521 results
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,
, Revision: 18, Authorised, Last updated: 20/09/2022
Tenofovir disoproxil Mylan Blood-Borne Infections Communicable … Authorised tenofovir disoproxil Overview This is a summary … assessment report (EPAR) for Tenofovir disoproxil Mylan. It explains how the … -
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva
tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016,, Revision: 13, Authorised, Last updated: 04/07/2023
Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … Authorised tenofovir disoproxil Overview This is a summary … assessment report (EPAR) for Tenofovir disoproxil Zentiva. It explains how … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan
emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016,, Revision: 14, Authorised, Last updated: 27/07/2023
Emtricitabine/Tenofovir disoproxil Mylan Blood-Borne Infections Communicable … rised emtricitabinetenofovir disoproxil Overview Emtricitabine/Tenofovir … Overview Emtricitabine/Tenofovir disoproxil Mylan is an HIV medicine … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d.
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017,, Revision: 10, Authorised, Last updated: 22/06/2023
Emtricitabine/Tenofovir disoproxil Krka d.d. Blood-Borne Infections Communicable … rised emtricitabinetenofovir disoproxil Overview Emtricitabine/Tenofovir … Overview Emtricitabine/Tenofovir disoproxil Krka d.d. is an HIV medicine … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 09/12/2016,, Revision: 12, Authorised, Last updated: 21/06/2023
Emtricitabine/Tenofovir disoproxil Krka Blood-Borne Infections Communicable … rised emtricitabinetenofovir disoproxil Overview Emtricitabine/Tenofovir … Overview Emtricitabine/Tenofovir disoproxil Krka is an HIV medicine that … -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 10, Authorised, Last updated: 20/06/2023
renz/Emtricitabine/Tenofovir disoproxil Krka Blood-Borne Infections Communicable … efavirenzemtricitabinetenofovir disoproxil Overview This is a summary … Efavirenz/Emtricitabine/Tenofovir disoproxil Krka. It explains how the … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva
emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016,, Revision: 7, Authorised, Last updated: 30/05/2023
Emtricitabine/Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … Emtricitabine/Tenofovir disoproxil Zentiva … Emtricitabine/Tenofovir disoproxil Zentiva , INN-emtricitabine/tenofovir … -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 15, Authorised, Last updated: 30/05/2023
renz/Emtricitabine/Tenofovir disoproxil Mylan Blood-Borne Infections Communicable … renz/Emtricitabine/Tenofovir disoproxil Mylan … Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan efavirenz / emtricitabine … -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 10, Authorised, Last updated: 01/06/2023
renz/Emtricitabine/Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … efavirenzemtricitabinetenofovir disoproxil Overview This is a summary … Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva. It explains how … -
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Opinion/decision on a Paediatric investigation plan (PIP): Viread, tenofovir disoproxil fumarate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000533-PIP01-08-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: XKey facts Viread tenofovir disoproxil fumarate Infectious diseasesP/0073/2022EMEA-000533-PIP01-08-M11 … paediatric investigation plan for tenofovir disoproxil (Viread), (EMEA-000533-PIP01-08-M11 … paediatric investigation plan for tenofovir disoproxil (Viread), (EMEA-000533-PIP01-08-M11 … -
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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: 04/01/2023tenofovir disoproxil … the co-administration of tenofovir disoproxil fumarate (TDF, Viread1) and … the co-administration of tenofovir disoproxil fumarate (TDF, Viread1) and … -
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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: Xsubstance doravirine lamivudine tenofovir disoproxil (fumarate) Therapeutic area … doravirine / lamivudine / tenofovir disoproxil (fumarate) (Delstrigo), (EMEA-001695-PIP01-14-M04 … doravirine / lamivudine / tenofovir disoproxil (fumarate) (Delstrigo), (EMEA-001695-PIP01-14-M04 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Truvada, emtricitabine, tenofovir disoproxil fumarate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
