5391 results
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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: XActive substance EGFR-cMET bispecific antibody Therapeutic … 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Withdrawn application: Egranli
date of withdrawal: 04/11/2014, Initial authorisation, Last updated: 16/02/2015Egranli: Withdrawn application … Egranli, INN-balugrastim 30 … initial authorisation) Egranli balugrastim On 25 September … -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Withdrawn application: Egrifta
date of withdrawal: 21/06/2012, Initial authorisation, Last updated: 18/07/2012Egrifta: Withdrawn application … authorisation application for Egrifta (tesamorelin) On 21 June … marketing authorisation for Egrifta, for the treatment of excess … -
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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, Revision: 1, Withdrawn, Last updated: 25/10/2011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. International non-proprietary … 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Date of authorisation: 08/06/2010,, Withdrawn, Last updated: 30/06/2011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. International non-proprietary … as ovalbumin (a protein in egg white egg or chicken proteins, neomycin … strain (X-179A)*propagated in eggs. … -
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Orphan designation: 20% Intravenous fat emulsion consisting of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection for: Treatment of poisoning by local anaesthetics
Date of first decision: 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): 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 eggs International non-proprietary … 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: 16/04/2019, Compliance check: Xstrain (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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National expert: Adalheidur Eggertsdottir, Icelandic Medicines Agency (updated)
- Declaration of interests - 80.28 KB | PDF
- Curriculum Vitae - 18 KB | PDF
Vitae PERSONAL INFORMATION Adalheidur Eggertsdottir WORK EXPERIENCE April 2019 … Eggertsdottir 2020-12-29 Classified as … interests I, Adalheidur Eggertsdottir Organisation/Company: Icelandic … -
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National expert: Egle Daniuleviciute, Lithuania States Medicines Control Agency (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 72.76 KB | PDF
vitae PERSONAL INFORMATION Egle Daniuleviciute WORK EXPERIENCE 2014–Present … 2 Curriculum vitae Egle Daniuleviciute – CTFG … declaration of interests I, EGL? DANIULEVI?I?T? Organisation/Company … -
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National expert: Iveta Eglite, Latvian State Agency of Medicines (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 16.65 KB | PDF
Vitae PERSONAL INFORMATION Iveta Eglite WORK EXPERIENCE February … Eglite 2020-12-14 Classified as … declaration of interests I, Iveta Eglite Organisation/Company: Latvian … -
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National expert: Egberdina Botjes, European Medicines Agency (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 16.22 KB | PDF
Vitae PERSONAL INFORMATION Egberdina Botjes WORK EXPERIENCE January … declaration of interests I, Egberdina Botjes Organisation/Company … EMA website. Full Name: Egberdina (Erna) Botjes Bronsdijk Date … -
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National expert: Egidijus Morkunas, Lithuania States Medicines Control Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 17.47 KB | PDF
Vitae PERSONAL INFORMATION Egidijus Morkunas WORK EXPERIENCE September … declaration of interests I, Egidijus Morkunas Organisation/Company … EMA website. Full Name: Egidijus Morkunas Date: 2020-12-29 For … -
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National expert: Egle Karinauske, Lithuania States Medicines Control Agency (updated)
- Declaration of interests - 79.77 KB | PDF
- Curriculum Vitae - 17.97 KB | PDF
Vitae PERSONAL INFORMATION Egle Karinauske WORK EXPERIENCE August … declaration of interests I, Egle Karinauske Organisation/Company … EMA website. Full Name: Egle Karinauske Date: 2020-12-15 For … -
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National expert: Egbert Flory, Paul-Ehrlich-Institute (updated)
- Declaration of interests - 80.02 KB | PDF
- Curriculum Vitae - 22.1 KB | PDF
Vitae PERSONAL INFORMATION Egbert Flory WORK EXPERIENCE … declaration of interests I, Egbert Flory Organisation/Company … EMA website. Full Name: Egbert Flory Date: 2021-01-11 For … -
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National expert: Erlend Johannessen Egeland, Norwegian Medicines Agency (updated)
- Declaration of interests - 79.77 KB | PDF
- Curriculum Vitae - 17.7 KB | PDF
INFORMATION Erlend Johannessen Egeland WORK EXPERIENCE August … transplantation Renal failure Publications 1 Egeland EJ, Witczak BJ, Zaré HK … 2020; 108(4): 866-873 2. Egeland EJ, Reisæter AV, Robertsen … -
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National expert: Susanne Mueller-Egert, Paul-Ehrlich-Institute (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 17 KB | PDF
INFORMATION Susanne Mueller-Egert WORK EXPERIENCE February … Mueller-Egert 2020-12-07 Classified as … interests I, Susanne Mueller-Egert Organisation/Company: Paul-Ehrlich-Institute Country … -
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National expert: Bjoern Egil Olsen, Norwegian Medicines Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 17.18 KB | PDF
Vitae PERSONAL INFORMATION Bjoern Egil Olsen WORK EXPERIENCE March … declaration of interests I, Bjoern Egil Olsen Organisation/Company … website. Full Name: Bjørn Egil Olsen Date: 2020-12-09 For … -
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National expert: Hedvig Marie Egeland Nordeng, European Medicines Agency (updated)
- Declaration of interests - 80.23 KB | PDF
- Curriculum Vitae - 20.85 KB | PDF
INFORMATION Hedvig Marie Egeland Nordeng WORK EXPERIENCE January … interests I, Hedvig Marie Egeland Nordeng Organisation/Company … Hedvig Marie Egeland Nordeng … -
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Press release: Ferrer Internacional, S.A. withdraws its marketing authorisation application for Egrifta (tesamorelin)
Last updated: 26/06/2012authorisation application for Egrifta (tesamorelin … authorisation application for Egrifta (tesamorelin … authorisation application for Egrifta (tesamorelin) The European … -
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Generic and biosimilar medicines in the centralised procedure: 3rd EMA-EGA information day
London, 10/11/2010, Last updated: 09/11/2010centralised procedure: 3rd EMA-EGA information day … centralised procedure: 3rd EMA-EGA information day … Third EMA-EGA info day - Generic and biosimilar … -
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Second EMEA - EGA Info Day - Generic and Biosimilar Medicines in the Centralised Procedure
London, 03/10/2008, Last updated: 01/10/2008Second EMEA - EGA Info Day - Generic and Biosimilar … Second EMEA - EGA Info Day - Generic and Biosimilar … Microsoft Word - EMEA-EGA info day-3.10.08 … -
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EMEA - EGA Info Day on Generic and Biosimilar Medicinal Products and the Centralised Procedure
London, 25/11/2006, Last updated: 25/11/2006EMEA - EGA Info Day on Generic and Biosimilar … EMEA - EGA Info Day on Generic and Biosimilar … Microsoft Word - EMEA-EGA info day_24.11.06_version … -
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Veterinary medicine European public assessment report (EPAR): Vectormune ND
cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain, Chicken, Embryonated eggs
Date of authorisation: 08/09/2015, Revision: 6, Authorised, Last updated: 06/10/2020watery diarrhoea and reduced egg production. MD is a herpesvirus … directly into 18-day-old eggs containing embryos (unhatched … layers (chickens bred for egg production). For MD protection …