72 results
Keyword ripretinib Remove keyword
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Human medicine European public assessment report (EPAR): Qinlock
ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021,
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, Revision: 2, Authorised, Last updated: 23/02/2023
ripretinib … EMEA/H/C/005614 Qinlock (ripretinib) An overview of Qinlock … contains the active substance ripretinib. How is Qinlock used? Qinlock … -
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Orphan designation: 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea for: Treatment of gastrointestinal stromal tumours
Date of designation: 08/11/2017, Positive, Last updated: 23/11/2021was updated in August 2021. Ripretinib has been authorised in the … Qinlock Qinlock ripretinib 1-[4-bromo-5-[1-ethyl-7-(met … fluorophenyl]-3-phenylurea ripretinib … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021
CHMP, Last updated: 17/09/2021ripretinib) for the treatment of advanced … -
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Human medicine European public assessment report (EPAR): Ayvakyt (updated)
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,, , 
, Revision: 6, Authorised, Last updated: 14/03/2023
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Orphan designation: Rebastinib for: Treatment of ovarian cancer
Date of designation: 12/11/2021, Positive, Last updated: 07/02/2023 -
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Orphan designation: Linerixibat for: Treatment of primary biliary cholangitis
Date of designation: 12/11/2021, Positive, Last updated: 29/11/2022 -
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Orphan designation: Autologous CD34+ enriched cells transduced with a self-inactivating lentiviral vector containing the codon-optimized RPS19 gene for: Treatment of Diamond-Blackfan anaemia
Date of designation: 12/11/2021, Positive, Last updated: 11/11/2022 -
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Orphan designation: Fingolimod for: Treatment of adrenoleukodystrophy
Date of designation: 12/11/2021, Positive, Last updated: 11/11/2022 -
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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: 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: 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: Mosunetuzumab for: Treatment of follicular lymphoma
Date of designation: 12/11/2021, Positive, Last updated: 23/06/2022 -
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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 -
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Orphan designation: Anti-CD38 IgG4 human monoclonal antibody for: Treatment of amyotrophic lateral sclerosis
Date of designation: 12/11/2021, Positive, Last updated: 07/06/2022 -
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Orphan designation: Nadunolimab for: Treatment of pancreatic cancer
Date of designation: 12/11/2021, Positive, Last updated: 08/06/2022 -
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Orphan designation: paclitaxel, polyoligo(ethylene glycol)methacrylate-co-poly(vinylbenzyldithiodibutyric acid-gemcitabine) for: Treatment of pancreatic cancer
Date of designation: 12/11/2021, Positive, Last updated: 08/06/2022 -
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Orphan designation: Udonitrectag lysine for: Treatment in solid organ transplantation
Date of designation: 12/11/2021, Positive, Last updated: 08/06/2022 -
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Orphan designation: Cannabidiol, Dronabinol for: Treatment of complex regional pain syndrome
Date of designation: 12/11/2021, Positive, Last updated: 08/06/2022 -
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Orphan designation: 5-fluoro-4-(4-fluoro-2-methoxyphenyl)-N-{4-[(S-methylsulfonimidoyl)methyl] pyridin-2-yl}pyridin-2-amine for: Treatment of diffuse large B-cell lymphoma
Date of designation: 12/11/2021, Positive, Last updated: 09/06/2022 -
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Orphan designation: Ibrexafungerp for: Treatment of invasive candidiasis
Date of designation: 12/11/2021, Positive, Last updated: 09/06/2022 -
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Orphan designation: 2-[1-(3-{6-[(1E)-(hydroxyimino)methyl]-5-methyl-4-oxo-7-propyl-3H,4H-pyrrolo[2,1-f][1,2,4]triazin-2-yl}-4-propoxybenzenesulfonyl)piperidin-4-yl]ethyl nitrate for: Treatment of systemic sclerosis
Date of designation: 12/11/2021, Positive, Last updated: 07/06/2022 -
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Orphan designation: (14S)-8-[3-(2-{dispiro[2.0.24.13]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lamba6-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.111,14.05,10]tetracosa-1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate, deutivacaftor, tezacaftor for: Treatment of cystic fibrosis
Date of designation: 12/11/2021, Positive, Last updated: 07/06/2022 -
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Orphan designation: D-lactic acid, glycolic acid for: Treatment of amyotrophic lateral sclerosis
Date of designation: 12/11/2021, Positive, Last updated: 07/06/2022 -
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Orphan designation: Soticlestat for: Treatment of Lennox-Gastaut syndrome
Date of designation: 12/11/2021, Positive, Last updated: 09/06/2022