Hexal AG

This sponsor has funded 3 studies across 17 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
12171 Ongoing Retrospective Cohort Study on the Risk of Venous Thromboembolism with the use of combined oral contraceptives containing Chlormadinone... No No
14525 Ongoing Multicenter non-interventional post-authorization safety study (NI-PASS) to monitor the incidence of relevant and expected rare adverse events... No Yes
33796 Ongoing A pregnancy exposure registry study to assess clinical follow-up and outcomes of pregnancies exposed to ulipristal acetate 30 mg. Yes No

PAS by Risk Management Plan (RMP) requirement

Hexal AG

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.