Directorate-General for Health and Consumers (DG SANCO)
This sponsor has funded 1 studies across 16 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 8618 | Finalised | Not included in RMP | Lamotrigine use in Pregnancy and Risk of Orofacial Clefts II | No | No |
PAS by Risk Management Plan (RMP) requirement
Directorate-General for Health and Consumers (DG SANCO)
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
Directorate-General for Health and Consumers (DG SANCO)
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
Directorate-General for Health and Consumers (DG SANCO)
16 Study countries specified are the following:
- Belgium
- Croatia
- Denmark
- Finland
- France
- Germany
- Ireland
- Italy
- Malta
- Netherlands
- Norway
- Portugal
- Spain
- Sweden
- Switzerland
- United Kingdom