Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

This sponsor has funded 6 studies across 1 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
2548 Planned Unspecified RISK OF AGRANULOCYTOSIS ASSOCIATED WITH THE USE OF DRUGS No No
3145 Ongoing Not included in RMP Identification of drug-induced liver injury (DILI) cases in Spain, a national DILI registry (Spanish DILI Registry) No No
7607 Ongoing Unspecified Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm) Yes No
41134 Finalised Not included in RMP 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 Not included in RMP Metamizole and risk of agranulocytosis Yes No
49085 Planned Not included in RMP 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.