Astellas Pharma Singapore
This sponsor has funded 1 studies across 8 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 17838 | Finalised | Non-EU RMP-only | Non-interventional Study on the Safety and Efficacy for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania –... | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Astellas Pharma Singapore
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
Astellas Pharma Singapore
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
Astellas Pharma Singapore
8 Study countries specified are the following:
- Australia
- Hong Kong
- Indonesia
- Korea, Republic of
- Malaysia
- Singapore
- Taiwan
- Thailand