prasterone


( Last Updated : October 21, 2021)
Generic Name:
prasterone
Project Status:
Active
Therapeutic Area:
Postmenopausal vulvovaginal atrophy
Manufacturer:
Lupin Pharma Canada Ltd.
Call for patient/clinician input open:
Brand Name:
Intrarosa
Project Line:
Reimbursement Review
Project Number:
SR0707-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
Intrarosa (prasterone vaginal ovules) is indicated for treatment of postmenopausal vulvovaginal atrophy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Intrarosa (prasterone vaginal ovules) is indicated for treatment of postmenopausal vulvovaginal atrophy.
  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/clinician input open02-Sep-21
Call for patient/clinician input closed25-Oct-21
Submission received01-Oct-21
Submission accepted18-Oct-21
Review initiated19-Oct-21
Draft CADTH review report(s) provided to sponsor for comment07-Jan-22
Deadline for sponsors comments18-Jan-22
CADTH review report(s) and responses to comments provided to sponsor10-Feb-22
Expert committee meeting (initial)23-Feb-22
Draft recommendation issued to sponsorMarch 07, 2022
To
March 09, 2022
Draft recommendation posted for stakeholder feedback17-Mar-22
End of feedback period31-Mar-22