Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
This sponsor has funded 5 studies across 9 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 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 |
| 3953 | Ongoing | Pharmacovigilance in gerontopsychiatric patients (GAP) | No | No |
| 6539 | Finalised | Pharmacoepidemiological Safety Study of Neuroleptics and Antidepressants in the Area of Geriatric Psychiatrics (PhaSiNAg) | No | Yes |
| 7034 | Finalised | Off-label use of neuroleptics and antidepressants and risks of psychostimulant use in ADHD patients during childhood and adolescents (OLUNAR) | No | No |
| 49089 | Planned | Endogenous formation of nitrosamines from drug substance (GITox) | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
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
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
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
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
9 Study countries specified are the following:
- Australia
- Finland
- France
- Germany
- Italy
- Netherlands
- Switzerland
- Türkiye
- United Kingdom