Post-Authorization Activity Table (PAAT) for Veklury
Updated: 2024-05-17
The following table describes post-authorization activity for Veklury, a product which contains the medicinal ingredient remdesivir. For more information on the type of information found in PAATs, please refer to the Frequently Asked Questions: Summary Basis of Decision (SBD) Project: Phase II and to the List of abbreviations found in Post-Authorization Activity Tables (PAATs).
For additional information about the drug submission process, refer to the Guidance Document: The Management of Drug Submissions and Applications.
Drug Identification Number (DIN):
- DIN 02502143 - 100 mg remdesivir/vial, powder for solution, intravenous administration
- DIN 02502135 - 100 mg remdesivir/20 mL (5 mg/mL), solution, intravenous administration
Post-Authorization Activity Table (PAAT)
| Activity/submission type, control number | Date submitted | Decision and date | Summary of activities |
|---|---|---|---|
| SNDS-C # 275344 | 2023-05-15 | Issued NOC 2024-05-06 | Submission filed as a Level I – Supplement in response to commitments made as per the provisions of the Guidance Document: Notice of Compliance with Conditions (NOC/c). The submission provided data for study GS-US-540-9014. Based on the data submitted, the benefit-harm-uncertainty profile of Veklury remains favourable when used as directed in the Product Monograph and an NOC was issued. As a result of the submission, commitment iv is considered to be met, and the conditions were removed from the NOC that had been issued 2020-07-27. |
| SNDS # 275995 | 2023-06-05 | Issued NOC 2024-02-06 | Submission filed as a Level I – Supplement to add alternate manufacturing sites for the production of the drug product and an alternative rubber stopper. The information was reviewed and considered acceptable. An NOC was issued. |
| SNDS-C # 270659 | 2022-12-15 | Issued NOC under NOC/c Guidance 2023-11-17 | Submission filed as a Level I – Supplement in response to commitments made as per the provisions of the Guidance Document: Notice of Compliance with Conditions (NOC/c). The submission provided data for study GS-US-540-9015. The information was reviewed and considered acceptable. An NOC was issued under the NOC/c Guidance. |
| SNDS # 266313 | 2022-08-02 | Issued NOC 2023-06-15 | Submission filed as a Level I – Supplement for a new indication. The indication authorized was: the treatment of coronavirus disease 2019 (COVID-19) in pediatric patients at least 4 weeks of age and weighing at least 3 kg to less than 40 kg with pneumonia requiring supplemental oxygen (hospitalized pediatric patients) and pediatric patients weighing at least 40 kg who are at high risk for progression to severe COVID-19, including hospitalization or death (non-hospitalized pediatric patients). The submission was reviewed and considered acceptable, and an NOC was issued. A Regulatory Decision Summary was published. |
| PSUR # 269953 | 2023-01-13 | Review completed 2023-06-01 | Submission filed in response to commitments made as per the provisions of the NOC/c Guidance. PSUR #5 for the period 2022-05-07 to 2022-11-06. The current post-market safety data are consistent with the labelled safety profile of Veklury. Health Canada will continue to monitor any new emerging evidence from all available sources as part of its post-authorization monitoring for Veklury. |
| PSUR # 242336 | 2022-07-21 | Review completed 2022-11-23 |
Submission filed in response to commitments made as per the provisions of the NOC/c Guidance. PSUR #4 for the period 2021-11-07 to 2022-05-06. The current post-market safety data are consistent with the labelled safety profile of Veklury. Health Canada will continue to monitor any new emerging evidence from all available sources as part of its post-authorization monitoring for Veklury. |
| SNDS-C # 252849 | 2021-05-19 | Issued NOC under NOC/c Guidance 2022-10-14 |
Submission filed as a Level I – Supplement in response to quality-specific commitments made as per the provisions of the NOC/c Guidance. The information was reviewed and considered acceptable. An NOC was issued under the NOC/c Guidance. |
| PSUR # 242334 | 2022-01-27 | Review completed 2022-05-06 |
Submission filed in response to commitments made as per the provisions of the NOC/c Guidance. PSUR #3 for the period 2021-05-07 to 2021-11-06. The current post-market safety data are consistent with the labelled safety profile of Veklury. Health Canada will continue to monitor any new emerging evidence from all available sources as part of its post-authorization monitoring for Veklury. |
| SNDS # 250151 | 2021-03-05 | Issued NOC 2022-04-22 |
Submission filed as a Level I – Supplement to add a new indication for Veklury. The indication authorized was for use in non-hospitalized adults with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. A Regulatory Decision Summary was published. |
