77 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: 16/09/2021, Compliance check: V, 11/12/2020Invented 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: 11, Authorised, Last updated: 09/02/2022Zepatier Hepatitis C Flaviviridae … 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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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021
CHMP, Last updated: 17/09/2021Zepatier. … -
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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: 16, Authorised, Last updated: 20/06/2022
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List of medicines under additional monitoring
Last updated: 25/05/2022completed Vosevi - PASS completed Zepatier - PASS completed Viekirax …
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Human medicine European public assessment report (EPAR): Atripla
efavirenz, emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 13/12/2007, Revision: 36, Withdrawn, Last updated: 21/01/2022 -
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Human medicine European public assessment report (EPAR): Rezolsta
darunavir, cobicistat, HIV Infections
Date of authorisation: 19/11/2014, Revision: 13, Authorised, Last updated: 14/01/2022 -
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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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Human medicine European public assessment report (EPAR): Prezista
darunavir, HIV Infections
Date of authorisation: 11/02/2007, Revision: 52, Authorised, Last updated: 14/01/2022 -
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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 … -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 22/06/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 16-19 May 2022
European Medicines Agency, Amsterdam, the Netherlands, from 16/05/2022 to 19/05/2022, Last updated: 16/05/2022 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 17/06/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 21/06/2021 to 24/06/2021, Last updated: 07/12/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 March 2022 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2022 to 24/03/2022, Last updated: 31/05/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2021
European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2021 to 22/04/2021, Last updated: 07/12/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
PRAC, Last updated: 17/09/2021 -
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PRAC recommendations on safety signals
Last updated: 30/05/2022 -
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Download medicine data
Last updated: 02/12/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 24-27 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 24/01/2022 to 27/01/2022, Last updated: 16/03/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2021 to 10/06/2021, Last updated: 07/06/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/02/2021 to 11/02/2021, Last updated: 08/02/2021