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Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases.
Sheean, Maria E; Malikova, Eva; Duarte, Dinah; Capovilla, Giuseppe; Fregonese, Laura; Hofer, Matthias P; Magrelli, Armando; Mariz, Segundo; Mendez-Hermida, Fernando; Nistico, Robert; Leest, Tim; Sipsas, Nikolaos V; Tsigkos, Stelios; Vitezic, Dinko; Larsson, Kristina; Sepodes, Bruno; Stoyanova-Beninska, Violeta.
Afiliação
  • Sheean ME; 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.
  • Malikova E; 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.
  • Duarte D; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; INFARMED - Autoridade Nacional do Medicamento, Lisbon, Portugal.
  • Capovilla G; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; C. Poma Hospital, Mantova, Italy; Fondazione Poliambulanza, Brescia, Italy.
  • Fregonese L; Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.
  • Hofer MP; Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.
  • Magrelli A; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; National Center for Drug Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy.
  • Mariz S; Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.
  • Mendez-Hermida F; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
  • Nistico R; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Malta Medicines Authority, San Gwann, Malta.
  • Leest T; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; The Federal Agency for Medicines and Health Products, Brussels, Belgium.
  • Sipsas NV; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Medical School, National and Kapodistrian University of Athens, Athens, Greece.
  • Tsigkos S; Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.
  • Vitezic D; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; University of Rijeka Medical School and University Hospital Centre Rijeka, Rijeka, Croatia.
  • Larsson K; Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.
  • Sepodes B; 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.
  • Stoyanova-Beninska V; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Medicines Evaluation Board, Utrecht, The Netherlands.
Drug Discov Today ; 25(2): 274-291, 2020 02.
Article em En | MEDLINE | ID: mdl-31704277
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produção de Droga sem Interesse Comercial / Doenças Transmissíveis / Doenças Raras / Doenças Negligenciadas Limite: Animals / Humans Idioma: En Revista: Drug Discov Today Assunto da revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2020 Tipo de documento: Article
Texto completo
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produção de Droga sem Interesse Comercial / Doenças Transmissíveis / Doenças Raras / Doenças Negligenciadas Limite: Animals / Humans Idioma: En Revista: Drug Discov Today Assunto da revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2020 Tipo de documento: Article