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Opinion/decision on a Paediatric investigation plan (PIP): Natpar,
Decision type: PM: decision on the application for modification of an agreed PIP, PIP number: EMEA-001526-PIP01-13-M03, decision date: 17/04/2019, Last updated: 24/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Deltyba,
Decision type: PM: decision on the application for modification of an agreed PIP, PIP number: EMEA-001113-PIP01-10-M06, decision date: 14/08/2019, Last updated: 20/11/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri,
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, PIP number: EMEA-000713-PIP02-10-M05, decision date: 20/07/2018, Last updated: 28/11/2018, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva,
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), PIP number: EMEA-001304-PIP03-17, decision date: 11/04/2018, Last updated: 25/07/2018, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Humenza,
Decision type: PM: decision on the application for modification of an agreed PIP, PIP number: EMEA-000669-PIP01-09-M02, decision date: 04/01/2019, Last updated: 16/04/2019, compliance check: X -
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Withdrawn application: Repaglinide Sun
repaglinide, date of withdrawal: 25/03/2010, Initial authorisation, Last updated: 15/05/2010 -
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Withdrawn application: Aripiprazole Mylan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Withdrawn application: Pioglitazone ratiopharm
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012 -
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Withdrawn application: Desloratadine Krka
desloratadine, date of withdrawal: 14/10/2011, Initial authorisation, Last updated: 17/11/2011 -
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Withdrawn application: Topotecan SUN
topotecan, date of withdrawal: 03/01/2011, Initial authorisation, Last updated: 23/02/2011 -
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Withdrawn application: Omontys
peginesatide, date of withdrawal: 28/06/2013, Initial authorisation, Last updated: 28/06/2013 -
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Withdrawn application: Translarna
ataluren, date of withdrawal: 06/03/2017, Post-authorisation, Last updated: 24/03/2017 -
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Withdrawn application: Memantine FGK
memantine, date of withdrawal: 18/12/2012, Initial authorisation, Last updated: 10/04/2013 -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 07/05/2015, Initial authorisation, Last updated: 20/07/2015 -
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Withdrawn application: Pioglitazone ratio
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012 -
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Withdrawn application: Alendronic Acid / Colecalciferol Mylan
alendronic acid / colecalciferol, date of withdrawal: 27/05/2016, Initial authorisation, Last updated: 02/02/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Bavencio,
Decision type: PM: decision on the application for modification of an agreed PIP, PIP number: EMEA-001849-PIP02-15-M02, decision date: 15/08/2018, Last updated: 13/01/2019, compliance check: X -
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Withdrawn application: Pemetrexed ditromethamine Hospira
pemetrexed, date of withdrawal: 22/09/2016, Initial authorisation, Last updated: 21/12/2016 -
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Withdrawn application: Kyndrisa
drisapersen, date of withdrawal: 31/05/2016, Initial authorisation, Last updated: 06/09/2016 -
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Withdrawn application: Pioglitazone Teva Generics
pioglitazone, date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012 -
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Withdrawn application: Ibandronic Acid Hexal
ibandronic acid, date of withdrawal: 21/07/2011, Initial authorisation, Last updated: 22/08/2011 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva,
Decision type: PM: decision on the application for modification of an agreed PIP, PIP number: EMEA-001304-PIP02-13-M04, decision date: 12/06/2019, Last updated: 08/11/2019, compliance check: X -
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Withdrawn application: Rotigotine Mylan
rotigotine, date of withdrawal: 22/12/2017, Initial authorisation, Last updated: 11/07/2018 -
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Withdrawn application: Tigecycline Accord
tigecycline, date of withdrawal: 12/09/2017, Initial authorisation, Last updated: 10/10/2017 -
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Withdrawn application: Ertapenem Hospira
ertapenem, date of withdrawal: 13/09/2016, Initial authorisation, Last updated: 06/12/2016