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In the European Union (EU), the European Medicines Agency (EMA) defines a drug as "orphan" if it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically and seriously debilitating condition affecting not more than 5 in 10,000 EU people. [6]
The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]
[2] [3] [4] Only thirty-eight orphan drugs had been approved prior to the 1983 Act; by 2014 "468 indication designations covering 373 drugs have been approved." [5] Partly as a result of the 1983 US Orphan Drug Act, Japan adopted it in 1993 as did the European Union in 2000. [5]
NanoViricides Submits DengueCide™ Orphan Drug Designation Letter of Intent to File with the European Medicines Agency WEST HAVEN, Conn.--(BUSINESS WIRE)-- NanoViricides, Inc. (OTC BB: NNVC) (the ...
In the UK it is available only via a named patient access program. [9] Vonicog alfa was approved for medical use in the United States in December 2015, in the European Union in August 2018, and in Australia in April 2020. [4] [6] [5] [10] It was granted orphan drug designations in both the United States and the European Union. [5] [1]
Orphanet is an organisation and knowledge base dedicated to rare diseases as well as corresponding diagnosis, orphan drugs, clinical trials and expert networks. [1] Orphanet was founded in France in 1997 by Inserm, the French National Institute of Health and Medical Research. The website is managed by a network of academic establishments from ...
Lists of all drugs that have received orphan status in the United States and Europe are available from the U.S. Food and Drug Administration and the European Commission, respectively: FDA List of Orphan Designations and Approvals [dead link ] European Commission Register of designated Orphan Medicinal Products
In July 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended a conditional marketing authorization for epcoritamab (Tepkinly). [14] It was approved for medical use in the European Union in September 2023. [5] The EMA granted orphan drug designation to epcoritamab in both February and June 2022 ...