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430 results
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Withdrawn application: Corluxin
date of withdrawal: 23/03/2015, Initial authorisation, Last updated: 12/06/2015 -
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Orphan designation: Sodium benzoate for: Treatment of N-acetylglutamate synthetase (NAGS) deficiency
Date of designation: 18/11/2016, Positive, Last updated: 14/12/2016 -
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Withdrawn application: Omontys
date of withdrawal: 28/06/2013, Initial authorisation, Last updated: 28/06/2013 -
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Withdrawn application: Begedina
date of withdrawal: 04/07/2016, Initial authorisation, Last updated: 22/07/2016 -
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Withdrawn application: Orathecin
date of withdrawal: 19/01/2006, Initial authorisation, Last updated: 23/01/2006 -
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Withdrawn application: Oncophage
date of withdrawal: 23/11/2009, Initial authorisation, Last updated: 21/12/2009 -
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Withdrawn application: Enpaxiq
date of withdrawal: 20/02/2017, Initial authorisation, Last updated: 09/06/2017 -
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Withdrawn application: Spanidin
date of withdrawal: 17/06/2008, Initial authorisation, Last updated: 19/06/2008 -
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Orphan designation: (-)-17(Cyclopropylmethyl)-1,14 beta-dihydroxy-4,5 alpha-epoxy-6beta-[N-methyl-trans-3-(3-furyl) acrylamido] morphinan hydrochloride (nalfurafine) for: Treatment of uraemic pruritus
Date of designation: 11/09/2002, Positive, Last updated: 14/02/2017 -
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Withdrawn application: Infinia
date of withdrawal: 21/06/2017, Initial authorisation, Last updated: 16/02/2018 -
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Withdrawn application: Surfaxin
date of withdrawal: 07/06/2006, Initial authorisation, Last updated: 08/06/2006 -
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Withdrawn application: Kiacta
date of withdrawal: 13/03/2008, Initial authorisation, Last updated: 17/03/2008 -
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Withdrawn application: Voraxaze
date of withdrawal: 21/05/2007, Initial authorisation, Last updated: 29/05/2007 -
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Withdrawn application: Loulla
mercaptopurine, date of withdrawal: 19/12/2012, Initial authorisation, Last updated: 18/01/2013 -
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Withdrawn application: Retisert
date of withdrawal: 16/07/2007, Initial authorisation, Last updated: 23/07/2007 -
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Withdrawn application: Blectifor
caffeine citrate, date of withdrawal: 09/03/2017, Initial authorisation, Last updated: 16/05/2017 -
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Withdrawn application: orBec
date of withdrawal: 22/05/2008, Initial authorisation, Last updated: 23/05/2008 -
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Withdrawn application: Cerepro
date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 01/02/2011 -
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Withdrawn application: Folcepri
date of withdrawal: 16/05/2014, Initial authorisation, Last updated: 14/08/2014 -
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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, 12/12/2014 -
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Orphan designation: Beclomethasone 17, 21-dipropionate for: Treatment of intestinal graft-versus-host disease
Date of designation: 13/03/2002, Positive, Last updated: 08/06/2020 -
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Orphan designation: Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin for: Treatment of follicular lymphoma
Date of designation: 28/08/2006, Positive, Last updated: 14/06/2012 -
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Orphan designation: edaravone for: Treatment of amyotrophic lateral sclerosis
Date of designation: 19/06/2015, Positive, Last updated: 21/05/2019 -
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Orphan designation: Murine monoclonal antibody against CD26 for: Treatment of graft-versus-host disease
Date of designation: 26/11/2010, Positive, Last updated: 22/01/2014 -
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Orphan designation: Human heterologous liver cells for: Treatment of hyperargininaemia
Date of designation: 17/12/2010, Positive, Last updated: 16/08/2016