Health Insurance Review and Assessment Service (HIRA)
This sponsor has funded 2 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 44893 | Planned | Safety outcomes of Selective Serotonin Reuptake Inhibitors in Adolescent Attention-Deficit/Hyperactivity Disorder (The ASSURE study) | Yes | No |
| 103757 | Finalised | Comparative Effectiveness and Safety of Selective Serotonin Reuptake Inhibitors in Adult Attention-Deficit/Hyperactivity Disorder and comorbid... | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Health Insurance Review and Assessment Service (HIRA)
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
Health Insurance Review and Assessment Service (HIRA)
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
Health Insurance Review and Assessment Service (HIRA)
1 Study countries specified are the following:
- Korea, Republic of