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buprenorphine hydrochloride

Last Updated: June 13, 2018
Result type: Reports
Project Number: SR0550-000
Product Line: Common Drug Review

Generic Name: buprenorphine hydrochloride

Brand Name: Probuphine

Manufacturer: Knight Therapeutics Inc.

Indications: Opioid drug dependence, treatment

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedNovember 22, 2017
Patient group input closedJanuary 18, 2018
Clarification:

- No patient input submission received

Submission receivedDecember 21, 2017
Submission accepted for reviewJanuary 12, 2018
Review initiatedJanuary 15, 2018
Draft CDR review report(s) sent to applicantApril 03, 2018
Comments from applicant on draft CDR review report(s) receivedApril 12, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 19, 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 29, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJune 12, 2018
Clarification:

- Reconsideration requested

- Reconsideration request under assessment by CADTH

Tags

mental health, drug implants, opioid-related disorders, addiction, Probuphine; buprenorphine hydrochloride