Boehringer Ingelheim Korea
This sponsor has funded 2 studies across 1 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 41912 | Ongoing | Not included in RMP | A regulatory requirement non-interventional study to monitor the safety and effectiveness of Ofev(Nintedanib, 150mg/100mg, BID) in Korean patients | No | No |
| 107293 | Planned | Non-EU RMP-only | A regulatory non-interventional study to monitor the safety and efficacy of JARDIANCE® (Empagliflozin 10 mg) in Korean patients with Chronic Kidney... | No | No |
PAS by Risk Management Plan (RMP) requirement
Boehringer Ingelheim Korea
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
Boehringer Ingelheim Korea
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
Boehringer Ingelheim Korea
1 Study countries specified are the following:
- Korea, Republic of