ravulizumab

Details

Generic Name:
ravulizumab
Project Status:
Withdrawn
Therapeutic Area:
Paroxysmal nocturnal hemoglobinuria.
Manufacturer:
Alexion Pharma Canada Corp
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0623-000
Call for patient/clinician input closed:
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with paroxysmal nocturnal hemoglobinuria.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​For the treatment of adult patients with paroxysmal nocturnal hemoglobinuria.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedMay 27, 2019
Patient group input closedJuly 16, 2019
Clarification:

- Patient input submission received from Aplastic Anemia and Myelodysplasia Association of Canada (AAMAC) and the Canadian Association of PNH Patients

Patient input summary sent for review to patient input groupsAugust 08, 2019
Patient group comments on input summary closedAugust 15, 2019
Clarification:

- Patient input summary feedback received

Submission receivedJuly 04, 2019
Submission acceptedJuly 18, 2019
Review initiatedJuly 23, 2019
Clarification:

- Submission temporarily suspended at the request of the sponsor

- Voluntarily withdrawn by the sponsor on November 19, 2020