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The European landscape for gene therapies in orphan diseases: 6-year experience with the EMA Committee for Orphan Medicinal Products.
Palomo, Gloria M; Pose-Boirazian, Tomas; Naumann-Winter, Frauke; Costa, Enrico; Duarte, Dinah M; Kalland, Maria E; Malikova, Eva; Matusevicius, Darius; Vitezic, Dinko; Larsson, Kristina; Magrelli, Armando; Stoyanova-Beninska, Violeta; Mariz, Segundo.
Afiliação
  • Palomo GM; Agencia Española de Medicamentos y Productos Sanitarios, Calle Campezo 1 Edificio 8, 28022 Madrid, Spain; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands. Electronic address: gpalomo@aemps.es.
  • Pose-Boirazian T; Orphan Medicines Office, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands.
  • Naumann-Winter F; Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands.
  • Costa E; Agenzia Italiana del Farmaco, Via del Tritone 181, 00187 Rome, Italy; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands.
  • Duarte DM; INFARMED - National Authority of Medicines and Health Products, I.P., Avenida do Brasil 53, 1749-004 Lisbon, Portugal; Universidade de Lisboa, Faculdade de Farmácia, Avenida Professor Gama Pinto, 1649-003 Lisbon, Portugal; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico
  • Kalland ME; Statens Legemiddelverk/The Norwegian Medicines Agency, Grensesvingen 26, 0663 Oslo, Norway; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands.
  • Malikova E; State Institute for Drug Control, Kvetná 11, 825 08 Bratislava, Slovakia; Department of Pharmacology and Toxicology, Comenius University, Odbojárov 10, 832 32 Bratislava, Slovakia; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Ne
  • Matusevicius D; Läkemedelsverket, Dag Hammarskjölds väg 42, 75237 Uppsala, Sweden; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands.
  • Vitezic D; Rijeka University School of Medicine and University Hospital Centre Rijeka, Brace Branchetta 20, 51000 Rijeka, Croatia; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands.
  • Larsson K; Orphan Medicines Office, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands.
  • Magrelli A; National Center for Drug Research and Evaluation, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands.
  • Stoyanova-Beninska V; College ter Beoordeling van Geneesmiddelen, Graadt van Roggenweg 500, 3531 AH Utrecht, the Netherlands; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands.
  • Mariz S; Orphan Medicines Office, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands. Electronic address: segundo.mariz@ema.europa.eu.
Mol Ther ; 31(12): 3414-3423, 2023 Dec 06.
Article em En | MEDLINE | ID: mdl-37794679
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Produção de Droga sem Interesse Comercial / Doenças Raras Tipo de estudo: Guideline / Risk_factors_studies Limite: Humans Idioma: En Revista: Mol Ther Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Produção de Droga sem Interesse Comercial / Doenças Raras Tipo de estudo: Guideline / Risk_factors_studies Limite: Humans Idioma: En Revista: Mol Ther Ano de publicação: 2023 Tipo de documento: Article