Canadian Agency for Drugs and Technologies in Health (CADTH)
This sponsor has funded 2 studies across 3 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 104164 | Ongoing | Not included in RMP | Association between opioid use and the development of diverticulitis (Opioids Diverticulitis) | No | No |
| 107333 | Planned | Not included in RMP | The Use of Oral Fluoroquinolones in Canada: Drug Utilization Study Update | No | No |
PAS by Risk Management Plan (RMP) requirement
Canadian Agency for Drugs and Technologies in Health (CADTH)
The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.
Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.
PAS by study status
Canadian Agency for Drugs and Technologies in Health (CADTH)
The study status is defined according to the timeline dates specified.
Planned studies have not collected any data yet.
Ongoing studies collect data and should publish protocols as soon as possible.
Finalised studies should publish results in the first two weeks after finalisation.
Countries
Canadian Agency for Drugs and Technologies in Health (CADTH)
3 Study countries specified are the following:
- Canada
- United Kingdom
- United States