About this document
Oxlumo Assessment Report by EMA by reshma.b85 is a document available to read on EtoBox.
The document is an assessment report for the medicinal product Oxlumo (lumasiran), submitted for marketing authorization to the European Medicines Agency (EMA) for the treatment of primary hyperoxaluria type 1. It details the submission process, scientific discussions on quality, non-clinical and clinical aspects, and the benefit-risk balance of the product. The report also includes information on the regulatory procedures followed, including the accelerated assessment and the involvement of the Committee f
- Author
- reshma.b85
- Language
- EN