Helsinn Healthcare
This sponsor has funded 2 studies across 6 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 2181 | Finalised | EU RMP category 1 | Study of Acute Liver Transplant: A study of NSAIDs-exposed acute liver failure in European transplant centres (SALT-I) | No | No |
| 2225 | Finalised | Not included in RMP | Risk of Upper Gastrointestinal Complications in Users of Nonsteroidal Anti-inflammatory Drugs | No | No |
PAS by Risk Management Plan (RMP) requirement
Helsinn Healthcare
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
Helsinn Healthcare
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
Helsinn Healthcare
6 Study countries specified are the following:
- Greece
- Ireland
- Italy
- Netherlands
- Portugal
- United Kingdom