seladelpar

Details

Generic Name:
seladelpar
Project Status:
Pending
Therapeutic Area:
primary biliary cholangitis
Manufacturer:
Gilead Sciences Canada, Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0899-000
Call for patient/clinician input closed:
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
​For the treatment of primary biliary cholangitis, including pruritus, in adults in combination with ursodeoxycholic acid (UDCA) who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
Submission Type:
Initial
Fee Schedule:
Pending
Indications:
​For the treatment of primary biliary cholangitis, including pruritus, in adults in combination with ursodeoxycholic acid (UDCA) who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
Anticipated Date:
  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.