PIP number: EMEA-001091-PIP02-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 03/12/2015, Last updated: 02/02/2016, Compliance check: V, 16/12/2016Active substance emtricitabine tenofovir disoproxil fumarate Decision number … waiver for emtricitabine / tenofovir disoproxil fumarate (Truvada), (EMEA-001091-PIP02- 15 … waiver for emtricitabine / tenofovir disoproxil fumarate (Truvada), (EMEA-001091-PIP02- 15 … -
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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: 11, Authorised, Last updated: 04/08/2023doravirine / lamivudine / tenofovir disoproxil … doravirine / lamivudine / tenofovir disoproxil) An overview of Delstrigo … other HIV medicines without tenofovir disoproxil cannot be used because of … -
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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: 02/02/2023emtricitabine / tenofovir disoproxil … Truvada (emtricitabine / tenofovir disoproxil) An overview of Truvada and … emtricitabine (200 mg) and tenofovir disoproxil (245 mg). How is Truvada … -
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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: 21/01/2022efavirenz / emtricitabine / tenofovir disoproxil … efavirenz / emtricitabine / tenofovir disoproxil) in the European Union (EU … efavirenz / emtricitabine / tenofovir disoproxil) An overview of Atripla and … -
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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: Xrilpivirine hydrochloride tenofovir disoproxil fumarate Therapeutic area … emtricitabine rilpivirine tenofovir disoproxil emtricitabine rilpivirine … rilpivirine hydrochloride tenofovir disoproxil fumarate 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: 02/02/2023cobicistat / emtricitabine / tenofovir disoproxil … INN-Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil (as fumarate) 30 Churchill … cobicistat / emtricitabine / tenofovir disoproxil This is a summary of the … -
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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: 13/12/2022emtricitabine / rilpivirine / tenofovir disoproxil … INN-Emtricitabine/Rilpivirine/Tenofovir Disoproxil 30 Churchill Place … emtricitabine / rilpivirine / tenofovir disoproxil This is a summary of the … -
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Withdrawn application: Eviplera
emtricitabine, rilpivirine, tenofovir disoproxil, date of withdrawal: 16/07/2013, Post-authorisation, Last updated: 26/07/2013emtricitabine / rilpivirine / tenofovir disoproxil) On 16 July 2013, Gilead … rilpivirine (25 mg) and tenofovir disoproxil (245 mg). It is available … emtricitabine rilpivirine tenofovir disoproxil emtricitabine rilpivirine … -
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Orphan designation: tenofovir disoproxil fumarate for: Treatment of Aicardi-Goutières syndrome
Date of designation: 15/01/2015, Positive, Last updated: 05/03/2015tenofovir disoproxil fumarate … opinion on orphan designation Tenofovir disoproxil fumarate for the treatment … Yanick Crow, France, for tenofovir disoproxil fumarate for the treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): elvitegravir, emtricitabine, tenofovir disoproxil (as fumarate), cobicistat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000970-PIP01-10-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2016, Last updated: 19/01/2017, Compliance check: V, 16/12/2016elvitegravir emtricitabine tenofovir disoproxil (as fumarate) cobicistat … elvitegravir / emtricitabine / tenofovir disoproxil (as fumarate) / cobicistat … elvitegravir / emtricitabine / tenofovir disoproxil (as fumarate) / cobicistat … -
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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: 17/02/2023substances emtricitabine and tenofovir alafenamide. How is Descovy … and either 10 or 25 mg of tenofovir alafenamide. The recommended … EPAR). How does Descovy work? Tenofovir alafenamide is a ‘prodrug’ … -
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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: 31/05/2023Authorised tenofovir alafenamide Overview This … medicine. active substance tenofovir alafenamide. How is Vemlidy … active substance in Vemlidy, tenofovir alafenamide, works by stopping … -
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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: 20/02/2023emtricitabine, rilpivirine and tenofovir alafenamide. It is only used … transcriptase inhibitors, tenofovir or emtricitabine, and who … mg rilpivirine, and 25 mg tenofovir alafenamide. The recommended …