7256 results
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Human medicine European public assessment report (EPAR): Arepanrix
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 23/03/2010,
, Revision: 1, Withdrawn, Last updated: 25/10/2011
strain (X-179A)*propagated in eggs.pandemic influenza vaccine (H1N1)v … in the vaccine, such as egg or chicken protein, ovalbumin … protein, ovalbumin (a protein in egg white), formaldehyde and … -
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Human medicine European public assessment report (EPAR): Humenza
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 08/06/2010,, Withdrawn, Last updated: 30/06/2011
strain (X-179A)*propagated in eggs.pandemic influenza vaccine (H1N1 … as ovalbumin (a protein in egg white egg or chicken proteins, neomycin … strain (X-179A)*propagated in eggs. … -
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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 (updated)
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 … -
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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: 28/11/2022cobicistat, emtricitabine and tenofovir alafenamide. Expand section … elvitegravir’s antiviral effect. Tenofovir alafenamide is a ‘prodrug’ … alafenamide is a ‘prodrug’ of tenofovir, meaning that it is converted … -
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Human medicine European public assessment report (EPAR): Symtuza
darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017, Revision: 17, Authorised, Last updated: 21/03/2023cobicistat, emtricitabine and tenofovir alafenamide. Expand section … emtricitabine and 10 mg tenofovir alafenamide. The recommended … antiviral activity in the body. Tenofovir alafenamide is a ‘prodrug’ … -
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Emtricitabine/tenofovir disoproxil product-specific bioequivalence guidance
Last updated: 10/04/2015Emtricitabine/tenofovir disoproxil product-specific bioequivalence … Emtricitabine/tenofovir disoproxil product-specific bioequivalence … Emtricitabine/Tenofovir Disoproxil film-coated tablets 200mg/245 …
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Orphan designation: Refusal of orphan designation for the treatment of poisoning by local anaesthetics
Date of refusal of designation: 03/04/2017, Negative, Last updated: 15/05/2017of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25 … of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25 … of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25 … -
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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: 28/04/2023bictegravir / emtricitabine / tenofovir alafenamide … bictegravir / emtricitabine / tenofovir alafenamide) An overview … bictegravir, emtricitabine and tenofovir alafenamide. It is only used … -
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Emtricitabine / rilpivirine / tenofovir disoproxil product-specific bioequivalence guidance
Last updated: 10/07/2017Emtricitabine / rilpivirine / tenofovir disoproxil product-specific bioequivalence … Emtricitabine / rilpivirine / tenofovir disoproxil product-specific bioequivalence … tabine/rilpivirine/tenofovir disoproxil film-coated tablets 200 mg/25 …
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Elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil product-specific bioequivalence guidance
Last updated: 10/07/2017cobicistat / emtricitabine / tenofovir disoproxil product-specific bioequivalence … cobicistat, emtricitabine, tenofovir disoproxil. … stat/emtricitabine/tenofovir disoproxil film-coated tablets 150 mg/150 …
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Human medicine European public assessment report (EPAR): Daronrix
Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs, Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 21/03/2007,
, Withdrawn, Last updated: 02/07/2013
A/Vietnam/1194/2004 (H5N1)* produced in eggspandemic influenza vaccine (whole … in the vaccine, such as eggs, chicken protein or gentamicin … A/Vietnam/1194/2004 (H5N1)* produced in eggs … -
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Opinion/decision on a Paediatric investigation plan (PIP): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000669-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for injection
Decision date: 04/01/2019, Last updated: 21/09/2021, Compliance check: V, 26/04/2019strain (X-179A)*propagated in eggs. … -
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Opinion/decision on a Paediatric investigation plan (PIP): Arepanrix, Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000687-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for emulsion for injection
