The European Medicines Agency Review of Ofatumumab (Arzerra®) for the Treatment of Chronic Lymphocytic Leukemia in Patients Refractory to Fludarabine and Alemtuzumab: Summary of the Scientific Assessment of the European Medicines Agency Committee for Medicinal Products for Human Use

On April 19, 2010, the European Commission issued a conditional marketing authorization valid throughout the European Union (EU) for ofatumumab (Arzerra®; Glaxo Group Ltd, Greenford, Middlesex, U.K.). The decision was based on the favorable opinion of the Committee for Medicinal Products for Human U...

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Hlavní autoři: Gravanis, Iordanis, Ersbøll, Jens, Skovlund, Eva, Abadie, Eric, Marty, Michel, Pignatti, Francesco
Médium: Artigo
Jazyk:Inglês
Vydáno: AlphaMed Press 2010
Témata:
Regulatory Issues: EMA
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC3227918/
https://ncbi.nlm.nih.gov/pubmed/21156732
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2010-0255
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