Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen

Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen

Abstract Background In the European Union (EU) and United States (US), specific regulations have been released to provide incentives to develop and sell orphan medicinal products. We analysed the status of orphan drugs designated that not yet received a marketing authorisation or already marketed fo...

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Bibliographic Details
Main Authors: Viviana Giannuzzi, Rosa Conte, Annalisa Landi, Serena Antonella Ottomano, Donato Bonifazi, Paola Baiardi, Fedele Bonifazi, Adriana Ceci
Format: Article
Language:English
Published: BMC 2017-04-01
Series:Orphanet Journal of Rare Diseases
Subjects:
Orphan drugs
Orphan designations
Medicinal products for rare diseases
Register
Therapeutic needs
Online Access:http://link.springer.com/article/10.1186/s13023-017-0617-1

Internet

http://link.springer.com/article/10.1186/s13023-017-0617-1

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