Orphan designation: Sirolimus, Prevention of arteriovenous access dysfunction in haemodialysis patients, 13/11/2013, Positive
On 13 November 2013, orphan designation (EU/3/13/1204) was granted by the European Commission to S-Cubed Limited, United Kingdom, for sirolimus for the prevention of arteriovenous access dysfunction in patients undergoing surgical creation of an arteriovenous access for haemodialysis.
The sponsorship was transferred to TMC Pharma (EU) Limited, Ireland, in January 2019.
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