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22/02/2019 Joint Audit Programme (updated)
22/02/2019 Orphan designation: Smilagenin for the: Treatment of amyotrophic lateral sclerosis, 27/09/2011, Positive (updated)
22/02/2019 Orphan designation: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells for the: Treatment of thromboangiitis obliterans (Buerger's disease), 21/05/2015, Positive (updated)
22/02/2019 Orphan designation: Choline tetrathiomolybdate for the: Treatment of Wilson's disease, 24/01/2013, Positive (updated)
22/02/2019 Orphan designation: Triheptanoin for the: Treatment of mitochondrial trifunctional protein deficiency, 28/07/2015, Positive (updated)
22/02/2019 ICH M9 on biopharmaceutics classification system based biowaivers (updated)
22/02/2019 Orphan designation: Triheptanoin for the: Treatment of long-chain 3-hydroxyacyl-coA dehydrogenase deficiency, 28/07/2015, Positive (updated)
22/02/2019 Orphan designation: Triheptanoin for the: Treatment of very long-chain acyl-CoA dehydrogenase deficiency, 19/06/2015, Positive (updated)
22/02/2019 Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa) for the: Treatment of pancreatic cancer, 16/12/2014, Positive (updated)
22/02/2019 Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor for the: Treatment of follicular lymphoma, 25/05/2018, Positive (updated)