Canada’s Drug Agency | Drugs, Health Technologies and Systems.

fluticasone furoate/vilanterol

Details

Key Milestones2

Call for patient input postedApril 04, 2018
Patient group input closedMay 24, 2018
Clarification:

- No patient input submission received

Submission receivedMay 02, 2018
Submission acceptedMay 16, 2018
Review initiatedMay 17, 2018
Draft Canada's Drug Agency review report(s) sent to sponsorAugust 01, 2018
Comments from sponsor on draft Canada's Drug Agency review report(s) receivedAugust 13, 2018
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) receivedAugust 15, 2018
Clarification:

- Voluntarily withdrawn by the manufacturer on 2018-08-14

Last Updated : June 18, 2020

ertugliflozin and metformin

Details

Key Milestones2
Call for patient input posted April 02, 2018
Patient group input closed May 22, 2018
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups May 31, 2018
Patient group comments on input summary closed June 07, 2018
Clarification:

- Patient input summary feedback received
Submission received April 30, 2018
Submission accepted for review May 14, 2018
Review initiated May 15, 2018
Draft CDR review report(s) sent to applicant August 07, 2018
Comments from applicant on draft CDR review report(s) received August 16, 2018
Redaction requests from applicant on draft CDR review report(s) received August 23, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant September 07, 2018
Canadian Drug Expert Committee (CDEC) meeting September 19, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 03, 2018
Embargo period ended and validation of redacted CDR review report(s) received October 29, 2018
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested
Applicant's request for reconsideration placed on CDEC agenda January 16, 2019
CDEC Final Recommendation issued to applicant and drug plans January 23, 2019
CDEC Final Recommendation posted January 25, 2019
Final CDR review report(s) posted February 07, 2019
Last Updated : February 7, 2019

ertugliflozin

Details

Key Milestones2
Call for patient input posted April 02, 2018
Patient group input closed May 22, 2018
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups -
Patient group comments on input summary closed -
Submission received April 30, 2018
Submission accepted for review May 14, 2018
Review initiated May 15, 2018
Draft CDR review report(s) sent to applicant August 07, 2018
Comments from applicant on draft CDR review report(s) received August 16, 2018
Redaction requests from applicant on draft CDR review report(s) received August 23, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant September 07, 2018
Canadian Drug Expert Committee (CDEC) meeting September 19, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 03, 2018
Embargo period ended and validation of redacted CDR review report(s) received October 29, 2018
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested
Applicant's request for reconsideration placed on CDEC agenda January 16, 2019
CDEC Final Recommendation issued to applicant and drug plans January 23, 2019
CDEC Final Recommendation posted January 25, 2019
Final CDR review report(s) posted February 08, 2019
Last Updated : February 8, 2019

Opdivo in combo with Yervoy for Renal Cell Carcinoma – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : November 16, 2018

lixisenatide + insulin glargine

Details

Key Milestones2
Call for patient input posted March 21, 2018
Patient group input closed May 10, 2018
Patient input summary sent for review to patient input groups June 21, 2018
Patient group comments on input summary closed June 29, 2018
Clarification:

- Patient input summary feedback received
Submission received May 18, 2018
Submission accepted for review June 04, 2018
Review initiated June 05, 2018
Draft CDR review report(s) sent to applicant August 20, 2018
Comments from applicant on draft CDR review report(s) received August 29, 2018
Redaction requests from applicant on draft CDR review report(s) received September 06, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant October 04, 2018
Canadian Drug Expert Committee (CDEC) meeting October 17, 2018
Clarification:

- Deferred to November 21, 2018 CDEC meeting
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans December 03, 2018
Embargo period ended and validation of redacted CDR review report(s) received December 17, 2018
CDEC Final Recommendation issued to applicant and drug plans December 24, 2018
CDEC Final Recommendation posted January 3, 2019
Final CDR review report(s) and patient input posted January 30, 2019
Last Updated : January 30, 2019

Tapentadol Hydrochloride

Details

Key Milestones2
Call for patient input posted March 19, 2018
Patient group input closed May 08, 2018
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups May 14, 2018
Patient group comments on input summary closed May 22, 2018
Clarification:

- Patient input summary feedback received
Submission received April 17, 2018
Submission accepted for review May 01, 2018
Review initiated May 02, 2018
Draft CDR review report(s) sent to applicant July 20, 2018
Comments from applicant on draft CDR review report(s) received July 31, 2018
Redaction requests from applicant on draft CDR review report(s) received August 08, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant September 07, 2018
Canadian Drug Expert Committee (CDEC) meeting September 19, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 01, 2018
Embargo period ended and validation of redacted CDR review report(s) received October 16, 2018
CDEC Final Recommendation issued to applicant and drug plans October 23, 2018
CDEC Final Recommendation posted October 25, 2018
Final CDR review report(s) and patient input posted October 29, 2018
Last Updated : December 21, 2018

Erleada for Castrate Resistant Prostate Cancer - Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : November 16, 2018

Perjeta-Herceptin Combo Pack for Early Breast Cancer – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : December 14, 2018

Gazyva for Follicular Lymphoma (previously untreated) – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : November 16, 2018

fluticasone furoate/umeclidinium/vilanterol

Details

Key Milestones2
Call for patient input posted January 31, 2018
Patient group input closed March 22, 2018
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups April 03, 2018
Patient group comments on input summary closed April 10, 2018
Clarification:

- Patient input summary feedback received
Submission received March 01, 2018
Submission accepted for review March 15, 2018
Review initiated March 16, 2018
Draft CDR review report(s) sent to applicant June 04, 2018
Comments from applicant on draft CDR review report(s) received June 13, 2018
Redaction requests from applicant on draft CDR review report(s) received June 20, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant July 06, 2018
Canadian Drug Expert Committee (CDEC) meeting July 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans August 01, 2018
Embargo period ended and validation of redacted CDR review report(s) received August 16, 2018
CDEC Final Recommendation issued to applicant and drug plans August 23, 2018
CDEC Final Recommendation posted August 27, 2018
Final CDR review report(s) and patient input posted September 18, 2018
Last Updated : September 19, 2018