87 results
Keyword Eviplera Remove keyword
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Withdrawn application: Eviplera
emtricitabine, rilpivirine, tenofovir disoproxil, date of withdrawal: 16/07/2013, Post-authorisation, Last updated: 26/07/2013Eviplera: Withdrawn application … marketing authorisation for Eviplera (emtricitabine / rilpivirine … of the anti-HIV medicine Eviplera from the treatment of patients … -
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Opinion/decision on a Paediatric investigation plan (PIP): Eviplera, emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-000774-PIP01-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 23/08/2018, Last updated: 05/02/2019, Compliance check: XInvented name Eviplera Active substance emtricitabine … Eviplera Eviplera emtricitabine rilpivirine tenofovir … -
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Human medicine European public assessment report (EPAR): Eviplera
emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 27/11/2011, Revision: 25, Authorised, Last updated: 13/12/2022Eviplera Blood-Borne Infections Communicable … Eviplera … Eviplera, INN-Emtricitabine/Rilpivirine/Tenofovir … -
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Human medicine European public assessment report (EPAR): Odefsey
emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/06/2016, Revision: 20, Authorised, Last updated: 20/02/2023already approved in the EU as Eviplera to treat HIV-1 infection … HIV-1 infection, although in Eviplera tenofovir is present as tenofovir … alternative treatment option to Eviplera with similar effectiveness … -
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Press release: Updated advice on body fat changes and lactic acidosis with HIV medicines
CHMP, Last updated: 23/10/2015Edurant, Emtriva, Epivir, Eviplera, Evotaz, Intelence, Invirase … Atripla, Emtriva, Epivir, Eviplera, Kivexa, Lamivudine ViiV … Edurant, Emtriva, Epivir, Eviplera, Evotaz, Intelence, Invirase … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 October 2013
CHMP, Last updated: 25/10/2013Eviplera … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2013
CHMP, Last updated: 26/07/2013Eviplera … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 2015
CHMP, Last updated: 23/10/2015Emtriva: EPAR Epivir: EPAR Eviplera: EPAR Heparesc: EPAR Imlygic … Zerit: EPAR Ziagen: EPAR Eviplera: Withdrawn application Veraseal … Paediatric investigation plan Eviplera: Paediatric investigation … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 September 2011
CHMP, Last updated: 23/09/2011PDF icon application/pdf Eviplera emtricitabine / rilpivirine … -
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Human medicine European public assessment report (EPAR): Stribild
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 24/05/2013, Revision: 25, Authorised, Last updated: 02/02/2023 -
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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): Truvada
emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 20/02/2005, Revision: 46, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Descovy
emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/04/2016, Revision: 20, Authorised, Last updated: 17/02/2023 -
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Human medicine European public assessment report (EPAR): Viread
tenofovir disoproxil fumarate, Hepatitis B, Chronic; HIV Infections
Date of authorisation: 04/02/2002, Revision: 58, Authorised, Last updated: 04/01/2023 -
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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): 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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Human medicine European public assessment report (EPAR): Emtriva
emtricitabine, HIV Infections
Date of authorisation: 24/10/2003, Revision: 33, Authorised, Last updated: 18/04/2023 -
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Human medicine European public assessment report (EPAR): Edurant
rilpivirine hydrochloride, HIV Infections
Date of authorisation: 28/11/2011, Revision: 20, Authorised, Last updated: 28/10/2022 -
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Human medicine European public assessment report (EPAR): Epclusa (updated)
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,
, Revision: 22, Authorised, Last updated: 27/09/2023
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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): Vemlidy
tenofovir alafenamide fumarate, Hepatitis B
Date of authorisation: 09/01/2017, Revision: 16, Authorised, Last updated: 31/05/2023 -
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Human medicine European public assessment report (EPAR): Vitekta
elvitegravir, HIV Infections
Date of authorisation: 13/11/2013,, Revision: 4, Withdrawn, Last updated: 29/05/2017
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Opinion/decision on a Paediatric investigation plan (PIP): emtricitabine, rilpivirine, tenofovir alafenamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001679-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 11/08/2022, Last updated: 31/08/2023, Compliance check: Xdisoproxil has been approved as Eviplera since 2011. The combination … -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 25/09/2023 -
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Expert meeting on paediatric development of fixed-dose combinations for the treatment of the human immunodeficiency virus (HIV)
European Medicines Agency, London, UK, 10/11/2015, Last updated: 05/01/2016completion date) FTC/RPV/TDF (Eviplera) * 2010 No (2019) EVG/FTC/TDF/COBI … range of PIP FTC/RPV/TDF (Eviplera) * 2010 No > 6 years EVG/FTC/TDF/COBI … range of PIP FTC/RPV/TDF (Eviplera) * 2010 No > 6 years EVG/FTC/TDF/COBI …