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36 results
Medicine
Periodic safety update report single assessments Remove Periodic safety update report single assessments filter
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Orphan designation: Refusal of orphan designation for the treatment of uveal melanoma
Date of refusal of designation: 11/01/2022, Negative, Last updated: 09/06/2022 -
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Orphan designation: Refusal of orphan designation for the treatment of partial deep dermal and full-thickness burns
Date of refusal of designation: 13/03/2018, Negative, Last updated: 11/04/2018 -
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Orphan designation: Refusal of orphan designation for the treatment of poisoning by local anaesthetics
Date of refusal of designation: 03/04/2017, Negative, Last updated: 15/05/2017 -
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Orphan designation: Refusal of orphan designation for the treatment of narcolepsy
Date of refusal of designation: 13/07/2016, Negative, Last updated: 09/01/2017 -
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Orphan designation: Refusal of orphan designation for the treatment of fibromyalgia
Date of refusal of designation: 06/10/2016, Negative, Last updated: 13/12/2016 -
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Orphan designation: Refusal of orphan designation for the treatment of uraeumic pruritus
Date of refusal of designation: 27/02/2015, Negative, Last updated: 02/10/2015 -
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Orphan designation: Refusal of orphan designation for the treatment of non-small cell lung cancer that is anaplastic lymphoma kinase (ALK) positive
Date of refusal of designation: 28/03/2014, Negative, Last updated: 10/03/2015 -
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Orphan designation: Refusal of orphan designation for the treatment of autosomal dominant polycystic kidney disease
Date of refusal of designation: 11/12/2014, Negative, Last updated: 10/03/2015 -
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Orphan designation: Refusal of orphan designation for the treatment of complex regional pain syndrom
Date of refusal of designation: 17/04/2013, Negative, Last updated: 23/04/2013 -
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Orphan designation: Refusal of orphan designation for the treatment of P-gp positive breast cancer
Date of refusal of designation: 21/03/2012, Negative, Last updated: 06/09/2012 -
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Orphan designation: Refusal of orphan designation for the treatment of off-periods in adult patients with advanced Parkinson's disease
Date of refusal of designation: 09/09/2010, Negative, Last updated: 30/03/2012 -
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Orphan designation: Refusal of orphan designation for the treatment of amyotropic lateral sclerosis
Date of refusal of designation: 16/01/2011, Negative, Last updated: 20/12/2011 -
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Orphan designation: Refusal of orphan designation for the treatment of cystic fibrosis
Date of refusal of designation: 16/07/2010, Negative, Last updated: 09/08/2010 -
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Orphan designation: Refusal of orphan designation for the treatment of pancreatic cancer
Date of refusal of designation: 16/07/2010, Negative, Last updated: 05/08/2010 -
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Orphan designation: Refusal of orphan designation for the prevention of graft rejection after liver transplantation
Date of refusal of designation: 10/09/2008, Negative, Last updated: 30/10/2009 -
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Orphan designation: Refusal of orphan designation for the treatment of B-cell non-Hodgkin's lymphoma
Date of refusal of designation: 01/02/2002, Negative, Last updated: 17/09/2009 -
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Orphan designation: Refusal of orphan designation for the treatment of pancreatic cancer
Date of refusal of designation: 04/12/2007, Negative, Last updated: 29/07/2008 -
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Orphan designation: Refusal of orphan designation for the treatment of painful HIV-associated neuropathy
Date of refusal of designation: 21/09/2006, Negative, Last updated: 19/07/2007 -
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Orphan designation: Refusal of orphan designation for the treatment of painful HIV-associated neuropathy
Date of refusal of designation: 21/09/2006, Negative, Last updated: 19/07/2007 -
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Orphan designation: Refusal of orphan designation for the treatment of status epilepticus
Date of refusal of designation: 01/03/2004, Negative, Last updated: 12/12/2005 -
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Orphan designation: Refusal of orphan designation for the treatment of active phase of Peyronie's disease
Date of refusal of designation: 16/06/2005, Negative, Last updated: 27/10/2005 -
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Orphan designation: Refusal of orphan designation for the treatment of patent ductus arteriosus in premature neonates of less than 34 week gestational age
Date of refusal of designation: 24/06/2005, Negative, Last updated: 11/10/2005 -
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Orphan designation: Refusal of orphan designation for the prevention of patent ductus arteriosus in premature neonates of less than 34 week of gestational age
Date of refusal of designation: 07/07/2005, Negative, Last updated: 11/10/2005 -
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Orphan designation: Refusal of orphan designation for the treatment of malignant melanoma
Date of refusal of designation: 24/08/2004, Negative, Last updated: 16/03/2005 -
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Orphan designation: Refusal of orphan designation for the treatment of carcinoma in situ of the urinary bladder
Date of refusal of designation: 18/12/2002, Negative, Last updated: 14/01/2003