2595 results
Keyword oncology Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Raltitrexed
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: Raltitrexed, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 27/01/2009, Last updated: 06/03/2009, Compliance check: XRaltitrexed Oncology … Key facts Tomudex Raltitrexed OncologyP/17/2009Raltitrexed Powder for solution for injection … -
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Opinion/decision on a Paediatric investigation plan (PIP): Casopitant
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: Casopitant, Route(s) of administration: Intravenous infusion, Oral use, Pharmaceutical form(s): Powder for solution for infusion, Film-coated tablet
Decision date: 27/01/2009, Last updated: 06/03/2009, Compliance check: XCasopitant Oncology … Key facts Casopitant OncologyP/6/2009Casopitant Powder for solution for infusion … -
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Opinion/decision on a Paediatric investigation plan (PIP): Arzoxifene
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: Arzoxifene, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 23/05/2008, Last updated: 17/06/2008, Compliance check: XArzoxifene Oncology … Key facts Arzoxifene OncologyP/29/2008Arzoxifene Film-coated tablet Breast … -
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Opinion/decision on a Paediatric investigation plan (PIP): Velcade, bortezomib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: Bortezomib, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder of solution for injection
Decision date: 14/09/2008, Last updated: 10/10/2008, Compliance check: XBortezomib Oncology … bortezomib Therapeutic area Oncology Decision number P/78/2008 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Taxotere, docetaxel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: Docetaxel, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate and solvent for solution for infusion
Decision date: 16/05/2008, Last updated: 04/06/2008, Compliance check: XDocetaxel Oncology … docetaxel Therapeutic area Oncology Decision number P/22/2008 … -
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Opinion/decision on a Paediatric investigation plan (PIP): calcium carbonate, cholecalciferol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/0325/2014, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/12/2014, Last updated: 23/02/2015, Compliance check: XP/0325/2014 Oncology … carbonate cholecalciferol OncologyP/0325/2014P/0325/2014 Film-coated tablet Prevention … -
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Opinion/decision on a Paediatric investigation plan (PIP): Chimeric antibody to mesothelin (MORAB-009)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/118/2010, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 07/07/2010, Last updated: 29/07/2010, Compliance check: XP/118/2010 Oncology … to mesothelin (MORAB-009) OncologyP/118/2010P/118/2010 Solution for infusion Mesothelioma … -
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Opinion/decision on a Paediatric investigation plan (PIP): Forodesine hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: Forodesine hydrochloride, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 04/05/2010, Last updated: 28/07/2010, Compliance check: XForodesine hydrochloride Oncology … Forodesine hydrochloride OncologyP/69/2010Forodesine hydrochloride Capsule, hard … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vorinostat
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/82/2010, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 30/04/2010, Last updated: 27/07/2010, Compliance check: XP/82/2010 Oncology … Key facts Vorinostat OncologyP/82/2010P/82/2010 Capsule, hard Malignant pleural … -
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Opinion/decision on a Paediatric investigation plan (PIP): (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy- 10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,- 14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]- oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyldimethyl-phosphinate (MK-8669, or AP23573)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: P/2/2010, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Gastro-resistant tablet, Age-appropriate dosage form, other, Age-appropriate dosage form for parenteral use
Decision date: 25/01/2010, Last updated: 25/02/2010, Compliance check: XP/2/2010 Oncology … oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyldimethyl-phosphinate (MK-8669, or AP23573) OncologyP/2/2010P/2/2010 Gastro-resistant tablet Age-appropriate … -
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Opinion/decision on a Paediatric investigation plan (PIP): omacetaxine mepesuccinate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: Omacetaxine mepesuccinate, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 15/07/2009, Last updated: 16/09/2009, Compliance check: XOmacetaxine mepesuccinate Oncology … omacetaxine mepesuccinate OncologyP/138/2009Omacetaxine mepesuccinate Powder for … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mercaptopurine monohydrate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: Mercaptopurine monohydrate, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 20/04/2009, Last updated: 10/06/2009, Compliance check: XMercaptopurine monohydrate Oncology … Mercaptopurine monohydrate OncologyP/73/2009Mercaptopurine monohydrate Oral suspension … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lapatinib ditosilate monohydrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: Lapatinib ditosylate monohydrate, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 24/02/2009, Last updated: 23/04/2009, Compliance check: Xinib ditosylate monohydrate Oncology … Lapatinib ditosilate monohydrate OncologyP/36/2009Lapatinib ditosylate monohydrate Film-coated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human granulocyte colony stimulating factor, recombinant human albumin fusion protein
