Actelion

This sponsor has funded 9 studies across 34 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
4523 Finalised EU RMP category 3 Disease characteristics and outcomes of pulmonary arterial hypertension in children and adolescents in real-world clinical settings: Sytematic Review... No No
4619 Finalised EU RMP category 3 Disease Registry for Patients with Digital Ulcers associated with Systemic Sclerosis (DUO Registry) No No
4622 Finalised EU RMP category 3 Disease registry for patients with Niemann-Pick Type C disease (NPC Registry) No No
7910 Finalised Not included in RMP Multi-center non-drug-interventional extension study to assess long-term safety and effects on growth in patients who received bosentan or placebo as... No No
19085 Ongoing EU RMP category 3 Post-authorisation safety study (PASS): observational cohort study of PAH patients newly treated with either Uptravi (selexipag) or any other... No No
22154 Finalised Not included in RMP Serum soluble vascular cell adhesion molecule-1 overexpression is a disease marker in patients with first-time diagnosed antinuclear antibodies: a... Yes No
25699 Ongoing EU RMP category 3 Post-authorisation safety study (PASS) to evaluate risk minimisation measures for medication errors with Uptravi during the titration phase in... No No
32492 Finalised Not included in RMP Use, safety and Tolerability of IntraVenous epOprostenoL (Veletri®) in patients with severe pulmonary arterIal hypertension: A 6-month, open label,... Yes Yes
49227 Ongoing EU RMP category 3 Post-authorisation Safety Study (PASS): Retrospective Medical Chart Review of Patients with PAH Newly Treated With Either Uptravi® (selexipag) or any... No No

PAS by Risk Management Plan (RMP) requirement

Actelion

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.