34 results
Keyword Delstrigo Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Delstrigo, doravirine, lamivudine, tenofovir disoproxil (fumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001695-PIP01-14-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 12/04/2021, Last updated: 18/01/2022, Compliance check: XInvented name Delstrigo Active substance doravirine … tenofovir disoproxil (fumarate) (Delstrigo), (EMEA-001695-PIP01-14-M04 … tenofovir disoproxil (fumarate) (Delstrigo), (EMEA-001695-PIP01-14-M04 … -
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Human medicine European public assessment report (EPAR): Delstrigo
doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 22/11/2018,
, Revision: 9, Authorised, Last updated: 11/10/2022
Delstrigo Blood-Borne Infections Communicable … doravirinelamivudinetenofovir disoproxil Overview Delstrigo is an antiviral medicine … that work in the same way as Delstrigo’s The substance responsible … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018
CHMP, Last updated: 21/09/2018Delstrigo … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022
CHMP, Last updated: 25/02/2022Delstrigo … -
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National expert: Roberto Cauda, European Medicines Agency (updated)
- Declaration of interests - 81.43 KB | PDF
- Curriculum Vitae - 18.78 KB | PDF
01/2015-09/2022 Merck Sharp &Dohme Delstrigo HIV Cauda 2022-11-23 2 Classified … -
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National expert: Pere Domingo, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 82.83 KB | PDF
- Curriculum Vitae - 135.21 KB | PDF
Isentress HD, Pfifeltro, Delstrigo HIV infection 04/2020-(current … -
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Human medicine European public assessment report (EPAR): Pifeltro
doravirine, HIV Infections
Date of authorisation: 22/11/2018,, Revision: 7, Authorised, Last updated: 11/10/2022
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Human medicine European public assessment report (EPAR): Sunlenca
Lenacapavir sodium, HIV Infections
Date of authorisation: 17/08/2022,, Authorised, Last updated: 25/08/2022
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List of medicines under additional monitoring (updated)
Last updated: 25/01/2023 -
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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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Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 October 2021
European Medicines Agency, Amsterdam, the Netherlands, from 25/10/2021 to 28/10/2021, Last updated: 02/08/2022 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 27/01/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 8-11 November 2021
Online, from 08/11/2021 to 11/11/2021, Last updated: 20/01/2022 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 18/01/2023 -
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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): 25-29 January 2021
Virtual meeting, from 25/01/2021 to 29/01/2021, Last updated: 04/03/2021 -
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Parallel distribution: Regulatory and procedural guidance
Last updated: 09/06/2021 -
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Download medicine data
Last updated: 02/12/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 16-19 August 2021
Written procedure, from 16/08/2021 to 19/08/2021, Last updated: 04/11/2019 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 September-1 October 2020
Virtual meeting, from 28/09/2020 to 01/10/2020, Last updated: 29/09/2020 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 February 2022
European Medicines Agency, Amsterdam, the Netherlands, from 21/02/2022 to 24/02/2022, Last updated: 06/04/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 April 2021
European Medicines Agency, Amsterdam, the Netherlands, from 06/04/2021 to 09/04/2021, Last updated: 27/02/2018 -
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Newsletters (updated)
Last updated: 16/01/2023 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
PRAC, Last updated: 09/04/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 April 2022
European Medicines Agency, Amsterdam, the Netherlands, from 04/04/2022 to 07/04/2022, Last updated: 21/06/2021