H. Lundbeck

This sponsor has funded 5 studies across 15 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
5678 Ongoing EU RMP category 3 Non-interventional multi-country prospective cohort study to investigate patterns of use of Selincro® and frequency of adverse drug reactions in... No No
14033 Finalised EU RMP category 3 Non-interventional Cohort Study to Investigate Sertindole Prescription Management in Real-Life Practice Yes No
14083 Ongoing EU RMP category 3 Use of Nalmefene (Selincro®) in European databases: Cohort design using longitudinal electronic medical records or claims databases Yes No
19199 Ongoing EU RMP category 3 A non-interventional post-authorisation safety study (PASS) of vortioxetine in Europe Yes No
21056 Ongoing EU RMP category 3 Extrapyramidal symptoms in patients treated with Abilify Maintena®: Cohort study with a 2-year follow-up using European automated healthcare databases Yes No

PAS by Risk Management Plan (RMP) requirement

H. Lundbeck

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.