8 results
Keyword Blinatumomab Remove keyword
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Orphan designation: 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,
Decision type: PM: decision on the application for modification of an agreed PIP, PIP number: EMEA-000574-PIP02-12-M02, 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
Date of authorisation: 23/11/2015,,
, 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
Date of authorisation: 22/08/2018,,
, Authorised, Last updated: 19/09/2018
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 (updated)
Date of authorisation: 28/06/2017,,
, Revision: 5, Authorised, Last updated: 25/11/2019
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Human medicine European public assessment report (EPAR): Yescarta
Date of authorisation: 23/08/2018,,
, Revision: 2, Authorised, Last updated: 27/05/2019
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Human medicine European public assessment report (EPAR): Spectrila
Date of authorisation: 14/01/2016,, Revision: 3, Authorised, Last updated: 08/05/2019
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Orphan designation: for: Treatment of B-cell acute lymphoblastic leukaemia
Date of first decision: 07/06/2013, Positive, Last updated: 25/06/2013