Gedeon Richter

This sponsor has funded 5 studies across 18 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
4282 Finalised Not included in RMP Butoconazole use in pregnancy: population-based case-control studies on adverse pregnancy outcomes in Hungary (study protocol RGD-77425) Yes Yes
7857 Finalised EU RMP category 3 Active post-marketing surveillance of Levonorgestrel IUS insertion related difficulties: a non-interventional post-authorisation safety study Yes No
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
16792 Ongoing EU RMP category 3 A prospective, multi-national, multicentre, non-interventional study to evaluate the long term safety of Esmya, in particular the endometrial safety,... Yes No
106503 Ongoing Not included in RMP ContrAceptive Research on E4 – Health Effects on eveRyday wellbeing (CARE4HER): A post-authorisation, observational, single-arm, open-label study to... No No

PAS by Risk Management Plan (RMP) requirement

Gedeon Richter

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.