Bundesministerium für Gesundheit (BMG)
This sponsor has funded 2 studies across 12 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 2566 | Finalised | Pregnancy outcome after rheumatologic methotrexate (MTX) treatment prior to or during early pregnancy: a prospective multicenter cohort study... | Yes | No |
| 3435 | Ongoing | The safety of anti-tumor necrosis factor-α (TNF-α) agents in pregnancy. An observational prospective multicenter study (TNF-α Blocker in Pregnancy) | No | No |
PAS by Risk Management Plan (RMP) requirement
Bundesministerium für Gesundheit (BMG)
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
Bundesministerium für Gesundheit (BMG)
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
Bundesministerium für Gesundheit (BMG)
12 Study countries specified are the following:
- Australia
- Canada
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Switzerland
- Türkiye
- United Kingdom
- United States