Celltrion Hungary
This sponsor has funded 2 studies across 5 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 25213 | Planned | The safety and clinical effectiveness of rapid infusion with CT-P10 in patients with non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia: a... | Yes | No |
| 25317 | Ongoing | Clinical effectiveness and safety of CT-P10 in patients with diffuse large B-cell lymphoma: an observational study in Europe | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Celltrion Hungary
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
Celltrion Hungary
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
Celltrion Hungary
5 Study countries specified are the following:
- France
- Germany
- Italy
- Spain
- United Kingdom