Oral Retinoids Marketing Authorisation Holder Consortium (Oral Retinoids MAH Consortium)
This sponsor has funded 1 studies across 4 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 32302 | Finalised | Evaluation of the effectiveness of pregnancy prevention programme (PPP) for oral retinoids (acitretin, alitretinoin, and isotretinoin): a European... | Yes | Yes |
PAS by Risk Management Plan (RMP) requirement
Oral Retinoids Marketing Authorisation Holder Consortium (Oral Retinoids MAH Consortium)
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
Oral Retinoids Marketing Authorisation Holder Consortium (Oral Retinoids MAH Consortium)
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
Oral Retinoids Marketing Authorisation Holder Consortium (Oral Retinoids MAH Consortium)
4 Study countries specified are the following:
- France
- Germany
- Spain
- Sweden