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272 results
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Summary of opinion: Omblastys
iodine (131I) omburtamab, opinion date: 15/12/2022, Negative, Last updated: 16/12/2022 -
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Summary of opinion: Tolvaptan Accord
tolvaptan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Sun
sitagliptin, metformin hydrochloride, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Dimethyl fumarate Accord
dimethyl fumarate, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
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Summary of opinion: Sugammadex Adroiq
sugammadex, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
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Summary of opinion: Fintepla
fenfluramine, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Revestive
teduglutide, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Lytgobi
futibatinib, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Jaypirca
pirtobrutinib, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Columvi
glofitamab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Orphan designation: (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazin-yl)pyrimidin-5-yl)ethan-1-amine for: Treatment of gastrointestinal stromal tumours
Date of designation: 17/07/2017, Positive, Last updated: 22/05/2019 -
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Orphan designation: Masitinib mesilate for: Treatment of pancreatic cancer
Date of designation: 28/10/2009, Positive, -
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Orphan designation: Glyceryl tri-(4-phenylbutyrate) for: Treatment of hyperargininaemia
Date of designation: 10/06/2010, Positive, Last updated: 18/11/2022 -
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Orphan designation: Gallium (68Ga)-edotreotide for: Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 19/03/2015, Positive, Last updated: 03/05/2023 -
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Orphan designation: Treprostinil diethanolamine for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of designation: 26/08/2005, Positive, Last updated: 13/01/2022 -
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Orphan designation: Caffeine citrate for: Prevention of bronchopulmonary dysplasia
Date of designation: 11/04/2014, Positive, -
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Orphan designation: 1,3-Propanedisulfonic acid, disodium salt for: Treatment of systemic secondary amyloidosis
Date of designation: 31/07/2001, Positive, -
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Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa) for: Treatment of mucopolysaccharidosis type VII (Sly syndrome)
Date of designation: 21/03/2012, Positive, Last updated: 11/11/2020 -
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Orphan designation: Donor T lymphocytes depleted ex vivo of host alloreactive T cells using photodynamic treatment- for: Treatment in haematopoietic stem cell transplantation
Date of designation: 27/06/2016, Withdrawn, Last updated: 28/02/2022 -
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Orphan designation: Fluocinolone acetonide for: Treatment of non-infectious uveitis affecting the posterior segment of the eye
Date of designation: 07/03/2005, Positive, Last updated: 30/05/2007 -
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Orphan designation: Recombinant human alpha-Mannosidase (velmanase alfa) for: Treatment of alpha-mannosidosis
Date of designation: 26/01/2005, Positive, -
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Orphan designation: Carboxypeptidase G2 (glucarpidase) for: Adjunctive treatment in patients at risk of methotrexate toxicity
Date of designation: 03/02/2003, Positive, Last updated: 20/01/2022 -
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Orphan designation: Recombinant fusion protein linking human coagulation factor IX with human albumin for: Treatment of haemophilia B
Date of designation: 04/02/2010, Positive, Last updated: 28/03/2018 -
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Orphan designation: Decitabine for: Treatment of acute myeloid leukaemia
Date of designation: 08/06/2006, Positive, Last updated: 19/09/2013