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Sylvant Multicentric Castleman's Disease - Details

Project Number pCODR 10052
Brand Name Sylvant
Generic Name Siltuximab
Strength 100mg/vial and 400mg/vial
Tumour Type Lymphoma
Indication Multicentric Castleman's Disease (MCD)
Funding Request For the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV)-negative and human herpes virus-8 (HHV-8)-negative
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date December 3, 2014
Manufacturer Janssen Inc.
Submitter Janssen Inc.
Submission Date January 30, 2015
Submission Deemed Complete February 6, 2015
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ February 13, 2015
Check-point meeting March 23, 2015
pERC Meeting May 21, 2015
Initial Recommendation Issued June 4, 2015
Feedback Deadline ‡ June 18, 2015
Final Recommendation Issued June 22, 2015
Notification to Implement Issued July 8, 2015

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.