| Safety review Control # 259111 |
2021-12-21 | Review completed 2022-02-18 |
Health Canada's review concluded that Veklury is expected to maintain effectiveness against the Omicron SARS-CoV-2 variant based on the data available at this time and no Product Monograph updates are necessary at this time. |
| SNDS-C # 248928 | 2021-01-29 | Issued NOC 2022-01-24 |
Submission filed as a Level I – Supplement in response to commitments made as per the provisions of the NOC/c Guidance. The submission provided data for the following studies: CO-US-540-5776, GS-US-540-5773, GS-US-5774, and GS-US-540-5758. Based on the data submitted, the benefit-harm-uncertainty profile of Veklury remains favourable when used as directed in the Product Monograph and an NOC was issued. The conditions related to the submission of confirmatory Phase III clinical trial evidence are considered to be met. |
| PSUR # 242333 | 2021-07-27 | Review completed 2021-11-25 |
Submission filed in response to commitments made as per the provisions of the NOC/c Guidance. PSUR #2 for the period 2020-11-07 to 2021-05-06. The current post-market safety data are consistent with the labelled safety profile of Veklury. Health Canada will continue to monitor any new emerging evidence from all available sources as part of its post-authorization monitoring for Veklury. |
| SNDS # 254319 | 2021-06-30 | Issued NOC 2021-11-23 |
Submission filed as a Level II – Supplement (Safety) to update the Product Monograph (PM) with new information regarding anaphylactic reaction and hypersensitivity, and to update the PM to the new template. As a result of the SNDS, additions were made to the Warnings and Precautions and Adverse Reactions sections of the PM and Part III: Patient Medication Information. An NOC was issued. |
| Risk Management Plan update Control # 257313 |
2021-11-05 | Review completed 2021-11-22 |
The updated Canadian Addendum (version 3.0) to the Risk Management Plan (RMP) was filed as requested by Health Canada. The review found that this document is acceptable. |
| Risk Management Plan update Control # 251662 |
2021-06-14 | Review completed 2021-09-29 |
The updated European Union (EU) Risk Management Plan (RMP) version 2.0 and Canadian Addendum were filed as requested by Health Canada. The review of the updated EU RMP in conjunction with the Canadian Addendum found that these documents are acceptable with revisions that were requested to be addressed by the sponsor within 30 days. |
| Summary Safety Review posted | Not applicable | Posted 2021-08-18 |
Summary Safety Review posted for Veklury (remdesivir), assessing the potential risk of sinus bradycardia. Health Canada’s review concluded that a link between the use of Veklury and the risk of sinus bradycardia is possible. Health Canada will work with the sponsor to update the Product Monograph. |
| SNDS # 250729 | 2021-03-22 | Issued NOC 2021-08-12 |
Submission filed as a Level I – Supplement to update the Product Monograph for Veklury to add laboratory abnormality information regarding increased prothrombin time/International Normalized Ratio (PT/INR). As a result of the submission, the Dosage and Administration, Adverse Reactions, and Patient Medication Information sections of the Product Monograph were updated. The benefit/risk profile for Veklury remains positive when used for its approved indication. |
| Safety review Control # 249357 |
Not applicable | Review completed 2021-07-13 |
Health Canada’s review concluded that there is currently some evidence supporting a causal association between Veklury and sinus bradycardia. Health Canada will work with the sponsor to update the Product Monograph. |
| Expedited summary safety report Control # 252344 |
2021-04-30 | Filed 2021-06-15 |
Submission filed in response to a Health Canada request and provided an expedited summary safety report for the period 2021-01-01 to 2021-03-31. The current post-market safety data are consistent with the labelled safety profile of Veklury. Health Canada will continue to monitor any new emerging evidence from all available sources as part of its post-authorization monitoring for Veklury. |
| DIN 02502135 cancelled (pre-market) | Not applicable | Discontinuation date: 2021-04-13 |
The manufacturer notified Health Canada that sale of the drug has been discontinued pre-market. Health Canada cancelled the DIN pursuant to section C.01.014.6(1)(a) of the Food and Drug Regulations. DIN 02502143 remains active. |
| Summary Safety Review posted | Not applicable | Posted 2021-04-09 |
Summary Safety Review posted for Veklury (remdesivir), assessing the potential risks of acute kidney injury (AKI) and acute renal failure (ARF). Health Canada's review could not establish a direct link between the use of Veklury and the risk of AKI/ARF. The safety information for Veklury is appropriate at this time. |
