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311 results
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Withdrawn application: Imbarkyd
bardoxolone methyl, date of withdrawal: 09/11/2022, Initial authorisation, Last updated: 07/02/2023 -
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Withdrawn application: Miplyffa
arimoclomol, date of withdrawal: 22/03/2022, Initial authorisation, Last updated: 08/02/2023 -
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Withdrawn application: Aliqopa
copanlisib, date of withdrawal: 20/12/2021, Initial authorisation, Last updated: 10/02/2023 -
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Withdrawn application: Tibsovo
ivosidenib, date of withdrawal: 13/10/2020, Initial authorisation, Last updated: 16/04/2021 -
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Withdrawn application: Garsun
artesunate, date of withdrawal: 08/12/2022, Initial authorisation, Last updated: 01/03/2023 -
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Withdrawn application: Opsumit
macitentan, date of withdrawal: 08/11/2019, Post-authorisation, Last updated: 17/02/2020 -
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Withdrawn application: Translarna
ataluren, date of withdrawal: 06/03/2017, Post-authorisation, Last updated: 24/03/2017 -
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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: 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: 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: Mepolizumab for: Treatment of hypereosinophilic syndrome
Date of designation: 29/07/2004, Withdrawn, Last updated: 23/10/2020 -
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Orphan designation: Taliglucerase alfa for: Treatment of Gaucher disease
Date of designation: 23/03/2010, Positive, Last updated: 10/03/2011 -
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Orphan designation: Human heterologous liver cells for: Treatment of argininosuccinic aciduria
Date of designation: 17/12/2010, Positive, Last updated: 16/08/2016 -
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Orphan designation: Glyceryl tri-(4-phenylbutyrate) for: Treatment of ornithine carbamoyltransferase deficiency
Date of designation: 10/06/2010, Positive, Last updated: 18/11/2022 -
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Orphan designation: Isavuconazonium sulfate for: Treatment of invasive aspergillosis
Date of designation: 04/07/2014, Positive, Last updated: 21/05/2019 -
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Orphan designation: Levamisole (hydrochloride) for: Treatment of nephrotic syndrome
Date of designation: 28/10/2005, Positive, Last updated: 08/08/2006 -
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Orphan designation: Nanoliposomal irinotecan for: Treatment of pancreatic cancer
Date of designation: 09/12/2011, Positive, Last updated: 17/12/2018 -
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Orphan designation: cytarabine, daunorubicin for: Treatment of acute myeloid leukaemia
Date of designation: 11/01/2012, Positive, Last updated: 08/10/2014 -
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Orphan designation: Adenovirus-mediated herpes-simplex-virus thymidine-kinase (HKSV-tk) gene for: Treatment of high-grade glioma with subsequent use of ganciclovir sodium
Date of designation: 06/02/2002, Positive, Last updated: 16/09/2021 -
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Orphan designation: Human heterologous liver cells for: Treatment of carbamoyl-phosphate synthase-1 deficiency
Date of designation: 17/12/2010, Positive, Last updated: 16/08/2016