9173 results
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Referral: Escitalopram
escitalopram, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 18/02/2010, Last updated: 29/09/2010Escitalopram … review of a group of generic escitalopram-containing medicines that were authorised … issued in due course. What is escitalopram? Escitalopram is an antidepressant used … -
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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Withdrawn application: Egranli
date of withdrawal: 04/11/2014, Initial authorisation, Last updated: 16/02/2015Egranli: Withdrawn application … Egranli, INN-balugrastim 30 … initial authorisation) Egranli balugrastim On 25 September … -
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Withdrawn application: Egrifta
date of withdrawal: 21/06/2012, Initial authorisation, Last updated: 18/07/2012Egrifta: Withdrawn application … authorisation application for Egrifta (tesamorelin) On 21 June … marketing authorisation for Egrifta, for the treatment of excess … -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): 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, Withdrawn, Last updated: 30/06/2011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): 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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Referral: Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 19/08/2005, Last updated: 03/11/2005atomoxetine, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … atomoxetine, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … citalopram, duloxetine 1 , escitalopram, fluoxetine,fluvoxamine, mianserine … -
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015submitted by stakeholders (e.g. healthcare professionals … acid ropinirole cefpodoxime quetiapine trimetazidine bosentan tramadol paracetamol escitalopram trimetazidine hydrochloride entacapone valsartan hydrochlorothiazide donepezil … hydrochloride clopidogrel hydrochloride escitalopram oxalate metformin hydrochloride trimetazidine … -
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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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Referral: Galantamine Stada
galantamine, associated names: Galantamina, Galantamine Tiefenbacher, Galantamina Ciclum, Galatnax xl, Galastad, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/09/2010, EC decision date: 21/02/2011, Last updated: 08/06/2012Galantamine Stada … the medicine Galantamine Stada. The Agency's Committee for … the benefits of Galantamine Stada do not outweigh its risks … -
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News: Update on investigation by Italian authorities into the supply of stolen medicines
Last updated: 03/06/2014Update on investigation by Italian authorities into the supply … authorities in Italy and Germany: Italian medicines agency (AIFA) Paul … announced investigation by Italian authorities into the supply … -
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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 …