Medical Developments International (MDI)
This sponsor has funded 2 studies across 1 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 13034 | Finalised | Non-EU RMP-only | Evaluation of the effectiveness of Penthrox® (methoxyflurane) educational tools adopted as additional risk minimisation measures: Healthcare... | No | No |
| 13040 | Ongoing | Non-EU RMP-only | Post Authorisation Safety Study (PASS) to Evaluate the Risks of Hepatotoxicity and Nephrotoxicity from Administration of Methoxyflurane (Penthrox®)... | No | No |
PAS by Risk Management Plan (RMP) requirement
Medical Developments International (MDI)
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
Medical Developments International (MDI)
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
Medical Developments International (MDI)
1 Study countries specified are the following:
- United Kingdom