Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
This sponsor has funded 6 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 2548 | Planned | RISK OF AGRANULOCYTOSIS ASSOCIATED WITH THE USE OF DRUGS | No | No |
| 3145 | Ongoing | Identification of drug-induced liver injury (DILI) cases in Spain, a national DILI registry (Spanish DILI Registry) | No | No |
| 7607 | Ongoing | Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm) | Yes | No |
| 41134 | Finalised | Real-world effectiveness of different COVID-19 vaccines in Spain: a cohort study based on public electronic health records (BIFAP) (effectiveness of... | Yes | Yes |
| 41314 | Planned | Metamizole and risk of agranulocytosis | Yes | No |
| 49085 | Planned | Risk of thromboembolic events and thrombocytopenia after vaccination against COVID-19 (Thrombosis risk COVID-19 vaccination) | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
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
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
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
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
1 Study countries specified are the following:
- Spain