Dynavax Technologies
This sponsor has funded 3 studies across 1 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 50452 | Finalised | EU RMP category 3 | Post-Marketing Observational Surveillance Study to Evaluate the Occurrence of Acute Myocardial Infarction in Adults 18 Years of Age and Older Who... | Yes | No |
| 50455 | Finalised | EU RMP category 3 | Post-Marketing Observational Surveillance Study to Evaluate the Incidence of New-Onset Immune-Mediated Diseases, Herpes Zoster, and Anaphylaxis in... | Yes | No |
| 50522 | Ongoing | EU RMP category 3 | HEPLISAV-B® Pregnancy Registry: an observational study on the safety of HEPLISAV-B exposure in pregnant women and their offspring (DV2-HBV-27) | No | No |
PAS by Risk Management Plan (RMP) requirement
Dynavax Technologies
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
Dynavax Technologies
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
Dynavax Technologies
1 Study countries specified are the following:
- United States