66 results
Keyword Bylvay Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Bylvay, Odevixibat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002054-PIP01-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: XInvented name Bylvay Active substance Odevixibat … investigation plan for odevixibat (Bylvay), (EMEA-002054-PIP01-16-M03 … investigation plan for odevixibat (Bylvay), (EMEA-002054-PIP01-16-M03 … -
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Human medicine European public assessment report (EPAR): Bylvay (updated)
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,
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, Revision: 2, Authorised, Last updated: 12/05/2023
Bylvay Digestive System Diseases Liver … Bylvay … EMA/295840/2021 EMEA/H/C/004691 Bylvay (odevixibat) An overview of Bylvay and why it is authorised … -
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Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid for: Treatment of progressive familial intrahepatic cholestasis
Date of designation: 17/07/2012, Positive, Last updated: 28/07/2021been authorised in the EU as Bylvay since 16 July 2021. On 17 … Bylvay Bylvay odevixibat (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic … -
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News: First treatment for rare liver disease
CHMP, Last updated: 21/05/2021in the European Union for Bylvay (odevixibat) for the treatment … transplantation. The active substance of Bylvay is odevixibat, a reversible … the efficacy and safety of Bylvay in children with PFIC. The … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 May 2021
CHMP, Last updated: 21/05/2021Bylvay … -
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Orphan designation: Bomedemstat ditosilate for: Treatment of essential thrombocythaemia
Date of designation: 21/06/2021, Positive, Last updated: 02/05/2023 -
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Orphan designation: Humanised IgG2 monoclonal antibody against TNFSF13 for: Treatment of primary IgA nephropathy
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: L-ergothioneine for: Treatment of cystinuria
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Tislelizumab for: Treatment of nasopharyngeal cancer
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Adeno-associated virus serotype 9 expressing human CLN5 for: Treatment of neuronal ceroid lipofuscinosis
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Allogenic placenta-derived mesenchymal stromal cells secretome for: Treatment of pre-eclampsia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: imatinib for: Treatment of pulmonary arterial hypertension
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropane-2-yl)-1H-pyrazole-4-carboxamide for: Treatment of mantle cell lymphoma
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Adeno-associated virus serotype 9 containing the human FXN gene isoform 1 for: Treatment of Friedreich's ataxia
Date of designation: 21/06/2021, Withdrawn, Last updated: 11/05/2022 -
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Orphan designation: Hydrocortisone hydrogen succinate for: Prevention of bronchopulmonary dysplasia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: melatonin for: Prevention of retinopathy of prematurity
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3 for: Treatment of achondroplasia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: H-D-valyl1-D-alanyl-D-glutamyl-D-alanyl-D-arginyl5-D-glutamyl-D-glutamyl-D-leucyl-D-glutamyl-D-arginyl10-D-leucyl-D-glutamyl-D-alanyl-D-arginyl-D-leucyl15-glycyl-D-glutaminyl-D-alanyl-D-arginyl-glycyl20-D-glutamyl-D-leucyl-D-lysyl-D-lysyl-D-tryptophyl25-D-lysyl-D-methionyl-D-arginyl-D-arginyl-D-asparaginyl30-D-glutaminyl-D-phenylalanyl-D-tryptophyl-D-leucyl-D-lysyl35-D-leucyl-D-glutaminyl-D-arginine for: Treatment of glioma
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Adeno-associated viral vector LK03 encoding human methylmalonyl-CoA mutase for: Treatment of methylmalonic acidaemia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Committee for Orphan Medicinal Products (COMP): 13-15 June 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 13/06/2023 to 15/06/2023, Last updated: 09/06/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 February 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 06/02/2023 to 09/02/2023, Last updated: 17/05/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 27-30 March 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 27/03/2023 to 30/03/2023, Last updated: 22/05/2023 -
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List of medicines under additional monitoring (updated)
Last updated: 30/05/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 February 2023
European Medicines Agency, Amsterdam, the Netherlands, from 20/02/2023 to 23/02/2023, Last updated: 24/04/2023 -
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PRIME: priority medicines (updated)
Last updated: 06/06/2023