Ministry of Health and Welfare (MOHW)
This sponsor has funded 1 studies across 6 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 38902 | Planned | Non-EU RMP-only | Comparative risk of the incident cancer between histamine-2 receptor antagonists (Risk of cancer between H2RAs) | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Ministry of Health and Welfare (MOHW)
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
Ministry of Health and Welfare (MOHW)
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
Ministry of Health and Welfare (MOHW)
6 Study countries specified are the following:
- France
- Germany
- Korea, Republic of
- Spain
- United Kingdom
- United States