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Opinion/decision on a Paediatric investigation plan (PIP): Maviret, glecaprevir, pibrentasvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001832-PIP01-15-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 17/04/2019, Last updated: 21/09/2021, Compliance check: V, 11/12/2019Invented name Maviret Active substance glecaprevir … Maviret Maviret glecaprevir pibrentasvir g … -
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Human medicine European public assessment report (EPAR): Maviret
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, Revision: 21, Authorised, Last updated: 02/03/2023
Maviret Infections Communicable … Maviret … EMA/263042/2021 EMEA/H/C/004430 Maviret (glecaprevir / pibrentasvir … -
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Press release: Two new medicines recommended for the treatment of chronic hepatitis C
CHMP, Last updated: 23/06/2017Maviret and Vosevi evaluated under … of chronic hepatitis C Maviret and Vosevi evaluated under … European Union (EU) for Maviret and Vosevi, two new medicines … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021
CHMP, Last updated: 23/04/2021Spiromax, DuoResp Spiromax, Maviret, Nulojix, Opdivo, Tagrisso … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 2019
CHMP, Last updated: 01/02/2019Maviret … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2017
CHMP, Last updated: 23/06/2017Maviret … -
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National expert: Wim Laleman, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 43.8 KB | PDF
- Curriculum Vitae - 23.41 KB | PDF
endoscopy Current 01-01- 2018 22-03- 2023 Abbvie Individual product related maviret hepatitis c null Current 01-03- 2021 22-03- 2023 Boehringer … -
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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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Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 July 2022
European Medicines Agency, Amsterdam, the Netherlands, from 04/07/2022 to 07/07/2022, Last updated: 31/03/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/05/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/03/2022 to 10/03/2022, Last updated: 22/11/2022 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 31/05/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/01/2022 to 13/01/2022, Last updated: 07/10/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 February 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/02/2022 to 10/02/2022, Last updated: 07/11/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 22/02/2021 to 25/02/2021, Last updated: 07/12/2021 -
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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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Committee for Medicinal Products for Human Use (CHMP): 21-24 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2022 to 24/03/2022, Last updated: 12/08/2022 -
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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 -
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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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Committee for Medicinal Products for Human Use (CHMP): 25-29 January 2021
Virtual meeting, from 25/01/2021 to 29/01/2021, Last updated: 04/03/2021 -
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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): 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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Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2020
Virtual meeting, from 14/09/2020 to 17/09/2020, Last updated: 10/03/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 September 2018
European Medicines Agency, London, UK, from 03/09/2018 to 06/09/2018, Last updated: 13/03/2014 -
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Committee for Medicinal Products for Human Use (CHMP): 17-20 September 2018
European Medicines Agency, London, UK, from 17/09/2018 to 20/09/2018, Last updated: 31/10/2018