 kilograms. Ronapreve contains two The substance … -
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News: EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
CHMP, PDCO, PRAC, Last updated: 11/10/2021marketing authorisation for Ronapreve (casirivimab / imdevimab … marketing authorisation for Ronapreve (casirivimab / imdevimab … -
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News: COVID-19: EMA recommends authorisation of two monoclonal antibody medicines
CHMP, Last updated: 12/11/2021News 11/11/2021 Ronapreve and Regkirona are now authorised … has recommended authorising Ronapreve (casirivimab/imdevimab) and … Committee recommended authorising Ronapreve for treating COVID-19 in … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023
CHMP, Last updated: 26/05/2023Ronapreve … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021
CHMP, Last updated: 12/11/2021Ronapreve … -
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News: ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2
Last updated: 09/12/2022Regkirona (regdanvimab), Ronapreve (casirivimab / imdevimab … https://www.ema.europa.eu/documents/overview/evusheld-epar-medicine-overview_en.pdf 2: Ronapreve EPAR Ronapreve | European Medicines Agency … -
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News: COVID-19: EMA recommends authorisation of antibody medicine Xevudy
CHMP, Last updated: 16/12/2021approval of Regkirona and Ronapreve in November. Monoclonal antibodies … -
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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: 6, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Veklury
remdesivir, COVID-19 virus infection
Date of authorisation: 03/07/2020,, Revision: 22, Authorised, Last updated: 19/10/2023
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Human medicine European public assessment report (EPAR): Xevudy
Sotrovimab, COVID-19 virus infection
Date of authorisation: 17/12/2021,, Revision: 11, Authorised, Last updated: 13/10/2023
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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: 19/10/2023 -
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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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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): 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): RoActemra
tocilizumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Cytokine Release Syndrome; Giant Cell Arteritis; COVID-19 virus infection
Date of authorisation: 15/01/2009, Revision: 41, Authorised, Last updated: 16/10/2023 -
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Human medicine European public assessment report (EPAR): Kineret
anakinra, Arthritis, Rheumatoid; COVID-19 virus infection
Date of authorisation: 08/03/2002, Revision: 34, Authorised, Last updated: 17/07/2023 -
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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: 41, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,, Revision: 30, Authorised, Last updated: 21/09/2023
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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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COVID-19 medicines that received EMA advice
Last updated: 06/06/2023 -
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COVID-19 medicines
Last updated: 15/09/2023Paediatric investigation plan Ronapreve (casirivimab / imdevimab …
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Withdrawn application: Olumiant
baricitinib, date of withdrawal: 07/12/2022, Post-authorisation, Last updated: 02/02/2023