Post-Authorization Activity Table (PAAT) for Paxlovid

Updated: 2024-09-20

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 # 285210	2024-03-22	Issued NOC 2024-08-14	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. An NOC was issued.
PSUR # 260408	2024-03-08	Review completed 2024-07-31	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 #4 for the period 2023-07-01 to 2023-12-30. 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 # 281726	2023-12-11	Issued NOC 2024-07-24	Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations, as a Level I – Supplement. Canadian-specific bilingual labelling was submitted. The submission was reviewed and considered acceptable, and an NOC was issued. With this submission, Health Canada considers that the terms and conditions assigned to Paxlovid DIN 02524031 have been fulfilled.
PSUR # 260407	2023-09-11	Review completed 2024-01-19	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 #3 for the period 2023-01-01 to 2023-06-30. 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 # 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.