Grifols
This sponsor has funded 2 studies across 5 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 25809 | Finalised | A post-authorization study to assess the safety and efficacy of Fanhdi (Double-inactivated human anti-hemophilic factor) in subjects with Von... | Yes | Yes |
| 42043 | Planned | Post-Authorization Long Term Safety Surveillance Study of Fostamatinib in Adult Patients with Chronic Immune Thrombocytopenia (cITP) who are... | No | No |
PAS by Risk Management Plan (RMP) requirement
Grifols
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
Grifols
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
Grifols
5 Study countries specified are the following:
- France
- Germany
- Italy
- Spain
- United Kingdom