Celgene

This sponsor has funded 9 studies across 18 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
7020 Finalised Not included in RMP Database Study of Thalidomide (Thalidomide Celgene®) in Germany: Monitoring Off-Label Use No No
7023 Finalised EU RMP category 3 Database study of lenalidomide (Revlimid®) in Germany: Monitoring off-label use No No
7252 Ongoing EU RMP category 1 A non-interventional post authorisation registry of patients treated with pomalidomide for relapsed and refractory multiple myeloma who have received... No No
7412 Finalised EU RMP category 1 A prospective non-interventional post-authorization safety study (PASS), designed as a disease registry of patients with transfusion dependent IPSS... No Yes
10153 Ongoing EU RMP category 1 A prospective non-interventional post-authorization safety study (PASS) of lenalidomide in previously untreated adult multiple myeloma patients who... No No
22604 Ongoing EU RMP category 1 A post-authorisation, non-interventional, retrospective, drug-utilisation study to describe the pattern of use of lenalidomide in patients with... No No
23366 Ongoing EU RMP category 3 A Non-interventional, Post-authorization Safety Study of Patients with Relapsed or Refractory Mantle Cell Lymphoma to Further Investigate and... No No
25626 Ongoing Not included in RMP Long-term non-interventional monitoring of patients newly diagnosed with bronchogenic carcinoma (LUCAS) No No
42016 Finalised EU RMP category 3 A Study to Evaluate the Effectiveness of the Additional Risk Minimisation Measures (aRMMs) for REBLOZYL Among Healthcare Professionals (HCPs) in the... Yes No

PAS by Risk Management Plan (RMP) requirement

Celgene

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.