121 results
Keyword Luspatercept Remove keyword
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Human medicine European public assessment report (EPAR): Reblozyl (updated)
Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia
Date of authorisation: 25/06/2020,
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, Revision: 4, Authorised, Last updated: 20/03/2023
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-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 27/01/2021, Last updated: 06/10/2021, 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 (updated)
Date of designation: 29/07/2014, Positive, Last updated: 21/03/2023the human IgG1 Fc domain (luspatercept) Overview On 29 July 2014 … medicine is now known as luspatercept. The sponsorship was transferred … the human IgG1 Fc domain (luspatercept)Treatment of beta thalassaemia intermedia … -
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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 Overview On 28 February 2020 … B.V., the Netherlands, for luspatercept (also known as ACE-536) for … medicine expected to work? Luspatercept is an engineered protein … -
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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: Antonis Kattamis, European Medicines Agency (updated)
- Declaration of interests - 81.57 KB | PDF
- Curriculum Vitae - 18.25 KB | PDF
11/2016-(current) Bristol Myers Squibb luspatercept thalassemia 08/2021-(current … 12/2016-(current) Bristol Myers Squibb luspatercept thalassemia 03/2022-(current … -
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National expert: Holger Cario, European Medicines Agency (updated)
- Declaration of interests - 81.49 KB | PDF
- Curriculum Vitae - 33.05 KB | PDF
Bristol-Myers Squibb GmbH & Co. KGaA Luspatercept Thalassemia 09/2022-(current … 03/2022-(current) BMS /(Celgene) Luspatercept Thalassemia 2.7 Grant … -
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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: Gian Luca Forni, European Medicines Agency (updated)
- Declaration of interests - 81.18 KB | PDF
- Curriculum Vitae - 33.83 KB | PDF
Indication 06/2018-(current) BMS Luspatercept Anemia correction In Thalassemia … -
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National expert: Bruno Quesnel, European Medicines Agency (updated)
- Declaration of interests - 82.76 KB | PDF
- Curriculum Vitae - 59.23 KB | PDF
02/2018-(current) CELGENE/BMS LUSPATERCEPT transfusion-dependent myelodysplastic … -
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National expert: Iwona Malinowska, Office For Registration Of Medicinal Products Medical Devices And Biocidal Products (updated)
- Declaration of interests - 79.77 KB | PDF
- Curriculum Vitae - 33.52 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 - 80.94 KB | PDF
- Curriculum Vitae - 39.72 KB | PDF
Medicines Agency Review of Luspatercept for the Treatment of Adult … -
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National expert: Lucia De Franceschi, European Medicines Agency (updated)
- Declaration of interests - 81.92 KB | PDF
- Curriculum Vitae - 47.07 KB | PDF
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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 (updated)
Date of designation: 09/12/2022, Positive, Last updated: 14/03/2023 -
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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: Navtemadlin for: Treatment of Merkel cell carcinoma
Date of designation: 14/01/2022, Positive, Last updated: 09/06/2022 -
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Orphan designation: insulin human for: Prevention of retinopathy of prematurity
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: 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