7187 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: 16, 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: 12, Authorised, Last updated: 15/09/2022
Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … Tenofovir disoproxil Zentiva … summary for the public Tenofovir disoproxil Zentiva tenofovir disoproxil This is a summary of the … -
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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: 12, Authorised, Last updated: 06/02/2023
Emtricitabine/Tenofovir disoproxil Mylan Blood-Borne Infections Communicable … Emtricitabine/Tenofovir disoproxil Mylan … Emtricitabine/Tenofovir disoproxil Mylan Procedural steps taken … -
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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: 9, Authorised, Last updated: 05/12/2022
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): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 13, Authorised, Last updated: 14/09/2022
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): Emtricitabine/Tenofovir disoproxil Krka d.d.
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017,, Revision: 9, Authorised, Last updated: 15/06/2022
Emtricitabine/Tenofovir disoproxil Krka d.d. Blood-Borne Infections Communicable … Emtricitabine/Tenofovir disoproxil Krka d.d … Emtricitabine/tenofovir disoproxil Krka d.d. Procedural steps … -
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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: 8, Authorised, Last updated: 18/05/2022
renz/Emtricitabine/Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … renz/Emtricitabine/Tenofovir disoproxil Zentiva … Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, INN-Efavirenz/Emtricitabine/Tenofovir … -
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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: 11, Authorised, Last updated: 29/10/2021
Emtricitabine/Tenofovir disoproxil Krka Blood-Borne Infections Communicable … Emtricitabine/Tenofovir disoproxil Krka … Emtricitabine/Teno fovir disoproxil Krka 200 mg / 245 mg Film-coated … -
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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: 6, Authorised, Last updated: 21/07/2021
Emtricitabine/Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … Emtricitabine/Tenofovir disoproxil Zentiva … Emtricitabine/Tenofovir disoproxil Zentiva , INN-emtricitabine/tenofovir … -
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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-M10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 14/04/2021, Last updated: 18/01/2022, Compliance check: Xname Viread Active substance tenofovir disoproxil fumarate Therapeutic area … paediatric investigation plan for tenofovir disoproxil fumarate) (Viread), (EMEA-000533-PIP01-08-M10 … paediatric investigation plan for tenofovir disoproxil fumarate) (Viread), (EMEA-000533-PIP01-08-M10 … -
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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: 04/01/2023Authorised tenofovir disoproxil Overview Viread is a medicine … medicine. active substance tenofovir disoproxil. How is Viread used? Viread … active substance in Viread, tenofovir … -
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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: 10, Authorised, Last updated: 20/02/2023
doravirinelamivudinetenofovir disoproxil Overview Delstrigo is an … other HIV medicines without tenofovir disoproxil cannot be used because of … doravirine, lamivudine and tenofovir … -
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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: 02/02/2023elvitegravircobicistatemtricitabinetenofovir disoproxil Overview This is a summary … cobicistat, emtricitabine and tenofovir disoproxil. It is used to treat patients … HIV medicines not including 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: 13/12/2022emtricitabinerilpivirinetenofovir disoproxil Overview This is a summary … mg), rilpivirine (25 mg) and tenofovir disoproxil (245 mg). It is available … transcriptase inhibitors (NNRTIs), tenofovir or emtricitabine, and who … -
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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 Overview On 15 January … Yanick Crow, France, for tenofovir disoproxil fumarate for the treatment … Aicardi-Goutières syndrome. Tenofovir … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): EGFR-cMET bispecific antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002573-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 16/08/2019, Last updated: 20/11/2019, Compliance check: XKey facts EGFR-cMET bispecific antibody OncologyP/0289/2019EMEA-002573-PIP01-19 … product specific waiver for EGFR-cMET bispecific antibody (EMEA-002573-PIP01-19 … EGFR-cMET bispecific antibody … -
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Withdrawn application: Egranli
date of withdrawal: 04/11/2014, Initial authorisation, Last updated: 16/02/2015Egranli: Withdrawn application … Egranli, INN-balugrastim 30 … initial authorisation) Egranli balugrastim On 25 September … -
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Withdrawn application: Egrifta
date of withdrawal: 21/06/2012, Initial authorisation, Last updated: 18/07/2012Egrifta: Withdrawn application … authorisation application for Egrifta (tesamorelin) On 21 June … marketing authorisation for Egrifta, for the treatment of excess …