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letermovir

Last Updated: July 9, 2018
Result type: Reports
Project Number: SR0545-000
Product Line: Common Drug Review

Generic Name: letermovir

Brand Name: Prevymis

Manufacturer: Merck Canada Inc.

Indications: Cytomegalovirus infection, prophylaxis

Submission Type: New

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: June 20, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedNovember 03, 2017
Patient group input closedDecember 22, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJanuary 10, 2018
Patient group comments on input summary closedJanuary 17, 2018
Clarification:

- Patient input summary feedback received

Submission receivedDecember 07, 2017
Submission accepted for reviewDecember 21, 2017
Review initiatedDecember 22, 2017
Draft CDR review report(s) sent to applicantMarch 15, 2018
Comments from applicant on draft CDR review report(s) receivedMarch 26, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 03, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantMay 04, 2018
Canadian Drug Expert Committee (CDEC) meetingMay 16, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansMay 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJune 13, 2018
CDEC Final Recommendation issued to applicant and drug plansJune 20, 2018
CDEC Final Recommendation postedJune 22, 2018
Final CDR review report(s) and patient input postedJuly 09, 2018

Tags

infectious diseases, cystinosis, delayed-action preparations, hiv/aids, cysteamine bitartrate; Procysbi; nephropathic; cystinosis; extended release; delayed action; delayed release; controlled release; Long acting; time release