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144 results
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Withdrawn application: Loulla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Withdrawn application: Cerepro
date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 01/02/2011 -
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Withdrawn application: Tyvaso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Withdrawn application: Oncophage
date of withdrawal: 23/11/2009, Initial authorisation, Last updated: 21/12/2009 -
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Withdrawn application: Advexin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Withdrawn application: Ethyl Eicosapent soft gelatin capsules
date of withdrawal: 01/12/2009, Initial authorisation, Last updated: 08/12/2009 -
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Withdrawn application: Bosatria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Withdrawn application: Theraloc
date of withdrawal: 01/12/2008, Initial authorisation, Last updated: 04/12/2008 -
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Withdrawn application: Vekacia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Withdrawn application: Spanidin
date of withdrawal: 17/06/2008, Initial authorisation, Last updated: 19/06/2008 -
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Withdrawn application: orBec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Withdrawn application: Kiacta
date of withdrawal: 13/03/2008, Initial authorisation, Last updated: 17/03/2008 -
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Withdrawn application: Retisert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Withdrawn application: Cerepro
date of withdrawal: 13/07/2007, Initial authorisation, Last updated: 20/07/2007 -
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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: Surfaxin
date of withdrawal: 07/06/2006, Initial authorisation, Last updated: 08/06/2006 -
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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: Epjevy
date of withdrawal: 07/02/2019, Initial authorisation, Last updated: 01/03/2019 -
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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: Aliqopa
copanlisib, date of withdrawal: 20/12/2021, Initial authorisation, Last updated: 28/01/2022 -
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Withdrawn application: Imbarkyd
bardoxolone methyl, date of withdrawal: 09/11/2022, Initial authorisation, Last updated: 16/12/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Namuscla, Mexiletine hydrochloride (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002012-PIP01-16-M03, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, tezacaftor, ivacaftor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001640-PIP01-14-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 30/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001526-PIP01-13-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cerdelga, Eliglustat (tartrate) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000461-PIP02-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X