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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Bibliografiske detaljer
Udgivet i:Orphanet J Rare Dis
Main Authors: Polsinelli, Benedetta, Tsigkos, Stelios, Naumann-Winter, Frauke, Mariz, Segundo, Sepodes, Bruno
Format: Artigo
Sprog:Inglês
Udgivet: BioMed Central 2017
Fag:
Letter to the Editor
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC5251220/
https://ncbi.nlm.nih.gov/pubmed/28109318
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s13023-017-0567-7
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