7304 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: 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Withdrawn application: Egranli
date of withdrawal: 04/11/2014, Initial authorisation, Last updated: 16/02/2015Egranli: Withdrawn application … Egranli, INN-balugrastim 30 … initial authorisation) Egranli balugrastim On 25 September … -
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Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of designation: 16/01/2014, Positive, Last updated: 23/01/2014Lactobacillus acidophilus and Bifidobacterium bifidum … Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … expected to work? Lactobacillus acidophilus and Bifidobacterium bifidum … -
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Withdrawn application: Egrifta
date of withdrawal: 21/06/2012, Initial authorisation, Last updated: 18/07/2012Egrifta: Withdrawn application … authorisation application for Egrifta (tesamorelin) On 21 June … marketing authorisation for Egrifta, for the treatment of excess … -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, Revision: 1, Withdrawn, Last updated: 25/10/2011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.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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Opinion/decision on a Paediatric investigation plan (PIP): 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-001354-PIP01-12, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal gel
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: X2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … 2,6-bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2 … 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … -
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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): 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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Human medicine European public assessment report (EPAR): Sibnayal
Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular
Date of authorisation: 30/04/2021, Revision: 1, Authorised, Last updated: 26/04/2022Diseases Acid-Base Imbalance Acidosis Acidosis, Renal Tubular … with distal renal tubular acidosis (dRTA), a disease in which … with distal renal tubular acidosis (dRTA), a disease in which … -
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Press release: Updated advice on body fat changes and lactic acidosis with HIV medicines
CHMP, Last updated: 23/10/2015body fat changes and lactic acidosis with HIV medicines … body fat changes and lactic acidosis with medicines for the treatment … require a warning about lactic acidosis. … -
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National expert: Iveta Eglite, State Agency Of Medicines (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 16.93 KB | PDF
Iveta Eglite … Iveta Eglite … Vitae PERSONAL INFORMATION Iveta Eglite WORK EXPERIENCE March 2021 … -
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National expert: Egle Daniuleviciute, State Medicines Control Agency (updated)
- Declaration of interests - 79.85 KB | PDF
- Curriculum Vitae - 17.85 KB | PDF
Egle Daniuleviciute … Egle Daniuleviciute … Vitae PERSONAL INFORMATION Egle Daniuleviciute WORK EXPERIENCE … -
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National expert: Egle Audova, State Agency Of Medicines (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 16.3 KB | PDF
Egle Audova … Egle Audova … Vitae PERSONAL INFORMATION Egle Audova WORK EXPERIENCE October … -
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National expert: Egberdina Botjes, European Medicines Agency (updated)
- Declaration of interests - 79.85 KB | PDF
- Curriculum Vitae - 16.47 KB | PDF
Egberdina Botjes … Egberdina Botjes … Vitae PERSONAL INFORMATION Egberdina Botjes WORK EXPERIENCE January … -
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National expert: Egbert Flory, Paul Ehrlich Institute (updated)
- Declaration of interests - 80.04 KB | PDF
- Curriculum Vitae - 22.08 KB | PDF
Egbert Flory … Egbert Flory … Vitae PERSONAL INFORMATION Egbert Flory WORK EXPERIENCE … -
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National expert: Susanne Mueller-Egert, Paul Ehrlich Institute (updated)
- Declaration of interests - 79.85 KB | PDF
- Curriculum Vitae - 16.67 KB | PDF
Susanne Mueller-Egert … Susanne Mueller-Egert … INFORMATION Susanne Mueller-Egert WORK EXPERIENCE February … -
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National expert: Bjoern Egil Olsen, Norwegian Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 16.67 KB | PDF
Bjoern Egil Olsen … Bjoern Egil Olsen … Vitae PERSONAL INFORMATION Bjoern Egil Olsen WORK EXPERIENCE March … -
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National expert: Kirsten Egebjerg Juul, Danish Medicines Agency (updated)
- Declaration of interests - 79.92 KB | PDF
- Curriculum Vitae - 19.27 KB | PDF
Kirsten Egebjerg Juul … Kirsten Egebjerg Juul … Vitae PERSONAL INFORMATION Kirsten Egebjerg Juul WORK EXPERIENCE June … -
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National expert: Hedvig Marie Egeland Nordeng, European Medicines Agency (updated)
- Declaration of interests - 80.24 KB | PDF
- Curriculum Vitae - 21.83 KB | PDF
Hedvig Marie Egeland Nordeng … Hedvig Marie Egeland Nordeng … INFORMATION Hedvig Marie Egeland Nordeng WORK EXPERIENCE January … -
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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 for the medicine Egrifta (tesamorelin), 2 mg, powder … for solution for injection. Egrifta was intended to be used for … -
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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 … Generic medicines Association (EGA) on generic and biosimilar … one day event is open to EGA members only. Documents Agenda … -
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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 … Documents Agenda - Second EMEA - EGA Info Day; Generic and Biosimilar … Centralised Procedure - For EGA Members Only PDF icon application/pdf …