LEO Pharma

This sponsor has funded 7 studies across 19 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
12360 Finalised EU RMP category 3 A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis (APPLES™) No Yes
21769 Finalised EU RMP category 3 Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids: Protopic JOint European Longitudinal Lymphoma and... Yes Yes
30280 Planned EU RMP category 3 The BRodalumab Assessment of Hazards: A Multinational Safety (BRAHMS) study in electronic healthcare databases No No
44659 Ongoing Not included in RMP Tralokinumab real world clinical use: An observational cohort study of atopic dermatitis patients prescribed tralokinumab (TRACE) No No
45322 Finalised Not included in RMP Managing PSOriasis in the REAL world: One-year prospective, observational study of the journey of patients with plaque psoriasis prescribed... No Yes
50585 Finalised Not included in RMP ENSTILAR RWE STUDY, IN FRENCH EMR DATABASE (THIN®) Yes No
104085 Planned EU RMP category 3 Post-authorisation Safety Study of Tralokinumab Use in Pregnancy: An Observational Study Based on Electronic Healthcare Data No No

PAS by Risk Management Plan (RMP) requirement

LEO Pharma

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.