Novo Nordisk Finland
This sponsor has funded 1 studies across 1 countries.
This sponsor has funded 1 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 2278 | Finalised | Assessment of association between severe hypoglycaemia and use of detemir, glargine and NPH insulins (ER11-9417/ U1111-1120-7164) | No | No |
Novo Nordisk Finland
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.
Novo Nordisk Finland
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.
Novo Nordisk Finland
1 Study countries specified are the following: