Bamlanivimab: Authorization information
On this page
Bamlanivimab was authorized for use for the COVID-19 pandemic. Authorization followed section 5 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. The interim authorization comes with terms and conditions the sponsor needs to meet. These terms and conditions ensure the continued quality, safety and efficacy of authorized products.
The drug must show promising evidence that it works well, is of high quality and is reasonably safe. The available data must demonstrate that the medicine’s benefits outweigh its risks. Following initial authorization, the company is required to provide to Health Canada additional results of clinical trials to confirm the efficacy and safety of the treatment.
Based on its review, Health Canada authorized bamlanivimab with terms and conditions. As a result, the manufacturer (Eli Lilly Canada, Inc.) will submit to Health Canada:
- post-market safety monitoring reports, including serious adverse drug reactions, and foreign regulatory actions related to the drug’s safety
- any further data on the safety and efficacy of the drug, including final data from ongoing clinical trials
- information on any cancelled lots, as it becomes available
- further quality data confirming that the manufacturing processes and controls will consistently produce a product of suitable quality for the intended use (or 'products')
Risk management plan
Companies are required to submit a risk management plan (RMP) to Health Canada when applying for a marketing authorization.
RMPs include information on:
- a medicine's safety profile
- how its risks will be prevented or minimized in patients
- plans for studies and other activities to gain more knowledge about the safety and effectiveness of the medicine
- monitoring and assessing the effectiveness of measures that minimize risk
Health Canada reviewed the RMP for bamlanivimab, and terms and conditions were imposed upon authorization. A revised RMP is expected to be submitted within 2 months of the product being marketed.
Health Canada continues to exchange information with our international regulatory counterparts on an ongoing basis. Such exchanges support the review process, pharmacovigilance and post-market safety monitoring activities.
We will continue to actively monitor and review all relevant data to determine whether changes to the interim authorization of bamlanivimab in Canada are required.
Report a problem or mistake on this page
- Date modified: