51 results
Keyword Zepatier Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Zepatier, grazoprevir, elbasvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001604-PIP01-13-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 04/09/2017, Last updated: 26/10/2017, Compliance check: XInvented name Zepatier Active substance grazoprevir … Zepatier Zepatier elbasvir grazoprevir grazo … -
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Human medicine European public assessment report (EPAR): Zepatier
elbasvir, grazoprevir, Hepatitis C, Chronic
Date of authorisation: 22/07/2016,
, Revision: 10, Authorised, Last updated: 08/12/2020
Zepatier Hepatitis C, Chronic … assessment report (EPAR) for Zepatier. It explains how the Agency … practical advice on how to use Zepatier. For practical information … -
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Press release: Two new combination therapies against chronic hepatitis C
CHMP, Last updated: 27/05/2016cting antivirals Epclusa and Zepatier recommended for approval … Direct-acting antivirals Epclusa and Zepatier recommended for approval … sofosbuvir/velpatasvir) and Zepatier (grazoprevir/elbasvir). HCV … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 May 2016
CHMP, Last updated: 27/05/2016Zepatier … -
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Press release: PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C
PRAC, Last updated: 02/12/2016sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir … sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir … sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir … -
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Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, 
, Revision: 11, Authorised, Last updated: 03/03/2021
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Press release: Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B
CHMP, Last updated: 16/12/2016sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir … sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir … sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir … -
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Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir, associated names: Sovaldi, Olysio, Viekirax, Harvoni, Exviera, Daklinza, Article 20 procedures
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 23/02/2017, Last updated: 09/03/2017sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir … sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir … sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 08/02/2021 to 11/02/2021, Last updated: 08/02/2021 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 16/02/2021 -
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List of medicines under additional monitoring (updated)
Last updated: 24/02/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 25-29 January 2021 (updated)
Virtual meeting, from 25/01/2021 to 29/01/2021, Last updated: 04/03/2021 -
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Support for industry on clinical data publication
Last updated: 16/09/2020 -
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Committee for Medicinal Products for Human Use (CHMP): 9-12 November 2020
Virtual meeting, from 09/11/2020 to 12/11/2020, Last updated: 07/01/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 May 2018
European Medicines Agency, London, UK, from 14/05/2018 to 17/05/2018, Last updated: 14/05/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 January 2018
European Medicines Agency, London, UK, from 08/01/2018 to 11/01/2018, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 August-1 September 2017
European Medicines Agency, London, UK, from 29/08/2017 to 01/09/2017, Last updated: 13/03/2014 -
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CHMP: Agendas, minutes and highlights
Last updated: 29/01/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 2017
European Medicines Agency, London, UK, from 27/11/2017 to 30/11/2017, Last updated: 27/11/2017 -
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Download medicine data
Last updated: 29/04/2020 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 30 August - 2 September 2016
European Medicines Agency, London, UK, from 30/08/2016 to 02/09/2016, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 July 2018
European Medicines Agency, London, UK, from 09/07/2018 to 12/07/2018, Last updated: 13/03/2014 -
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News: EMA 2017 annual report published
Last updated: 02/05/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 April 2018
European Medicines Agency, London, UK, from 09/04/2018 to 12/04/2018, Last updated: 13/03/2014 -
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News: EMA's proactive publication of clinical data a success
Last updated: 16/07/2018