7566 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Withdrawn application: Egranli
date of withdrawal: 04/11/2014, Initial authorisation, Last updated: 16/02/2015Egranli: Withdrawn application … Egranli: Withdrawal of the marketing … Egranli, INN-balugrastim 30 … -
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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 … designation Lactobacillus acidophilus and Bifidobacterium bifidum … Italy, for 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Withdrawn application: Egrifta
date of withdrawal: 21/06/2012, Initial authorisation, Last updated: 18/07/2012Egrifta: Withdrawn application … authorisation application for Egrifta (tesamorelin) On 21 June … marketing authorisation for Egrifta, for the treatment of excess … -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, Revision: 1, Withdrawn, Last updated: 25/10/2011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. 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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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 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: 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: 2, Authorised, Last updated: 30/06/2023Diseases 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: 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 … -
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National expert: Egle Sulioke, European Medicines Agency (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 23.43 KB | PDF
Egle Sulioke … Egle Sulioke … Vitae Personal information Egle Sulioke Work experience … -
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National expert: Egberdina Botjes, European Medicines Agency (updated)
- Declaration of interests - 39.35 KB | PDF
- Curriculum Vitae - 21.58 KB | PDF
Egberdina Botjes … Egberdina Botjes … Vitae Personal information Egberdina Botjes Work experience … -
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National expert: Iveta Eglite, State Agency of Medicines (updated)
- Declaration of interests - 39.29 KB | PDF
- Curriculum Vitae - 23.56 KB | PDF
Iveta Eglite … Iveta Eglite … Vitae Personal information Iveta Eglite Work experience … -
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National expert: Egle Daniuleviciute, State Medicines Control Agency (updated)
- Declaration of interests - 39.22 KB | PDF
- Curriculum Vitae - 27.49 KB | PDF
Egle Daniuleviciute … Egle Daniuleviciute … Vitae Personal information Egle Daniuleviciute Work experience … -
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National expert: Egbert Flory, Paul-Ehrlich-Institut (updated)
- Declaration of interests - 39.64 KB | PDF
- Curriculum Vitae - 32.52 KB | PDF
Egbert Flory … Egbert Flory … Vitae Personal information Egbert Flory Work experience … -
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National expert: Peter Egbert Hermann Schwarz, European Medicines Agency (updated)
- Declaration of interests - 40.75 KB | PDF
- Curriculum Vitae - 34.6 KB | PDF
Peter Egbert Hermann Schwarz … Peter Egbert Hermann Schwarz … Vitae Personal information Peter Egbert Hermann Schwarz Work experience … -
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National expert: Bjoern Egil Olsen, Norwegian Medicines Agency (updated)
- Declaration of interests - 39.36 KB | PDF
- Curriculum Vitae - 23.17 KB | PDF
Bjoern Egil Olsen … Bjoern Egil Olsen … Vitae Personal information Bjoern Egil Olsen Work experience … -
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National expert: Susanne Mueller-Egert, Paul-Ehrlich-Institut (updated)
- Declaration of interests - 39.38 KB | PDF
- Curriculum Vitae - 24.03 KB | PDF
Susanne Mueller-Egert … Susanne Mueller-Egert … information Susanne Mueller-Egert Work experience … -
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National expert: Kirsten Egebjerg Juul, Danish Medicines Agency (updated)
- Declaration of interests - 40.04 KB | PDF
- Curriculum Vitae - 30.12 KB | PDF
Kirsten Egebjerg Juul … Kirsten Egebjerg Juul … Vitae Personal information Kirsten Egebjerg Juul Work experience … -
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National expert: Hedvig Marie Egeland Nordeng, European Medicines Agency (updated)
- Declaration of interests - 40.23 KB | PDF
- Curriculum Vitae - 71.92 KB | PDF
Hedvig Marie Egeland Nordeng … Hedvig Marie Egeland Nordeng … information Hedvig Marie Egeland Nordeng Work experience … -
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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 …