Domperidone Collaboration Study Group
This sponsor has funded 2 studies across 5 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 16062 | Finalised | EU RMP category 1 | A Drug Utilisation Study of Domperidone in Europe Using Databases | Yes | Yes |
| 16095 | Finalised | EU RMP category 1 | A Post-Authorisation Safety Study (PASS) to Assess the Effectiveness of the Risk Minimisation Measures of Domperidone – Physician Survey | Yes | Yes |
PAS by Risk Management Plan (RMP) requirement
Domperidone Collaboration Study Group
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
Domperidone Collaboration Study Group
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
Domperidone Collaboration Study Group
5 Study countries specified are the following:
- Belgium
- France
- Germany
- Spain
- United Kingdom