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Review Reports: Regenerative Medical Products

The following English translations of review reports are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. PMDA shall not be responsible for any consequence resulting from use of the English versions.

The review reports were selected for translation among those of new regenerative medical products that recently received marketing approval, in consideration of relevant factors including the novelty and priority.

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A B C D E F G
H I J K L M N
O P Q R S T U
V W X Y Z    


A

Brand Name Non-proprietary Name Approved In English Japanese
Abecma idecabtagene vicleucel January 2022 PDF PDF
Alofisel darvadstrocel September 2021 PDF PDF

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B

Brand Name Non-proprietary Name Approved In English Japanese
Breyanzi
Initial Approval
lisocabtagene maraleucel March 2021 PDF PDF
Breyanzi
Partial Change Approval
lisocabtagene maraleucel December 2022 PDF PDF

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C

Brand Name Non-proprietary Name Approved In English Japanese
Carvykti ciltacabtagene autoleucel September 2022 PDF PDF
Collategene beperminogene perplasmid March 2019 PDF PDF

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D

Brand Name Non-proprietary Name Approved In English Japanese
Delytact teserpaturev June 2021 PDF PDF

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H

Brand Name Non-proprietary Name Approved In English Japanese
HeartSheet human (autologous) skeletal myoblast-derived cell sheet September 2015 PDF PDF

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J

Brand Name Non-proprietary Name Approved In English Japanese
JACC human autologous tissue for transplantation July 2012 PDF PDF
JACE(Note 1)
Initial Approval
human (autologous) epidermal cell sheet October 2007 PDF PDF
JACE
Partial Change Approval
human (autologous) epidermal cell sheet September 2016 PDF PDF
JACE
Partial Change Approval
human (autologous) epidermal cell sheet December 2018 PDF PDF
JACEMIN melanocyte-containing human (autologous) epidermis-derived cell sheet March 2023 PDF PDF

Note 1 This product was approved as a medical device under the previous regulatory framework.

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K

Brand Name Non-proprietary Name Approved In English Japanese
Kymriah
Initial Approval
tisagenlecleucel March 2019 PDF PDF1.
PDF2.
Kymriah
Partial Change Approval
tisagenlecleucel August 2022 PDF PDF

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L

Brand Name Non-proprietary Name Approved In English Japanese
Luxturna voretigene neparvovec June 2023 PDF PDF

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N

Brand Name Non-proprietary Name Approved In English Japanese
Nepic human (autologous) corneal limbus-derived corneal epithelial cell sheet March 2020 PDF PDF

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O

Brand Name Non-proprietary Name Approved In English Japanese
Ocural human (autologous) oral mucosa-derived epithelial cell sheet June 2021 PDF PDF

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S

Brand Name Non-proprietary Name Approved In English Japanese
Sakracy human (autologous) oral mucosa-derived epithelial cell sheet using human amniotic membrane substrate January 2022 PDF PDF
Stemirac human (autologous) bone marrow-derived mesenchymal stem cells December 2018 PDF PDF

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T

Brand Name Non-proprietary Name Approved In English Japanese
Temcell human (allogeneic) bone marrow-derived mesenchymal stem cells September 2015 PDF PDF

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V

Brand Name Non-proprietary Name Approved In English Japanese
Vyznova neltependocel March 2023 PDF PDF

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Y

Brand Name Non-proprietary Name Approved In English Japanese
YESCARTA
Initial Approval
axicabtagene ciloleucel January 2021 PDF PDF
YESCARTA
Partial Change Approval
axicabtagene ciloleucel December 2022 PDF PDF

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Z

Brand Name Non-proprietary Name Approved In English Japanese
ZOLGENSMA onasemnogene abeparvovec March 2020 PDF
PDF(Note 2)
PDF
PDF(Note 2)

Note 2 Errata sheet. The English translation has been corrected accordingly.

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