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Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit-The EU Regulator's Perspective.
Sheean, Maria E; Naumann-Winter, Frauke; Capovilla, Giuseppe; Kalland, Maria Elisabeth; Malikova, Eva; Mariz, Segundo; Matusevicius, Darius; Nistico, Robert; Schwarzer-Daum, Brigitte; Tsigkos, Stelios; Tzogani, Kyriaki; Larsson, Kristina; Magrelli, Armando; Stoyanova-Beninska, Violeta.
Affiliation
  • Sheean ME; European Medicines Agency, Amsterdam, Netherlands.
  • Naumann-Winter F; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.
  • Capovilla G; Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.
  • Kalland ME; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.
  • Malikova E; Carlo Poma Hospital, Mantova, Italy.
  • Mariz S; Fondazione Poliambulanza, Brescia, Italy.
  • Matusevicius D; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.
  • Nistico R; Statens Legemiddelverk, Oslo, Norway.
  • Schwarzer-Daum B; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.
  • Tsigkos S; State Institute for Drug Control, Bratislava, Slovakia.
  • Tzogani K; Department of Pharmacology and Toxicology, Comenius University, Bratislava, Slovakia.
  • Larsson K; European Medicines Agency, Amsterdam, Netherlands.
  • Magrelli A; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.
  • Stoyanova-Beninska V; Läkemedelsverket, Uppsala, Sweden.
Front Med (Lausanne) ; 8: 744625, 2021.
Article in En | MEDLINE | ID: mdl-34513895
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Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: Front Med (Lausanne) Year: 2021 Document type: Article Affiliation country: Netherlands Country of publication: Switzerland
Fulltext
Add to My VHL
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Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: Front Med (Lausanne) Year: 2021 Document type: Article Affiliation country: Netherlands Country of publication: Switzerland