This webpage provides regenerative medical products risk information which has come under review by the PMDA and MHLW. Information provided here is as follows:
Risk information suggested by a certain amount of accumulated information of defect or adverse event reports or Early Post-marketing Phase Vigilance (EPPV)
Safety measures such as revision of PRECAUTIONS in the package insert of the product might be taken after the ongoing review.
*When evaluations are completed, the information in the table below will be deleted. You will find the results of evaluation on the Revisions of PRECAUTIONS webpage.
|Risk Information of Ongoing Evaluation
|March 1, 2024
|Lymphoid neoplasm of CAR-positive T-cell origin