Otsuka Novel Products (ONPG)
This sponsor has funded 1 studies across 6 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 10618 | Finalised | A Multicentre, EU-wide, Non-Interventional Post-Authorisation Study to Assess the Safety and Usage of Delamanid In Routine Medical Practice in... | Yes | Yes |
PAS by Risk Management Plan (RMP) requirement
Otsuka Novel Products (ONPG)
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
Otsuka Novel Products (ONPG)
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
Otsuka Novel Products (ONPG)
6 Study countries specified are the following:
- Estonia
- France
- Germany
- Latvia
- Lithuania
- United Kingdom