13082 results
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan (updated)
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,
, Revision: 12, Authorised, Last updated: 11/02/2021
Tenofovir disoproxil Mylan HIV Infections … Authorised tenofovir disoproxil Overview This is a summary … a summary of the A set of documents describing the evaluation … -
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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: 8, Authorised, Last updated: 28/01/2021
Tenofovir disoproxil Zentiva HIV Infections … a summary of the A set of documents describing the evaluation … assessment report (EPAR) for Tenofovir disoproxil Zentiva. It explains how … -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (updated)
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 6, Authorised, Last updated: 22/02/2021
renz/Emtricitabine/Tenofovir disoproxil Zentiva HIV Infections … a summary of the A set of documents describing the evaluation … Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva. It explains how … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d. (updated)
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017,, Revision: 7, Authorised, Last updated: 22/02/2021
Emtricitabine/Tenofovir disoproxil Krka d.d. HIV Infections … Emtricitabine/Tenofovir disoproxil Krka d.d. is an HIV medicine … effects. Emtricitabine/Tenofovir disoproxil Krka d.d contains two The … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka (updated)
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 09/12/2016,, Revision: 8, Authorised, Last updated: 02/02/2021
Emtricitabine/Tenofovir disoproxil Krka HIV Infections … 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: 5, Authorised, Last updated: 26/11/2020
renz/Emtricitabine/Tenofovir disoproxil Krka HIV Infections … Efavirenz/Emtricitabine/Tenofovir disoproxil Krka. It explains how the … Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, patients should read … -
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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: 8, Authorised, Last updated: 19/08/2020
renz/Emtricitabine/Tenofovir disoproxil Mylan HIV Infections … Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan. It explains how the … Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, patients should read … -
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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: 6, Authorised, Last updated: 11/06/2020
Emtricitabine/Tenofovir disoproxil Mylan HIV Infections … Emtricitabine/Tenofovir disoproxil Mylan is an HIV medicine … effects. Emtricitabine/Tenofovir disoproxil Mylan is also used to help … -
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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: 4, Authorised, Last updated: 07/04/2020
Emtricitabine/Tenofovir disoproxil Zentiva HIV Infections … Emtricitabine/Tenofovir disoproxil Zentiva is used in combination … effects. Emtricitabine/Tenofovir disoproxil Zentiva is also used to help … -
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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-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 20/03/2020, Last updated: 31/07/2020, Compliance check: Xname Viread Active substance tenofovir disoproxil fumarate Therapeutic area … Viread Viread tenofovir disoproxil tenofovir disoproxil fumarate … -
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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: 55, Authorised, Last updated: 25/01/2021treat HIV infection before, doctors should only prescribe Viread … medicine. active substance tenofovir disoproxil. Expand section Collapse section … treatment should be started by a doctor who has experience in the … -
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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): Truvada
emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 20/02/2005, Revision: 43, Authorised, Last updated: 17/09/2020emtricitabine (200 mg) and tenofovir disoproxil (245 mg). Expand section … treatment should be started by a doctor who has experience in the … stop taking emtricitabine or tenofovir, or need to take different … -
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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: 5, Authorised, Last updated: 14/07/2020
doravirine, lamivudine and tenofovir disoproxil. The medicine is not suitable … resistant to lamivudine, tenofovir disoproxil or to medicines in the same … doravirine / lamivudine / tenofovir disoproxil) An overview of Delstrigo … -
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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: 34, Authorised, Last updated: 23/07/2020emtricitabine (200 mg) and tenofovir disoproxil (245 mg). Expand section … treatment should be started by a doctor who has experience in the … package leaflet or contact a doctor or pharmacist. How does Atripla … -
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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: 22, Authorised, Last updated: 06/07/2020leaflet or contact their doctor or pharmacist. Expand section … 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: 23, Authorised, Last updated: 26/06/2020mg), rilpivirine (25 mg) and tenofovir disoproxil (245 mg). It is available … transcriptase inhibitors (NNRTIs), tenofovir or emtricitabine, and who … Eviplera should be started by a doctor who has experience in 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 first decision: 15/01/2015, Positive, Last updated: 05/03/2015Yanick Crow, France, for tenofovir disoproxil fumarate for the treatment … Aicardi-Goutières syndrome. Tenofovir disoproxil fumarate is a type of antiviral … opinion on orphan designation 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): Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 20/04/2007, Revision: 30, Authorised, Last updated: 20/12/2019Docetaxel Zentiva (previously Docetaxel Winthrop) Head and Neck … Docetaxel Zentiva (previously Docetaxel Winthrop … safety and efficacy of the Docetaxel Winthrop medicinal product … -
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Withdrawn application: Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, date of withdrawal: 14/11/2008, Post-authorisation, Last updated: 17/11/2008Docetaxel Winthrop: Withdrawn applicati … acknowledged. London, 24 July 2008 Doc. Ref. EMEA/384759/2008 … AUTHORISATION for Taxotere/Docetaxel Winthrop International … -
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Human medicine European public assessment report (EPAR): Docetaxel Teva
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/01/2010,, Revision: 18, Authorised, Last updated: 23/11/2020
Docetaxel Teva Head and Neck Neoplasms Carcinoma … Docetaxel Teva … Pack size EU/1/09/611/001 Docetaxel TEVA 20 mg /0.72 ml Concentrate … -
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Human medicine European public assessment report (EPAR): Docetaxel Kabi
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020
Docetaxel Kabi Head and Neck Neoplasms Carcinoma … Docetaxel Kabi … initial authorisation) Docetaxel Kabi docetaxel On 15 March 2012 the Committee …