54 results
Keyword Enspryng Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Enspryng, satralizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001625-PIP03-21, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 28/10/2022, Last updated: 12/10/2023, Compliance check: XKey facts Enspryng satralizumab NeurologyP/0448/2022EMEA-001625-PIP03-21 … waiver for satralizumab (Enspryng), (EMEA-001625-PIP03-21 … 12/10/2023 EMA/834868/2022 Generic Enspryng: EPAR … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enspryng, satralizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001625-PIP02-21, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/12/2021, Last updated: 06/03/2023, Compliance check: XInvented name Enspryng Active substance satralizumab … Enspryng Enspryng satralizumab satralizumab … -
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Orphan designation: Humanised anti-IL-6 receptor monoclonal antibody (satralizumab) for: Treatment of neuromyelitis optica spectrum disorders
Date of designation: 27/06/2016, Positive, Last updated: 30/06/2021been authorised in the EU as Enspryng since 24 June 2021. Expand … Enspryng Enspryng satralizumab Humanised … the orphan designation of Enspryng (humanised anti-IL-6 receptor … -
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Human medicine European public assessment report (EPAR): Enspryng
satralizumab, Neuromyelitis Optica
Date of authorisation: 24/06/2021,
, Revision: 2, Authorised, Last updated: 24/03/2023
Enspryng Nervous System Diseases Autoimmune … Enspryng … EMA/298616/2021 EMEA/H/C/004788 Enspryng (satralizumab) An overview … -
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News: New treatment for rare autoimmune disease of nerve cells
CHMP, Last updated: 23/04/2021the European Union (EU) for Enspryng (satralizumab) for the treatment … 100,000 people in the EU. Enspryng works by reducing and preventing … active substance contained in Enspryng, is an antibody designed to … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021
CHMP, Last updated: 23/04/2021Enspryng … -
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Human medicine European public assessment report (EPAR): Uplizna
Inebilizumab, Neuromyelitis Optica
Date of authorisation: 25/04/2022,
, Revision: 2, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Ultomiris
ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019,, Revision: 13, Authorised, Last updated: 26/09/2023
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Orphan designation: 6-Amino-5-chloro-N-((1R)-1-(5-(((5-chloro-4-(trifluoromethyl)-2-pyridinyl)amino)carbonyl)-2-thiazolyl)ethyl)-4-pyrimidinecarboxamide for: Treatment of glioma
Date of designation: 20/05/2021, Positive, Last updated: 27/06/2023 -
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Orphan designation: zanubrutinib for: Treatment of marginal zone lymphoma
Date of designation: 20/05/2021, Withdrawn, Last updated: 05/01/2023 -
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Orphan designation: Adeno-associated virus serotype 9 expressing the cDNA for human MECP2 for: Treatment of Rett syndrome
Date of designation: 20/05/2021, Withdrawn, Last updated: 30/03/2022 -
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Orphan designation: begelomab for: Treatment of dermatomyositis
Date of designation: 20/05/2021, Positive, Last updated: 16/03/2022 -
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Orphan designation: Macitentan for: Treatment of functional single ventricle congenital heart disease
Date of designation: 20/05/2021, Positive, Last updated: 16/03/2022 -
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Orphan designation: Eflornithine for: Treatment of neuroblastoma
Date of designation: 20/05/2021, Positive, Last updated: 17/03/2022 -
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Orphan designation: Elamipretide for: Treatment of Barth syndrome
Date of designation: 20/05/2021, Positive, Last updated: 17/03/2022 -
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Orphan designation: Human IgG1 monoclonal antibody against alpha-synuclein for: Treatment of multiple system atrophy
Date of designation: 20/05/2021, Positive, Last updated: 17/03/2022 -
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Orphan designation: 2-[4-[3-(methylamino)-1-phenylpropoxy]phenyl]ethanol hydrochloride for: Treatment of fragile X syndrome
Date of designation: 20/05/2021, Positive, Last updated: 17/03/2022 -
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Orphan designation: Adeno-associated viral vector serotype 2.5T encoding the human cystic fibrosis transmembrane conductance regulator with a partial deletion in the R domain for: Treatment of cystic fibrosis
Date of designation: 20/05/2021, Positive, Last updated: 18/03/2022 -
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Orphan designation: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one for: Treatment of hyperphenylalaninemia
Date of designation: 20/05/2021, Positive, Last updated: 18/03/2022 -
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Orphan designation: Trehalose for: Treatment of amyotrophic lateral sclerosis
Date of designation: 20/05/2021, Positive, Last updated: 18/03/2022 -
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Orphan designation: Synthetic 2′-O-(2-methoxyethyl)-modified antisense oligonucleotide linked to a triantennary cluster of N-acetyl galactosamine sugars targeting transmembrane protease, serine 6 mRNA for: Treatment of beta thalassaemia intermedia and major
Date of designation: 20/05/2021, Positive, Last updated: 18/03/2022 -
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Orphan designation: melatonin for: Treatment of retinitis pigmentosa
Date of designation: 20/05/2021, Positive, Last updated: 18/03/2022 -
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Orphan designation: Autologous mobilised peripheral blood-derived CD34+ cells transduced ex vivo with a self-inactivating lentiviral vector containing a normal version of the coding region of the IL2RG gene for: Treatment of X-linked severe combined immunodeficiency
Date of designation: 20/05/2021, Positive, Last updated: 18/03/2022 -
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Orphan designation: Adeno-associated viral vector serotype 5 expressing the human Cone-Rod Homeobox gene for: Treatment of Leber's congenital amaurosis
Date of designation: 20/05/2021, Positive, Last updated: 18/03/2022 -
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Orphan designation: Dantrolene sodium, hemiheptahydrate for: Treatment of malignant hyperthermia
Date of designation: 20/05/2021, Positive, Last updated: 24/03/2022