Regulatory Decision Summary for Acetylsalicylic acid (*TRINOMIA)
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Summary of Cancellation: acetylsalicylic acid (*TRINOMIA)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
March 8, 2021
What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain market authorization for Trinomia (acetylsalicylic acid / atorvastatin (supplied as atorvastatin calcium trihydrate) / ramipril) oral capsule, to reduce the risk of cardiovascular events in patients with established cardiovascular disease, who have been adequately controlled with acetylsalicylic acid, atorvastatin and ramipril concomitantly, at equivalent therapeutic doses.
What did the company submit to support its submission?
The sponsor submitted quality, and published third party non-clinical and clinical data packages, as well as labelling information.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
At the time of cancellation, the clinical review was nearing completion. Health Canada had identified major deficiencies in the evidence that would have precluded issuing an authorization. The sponsor chose to cancel their submission.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact for patients using SAP or in clinical trials.
Additional information
*Proposed Brand Name:
TRINOMIA