Sun Pharmaceutical Industries
This sponsor has funded 3 studies across 7 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 5783 | Finalised | Post-authorization surveillance study comparing the efficacy and safety of Medabon (mifepristone/misoprostol) to historical data for early pregnancy... | Yes | Yes |
| 28453 | Ongoing | A non-interventional, multi-national, multi-center post authorization safety study (PASS) to assess the long term safety and tolerability of Odomzo... | No | No |
| 35766 | Planned | Physicians’ knowledge on the risks associated with Odomzo® exposure after the implementation of a risk minimization program (CLDE225A2405) | Yes | Yes |
PAS by Risk Management Plan (RMP) requirement
Sun Pharmaceutical Industries
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
Sun Pharmaceutical Industries
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
Sun Pharmaceutical Industries
7 Study countries specified are the following:
- France
- Germany
- Italy
- Spain
- Sweden
- Switzerland
- United Kingdom