Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT)
This sponsor has funded 1 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 7730 | Finalised | The risk of acute liver injury with the use of antibiotics. A replication study in the Utrecht Patient Oriented Database | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT)
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
Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT)
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
Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT)
1 Study countries specified are the following:
- Netherlands