Alnylam

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
36021 Ongoing EU RMP category 3 Patisiran-LNP Pregnancy Surveillance Program No No
40417 Ongoing EU RMP category 3 Prospective observational study to monitor and assess the safety of Onpattro® patisiran-LNP in a real-world cohort of hATTR amyloidosis patients No No
43201 Ongoing EU RMP category 3 ELEVATE, a Global Observational Longitudinal Prospective Registry of Patients With Acute Hepatic Porphyria (AHP) No No
43242 Planned EU RMP category 3 BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1) No No
108904 Planned EU RMP category 3 Prospective Observational Study to Monitor and Assess the Safety of Amvuttra® [Vutrisiran] in a Real-World Cohort of hATTR Amyloidosis Patients No No

PAS by Risk Management Plan (RMP) requirement

Alnylam

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.