Ferrer
This sponsor has funded 2 studies across 7 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 14236 | Ongoing | EU RMP category 3 | Post-Authorisation Observational Study to Evaluate the Safety of ADASUVE® (Staccato loxapine for inhalation) in Agitated Persons in Routine Clinical... | No | No |
| 105806 | Finalised | Not included in RMP | Characterization of the epidemiology, treatment patterns and burden of Pulmonary Hypertension Group 1 and 3 in France, Germany and the UK: a real-word... | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Ferrer
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
Ferrer
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
Ferrer
7 Study countries specified are the following:
- Austria
- France
- Germany
- Romania
- Spain
- Sweden
- United Kingdom