Post-Authorization Activity Table (PAAT) for Paxlovid

Updated2024-01-19

The following table describes post-authorization activity for Paxlovid, a product which contains the medicinal ingredients nirmatrelvir and ritonavir. 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 02524031 - 150 mg nirmatrelvir, tablet, and 100 mg ritonavir, tablet, co-packaged, oral administration

DIN 02527804 - 150 mg nirmatrelvir, tablet, and 100 mg ritonavir, tablet, co-packaged, oral administration, cards of 2 nirmatrelvir tablets and 2 ritonavir tablets

Post-Authorization Activity Table (PAAT)

Activity/submission type, control number Date submitted Decision and date Summary of activities
SNDS # 278009 2023-08-09 Issued NOC 2024-01-02 Submission filed as a Level II – Supplement (Safety) to update the PM with new efficacy information. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Microbiology section of the PM. An NOC was issued.
SNDS # 277393 2023-07-20 Issued NOC 2023-12-13 Submission filed as a Level II – Supplement (Safety) to update the PM with new safety and efficacy information. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Warnings and Precautions, Adverse Reactions, Clinical Trials, and Non-Clinical Toxicology sections of the PM. An NOC was issued.
SNDS # 274571 2023-04-21 Issued NOC 2023-10-04 Submission filed as a Level II – Supplement (Safety) to update the PM with new safety information. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Warnings and Precautions and Drug Interactions sections of the PM, and corresponding changes were made to Part III: Patient Medication Information. An NOC was issued.
SNDS # 267963 2022-09-16 Issued NOC 2023-08-30 Submission filed as a Level I – Supplement to update the PM with new safety information related to anaphylaxis. Information was also filed to fulfill clinical Terms and Conditions #5-8, 13, and 14 imposed on the authorization issued under the Food and Drug Regulations. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, and Non-Clinical Toxicology sections of the PM, and corresponding changes were made to Part III: Patient Medication Information. An NOC was issued.
PSUR # 260406 2023-03-09 Review completed 2023-06-29 Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PSUR #2 for the period 2022-07-01 to 2022-12-31. The current post-market safety data are consistent with the labelled safety profile for Paxlovid. Health Canada will continue to monitor any new emerging evidence from all available sources as part of its post-authorization monitoring for Paxlovid.
SNDS # 272114 2023-02-03 Issued NOC 2023-06-27 Submission filed as a Level II – Supplement (Safety) to update the PM with new safety information. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Contraindications, Adverse Reactions, and Drug Interactions sections of the PM, and corresponding changes were made to Part III: Patient Medication Information. An NOC was issued.
Risk Management Plan update
Control # 267690
2022-12-13 Review completed
2023-01-24

The updated European Union Risk Management Plan version 2.2 and Canadian Addendum dated November 2022 were filed following the review of RMP update # 264469 and Monthly safety report # 266286. The review found the RMP is acceptable at this time. The current post-market safety data are consistent with the labelled safety profile of Paxlovid.

PSUR # 260405 2022-09-08 Review completed
2023-01-16

Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PSUR #1 for the period 2021-12-31 to 2022-06-30. The current post-market safety data are consistent with the labelled safety profile for Paxlovid. Health Canada will continue to monitor any new emerging evidence from all available sources as part of its post-authorization monitoring for Paxlovid.

SNDS # 266236 2022-07-21 Issued NOC
2022-12-08

Submission filed as a Level II – Supplement (Safety) to update the PM with new safety information. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Adverse Reactions and Drug Interactions sections of the PM, and corresponding changes were made to Part III: Patient Medication Information. An NOC was issued.

SNDS # 269592 2022-10-11 Issued NOC
2022-12-01

Submission filed as a Level I – Supplement to extend the shelf life of nirmatrelvir tablets from 18 months to 24 months. The submission was reviewed and considered acceptable, and an NOC was issued.

SNDS # 266836 2022-08-09 Issued NOC
2022-09-26

Submission filed as a Level I – Supplement to extend the shelf life of nirmatrelvir tablets from 12 months to 18 months. The submission was reviewed and considered acceptable, and an NOC was issued.

Risk Management Plan update Control # 264649 2022-08-29 Review completed
2022-09-07

The updated Canadian Risk Management Plan (RMP) Addenda dated August 2022 was filed following the review of RMP update # 260404. The review found the RMP is acceptable with revisions at this time. The current post-market safety data are consistent with the labelled safety profile of Paxlovid.

