2220 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): 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 … human albumin fusion protein OncologyP/36/2011P/36/2011 Solution for injection 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): 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 … Key facts cediranib maleate OncologyP/86/2010P/86/2010 Tablet Treatment of high-grade … -
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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): 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): (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): 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): idecabtagene vicleucel (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002369-PIP01-18-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 19/02/2021, Last updated: 08/10/2021, Compliance check: XEMEA-002369-PIP01-18-M02 Oncology … facts idecabtagene vicleucel OncologyP/0068/2021EMEA-002369-PIP01-18-M02 Dispersion for injection … -
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Opinion/decision on a Paediatric investigation plan (PIP): Xalkori, crizotinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001493-PIP03-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral dosage form
Decision date: 27/01/2021, Last updated: 05/10/2021, Compliance check: XEMEA-001493-PIP03-18-M01 Oncology … Key facts Xalkori crizotinib OncologyP/0036/2021EMEA-001493-PIP03-18-M01 Capsule, hard Age-appropriate … -
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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 … the IgG1-class (ABT-874) OncologyP/266/2009EMEA-000552-PIP01-0 Solution for injection Psoriasis … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo, Olaratumab (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001760-PIP01-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/03/2019, Last updated: 08/10/2021, Compliance check: XEMEA-001760-PIP01-15-M03 Oncology … Olaratumab Therapeutic area Oncology Decision number P/0112/2019 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bavencio, avelumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001849-PIP02-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/12/2020, Last updated: 27/09/2021, Compliance check: XEMEA-001849-PIP02-15-M03 Oncology … Key facts Bavencio avelumab OncologyP/0504/2020EMEA-001849-PIP02-15-M03 Concentrate for solution … -
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Opinion/decision on a Paediatric investigation plan (PIP): Veliparib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000499-PIP02-10-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, Oral liquid
Decision date: 04/12/2020, Last updated: 23/09/2021, Compliance check: XEMEA-000499-PIP02-10-M01 Oncology … Key facts Veliparib OncologyP/0465/2020EMEA-000499-PIP02-10-M01 Capsule Oral liquid Treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Halaven, Eribulin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001261-PIP01-11-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: XEMEA-001261-PIP01-11-M06 Oncology … Eribulin Therapeutic area Oncology Decision number P/0040/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP01-10-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 28/01/2021, Last updated: 29/09/2021, Compliance check: XEMEA-000980-PIP01-10-M07 Oncology … vedotin Therapeutic area Oncology Decision number P/0013/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Alunbrig, brigatinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002296-PIP01-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate liquid dosage form, Film-coated tablet
Decision date: 09/12/2020, Last updated: 28/09/2021, Compliance check: XEMEA-002296-PIP01-17-M02 Oncology … brigatinib Therapeutic area Oncology Decision number P/0483/2020 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002147-PIP02-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 08/11/2019, Last updated: 21/09/2021, Compliance check: V, 11/12/2019EMEA-002147-PIP02-17-M01 Oncology … Key facts Sodium thiosulfate OncologyP/0368/2019EMEA-002147-PIP02-17-M01 Solution for infusion Prevention …