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netupitant / palonosetron

Last Updated: June 22, 2018
Result type: Reports
Project Number: SR0548-000
Product Line: Common Drug Review

Generic Name: netupitant / palonosetron

Brand Name: Akynzeo

Manufacturer: Purdue Pharma

Indications: Nausea and vomiting (chemotherapy induced) prevention

Submission Type: New Combination

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 16, 2017
Patient group input closedJanuary 12, 2018
Clarification:

- No patient input submission received

Submission receivedDecember 08, 2017
Submission accepted for reviewDecember 22, 2017
Review initiatedJanuary 02, 2018
Draft CDR review report(s) sent to applicantMarch 16, 2018
Comments from applicant on draft CDR review report(s) receivedMarch 27, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 04, 2018
Clarification:

- No redactions requested by the applicant

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 postedJune 22, 2018

Tags

cancer, digestive system, Antiemetic; antiemetics; Nausea; Vomiting; Cancer; Neoplasm; palonosetron; netupitant; Akynzeo