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Iron (III) Isomaltoside 1000

Last Updated: November 8, 2019
Result type: Reports
Project Number: SR0622-000
Product Line: Common Drug Review

Generic Name: Iron (III) Isomaltoside 1000

Brand Name: Monoferric

Manufacturer: Pharmacosmos A/S

Indications: iron deficiency anemia

Manufacturer Requested Reimbursement Criteria1: Reimbursed for the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy. The diagnosis must be based on laboratory tests.

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 postedMay 29, 2019
Patient group input closedJuly 18, 2019
Clarification:

- Patient input submission received from Crohn's and Colitis Canada and The Kidney Foundation of Canada

Patient input summary sent for review to patient input groupsJuly 30, 2019
Patient group comments on input summary closedAugust 06, 2019
Clarification:

- Patient input summary feedback received

Submission receivedJune 26, 2019
Submission accepted for reviewJuly 11, 2019
Review initiatedJuly 12, 2019
Draft CADTH review report(s) sent to sponsorOctober 02, 2019
Comments from sponsor on draft CADTH review report(s) receivedOctober 11, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorNovember 08, 2019
Canadian Drug Expert Committee (CDEC) meetingNovember 20, 2019
CDEC recommendation sent to sponsor and drug plansDecember 02, 2019
To
December 04, 2019