38 results
Keyword Kimmtrak Remove keyword
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Orphan designation: Tebentafusp for: Treatment of uveal melanoma
Date of designation: 19/02/2021, Positive, Last updated: 22/04/2022the orphan designation of Kimmtrak at the time of marketing … Kimmtrak Kimmtrak tebentafusp Tebentafusp te … the orphan designation of Kimmtrak at the time of marketing … -
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Human medicine European public assessment report (EPAR): Kimmtrak
tebentafusp, Uveal Neoplasms
Date of authorisation: 01/04/2022,
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, Authorised, Last updated: 22/04/2022
Kimmtrak Eye Neoplasms Eye Diseases Uveal … Kimmtrak … EMA/128686/2022 EMEA/H/C/004929 Kimmtrak (tebentafusp) An overview … -
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News: New medicine for rare type of eye cancer
CHMP, Last updated: 25/02/2022the European Union (EU) for Kimmtrak (tebentafusp), a monotherapy … medicine. active substance of Kimmtrak, is a type of treatment called … lived). The study showed that Kimmtrak prolonged patients’ lives … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022
CHMP, Last updated: 25/02/2022Kimmtrak … -
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Orphan designation: Treprostinil sodium for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 16/03/2022, Positive, Last updated: 13/02/2023 -
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Orphan designation: Alisporivir for: Treatment of collagen VI-related myopathies
Date of designation: 16/03/2022, Positive, Last updated: 14/12/2022 -
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Orphan designation: Adeno-associated virus serotype HSC 15 expressing human iduronate 2-sulfatase for: Treatment of mucopolysaccharidosis type II (Hunter Syndrome)
Date of designation: 16/03/2022, Positive, Last updated: 11/10/2022 -
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Orphan designation: Adeno-associated virus serotype HSC15, containing human homology arms, expressing human phenylalanine hydroxylase for: Treatment of phenylalanine hydroxylase deficiency
Date of designation: 16/03/2022, Positive, Last updated: 11/10/2022 -
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Orphan designation: Hymecromone for: Treatment of spinal cord injury
Date of designation: 16/03/2022, Positive, Last updated: 16/06/2022 -
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Orphan designation: Dersimelagon for: Treatment of erythropoietic protoporphyria
Date of designation: 16/03/2022, Positive, Last updated: 16/06/2022 -
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Orphan designation: Codergocrine mesilate, oxitriptan for: Treatment of fragile X syndrome
Date of designation: 16/03/2022, Positive, Last updated: 16/06/2022 -
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Orphan designation: Tropatepine hydrochloride for: Treatment of narcolepsy
Date of designation: 16/03/2022, Positive, Last updated: 16/06/2022 -
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Orphan designation: (S)-12-fluoro-4-(2-methylpyridin-3-yl)-7a,8,13,14-tetrahydro-7H-[1,2,4]triazolo[4',3':1,6]pyrido[3,2-b]benzofuro[4,3-fg][1,4]oxazonine for: Treatment of sickle cell disease
Date of designation: 16/03/2022, Positive, Last updated: 16/06/2022 -
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Orphan designation: Emactuzumab for: Treatment of tenosynovial giant cell tumour, localised and diffuse type
Date of designation: 16/03/2022, Positive, Last updated: 20/06/2022 -
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Orphan designation: Heterologous human adult liver-derived stem cells for: Treatment of argininosuccinic aciduria
Date of designation: 16/03/2022, Positive, Last updated: 20/06/2022 -
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Exemptions to labelling and package-leaflet obligations
Last updated: 19/04/2023 -
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List of medicines under additional monitoring (updated)
Last updated: 30/05/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 11/04/2023 to 14/04/2023, Last updated: 11/04/2023 -
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Management Board meeting: 16 March 2023
European Medicines Agency, Amsterdam, the Netherlands, 16/03/2023, Last updated: 04/04/2023 -
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Newsletters (updated)
Last updated: 30/05/2023 -
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European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting
Online, European Medicines Agency, Amsterdam, the Netherlands, 03/03/2023, Last updated: 31/03/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 August - 1 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 29/08/2022 to 01/09/2022, Last updated: 02/09/2022 -
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EMA event supporting materials
Last updated: 14/06/2022 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2022 to 24/03/2022, Last updated: 12/08/2022