159 results
Keyword Selinexor Remove keyword
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Human medicine European public assessment report (EPAR): Nexpovio
Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021,
, Revision: 7, Authorised, Last updated: 20/02/2023
Authorised selinexor Overview Nexpovio is a cancer … medicine. active substance selinexor. How is Nexpovio used … active substance in Nexpovio, selinexor, blocks the action of a protein … -
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Opinion/decision on a Paediatric investigation plan (PIP): Nexpovio, Selinexor
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002387-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 08/09/2021, Last updated: 10/01/2023, Compliance check: XNexpovio Active substance Selinexor Therapeutic area Oncology … product specific waiver for selinexor (Nexpovio), (EMEA-002387-PIP02-21 … product specific waiver for selinexor (Nexpovio), (EMEA-002387-PIP02-21 … -
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Orphan designation: Selinexor for: Treatment of plasma cell myeloma
Date of designation: 19/11/2014, Positive, Last updated: 07/06/2021Selinexor Overview On 19 November 2014 … Clinipace GmbH, Germany, for selinexor for the treatment of plasma … information to show that selinexor might be of significant benefit … -
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Orphan designation: Selinexor for: Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
Date of designation: 19/11/2014, Positive, Last updated: 09/02/2016Selinexor Overview On 19 November 2014 … Clinipace GmbH, Germany, for selinexor for the treatment of chronic … opinion on orphan designation: Selinexor for the treatment of chronic … -
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Orphan designation: Selinexor for: Treatment of myelofibrosis
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023Selinexor … Selinexor … -
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Orphan designation: Selinexor for: Treatment of glioma
Date of designation: 15/10/2021, Positive, Last updated: 21/01/2022Selinexor Overview This medicine was … with glioma were ongoing. Selinexor is authorised in the EU for … facts straight Key facts SelinexorTreatment of gliomaPositiveEU/3/21/2509 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Selinexor
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002387-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 06/12/2018, Last updated: 13/02/2019, Compliance check: XActive substance Selinexor Therapeutic area Oncology … Selinexor … -
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National expert: Ignace Vergote, European Medicines Agency (updated)
- Declaration of interests - 85.01 KB | PDF
- Curriculum Vitae - 16.73 KB | PDF
01/2020-(current) Karyopharm selinexor endometrial cancer 01/2020-(current … 01/2020-(current) Karyopharm Selinexor Endometrial cancer 01/2020-(current … -
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National expert: Pieter Sonneveld, European Medicines Agency (updated)
- Declaration of interests - 83.07 KB | PDF
- Curriculum Vitae - 25.29 KB | PDF
01/2011-(current) Karyopharm selinexor multiple myeloma 2.7 Grant … -
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Human medicine European public assessment report (EPAR): Tecvayli (updated)
Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022,, 
, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, 
, , Revision: 1, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,, , , Revision: 5, Authorised, Last updated: 21/12/2022
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Human medicine European public assessment report (EPAR): Pepaxti
Melphalan flufenamide hydrochloride, Multiple Myeloma
Date of authorisation: 17/08/2022, Revision: 1, Authorised, Last updated: 19/12/2022 -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 2021
CHMP, Last updated: 01/02/2021selinexor) for the treatment of relapsed … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022
CHMP, Last updated: 20/05/2022Nexpovio INN selinexor Marketing-authorisation holder … -
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Orphan designation: Allogeneic retinal pigment epithelial cells genetically modified with a non-viral vector to express human alpha-L-iduronidase for: Treatment of mucopolysaccharidosis type I
Date of designation: 15/10/2021, Withdrawn, Last updated: 20/12/2022 -
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Orphan designation: Dodecyl creatine ester, dodecyl creatine ester hydrochloride for: Treatment of creatine deficiency syndromes
Date of designation: 19/02/2021, Positive, Last updated: 06/02/2023 -
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Orphan designation: Adeno-associated virus serotype rh10 containing the human GALC gene for: Treatment of Krabbe disease
Date of designation: 15/10/2021, Positive, Last updated: 18/11/2022 -
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Orphan designation: Herpes simplex virus 1 expressing the human CFTR gene for: Treatment of cystic fibrosis
Date of designation: 26/03/2021, Positive, Last updated: 17/01/2023 -
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Orphan designation: Adeno-associated virus of serotype rh10 encoding Human MLC1 under the control of GFAP promoter for: Treatment of megalencephalic leukoencephalopathy with subcortical cysts
Date of designation: 15/10/2021, Positive, Last updated: 11/11/2022 -
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Orphan designation: Autologous haematopoietic stem and progenitor cell population containing CD34+ cells transduced with a lentiviral vector encoding the TCIRG1 cDNA ex vivo expanded for: Treatment of osteopetrosis
Date of designation: 15/10/2021, Positive, Last updated: 07/11/2022 -
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Orphan designation: Ilixadencel for: Treatment of gastrointestinal stromal tumours
Date of designation: 26/03/2021, Positive, Last updated: 28/09/2022 -
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Orphan designation: Bardoxolone methyl for: Treatment of autosomal dominant polycystic kidney disease
Date of designation: 20/08/2021, Positive, Last updated: 30/01/2023 -
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Orphan designation: Loncastuximab tesirine for: Treatment of diffuse large B-cell lymphoma
Date of designation: 20/08/2021, Withdrawn, Last updated: 26/01/2023 -
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Orphan designation: Mocravimod for: Treatment in haematopoietic stem cell transplantation
Date of designation: 15/10/2021, Positive, Last updated: 13/04/2022