| PSUR # 242337 | 2021-01-15 | Filed 2021-04-07 |
Submission filed in response to commitments made as per the provisions of the NOC/c Guidance. PSUR #1 for the period 2020-05-07 to 2020-11-06. The current post-market safety data are consistent with the labelled safety profile of Veklury. Health Canada will continue to monitor any new emerging evidence from all available sources as part of its post-authorization monitoring for Veklury. |
| SNDS # 247779 | 2020-12-23 | Issued NOC under NOC/c Guidance 2021-03-02 |
Submission filed as a Level I - Supplement to add an alternate manufacturing site for the production of the remdesivir drug substance. There were no changes to the manufacturing process for the drug substance. The information was reviewed and considered acceptable. An NOC was issued under the NOC/c Guidance. |
| Monthly safety report Control # 248787 |
2021-01-27 | Review completed 2021-02-19 |
Submission filed in response to commitments made as per the provisions of the NOC/c Guidance. Monthly safety report #6 for the period 2020-11-02 to 2020-12-31. Additional information has been requested from the manufacturer following international cases of sinus bradycardia (slow heart rate less than 60 bpm). Health Canada will review this information when provided. The current post-market safety data are consistent with the labelled safety profile of Veklury. |
| Safety review Control # 244656 |
Not applicable | Review completed 2021-02-11 |
Health Canada's review concluded that the evidence does not suggest any additional concern or new safety characteristic regarding Veklury and acute kidney injury. The safety information for Veklury available in the Product Monograph is appropriate at this time to mitigate the risk. Health Canada will continue to monitor any new emerging evidence from all available sources as part of its post-authorization monitoring for Veklury. |
| Monthly safety report Control # 247955 | 2020-12-24 | Review completed 2021-01-17 |
Submission filed in response to commitments made as per the provisions of the NOC/c Guidance. Monthly safety report #5 for the period 2020-11-02 to 2020-11-30. The current post-market safety data are consistent with the labelled safety profile of Veklury. |
| Monthly safety report Control # 245540 | 2020-11-19 | Review completed 2020-12-16 |
Submission filed in response to commitments made as per the provisions of the NOC/c Guidance. Monthly safety report #4 for the period 2020-10-02 to 2020-11-01. The current post-market safety data are consistent with the labelled safety profile of Veklury. |
| Monthly safety report Control # 245911 | 2020-10-28 | Review completed 2020-11-19 |
Submission filed in response to commitments made as per the provisions of the NOC/c Guidance. Monthly safety report #3 for the period 2020-09-03 to 2020-10-02. The current post-market safety data are consistent with the labelled safety profile of Veklury. |
| Monthly safety report Control # 244559 | 2020-09-29 | Review completed 2020-10-25 |
Submission filed in response to commitments made as per the provisions of the NOC/c Guidance. Monthly safety report #2 for the period 2020-08-04 to 2020-09-02. The current post-market safety data are consistent with the labelled safety profile of Veklury. |
| New safety review started by Health Canada | Not applicable | Started between 2020-10-01 |
Health Canada started a safety review for Veklury in response to international reports of acute kidney injury. |
| Monthly safety report Control # 243244 | 2020-08-21 | Review completed 2020-09-22 |
Submission filed in response to commitments made as per the provisions of the NOC/c Guidance. Monthly safety report #1 for the period 2020-07-05 to 2020-08-03. The current post-market safety data are consistent with the labelled safety profile of Veklury. |
| Drug product (DIN 02502143) market notification | Not applicable | Date of first sale: 2020-10-16 |
The manufacturer notified Health Canada of the date of first sale pursuant to C.01.014.3 of the Food and Drug Regulations. |
| Dear Healthcare Professional Letter posted | Not applicable | Posted 2020-09-15 |
Dear Healthcare Professional Letter posted (Importation of US Clinical Trial-Labelled Remdesivir for Injection Due to Shortage of Canadian-Labelled Remdesivir), containing product safety, supply, and important safety information for healthcare professionals and hospitals. |
| Advisory posted | Not applicable | Posted 2020-07-28 |
Advisory posted (Remdesivir authorized with conditions for the treatment of patients in Canada with severe COVID-19 symptoms), containing a product label update for healthcare professionals, hospitals, and the general public. |
| NDS # 240551 | 2020-06-19 | Issued NOC under NOC/c Guidance 2020-07-27 |
NOC issued under the NOC/c Guidance for New Drug Submission. |