Post-Authorization Activity Table (PAAT) for Sotrovimab
Updated: 2024-07-19
The following table describes post-authorization activity for Sotrovimab for Injection (herein referred to as sotrovimab), a product which contains the medicinal ingredient sotrovimab. 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 02518341 - 500 mg/8 mL (62.5 mg/mL) sotrovimab, solution, 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 | 2024-04-29 | As a result of the cancellation of NDS # 257895, the authorization of Sotrovimab as per the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 was revoked. |
| NDS # 257895 | 2021-10-25 | Cancellation Letter received 2024-04-29 | Submission filed for the treatment of mild to moderate COVID-19 in adults and adolescents (aged 12 years and older weighing at least 40 kg) who are at risk of progressing to severe COVID-19. The sponsor cancelled the submission before Health Canada completed the review. A Summary of Cancellation was published. |
| PBRER # 280323 | 2023-10-25 | Review completed 2024-04-12 | 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). PBRER #3 and #4 for the periods 2022-08-20 to 2023-02-19 and 2023-02-20 to 2023-08-19, respectively. The sponsor was asked to continue with the standard monitoring. |
| PBRER # 269087 | 2022-10-27 | Review completed 2023-02-01 |
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). PBRER #2 for the period 2022-02-20 to 2022-08-19. The sponsor was asked to continue with the standard monitoring. |
| Product Monograph revision Control # 251285 |
2022-05-13 | Review completed 2023-01-27 |
Health Canada issued a letter on 2022-04-28, further to section 21.2 of the of the Food and Drugs Act. The letter requested the sponsor revise the PM regarding the Omicron BA.2 variant. Modifications were subsequently made to the Microbiology section to reflect submitted data for Omicron BA.2, BA.2.12.1, BA.4, and BA.5 variants. The information was reviewed, and the PM found to be acceptable. |
| PBRER # 263753 | 2022-04-28 | 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). PBRER #1 for the period 2021-08-20 to 2022-02-19. The sponsor was asked to continue with the standard monitoring. Health Canada has recommended to move the periodic reporting intervals from every 6 months to annual. |
| Health Product Risk Communication | Not applicable | Posted 2022-04-14 |
Health Product Risk Communication posted (Sotrovimab for Injection – Risk of Treatment Failure due to Circulation of Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] Omicron BA.2 Subvariant), containing new safety information for healthcare professionals. |
| Monthly safety report Control # 259144 |
2021-11-30 | Review completed 2021-12-20 |
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 report for the period 2021-09-26 to 2021-10-25. The current post-market safety data are consistent with the labelled safety profile of Sotrovimab for Injection. Health Canada has recommended to move the periodic reporting intervals from monthly to every 6 months. |
| Monthly safety report Control # 258294 |
2021-11-02 | Review completed 2021-12-20 |
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 report for the period 2021-08-26 to 2021-09-25. The current post-market safety data are consistent with the labelled safety profile of Sotrovimab for Injection. |
| Monthly safety report Control # 257099 |
2021-09-28 | Review completed 2021-12-20 |
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 report for the period 2021-07-26 to 2021-08-25. The current post-market safety data are consistent with the labelled safety profile of Sotrovimab for Injection. |
| Monthly safety report Control # 256176 |
2021-08-31 | Review completed 2021-12-20 |
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 report for the period 2021-05-26 to 2021-06-25. The current post-market safety data are consistent with the labelled safety profile of Sotrovimab for Injection. |
| Drug product (DIN 02518341) market notification | Not applicable | Date of first sale: 2021-10-08 |
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. |
| Dear Healthcare Professional Letter | Not applicable | Posted 2021-10-04 |
Dear Healthcare Professional Letter posted (Authorization of Sotrovimab for Injection for Use in Relation to the COVID-19 Pandemic), containing important information about supply for healthcare professionals. |
| Amendment # 255479 | 2021-08-05 | Authorization amended 2021-09-14 |
An application submitted to amend the authorization in respect of this drug (relating to drug substance manufacturing process changes and Product Monograph updates) has been reviewed and it has been determined that the changes are acceptable. The Microbiology section of the Product Monograph was updated along with editorial changes. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Amendment # 255487 | 2021-08-04 | Authorization amended 2021-08-27 |
An application submitted to amend the authorization in respect of this drug (relating to extensions of the shelf life for the drug substance and drug product) has been reviewed and it has been determined that the changes are acceptable. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Application # 251285 | 2021-04-01 | Authorized (subject to terms and conditions) 2021-07-30 |
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). |