Alexion Pharmaceuticals

This sponsor has funded 7 studies across 32 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
13276 Ongoing EU RMP category 1 An observational disease and clinical outcomes registry of patients with lysosomal acid lipase (LAL) deficiency (ALX-LALD-501) Yes No
13514 Ongoing EU RMP category 2 AN OBSERVATIONAL, LONGITUDINAL, PROSPECTIVE, LONG-TERM REGISTRY OF PATIENTS WITH HYPOPHOSPHATASIA (ALX-HPP-501) Yes No
32702 Ongoing EU RMP category 3 An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients with atypical Hemolytic-Uremic Syndrome (aHUS Registry) (M11-001) Yes No
36476 Ongoing EU RMP category 3 Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry (M07-001) Yes No
37218 Ongoing Not included in RMP Swiss Soliris® and Ultomiris® Reimbursement Registry SSURR: An observational registry for capturing data of patients suffering from paroxysmal... No No
37301 Ongoing Not included in RMP Swiss Soliris® aHUS Reimbursement Registry SSaRR: Observational registry of patients suffering from atypical Hemolytic Uremic Syndrome (aHUS) who are... No No
44118 Finalised Not included in RMP Development of a predictive model algorithm to identify patients with hypophosphatasia, using Optimum Patient Care Record Database in United Kingdom Yes No

PAS by Risk Management Plan (RMP) requirement

Alexion Pharmaceuticals

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.