52 results
Keyword Infigratinib Remove keyword
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Orphan designation: Infigratinib for: Treatment of cholangiocarcinoma
Date of designation: 21/08/2020, Withdrawn, Last updated: 08/11/2022Infigratinib Overview On 21 August 2020 … Services GmbH, Germany, for infigratinib for the treatment of cholangiocarcinoma … opinion on orphan designation Infigratinib for the treatment of cholangiocarcinoma … -
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Withdrawn application: Febseltiq
infigratinib, date of withdrawal: 11/10/2022, Initial authorisation, Last updated: 30/01/2023infigratinib Overview Helsinn Birex Pharmaceuticals … medicine. active substance infigratinib and was to be available as … active substance in Febseltiq, infigratinib, belongs to a group of medicines … -
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Orphan designation: Infigratinib for: Treatment of achondroplasia
Date of designation: 19/07/2021, Positive, Last updated: 16/11/2021Infigratinib Overview This medicine was … medicine is expected to work Infigratinib belongs to a group of medicines … patients with achondroplasia, infigratinib is expected to reduce the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Infigratinib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002594-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 13/08/2021, Last updated: 08/09/2022, Compliance check: XKey facts Infigratinib Endocrinology, -gynacology-fertility-metabolismP/0331/2021EMEA-002594-PIP02-20 … granting of a deferral for infigratinib (EMEA-002594-PIP02-20) PDF … granting of a deferral for infigratinib, (EMEA-002594-PIP02-20) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Infigratinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002594-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: XKey facts Infigratinib OncologyP/0301/2019EMEA-002594-PIP01-19 … product specific waiver for infigratinib (EMEA-002594-PIP01-19) PDF … Infigratinib … -
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National expert: Nuno Sousa, National Authority Of Medicines And Health Products (updated)
- Declaration of interests - 85.13 KB | PDF
- Curriculum Vitae - 16.82 KB | PDF
06/2021-(current) QED Therapeutics, Inc. Infigratinib Advanced/Metastatic or Inoperable … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022
CHMP, Last updated: 11/11/2022Febseltiq INN infigratinib Marketing-authorisation applicant … -
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Orphan designation: 1-(4-(6-chloropyridazin-3-yl)piperazin-1-yl)-2-(4-cyclopropyl-3-fluorophenyl)ethan-1-one for: Treatment of propionic acidaemia
Date of designation: 19/07/2021, Positive, Last updated: 05/09/2022 -
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Orphan designation: 1-(4-(6-chloropyridazin-3-yl)piperazin-1-yl)-2-(4-cyclopropyl-3-fluorophenyl)ethan-1-one for: Treatment of pantothenate kinase-associated neurodegeneration
Date of designation: 19/07/2021, Positive, Last updated: 05/09/2022 -
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Orphan designation: tisagenlecleucel for: Treatment of follicular lymphoma
Date of designation: 19/07/2021, Positive, Last updated: 19/05/2022 -
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Orphan designation: Sirolimus for: Treatment of perivascular epithelioid cell tumours
Date of designation: 19/07/2021, Positive, Last updated: 21/12/2021 -
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Orphan designation: Zanidatamab for: Treatment of biliary tract cancer
Date of designation: 19/07/2021, Positive, Last updated: 12/11/2021 -
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Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues for: Treatment of familial chylomicronaemia syndrome
Date of designation: 19/07/2021, Positive, Last updated: 12/11/2021 -
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Orphan designation: Itolizumab for: Treatment of graft-versus-host disease
Date of designation: 19/07/2021, Positive, Last updated: 12/11/2021 -
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Orphan designation: Eftansomatropin alfa for: Treatment of growth hormone deficiency
Date of designation: 19/07/2021, Positive, Last updated: 12/11/2021 -
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Orphan designation: Lutetium (177Lu) omburtamab barzuxetan for: Treatment of medulloblastoma
Date of designation: 19/07/2021, Positive, Last updated: 12/11/2021 -
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Orphan designation: melatonin for: Treatment of non-traumatic spontaneous intracerebral haemorrhage
Date of designation: 19/07/2021, Positive, Last updated: 12/11/2021 -
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Orphan designation: Vodobatinib for: Treatment of chronic myeloid leukaemia
Date of designation: 19/07/2021, Positive, Last updated: 12/11/2021 -
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Orphan designation: humanised IgG2k Fc-modified bispecific monoclonal antibody against CD3 and BCMA for: Treatment of multiple myeloma
Date of designation: 19/07/2021, Positive, Last updated: 16/11/2021 -
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Orphan designation: mRNA encoding the human glycogen debranching enzyme for: Treatment of glycogen storage disease type III
Date of designation: 19/07/2021, Positive, Last updated: 16/11/2021 -
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Orphan designation: autologous CD34+ hematopoietic stem and progenitor cells genetically modified with the lentiviral vector encoding for the human palmitoyl-protein thioesterase 1 gene for: Treatment of neuronal ceroid lipofuscinosis
Date of designation: 19/07/2021, Positive, Last updated: 16/11/2021 -
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Orphan designation: 3,5-diiodothyropropionic acid for: Treatment of Allan-Herndon-Dudley syndrome
Date of designation: 19/07/2021, Positive, Last updated: 16/11/2021 -
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Orphan designation: Adeno-associated viral vector serotype Anc80 containing the 3' portion of human OTOF gene, adeno-associated viral vector serotype Anc80 containing the 5' portion of human OTOF gene for: Treatment of otoferlin gene-mediated hearing loss
Date of designation: 19/07/2021, Positive, Last updated: 16/11/2021 -
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Orphan designation: Adeno-associated virus vector serotype 1 containing the human GRN gene for: Treatment of frontotemporal dementia
Date of designation: 19/07/2021, Positive, Last updated: 16/11/2021 -
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Orphan designation: recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1 for: Treatment of adenosine triphosphate binding cassette transporter protein subfamily C member 6 deficiency
Date of designation: 19/07/2021, Positive, Last updated: 16/11/2021