Departament de Salut [Catalonia]
This sponsor has funded 2 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 28375 | Ongoing | USE OF PSYCHOTROPIC DRUGS IN CHILDREN AND ADOLESCENTS IN CATALONIA. A cohort study with real world data from the electronic primary health care... | Yes | No |
| 47450 | Planned | Uso de fármacos en mujeres embarazadas y lactantes. Consecuencias en la salud de estas mujeres y en la de su descendencia (Drug use in pregnant and... | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Departament de Salut [Catalonia]
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
Departament de Salut [Catalonia]
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
Departament de Salut [Catalonia]
1 Study countries specified are the following:
- Spain