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Evolving prevalence of haematological malignancies in orphan designation procedures in the European Union
The Committee for Orphan Medicinal Products (COMP) evaluates prevalence of rare conditions as one of the criteria for granting an orphan designation with a prevalence threshold of 5 in 10.000. At the time of Marketing Authorisation (MA) these criteria are reassessed to ensure they are still met. The...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5251220/ https://www.ncbi.nlm.nih.gov/pubmed/28109318 http://dx.doi.org/10.1186/s13023-017-0567-7 |