Aptalis
This sponsor has funded 3 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 3142 | Finalised | A Safety and Pharmacokinetic study in Real-life practice of Pylera® in France: The SAPHARY Study | Yes | Yes |
| 3901 | Finalised | Drug usage patterns of Pylera® in France using the national claims reimbursement database (DUS) | Yes | Yes |
| 35756 | Finalised | An observational multicenter study on antibiotic resistance of Helicobacter pylori in France (PHARE) | Yes | Yes |
PAS by Risk Management Plan (RMP) requirement
Aptalis
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
Aptalis
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
Aptalis
1 Study countries specified are the following:
- France