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Opinion/decision on a Paediatric investigation plan (PIP): Pumarix, Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005(H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000178-PIP01-07-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 08/05/2015, Last updated: 15/06/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Glybera, alipogene tiparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000292-PIP01-08-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 04/11/2016, Last updated: 23/01/2017, Compliance check: X -
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Withdrawn application: Advexin
date of withdrawal: 17/12/2008, Initial authorisation, Last updated: 19/12/2009 -
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Withdrawn application: Epostim
epoetin alfa, date of withdrawal: 15/03/2011, Initial authorisation, Last updated: 19/04/2011 -
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Withdrawn application: Cerepro
date of withdrawal: 13/07/2007, Initial authorisation, Last updated: 20/07/2007 -
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Withdrawn application: Bosatria
mepolizumab, date of withdrawal: 28/07/2009, Initial authorisation, Last updated: 29/07/2009 -
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Withdrawn application: Kyndrisa
date of withdrawal: 31/05/2016, Initial authorisation, Last updated: 06/09/2016 -
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Withdrawn application: Zafiride
date of withdrawal: 01/06/2017, Initial authorisation, Last updated: 08/02/2018 -
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Withdrawn application: Elmisol
date of withdrawal: 29/05/2017, Initial authorisation, Last updated: 18/07/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): ATryn, Antithrombin alfa
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001154-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/09/2011, Last updated: 18/10/2011, Compliance check: X -
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Withdrawn application: Prohippur
date of withdrawal: 03/04/2018, Initial authorisation, Last updated: 05/07/2018 -
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Withdrawn application: Winfuran
date of withdrawal: 17/01/2014, Initial authorisation, Last updated: 11/03/2014 -
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Withdrawn application: Theraloc
date of withdrawal: 01/12/2008, Initial authorisation, Last updated: 04/12/2008 -
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Withdrawn application: Xegafri
date of withdrawal: 05/05/2016, Initial authorisation, Last updated: 22/06/2016 -
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Withdrawn application: Vekacia
ciclosporin, date of withdrawal: 14/11/2008, Initial authorisation, Last updated: 18/11/2008 -
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Withdrawn application: Graspa
date of withdrawal: 14/11/2016, Initial authorisation, Last updated: 25/04/2017 -
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Withdrawn application: Tyvaso
date of withdrawal: 17/02/2010, Initial authorisation, Last updated: 17/05/2010 -
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Withdrawn application: Ethyl Eicosapent soft gelatin capsules
date of withdrawal: 01/12/2009, Initial authorisation, Last updated: 08/12/2009 -
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Withdrawn application: Corluxin
date of withdrawal: 23/03/2015, Initial authorisation, Last updated: 12/06/2015 -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 08/01/2016, Initial authorisation, Last updated: 29/03/2016 -
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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