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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...

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Detalles Bibliográficos
Autores principales: Polsinelli, Benedetta, Tsigkos, Stelios, Naumann-Winter, Frauke, Mariz, Segundo, Sepodes, Bruno
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
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