Post-Authorization Activity Table (PAAT) for Casirivimab and Imdevimab
Updated: 2024-09-20
The following table describes post-authorization activity for casirivimab and imdevimab, a product which contains the medicinal ingredients casirivimab and imdevimab. 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 02516691 – 300 mg/2.5 mL casirivimab and 300 mg/2.5 mL imdevimab, solutions, intravenous administration
DIN 02516705 – 1,332 mg/11.1 mL casirivimab and 1,332 mg/11.1 mL imdevimab, solutions, intravenous administration
Post-Authorization Activity Table (PAAT)
| Activity/submission type, control number | Date submitted | Decision and date | Summary of activities |
|---|---|---|---|
| Authorization by Interim Order Revoked | Not applicable | 2024-06-21 | As a result of the cancellation of NDS # 256264, the authorization of Casirivimab and Imdevimab as per the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 was revoked. |
| NDS # 256264 | 2021-09-01 | Cancellation Letter received 2024-06-21 | Submission filed for the treatment of mild to moderate COVID-19, confirmed by direct SARS-CoV-2 viral testing, in adults and adolescents (12 years of age and older weighing at least 40 kg) who were at high risk for progressing to hospitalization and/or death. The sponsor cancelled the submission before Health Canada completed the review. A Summary of Cancellation was published. |
| PSUR # 268136 | 2022-09-23 | Review completed 2022-12-29 |
Information filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). Six-month PSUR #2 for the period 2022-01-19 to 2022-07-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. Health Canada has recommended to move the periodic reporting intervals from every 6 months to annual. |
| PSUR # 262856 | 2022-03-30 | Review completed 2022-07-13 |
Information filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). Six-month PSUR #1 for the period 2021-07-19 to 2022-01-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Product Monograph update control # 249830 | Not applicable | Approved 2022-06-07 |
An Advisement Letter was issued by Health Canada on 2022-04-28, requesting the sponsor revise the Product Monograph (PM) to update the antiviral resistance information. The sponsor submitted changes to the Microbiology section of the PM; these were reviewed and considered acceptable. |
| Health Product Risk Communication | Not applicable | Posted 2022-01-07 |
Health Product Risk Communication posted (Casirivimab and Imdevimab – High Risk of Treatment Failure Due to Circulation of severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] Omicron Variant), containing new safety information for healthcare professionals. |
| Monthly safety report Control # 256732 |
2021-09-16 | Review completed 2021-12-07 |
Information filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). Monthly safety reports #1, 2 and 3 for the period 2021-06-01 to 2021-08-31. The current post-market safety data are consistent with the labelled safety profile of Casirivimab and Imdevimab. Health Canada has recommended to move the periodic reporting intervals from monthly to every 6 months. |
| Risk Management Plan update Control # 255269 |
2021-07-30 | Review closed 2021-09-16 |
The Core (European Union [EU]) Risk Management Plan (RMP) and Canadian Addendum were filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. Deficiencies continue to identified, but will be addressed as part of the review of the new drug submission for Casirivimab and Imdevimab filed under the Food and Drug Regulations. |
| Dear Healthcare Professional Letter | Not applicable | Posted 2021-07-30 |
Dear Healthcare Professional Letter posted (Authorization of Casirivimab and Imdevimab with English-only Labels for Use in Relation to the COVID-19 Pandemic), containing important information about supply and product safety for healthcare professionals. |
| Drug product (DIN 02516705) market notification | Not applicable | Date of first sale: 2021-07-29 |
The manufacturer notified Health Canada of the date of first sale in accordance with section 8 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. |
| Application # 249830 | 2021-02-24 | Authorized (subject to terms and conditions) 2021-06-09 |
Authorization issued (with imposed terms and conditions) under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). |