Janssen Biotech
This sponsor has funded 1 studies across 10 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 13986 | Ongoing | Non-EU RMP-only | An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis (OPAL) | No | No |
PAS by Risk Management Plan (RMP) requirement
Janssen Biotech
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
Janssen Biotech
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
Janssen Biotech
10 Study countries specified are the following:
- Austria
- Canada
- Czechia
- France
- Germany
- Greece
- Italy
- Korea, Republic of
- Spain
- United States