Decision date: 09/08/2010, Last updated: 07/10/2010, Compliance check: V, 12/12/2014strain (X-179A)*propagated in eggs. … -
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Opinion/decision on a Paediatric investigation plan (PIP): Descovy, emtricitabine, tenofovir alafenamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001577-PIP02-14-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Film-coated tablet
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: XActive substance emtricitabine tenofovir alafenamide Therapeutic area … referred to as emtricitabine / tenofovir alafenamide) for treatment … PIP) for emtricitabine / tenofovir alafenamide for the treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001766-PIP01-15-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Film-coated tablet
Decision date: 03/12/2021, Last updated: 22/03/2023, Compliance check: Xbictegravir emtricitabine tenofovir alafenamide Therapeutic area … bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy), (EMEA-001766-PIP01-15-M04 … bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy), (EMEA-001766-PIP01-15-M04 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Descovy, emtricitabine, tenofovir alafenamide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001577-PIP03-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 07/05/2018, Last updated: 21/09/2021, Compliance check: V, 20/09/2019Active substance emtricitabine tenofovir alafenamide Therapeutic area … ovy Descovy emtricitabine tenofovir alafenamide emtricitabine tenofovir alafenamide emtricitabine tenofovir alafenamide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vemlidy, Tenofovir alafenamide (as fumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001584-PIP01-13-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age appropriate non-tablet formulation
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: XVemlidy Active substance Tenofovir alafenamide (as fumarate … Vemlidy Vemlidy tenofovir alafenamide tenofovir alafenamide fumarate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001460-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/11/2020, Last updated: 09/03/2023, Compliance check: V, 25/06/2021cobicistat emtricitabine tenofovir alafenamide Infectious diseasesP/0435/2020EMEA-001460-PIP01-13-M05 … cobicistat / emtricitabine / tenofovir alafenamide (Genvoya) (EMEA-001460-PIP01-13-M05 … cobicistat / emtricitabine / tenofovir alafenamide (Genvoya) (EMEA-001460-PIP01-13-M05 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Symtuza, darunavir, cobicistat, emtricitabine, tenofovir alafenamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001825-PIP01-15-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: Xcobicistat emtricitabine tenofovir alafenamide Therapeutic area … cobicistat / emtricitabine / tenofovir alafenamide (Symtuza), (EMEA-001825-PIP01-15-M03 … cobicistat / emtricitabine / tenofovir alafenamide (Symtuza), (EMEA-001825-PIP01-15-M03 … -
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Summary of opinion: Genvoya
elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, opinion date: 21/07/2022, Positive, Last updated: 25/07/2022cobicistat / emtricitabine / tenofovir alafenamide On 21 July … class, emtricitabine or tenofovir in adults and paediatric … cobicistat emtricitabine tenofovir alafenamide elvitegravir co … -
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Opinion/decision on a Paediatric investigation plan (PIP): emtricitabine, rilpivirine, tenofovir alafenamide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
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: 13/05/2015, Last updated: 20/08/2015, Compliance check: Xemtricitabine rilpivirine tenofovir alafenamide Infectious diseasesP/0107/2015EMEA-001679-PIP01-14 … 0)1223 897284 E-mail: r egulatory.pip@gilead.com P: decision agreeing on a … emtricitabine / rilpivirine / tenofovir alafenamide (EMEA... PDF … -
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Opinion/decision on a Paediatric investigation plan (PIP): darunavir, cobicistat, emtricitabine, tenofovir alafenamide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001825-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 12/05/2016, Last updated: 02/06/2016, Compliance check: Xcobicistat emtricitabine tenofovir alafenamide Infectious diseasesP/0123/2016EMEA-001825-PIP01-15 … cobicistat / emtricitabine / tenofovir alafen... PDF icon application/pdf … cobicistat / emtricitabine / tenofovir alafenamide (EMEA-001825- PIP01-15 … -
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National expert: zuzana egyud, Institute For State Control Of Veterinary Biologicals And Medicaments (updated)
- Declaration of interests - 39.5 KB | PDF
- Curriculum Vitae - 22.07 KB | PDF
zuzana egyud … zuzana egyud … Vitae Personal information zuzana egyud Work experience …