133 results
Keyword Luspatercept Remove keyword
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Human medicine European public assessment report (EPAR): Reblozyl
Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia
Date of authorisation: 25/06/2020,
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, Revision: 5, Authorised, Last updated: 09/10/2023
Authorised luspatercept Overview Reblozyl is a medicine … medicine. active substance luspatercept. How is Reblozyl used? The … active substance in Reblozyl, luspatercept, regulates the maturation … -
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Opinion/decision on a Paediatric investigation plan (PIP): Reblozyl, Luspatercept
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001521-PIP01-13-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: XReblozyl Active substance Luspatercept Therapeutic area Haematology-Hemostaseology … Reblozyl Reblozyl luspatercept Luspatercept Luspatercept … -
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Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for: Treatment of beta thalassaemia intermedia and major
Date of designation: 29/07/2014, Positive, Last updated: 21/03/2023the human IgG1 Fc domain (luspatercept … Reblozyl Reblozyl luspatercept Recombinant fusion protein … the human IgG1 Fc domain (luspatercept Luspatercept … -
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Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for: Treatment of myelodysplastic syndromes
Date of designation: 22/08/2014, Positive, Last updated: 18/02/2021Reblozyl Reblozyl luspatercept Recombinant fusion protein … Fc domain (luspatercept) Luspatercept … -
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Orphan designation: Luspatercept for: Treatment of myelofibrosis
Date of designation: 28/02/2020, Positive, Last updated: 18/02/2021Luspatercept … Luspatercept … -
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Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001521-PIP02-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 15/08/2018, Last updated: 14/01/2019, Compliance check: XKey facts Luspatercept Haematology-HemostaseologyP/0254/2018EMEA-001521-PIP02-18 … product specific waiver for luspatercept (EMEA-001521-PIP02-18) PDF … Luspatercept … -
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National expert: Maria Dimopoulou, National Organization For Medicines (updated)
- Declaration of interests - 43.75 KB | PDF
- Curriculum Vitae - 41.23 KB | PDF
V; BEYOND Investigators. Luspatercept for the treatment of anaemia … activity Past 14-03- 2023 14-03- 2023 BMS Individual product related LUSPATERCEPT NON-TRANSFUSION DEPENDENT … indication Current 01-07- 2022 BMS/Celgene LUSPATERCEPT Non -transfusion Dependent … -
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National expert: Bruno Quesnel, European Medicines Agency (updated)
- Declaration of interests - 43.66 KB | PDF
- Curriculum Vitae - 77.37 KB | PDF
AML Past 01-02- 2018 01-11- 2022 CELGENE/BMS LUSPATERCEPT transfusion_dependent myelodysplastic … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020
CHMP, Last updated: 30/04/2020luspatercept) received a positive opinion … -
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National expert: Iwona Malinowska, Office For Registration Of Medicinal Products Medical Devices And Biocidal Products (updated)
- Declaration of interests - 39.31 KB | PDF
- Curriculum Vitae - 47.27 KB | PDF
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023
CHMP, Last updated: 27/01/2023Reblozyl INN luspatercept Marketing-authorisation holder … -
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National expert: Christian Gisselbrecht, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 41.61 KB | PDF
- Curriculum Vitae - 53.78 KB | PDF
Medicines Agency Review of Luspatercept for the Treatment of Adult … -
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Orphan designation: Iodine (124I) evuzamitide for: Diagnosis of ATTR amyloidosis
Date of designation: 09/12/2022, Positive, Last updated: 25/07/2023 -
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Orphan designation: Autologous T-cells transduced with a lentiviral vector encoding a chimeric antigen receptor against CD7 for: Treatment of acute lymphoblastic leukaemia
Date of designation: 09/12/2022, Positive, Last updated: 14/03/2023 -
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Orphan designation: Octreotide acetate for: Treatment of carcinoid syndrome
Date of designation: 13/01/2023, Positive, Last updated: 23/03/2023 -
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Orphan designation: Efgartigimod alfa for: Treatment of chronic inflammatory demyelinating polyneuropathy
Date of designation: 14/01/2022, Positive, Last updated: 09/06/2022 -
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Orphan designation: mRNA encoding human glucose-6-phosphatase variant S298C for: treatment of glycogen storage disease type Ia
Date of designation: 14/01/2022, Positive, Last updated: 09/06/2022 -
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Orphan designation: Fasudil hydrochloride for: Treatment of amyotrophic lateral sclerosis
Date of designation: 14/01/2022, Positive, Last updated: 09/06/2022 -
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Orphan designation: N-sulfoglucosamine sulfohydrolase fused to a humanised monoclonal antibody targeting the human transferrin receptor for: Treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome)
Date of designation: 14/01/2022, Positive, Last updated: 09/06/2022 -
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Orphan designation: Chimeric peptide of human glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues linked to a human immunoglobulin Fc fragment for: Treatment of primary biliary cholangitis
Date of designation: 14/01/2022, Positive, Last updated: 15/06/2022 -
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Orphan designation: Gadolinium-chelated polysiloxane nanoparticles for: Treatment of glioma
Date of designation: 14/01/2022, Positive, Last updated: 09/06/2022 -
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Orphan designation: Olorofim for: Treatment of invasive Scopulariopsis
Date of designation: 14/01/2022, Positive, Last updated: 09/06/2022 -
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Orphan designation: 5-((4'-(3,3-difluorocyclobutyl)-[1,1'-biphenyl]-4-yl)oxy)-1H-1,2,3-triazole-4-carboxylic acid for: Treatment of primary hyperoxaluria
Date of designation: 14/01/2022, Positive, Last updated: 09/06/2022 -
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Orphan designation: 5' moemC-(sp)-moemC-(p)-moeA-(p)-moemC-(p)-moeG-(p)-moeA-(p)-dmC-(sp)-dA-(sp)-dT-(sp)-dA-(sp)-dT-(sp)-dT-(sp)-dT-(sp)-dT-(sp)-dT-(sp)-dmC-(sp)-moeT-(p)-moeA-(sp)-moemC-(sp)-moeA 3' for: Treatment of SCN2A developmental and epileptic encephalopathy
Date of designation: 14/01/2022, Positive, Last updated: 09/06/2022 -
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Orphan designation: Adeno-associated virus serotype 9 expressing the human fukutin related protein and target sequence of the miR-208a for: Treatment of limb girdle muscular dystrophy
Date of designation: 14/01/2022, Positive, Last updated: 09/06/2022