63 results
Keyword Symtuza Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Symtuza, darunavir, cobicistat, emtricitabine, tenofovir alafenamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001825-PIP01-15-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: XInvented name Symtuza Active substance darunavir … tenofovir alafenamide (Symtuza), (EMEA-001825-PIP01-15-M03 … tenofovir alafenamide (Symtuza), (EMEA-001825-PIP01-15-M03 … -
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Human medicine European public assessment report (EPAR): Symtuza
darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017, Revision: 17, Authorised, Last updated: 21/03/2023Symtuza Blood-Borne Infections Communicable … Symtuza … initial authorisation) Symtuza darunavir / cobicistat … -
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Human medicine European public assessment report (EPAR): Rezolsta
darunavir, cobicistat, HIV Infections
Date of authorisation: 19/11/2014, Revision: 15, Authorised, Last updated: 13/12/2022administered with Rezolsta. Symtuza Co administration of Symtuza with a direct oral anticoagulant … is co administered with Symtuza. For more information … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017
CHMP, Last updated: 21/07/2017Symtuza … -
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Human medicine European public assessment report (EPAR): Prezista
darunavir, HIV Infections
Date of authorisation: 11/02/2007, Revision: 54, Authorised, Last updated: 03/03/2023 -
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Human medicine European public assessment report (EPAR): Rekambys (updated)
rilpivirine, HIV Infections
Date of authorisation: 17/12/2020,
, Revision: 8, Authorised, Last updated: 05/09/2023
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Human medicine European public assessment report (EPAR): Biktarvy
bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018, Revision: 16, Authorised, Last updated: 28/04/2023 -
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Human medicine European public assessment report (EPAR): Tybost
cobicistat, HIV Infections
Date of authorisation: 19/09/2013, Revision: 15, Authorised, Last updated: 14/02/2023cobicistat containing products Symtuza and Rezolsta include contraindications … -
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Human medicine European public assessment report (EPAR): Genvoya
elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 19/11/2015, Revision: 27, Authorised, Last updated: 28/11/2022 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 25/09/2023 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 11/09/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 16-19 August 2022
Written procedure, from 16/08/2022 to 19/08/2022, Last updated: 04/10/2022 -
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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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Committee for Medicinal Products for Human Use (CHMP): 7-10 November 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/11/2022 to 10/11/2022, Last updated: 10/01/2023 -
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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): 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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Committee for Medicinal Products for Human Use (CHMP): 10-13 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/10/2022 to 13/10/2022, Last updated: 23/11/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 August - 1 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 29/08/2022 to 01/09/2022, Last updated: 02/09/2022 -
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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 -
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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: 12/08/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 27-30 March 2023
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): 19-22 March 2018
European Medicines Agency, London, UK, from 19/03/2018 to 22/03/2018, Last updated: 31/05/2018 -
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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): 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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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 2018
European Medicines Agency, London, UK, from 05/03/2018 to 08/03/2018, Last updated: 05/03/2018