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migalastat

Last Updated: November 10, 2017
Result type: Reports
Project Number: SR0522-000
Product Line: Common Drug Review

Generic Name: migalastat

Brand Name: Galafold

Manufacturer: Amicus Therapeutics

Indications: Fabry Disease

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule1: Schedule A

Key Milestones2

Call for patient input posted3May 05, 2017
Patient group input closed3June 26, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJuly 21, 2017
Patient group comments on input summary closedJuly 28, 2017
Clarification:

- Patient input summary feedback received

Submission receivedJune 09, 2017
Submission accepted for reviewJune 23, 2017
Review initiatedJuly 05, 2017
Clarification:

- Submission temporarily suspended pending receipt of information

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CDR review report(s) sent to applicantOctober 23, 2017
Comments from applicant on draft CDR review report(s) receivedNovember 01, 2017
Redaction requests from applicant on draft CDR review report(s) receivedNovember 08, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantDecember 01, 2017
Canadian Drug Expert Committee (CDEC) meetingDecember 13, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJanuary 02, 2018
To
January 04, 2018

Tags

genetics, nervous system, fabry disease, migalastat