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Oncology
PIP number: P/36/2011, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 28/01/2011, Last updated: 24/02/2011, Compliance check: XP/36/2011 Oncology … protein Therapeutic area Oncology Decision number P/36/2011 … -
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Opinion/decision on a Paediatric investigation plan (PIP): cediranib maleate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: P/86/2010, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 01/06/2010, Last updated: 27/07/2010, Compliance check: XP/86/2010 Oncology … maleate Therapeutic area Oncology Decision number P/86/2010 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Libtayo, Cemiplimab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002007-PIP02-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 13/05/2022, Last updated: 17/05/2023, Compliance check: XEMEA-002007-PIP02-17-M02 Oncology … Cemiplimab Therapeutic area Oncology Decision number P/0179/2022 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Kisplyx, Lenvatinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001119-PIP03-19-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: XEMEA-001119-PIP03-19-M02 Oncology … Lenvatinib Therapeutic area Oncology Decision number P/0154/2022 … -
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Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-(1-(6-Amino-5-chloropyrimidine-4-carboxamido)ethyl)-N-(5-chloro-4-(trifluoromethyl)pyridin-2-yl)thiazole-5-carboxamide (DAY101)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002763-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Tablet
Decision date: 22/12/2020, Last updated: 05/05/2023, Compliance check: XEMEA-002763-PIP01-20 Oncology … R)-2-(1-(6-Amino-5-chloropyrimidine-4-carboxamido)ethyl)-N-(5-chloro-4-(trifluoromethyl)pyridin-2-yl)thiazole-5-carboxamide (DAY101) OncologyP/0500/2020EMEA-002763-PIP01-20 Age-appropriate oral formulation … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tapotoclax
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002631-PIP01-19-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 15/04/2022, Last updated: 19/04/2023, Compliance check: XEMEA-002631-PIP01-19-M01 Oncology … Key facts Tapotoclax OncologyP/0123/2022EMEA-002631-PIP01-19-M01 Concentrate for solution … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bempegaldesleukin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002492-PIP01-18-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 18/03/2022, Last updated: 19/04/2023, Compliance check: XEMEA-002492-PIP01-18-M02 Oncology … Key facts Bempegaldesleukin OncologyP/0099/2022EMEA-002492-PIP01-18-M02 Powder for concentrate for … -
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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-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: XEMEA-002010-PIP01-16-M03 Oncology … Yescarta Axicabtagene ciloleucel OncologyP/0114/2022EMEA-002010-PIP01-16-M03 Dispersion for infusion Treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Iclusig, Ponatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001186-PIP01-11-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate formulation
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: XEMEA-001186-PIP01-11-M03 Oncology … Key facts Iclusig Ponatinib OncologyP/0122/2022EMEA-001186-PIP01-11-M03 Film-coated tablet Capsule … -
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Opinion/decision on a Paediatric investigation plan (PIP): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), Dinutuximab beta
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001314-PIP01-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion, Powder and solvent for solution for injection, Powder for solution for infusion
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: XEMEA-001314-PIP01-12-M01 Oncology … Apeiron) Dinutuximab beta OncologyP/0093/2022EMEA-001314-PIP01-12-M01 Solution for infusion Concentrate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human monoclonal antibody to the p40 subunit of human interleukin-12 and human interleukin-23 of the IgG1-class (ABT-874)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-000552-PIP01-0, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 23/12/2009, Last updated: 25/02/2010, Compliance check: XEMEA-000552-PIP01-0 Oncology … ABT-874) Therapeutic area Oncology Decision number P/266/2009 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mylotarg, gemtuzumab ozogamicin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001733-PIP02-15-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 31/01/2022, Last updated: 14/04/2023, Compliance check: XEMEA-001733-PIP02-15-M02 Oncology … Mylotarg gemtuzumab ozogamicin OncologyP/0014/2022EMEA-001733-PIP02-15-M02 Powder for concentrate for …