Otsuka Pharmaceutical

This sponsor has funded 4 studies across 23 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3596 Finalised EU RMP category 3 Cilostazol Drug Utilisation Study Yes Yes
4714 Finalised Not included in RMP An Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With... No Yes
6083 Finalised EU RMP category 3 ABILIFY for the Adolescent Bipoloar I Mania Indication of Tool Effectiveness Evaluation Strategy Yes Yes
12842 Ongoing EU RMP category 1 A 9-year, Multicentre, Non-interventional, Post-authorisation Safety Study for Patients Prescribed JINARC® for Autosomal Dominant Polycystic Kidney... No No

PAS by Risk Management Plan (RMP) requirement

Otsuka Pharmaceutical

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.