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cyclosporine

Last Updated: July 10, 2019
Result type: Reports
Project Number: SR0615-000
Product Line: Common Drug Review

Generic Name: cyclosporine

Brand Name: Verkazia

Manufacturer: Santen Inc.

Indications: Severe vernal keratoconjunctivitis, pediatric (≥4 years)

Manufacturer Requested Reimbursement Criteria1: For the treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age through adolescence.

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedApril 23, 2019
Patient group input closedJune 12, 2019
Clarification:

- Patient input submission received from the Canadian Organization for Rare Disorders

Patient input summary sent for review to patient input groupsJuly 04, 2019
Patient group comments on input summary closedJuly 10, 2019
Clarification:

- Patient input summary feedback received

Submission receivedMay 22, 2019
Submission accepted for reviewJune 05, 2019
Review initiatedJune 06, 2019
Draft CADTH review report(s) sent to applicantAugust 21, 2019
Comments from applicant on draft CADTH review report(s) receivedAugust 30, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicantOctober 03, 2019
Canadian Drug Expert Committee (CDEC) meetingOctober 16, 2019
CDEC recommendation sent to applicant and drug plansOctober 28, 2019
To
October 30, 2019