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Keyword Blinatumomab Remove keyword
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Orphan designation: blinatumomab for: Treatment of acute lymphoblastic leukaemia
Date of first decision: 24/07/2009, Positive, Last updated: 08/12/2015opinion on orphan designation Blinatumomab for the treatment of acute … Micromet AG, Germany, for blinatumomab for the treatment of acute … information to show that blinatumomab might be of significant benefit … -
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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-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: Xpaediatric investigation plan for blinatumomab (Blincyto), (EMEA-000574-PIP02-12-M02 … paediatric investigation plan for blinatumomab (Blincyto), (EMEA-000574-PIP02-12-M02 … paediatric investigation plan for blinatumomab (Blincyto), powder for solution … -
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Human medicine European public assessment report (EPAR): Blincyto
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,
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, Revision: 10, Authorised, Last updated: 05/11/2019
Blincyto, INN-blinatumomab 30 Churchill Place … cancer medicine Blincyto (blinatumomab) is used in a safe and effective … contains the active substance blinatumomab. More information on Blincyto … -
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Human medicine European public assessment report (EPAR): Kymriah (updated)
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,, , Revision: 2, Authorised, Last updated: 29/06/2020
cancer medicines clofarabine, blinatumomab or a combination of clofarabine … cancer medicines clofarabine, blinatumomab or a combination of clofarabine … -
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Human medicine European public assessment report (EPAR): Besponsa
inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 28/06/2017,, , Revision: 6, Authorised, Last updated: 10/01/2020
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Human medicine European public assessment report (EPAR): Yescarta (updated)
axicabtagene ciloleucel, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 6, Authorised, Last updated: 26/06/2020
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Human medicine European public assessment report (EPAR): Spectrila (updated)
asparaginase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/01/2016,, Revision: 4, Authorised, Last updated: 18/06/2020
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Orphan designation: inotuzumab ozogamicin for: Treatment of B-cell acute lymphoblastic leukaemia
Date of first decision: 07/06/2013, Positive, Last updated: 25/06/2013