Apomorphine

Generic Name: apomorphine hydrochloride

Brand Name: Movapo

Manufacturer: Paladin Labs Inc.

Indications: Parkinson's disease

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule¹: Schedule A

Key Milestones2
Call for patient input posted3	07-Jun-17
Patient group input closed3	27-Jul-17
Clarification: - Patient input submission received
Patient input summary sent for review to patient input groups	08-Aug-17
Patient group comments on input summary closed	14-Aug-17
Clarification: - Patient input summary feedback received
Submission received	06-Jul-17
Submission accepted for review	20-Jul-17
Review initiated	21-Jul-17
Draft CDR review report(s) sent to applicant	20-Oct-17
Comments from applicant on draft CDR review report(s) received	31-Oct-17
Redaction requests from applicant on draft CDR review report(s) received	07-Nov-17
CDR review team's comments on draft CDR review report(s) sent to applicant	01-Dec-17
Canadian Drug Expert Committee (CDEC) meeting	13-Dec-17
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans	January 02, 2018 To January 04, 2018

1. Refer to Appendix 1 of the Procedure for the CADTH Common Drug Review for details regarding CDR application fee schedules.
2. Please refer to the Procedure for the CADTH Common Drug Review for complete details regarding the CDR process and targeted time frames for key milestones.
3. The call for patient group input is posted 20 business days in advance of the applicant's anticipated date of filing the CDR application. Patient groups have a total of 35 business days for preparing and submitting patient input.
4. The embargoed CDEC recommendation is held in confidence by all stakeholders and not acted upon until after CADTH has issued the notice of CDEC Final Recommendation.The applicant may make a request for reconsideration or resubmission based on reduced price during the embargo period, and the drug plans may make a request for clarification, as applicable (see section 8 of the Procedure for the CADTH Common Drug Review).
5. The timing for posting the CDEC Final Recommendation and CDR review report(s) depends on several factors including the need for consultation with the applicant regarding redaction issues.
6. The time frame required to address a request for clarification at the drug plans' request or request for reconsideration at the applicant's request depends on the amount of work required to address the request and the available dates for CDEC meetings.

Tags

parkinson