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133 results
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Withdrawn application: Voraxaze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Withdrawn application: Loulla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Withdrawn application: Retisert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Withdrawn application: Blectifor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Withdrawn application: orBec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Withdrawn application: Cerepro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Withdrawn application: Folcepri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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Withdrawn application: Vynpenta (previously AvacopanChemoCentryx)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Withdrawn application: Epjevy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Withdrawn application: Radicava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Withdrawn application: Xyndari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Withdrawn application: Upkanz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Withdrawn application: Puldysa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Withdrawn application: Roctavian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): Dacogen, Decitabine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000555-PIP01-09-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 09/08/2017, Last updated: 21/09/2021, Compliance check: V, 18/10/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Cystadrops, Cysteamine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000322-PIP01-08-M05, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 01/08/2017, Last updated: 29/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Alprolix, eftrenonacog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000914-PIP01-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 18/03/2020, Last updated: 03/08/2020, Compliance check: V, 24/07/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Strensiq, asfotase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000987-PIP01-10-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2019, Last updated: 21/09/2021, Compliance check: V, 18/10/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Vimizim, Recombinant human N-acetylgalactosamine-6-sulfatase (BMN110)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000973-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 30/03/2015, Last updated: 06/05/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Idelvion, albutrepenonacog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001107-PIP01-10-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for infusion, Powder and solvent for solution for injection
Decision date: 29/01/2020, Last updated: 11/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Holoclar, Ex-vivo expanded human autologous epithelium containing stem cells
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-001082-PIP02-11-M02, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Living tissue equivalent
Decision date: 07/12/2018, Last updated: 18/02/2019, Compliance check: X -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Spinraza, Nusinersen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001448-PIP01-13-M03, Route(s) of administration: Intrathecal use, Pharmaceutical form(s): Solution for injection
Decision date: 11/04/2018, Last updated: 25/07/2018, Compliance check: V, 29/06/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, inotuzumab ozogamicin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001429-PIP01-13-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 10/02/2020, Last updated: 12/06/2020, Compliance check: X