Agenzia Italiana del Farmaco (AIFA)

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
1578 Finalised Unspecified Long-term outcomes and adverse events of therapy with inhaled corticosteroids, long-acting beta-2-agonists and anticholinergic drugs in hospitalised... No No
1620 Finalised Not included in RMP Impact of Body Mass Index and Obesity on Clinical Response to Systemic Treatment for Psoriasis (Evidence from the Psocare Project) No No
5711 Finalised Not included in RMP Observational, non-interventional, multicenter study of adverse events in hemodialysis patients receiving ESA (erythropoiesis-stimulating agents)... No No
12410 Finalised Not included in RMP REDS (REspiratory Drugs Survey) STUDY. Active surveillance of respiratory drugs, especially Inhaled Steroids (IS) in children (REDS STUDY) Yes Yes
50139 Finalised Not included in RMP Switch pattern of biological drugs (originator and biosimilars) for the treatment of chronic immune-mediated inflammatory diseases through an Italian... Yes No
105426 Ongoing Not included in RMP Risk of serious infections with bDMARDs in psoriasis/psoriatic arthritis patients: a large-scale cohort study using the Italian VALORE Project... Yes No

PAS by Risk Management Plan (RMP) requirement

Agenzia Italiana del Farmaco (AIFA)

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.