Ministry of Health [Spain]
This sponsor has funded 2 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 3264 | Ongoing | Program for safe use of antipsychotics in pediatric population. Online Spanish safety registry for Neuroleptic treatment in children and adolescents... | Yes | No |
| 5668 | Ongoing | Effectiveness of an Interventional to Improve the Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention: Randomized Clinical... | No | No |
PAS by Risk Management Plan (RMP) requirement
Ministry of Health [Spain]
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
Ministry of Health [Spain]
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
Ministry of Health [Spain]
1 Study countries specified are the following:
- Spain