National Institute of Mental Health (NIMH)
This sponsor has funded 2 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 10694 | Ongoing | Infant and childhood neurodevelopmental outcomes following prenatal exposure to selective serotonin reuptake inhibitors: overview and design of a... | No | No |
| 33119 | Planned | Maternal Exposure to Antidepressants and Psychiatric Outcomes Among Offspring in a National Birth Cohort (Prenatal SSRIs and offspring Psychiatric... | No | No |
PAS by Risk Management Plan (RMP) requirement
National Institute of Mental Health (NIMH)
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
National Institute of Mental Health (NIMH)
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
National Institute of Mental Health (NIMH)
1 Study countries specified are the following:
- Finland