Last Updated : October 9, 2019
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 | June 07, 2018 |
| Patient group comments on input summary closed | June 14, 2018 |
| Clarification: - Patient input summary feedback received | |
| Submission received | April 30, 2018 |
| Submission accepted for review | May 14, 2018 |
| Review initiated | May 16, 2018 |
| Draft CDR review report(s) sent to applicant | July 31, 2018 |
| Comments from applicant on draft CDR review report(s) received | August 10, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | August 17, 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 18, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | October 25, 2018 |
| CDEC Final Recommendation posted | October 29, 2018 |
| Final CDR review report(s) and patient input posted | October 29, 2018 |
Last Updated : December 21, 2018
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | January 25, 2018 |
| Patient group input closed | March 16, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | March 28, 2018 |
| Patient group comments on input summary closed | April 05, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | February 23, 2018 |
| Submission accepted for review | March 09, 2018 |
| Review initiated | March 14, 2018 |
| Draft CDR review report(s) sent to applicant | May 31, 2018 |
| Comments from applicant on draft CDR review report(s) received | June 11, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | June 18, 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 24, 2018 |
| CDEC Final Recommendation posted | August 29, 2018 |
| Final CDR review report(s) and patient input posted | September 18, 2018 |
Last Updated : September 18, 2018
Details
Key Milestones2 | |
|---|---|
| Call for patient input posted | January 17, 2018 |
| Patient group input closed | March 08, 2018 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | March 16, 2018 |
| Patient group comments on input summary closed | March 23, 2018 |
| Clarification: - Patient input summary feedback received | |
| Submission received | February 20, 2018 |
| Submission accepted for review | March 06, 2018 |
| Review initiated | March 07, 2018 |
| Draft CDR review report(s) sent to applicant | May 24, 2018 |
| Comments from applicant on draft CDR review report(s) received | June 04, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | June 11, 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 | July 30, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | August 14, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | August 21, 2018 |
| CDEC Final Recommendation posted | August 23, 2018 |
| Final CDR review report(s) and patient input posted | August 31, 2018 |
Last Updated : August 31, 2018
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | December 14, 2017 |
| Patient group input closed | February 09, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | February 13, 2018 |
| Patient group comments on input summary closed | February 21, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | January 25, 2018 |
| Submission accepted for review | February 08, 2018 |
| Review initiated | February 13, 2018 |
| Draft CDR review report(s) sent to applicant | April 30, 2018 |
| Comments from applicant on draft CDR review report(s) received | May 09, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | May 16, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | June 08, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | June 20, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | July 05, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | August 17, 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 | October 17, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | October 24, 2018 |
| CDEC Final Recommendation posted | October 26, 2018 |
| Final CDR review report(s) and patient input posted | October 29, 2018 |
Last Updated : December 21, 2018
Details
Key Milestones2 | |
|---|---|
| Call for patient input posted | November 24, 2017 |
| Patient group input closed | January 22, 2018 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | February 01, 2018 |
| Patient group comments on input summary closed | February 08, 2018 |
| Clarification: - No patient input summary feedback received | |
| Submission received | December 22, 2017 |
| Submission accepted for review | January 15, 2018 |
| Review initiated | January 16, 2018 |
| Draft CDR review report(s) sent to applicant | April 02, 2018 |
| Comments from applicant on draft CDR review report(s) received | April 11, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | April 18, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | June 08, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | June 20, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | July 04, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | July 18, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | July 25, 2018 |
| CDEC Final Recommendation posted | July 27, 2018 |
| Final CDR review report(s) and patient input posted | August 07, 2018 |
Last Updated : August 8, 2018
Details
Key Milestones2 | |
|---|---|
| Call for patient input posted | November 03, 2017 |
| Patient group input closed | December 22, 2017 |
Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | January 09, 2018 |
| Patient group comments on input summary closed | January 16, 2018 |
Clarification: - Patient input summary feedback received | |
| Submission received | December 01, 2017 |
| Submission accepted for review | December 15, 2017 |
| Review initiated | December 18, 2017 |
| Draft CDR review report(s) sent to applicant | March 28, 2018 |
| Comments from applicant on draft CDR review report(s) received | April 09, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | April 16, 2018 |
Clarification: - Manufacturer waived the opportunity to request redactions | |
| CDR review team's comments on draft CDR review report(s) sent to applicant | May 04, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | May 16, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | May 30, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | July 12, 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 | October 17, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | October 24, 2018 |
| CDEC Final Recommendation posted | October 26, 2018 |
| Final CDR review report(s) and patient input posted | October 31, 2018 |
Last Updated : March 28, 2025
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | September 05, 2017 |
| Patient group input closed | October 25, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | April 18, 2018 |
| Patient group comments on input summary closed | April 25, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | October 04, 2017 |
| Submission accepted for review | February 20, 2018 |
| Clarification:
- Submission was not accepted for review on 19 Oct 2017 - Revised category 1 requirements received on 14 Feb 2018 |
|
| Review initiated | February 28, 2018 |
| Draft Canada's Drug Agency review report(s) sent to applicant | May 23, 2018 |
| Comments from applicant on draft Canada's Drug Agency review report(s) received | June 08, 2018 |
| Redaction requests from applicant on draft Canada's Drug Agency review report(s) received | June 15, 2018 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicant | July 06, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | July 18, 2018 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans | July 31, 2018 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | September 13, 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 | December 12, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | December 19, 2018 |
| CDEC Final Recommendation posted | December 21, 2018 |
| Final Canada's Drug Agency review report(s) and patient input posted | January 17, 2019 |
Last Updated : April 18, 2019
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | September 05, 2017 |
| Patient group input closed | October 25, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | March 29, 2018 |
| Patient group comments on input summary closed | April 06, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | October 04, 2017 |
| Submission accepted for review | October 19, 2017 |
| Review initiated | February 20, 2018 |
| Clarification:
- Initiation was delayed at the request of the manufacturer |
|
| Draft CDR review report(s) sent to applicant | May 16, 2018 |
| Comments from applicant on draft CDR review report(s) received | June 08, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | June 15, 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 | July 31, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | September 13, 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 | December 12, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | December 19, 2018 |
| CDEC Final Recommendation posted | December 21, 2018 |
| Final CDR review report(s) and patient input posted | January 21, 2019 |
Last Updated : January 21, 2019
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | April 26, 2018 |
| Patient group input closed | June 15, 2018 |
| Clarification:
- Patient input submission received from Canadian Skin Patient Alliance and Eczema Society of Canada |
|
| Patient input summary sent for review to patient input groups | June 28, 2018 |
| Patient group comments on input summary closed | July 06, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | May 25, 2018 |
| Submission accepted for review | June 11, 2018 |
| Clarification:
- Submission was not accepted for review on 8 Jun 2018 - Revised category 1 requirements received on 8 Jun 2018 |
|
| Review initiated | June 12, 2018 |
| Draft Canada's Drug Agency review report(s) sent to applicant | August 29, 2018 |
| Comments from applicant on draft Canada's Drug Agency review report(s) received | September 10, 2018 |
| Redaction requests from applicant on draft Canada's Drug Agency review report(s) received | September 21, 2018 |
| Clarification:
- Extension requested by applicant - Request granted |
|
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicant | October 04, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | October 17, 2018 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans | October 31, 2018 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | December 12, 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 | March 20, 2019 |
| CDEC Final Recommendation issued to applicant and drug plans | March 27, 2019 |
| CDEC Final Recommendation posted | April 02, 2019 |
| Final Canada's Drug Agency review report(s) and patient input posted | April 17, 2019 |
Last Updated : April 18, 2019