Accord Healthcare
This sponsor has funded 3 studies across 4 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 10541 | Ongoing | EU RMP category 3 | The Mycophenolate Pregnancy Registry | Yes | No |
| 24731 | Finalised | Not included in RMP | Etude d’impact de la communication menée auprès des médecins prescripteurs d’Epitomax® et ses génériques en France | No | No |
| 31084 | Ongoing | Not included in RMP | A non-randomized, prospective, multicenter, observational, post-authorization study to assess the efficacy of Pelgraz® (pegfilgrastim) in the primary... | No | No |
PAS by Risk Management Plan (RMP) requirement
Accord Healthcare
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
Accord Healthcare
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
Accord Healthcare
4 Study countries specified are the following:
- France
- Germany
- Italy
- United States