Eisai

This sponsor has funded 10 studies across 20 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
5180 Finalised EU RMP category 3 European Registry of Anti-Epileptic Drug Use in Patients with Lennox-Gastaut Syndrome (LGS) No Yes
7225 Ongoing Not included in RMP Post-marketing surveillance of long term administration of Inovelon tablets in patients with Lennox-Gastaut syndrome (INO01T) No No
7424 Finalised Non-EU RMP-only An observational post-marketing surveillance study on the status and factors for the development of peripheral neuropathy in patients with... No No
10320 Finalised EU RMP category 3 A global postmarketing observational safety study to evaluate the safety and tolerability of Fycompa (perampanel) as add-on therapy in epilepsy... No Yes
12771 Finalised Unspecified An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Prospective Study Evaluating Retention Rate, Seizure Control and... No No
14118 Finalised EU RMP category 3 Incidence and Resolution of Eribulin-induced peripheral Neuropathy (IRENE) Yes No
14555 Finalised Non-EU RMP-only Post-marketing surveillance of Lenvima in patients with unresectable thyroid cancer in Japan (LEN01T) No No
14611 Finalised EU RMP category 3 E2090-E044-501: A Retrospective database Study of the Prescribing of Zonismaide in UK General Practice: A Drug Utilisation Study as Part of... No Yes
36854 Ongoing EU RMP category 3 E7080-M000-508 (STELLAR) No No
105866 Finalised Not included in RMP A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First... No Yes

PAS by Risk Management Plan (RMP) requirement

Eisai

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.