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PMDA Risk Communications (regenerative medical products risk information of ongoing evaluation)

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.

(Reference) Notice Concerning "Standard Workflow for Consideration of Safety Measures Such as Revision of Electronic Drug Product Package Inserts"

Risk information for which some safety measures might be taken

Posted Date Nonproprietary Name Risk Information of Ongoing Evaluation Related Information Investigation Results
March 1, 2024 Axicabtagene ciloleucel Lymphoid neoplasm of CAR-positive T-cell origin
Idecabtagene vicleucel
Tisagenlecleucel
Lisocabtagene maraleucel

 

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