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Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases.

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作者单位: Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands; Max-Delbrück Center for Molecular Medicine in Helmholz Association, Berlin, Germany. Electronic address: maria.sheean@ema.europa.eu. [1] Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; State Institute for Drug Control, Bratislava, Slovak Republic; Comenius University, Department of Pharmacology and Toxicology, Bratislava, Slovak Republic. [2] Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; INFARMED - Autoridade Nacional do Medicamento, Lisbon, Portugal. [3] Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; C. Poma Hospital, Mantova, Italy; Fondazione Poliambulanza, Brescia, Italy. [4] Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands. [5] Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; National Center for Drug Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy. [6] Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain. [7] Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Malta Medicines Authority, San Ġwann, Malta. [8] Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; The Federal Agency for Medicines and Health Products, Brussels, Belgium. [9] Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Medical School, National and Kapodistrian University of Athens, Athens, Greece. [10] Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; University of Rijeka Medical School and University Hospital Centre Rijeka, Rijeka, Croatia. [11] Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; INFARMED - Autoridade Nacional do Medicamento, Lisbon, Portugal; Universidade de Lisboa - Faculdade de Farmácia, Lisbon, Portugal. [12] Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Medicines Evaluation Board, Utrecht, The Netherlands. [13]
DOI 10.1016/j.drudis.2019.10.015
PMID 31704277
发布时间 2021-04-30
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