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116 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Withdrawn application: Oncophage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Withdrawn application: Advexin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Withdrawn application: Ethyl Eicosapent soft gelatin capsules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Withdrawn application: Bosatria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Withdrawn application: Theraloc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Withdrawn application: Vekacia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Withdrawn application: Spanidin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Withdrawn application: orBec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Withdrawn application: Kiacta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Withdrawn application: Retisert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Withdrawn application: Cerepro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Withdrawn application: Voraxaze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Withdrawn application: Surfaxin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Withdrawn application: Orathecin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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Opinion/decision on a Paediatric investigation plan (PIP): Alofisel, darvadstrocel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001561-PIP01-13-M01, Route(s) of administration: Intralesional use, Pharmaceutical form(s): Suspension for injection
Decision date: 16/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP01-10-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 22/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Yescarta, axicabtagene ciloleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002010-PIP01-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 15/04/2020, Last updated: 09/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Blincyto, blinatumomab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000574-PIP02-12-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 18/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000335-PIP01-08-M14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules in sachet
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xospata, Gilteritinib (as fumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002064-PIP01-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 13/05/2020, Last updated: 04/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001915-PIP01-15-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/05/2020, Last updated: 04/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, tezacaftor, ivacaftor
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 formulation
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001659-PIP01-15-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X