Finnish Medicines Agency (Fimea)
This sponsor has funded 2 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 4799 | Finalised | Safety of the second generation antipsychotics during pregnancy (Second generation antipsychotics and pregnancy) | Yes | Yes |
| 13051 | Finalised | Drug transporter protein -mediated drug interactions during pregnancy and offspring outcome; with special emphasis on second-generation antipsychotics... | Yes | Yes |
PAS by Risk Management Plan (RMP) requirement
Finnish Medicines Agency (Fimea)
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
Finnish Medicines Agency (Fimea)
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
Finnish Medicines Agency (Fimea)
1 Study countries specified are the following:
- Finland