Hexal AG

This sponsor has funded 3 studies across 17 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
12171 Ongoing EU RMP category 1 Retrospective Cohort Study on the Risk of Venous Thromboembolism with the use of combined oral contraceptives containing Chlormadinone... No No
14525 Ongoing EU RMP category 3 Multicenter non-interventional post-authorization safety study (NI-PASS) to monitor the incidence of relevant and expected rare adverse events... No Yes
33796 Ongoing EU RMP category 3 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.