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276 results
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Withdrawn application: Oncophage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Withdrawn application: Enpaxiq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Withdrawn application: Spanidin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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Withdrawn application: Infinia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Withdrawn application: Surfaxin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Withdrawn application: Kiacta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Withdrawn application: Voraxaze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Withdrawn application: Loulla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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Opinion/decision on a Paediatric investigation plan (PIP): Incivo, telaprevir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000196-PIP01-08-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Chewable tablet
Decision date: 12/04/2017, Last updated: 29/05/2017, Compliance check: X -
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Withdrawn application: Retisert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Withdrawn application: Blectifor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Withdrawn application: orBec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Withdrawn application: Cerepro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): Vibativ, Telavancin (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000239-PIP01-08-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 01/12/2017, Last updated: 05/03/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): BindRen, colestilan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: EMEA-000878-PIP02-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules, Film-coated tablet
Decision date: 01/09/2011, Last updated: 29/01/2015, Compliance check: X -
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Withdrawn application: Vynpenta (previously AvacopanChemoCentryx)
date of withdrawal: 23/01/2019, Initial authorisation, Last updated: 15/05/2020 -
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Withdrawn application: Epjevy
date of withdrawal: 07/02/2019, Initial authorisation, Last updated: 01/03/2019 -
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Withdrawn application: Radicava
date of withdrawal: 24/05/2019, Initial authorisation, Last updated: 14/08/2019 -
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Withdrawn application: Xyndari
date of withdrawal: 18/09/2019, Initial authorisation, Last updated: 11/02/2020 -
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Withdrawn application: Upkanz
deferiprone, date of withdrawal: 10/08/2020, Initial authorisation, Last updated: 28/10/2020 -
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Withdrawn application: Puldysa
idebenone, date of withdrawal: 28/10/2020, Initial authorisation, Last updated: 18/01/2021 -
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Withdrawn application: Roctavian
Valoctocogene roxaparvovec, date of withdrawal: 04/11/2020, Initial authorisation, Last updated: 13/11/2020 -
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Withdrawn application: Tibsovo
ivosidenib, date of withdrawal: 13/10/2020, Initial authorisation, Last updated: 16/04/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Daklinza, Daclatasvir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001191-PIP01-11-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Chewable tablet, Film-coated tablet
Decision date: 08/11/2019, Last updated: 30/03/2020, Compliance check: X