Monthly safety report Control # 266286 2022-08-02 Review completed
2022-09-01

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #6 for the period 2022-06-01 to 2022-06-30. The current post-market safety data are consistent with the labelled safety profile of Paxlovid.

Drug product (DIN 02527804) market notification Not applicable Date of first sale:
2022-08-01

The manufacturer notified Health Canada of the date of first sale pursuant to C.01.014.3 of the Food and Drug Regulations.

Monthly safety report Control # 265412 2022-06-30 Review completed
2022-07-22

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #5 for the period 2022-05-01 to 2022-05-31. The manufacturer was requested to provide information in the next monthly safety report, following cases of rebound COVID-19. The current post-market safety data are consistent with the labelled safety profile of Paxlovid.

Monthly safety report Control # 264473 2022-05-31 Review completed
2022-06-21

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #4 for the period 2022-04-01 to 2022-04-30. The manufacturer was requested to provide information in the next monthly safety report, following cases of rebound COVID-19. The current post-market safety data are consistent with the labelled safety profile of Paxlovid.

SNDS # 263843 2022-04-29 Issued NOC
2022-06-13

Submission filed as a Level I – Supplement for new packaging specifically for patients with moderate renal impairment who require nirmatrelvir dose reduction. The new dose pack is expected to mitigate potential risk of medication errors in this patient population. The Serious Warnings and Precautions, Dosage and Administration, and Patient Medication Information sections of the Product Monograph (PM) were updated to reflect this information. The Adverse Reactions and Patient Medication Information sections of the PM were updated to reflect new information on hypersensitivity. The submission was reviewed and considered acceptable, and an NOC was issued. A new DIN (02527804) was issued for the new packaging.

SNDS # 261884 2022-02-28 Issued NOC
2022-05-25

Submission filed as a Level II – Supplement (Safety) to update the Product Monograph (PM). The Warnings and Precautions, Adverse Reactions, and Patient Medication Information sections of the PM were updated to reflect new information on hypersensitivity. Information was also filed to fulfill clinical Terms and Conditions #4, 9, 10, and 12. The submission was reviewed and considered acceptable, and an NOC was issued.

Monthly safety report
Control # 263579
2022-04-29 Review completed
2022-05-20

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #3 for the period 2022-03-01 to 2022-03-31. The manufacturer was requested to provide information in the next monthly safety report, following cases of rebound COVID-19. The current post-market safety data are consistent with the labelled safety profile of Paxlovid.

Risk Management Plan update Control # 260404 2022-02-04 Review completed
2022-05-18

The updated European Union Risk Management Plan version 1.2 and Canadian Addenda dated February and April 2022 were filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. The review found these documents acceptable with revisions that were requested to be addressed by the sponsor within 90 days.

Monthly safety report
Control # 262576
2022-03-31 Review completed
2022-04-21

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #2 for the period 2022-02-01 to 2022-02-28. The current post-market safety data are consistent with the labelled safety profile of Paxlovid.

SNDS # 261288 2022-02-11 Issued NOC
2022-04-14
Submission filed as a Level I – Supplement for a new manufacturing site for the drug product. The submission was reviewed and considered acceptable, and an NOC was issued. The terms and conditions that accompanied the NOC for NDS # 259186 remain applicable.
Monthly safety report
Control # 262056
2022-03-04 Review completed
2022-03-21
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #1 for the period 2021-12-15 to 2022-01-31. The current post-market safety data are consistent with the labelled safety profile of Paxlovid.
Drug product (DIN 02524031) market notification Not applicable Date of first sale:
2022-01-18
The manufacturer notified Health Canada of the date of first sale pursuant to C.01.014.3 of the Food and Drug Regulations.
Health Product Risk Communication Not applicable Posted
2022-01-17
Health Product Risk Communication posted (Paxlovid [nirmatrelvir and ritonavir]) - Dosing and Dispensing in Renal Impairment, Risk of Serious Adverse Reactions Due to Drug Interactions, and English-Only Labels), containing information on labelling, new safety information, and supply for healthcare professionals.
NDS # 259186 2021-12-01 Issued NOC (subject to terms and conditions)
2022-01-17
NOC issued for New Drug Submission. Terms and conditions were imposed on the authorization.