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Orphan designation: melatonin for: Treatment of partial deep dermal and full-thickness burns
Date of first decision: 13/03/2018, Negative, Last updated: 11/04/2018 -
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Orphan designation: 20% Intravenous fat emulsion consisting of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection for: Treatment of poisoning by local anaesthetics
Date of first decision: 03/04/2017, Negative, Last updated: 15/05/2017 -
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Orphan designation: 3-(3-Methanesulfonyl-phenyl)-1-propyl-piperidine hydrochloride for: Treatment of narcolepsy
Date of first decision: 13/07/2016, Negative, Last updated: 09/01/2017 -
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Orphan designation: Naltrexone for: Treatment of fibromyalgia
Date of first decision: 06/10/2016, Negative, Last updated: 13/12/2016 -
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Orphan designation: Nalbuphine hydrochloride for: Treatment of uraemic pruritus
Date of first decision: 27/02/2015, Negative, Last updated: 02/10/2015 -
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Orphan designation: 5-chloro-N2-[2-isopropoxy-5-methyl-4-(4-piperidinyl)phenyl]-N4-[2-(isopropylsulfonyl)phenyl]-2,4-pyrimidinediamine for: Treatment of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive
Date of first decision: 28/03/2014, Negative, Last updated: 10/03/2015 -
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Orphan designation: sodium ascorbate, menadione sodium bisulfite for: Treatment of autosomal dominant polycystic kidney disease
Date of first decision: 11/12/2014, Negative, Last updated: 10/03/2015 -
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Orphan designation: zoledronic acid for: Treatment of complex regional pain syndrome
Date of first decision: 17/04/2013, Negative, Last updated: 23/04/2013 -
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Orphan designation: Tariquidar for: treatment of P-gp positive breast cancer
Date of first decision: 21/03/2012, Negative, Last updated: 06/09/2012 -
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Orphan designation: Lentiviral vector expressing the truncated form of human tyrosine hydroxylase gene, human aromatic L amino-acid decarboxylase gene, human GTP-cyclohydrolase 1 gene for: Treatment of off-periods in adult patients with advanced Parkinson's disease
Date of first decision: 09/09/2010, Negative, Last updated: 30/03/2012 -
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Orphan designation: Nabilone for: Treatment of amyotrophic lateral sclerosis
Date of first decision: 16/01/2011, Negative, Last updated: 20/12/2011 -
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Orphan designation: Molgramostim for: Treatment of cystic fibrosis
Date of first decision: 16/07/2010, Negative, Last updated: 09/08/2010 -
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Orphan designation: Gastrin 17C diphtheria toxoid conjugate for: Treatment of pancreatic cancer
Date of first decision: 16/07/2010, Negative, Last updated: 05/08/2010 -
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Orphan designation: 4-[[[4-(4-Chlorophenoxy)phenyl]sulfonyl]-methyl]tetrahydro-N-hydroxy-2H-pyran-4-carboxamide for: Prevention of graft rejection after liver transplantation
Date of first decision: 10/09/2008, Negative, Last updated: 30/10/2009 -
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Orphan designation: ibritumomab tiuxetan for: Treatment of B-cell non-Hodgkin`s lymphoma
Date of first decision: 01/02/2002, Negative, Last updated: 17/09/2009 -
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Orphan designation: Chelidonii radix for: Treatment of pancreatic cancer
Date of first decision: 04/12/2007, Negative, Last updated: 29/07/2008 -
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Orphan designation: capsaicin for: Treatment of painful HIV-associated neuropathy
Date of first decision: 21/09/2006, Negative, Last updated: 19/07/2007 -
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Orphan designation: Tramadol hydrochloride for: Treatment of painful HIV-associated neuropathy
Date of first decision: 21/09/2006, Negative, Last updated: 19/07/2007 -
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Orphan designation: Midazolam Hydrochloride for: Treatment of status epilepticus
Date of first decision: 01/03/2004, Negative, Last updated: 12/12/2005 -
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Orphan designation: Sudismase for: Treatment of active phase of Peyronie's disease
Date of first decision: 16/06/2005, Negative, Last updated: 27/10/2005 -
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Orphan designation: Ibuprofen L-Lysinate (salt) for: Treatment of patent ductus arteriosus in premature neonates of less than 34 week gestational age
Date of first decision: 24/06/2005, Negative, Last updated: 11/10/2005 -
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Orphan designation: Ibuprofen L-Lysinate (salt) for: Prevention of patent ductus arteriosus in premature neonates of less than 34 week of gestational age
Date of first decision: 07/07/2005, Negative, Last updated: 11/10/2005 -
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Orphan designation: Histamine dihydrochloride for: Treatment of malignant melanoma
Date of first decision: 24/08/2004, Negative, -
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Orphan designation: Mycobacterial cell wall complex for: Treatment of carcinoma in situ of the urinary bladder
Date of first decision: 18/12/2002, Negative, Last updated: 14/01/2003 -
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Orphan designation: chlorproguanil hydrochloride, dapsone for: Treatment of acute uncomplicated plasmodium falciparum malaria
Date of first decision: 26/07/2002, Negative, Last updated: 08/01/2003