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.
Browse by letter
| Brand Name: A to M | A | B | C | D | E | F | G | H | I | J | K | L | M |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brand Name: N to Z | N | O | P | Q | R | S | T | U | V | W | X | Y | Z |
A
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| Abecma Initial Approval |
Idecabtagene vicleucel | January 2022 | English [2.34 MB] | Japanese [2.32 MB] |
| Abecma Partial Change Approval |
Idecabtagene vicleucel | December 2023 | English [607.25 KB] | Japanese [847.24 KB] |
| Akuugo | Vandefitemcel | July 2024 (Conditional and time-limited approval) |
English [1.31 MB] | Japanese [4.88 MB] |
| Alofisel | Darvadstrocel | September 2021 | English [953.40 KB] | Japanese [1.45 MB] |
B
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| Breyanzi Initial Approval |
Lisocabtagene maraleucel | March 2021 | English [1.19 MB] | Japanese [1.62 MB] |
| Breyanzi Partial Change Approval |
Lisocabtagene maraleucel | December 2022 | English [801.53 KB] | Japanese [950.46 KB] |
| Breyanzi Partial Change Approval |
Lisocabtagene maraleucel | August 2024 | English [505.47 KB] | Japanese [714.56 KB] |
C
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| Carvykti | Ciltacabtagene autoleucel | September 2022 | English [1.29 MB] | Japanese [1.10 MB] |
| Collategene(Note 3) | Beperminogene perplasmid | March 2019 (Conditional and time-limited approval) |
English [857.64 KB] | Japanese [6.47 MB] |
Note 3 Marketing authorization has expired.
D
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| Delytact | Teserpaturev | June 2021 (Conditional and time-limited approval) |
English [1.29 MB] | Japanese [2.46 MB] |
H
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| HeartSheet | Human (autologous) skeletal myoblast-derived cell sheet | September 2015 (Conditional and time-limited approval) |
English [421.56 KB] | Japanese [4.54 MB] |
| HeartSheet | Human (autologous) skeletal myoblast-derived cell sheet |
―
(Full approval was rejected (as of July 24, 2024).)
|
English [552.94 KB] | Japanese [3.16 MB] |
J
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| JACC | Human autologous tissue for transplantation | July 2012 | English [533.30 KB] | Japanese [968.73 KB] |
| JACE(Note 1) Initial Approval |
Human (autologous) epidermal cell sheet | October 2007 | English [337.66 KB] | Japanese [248.58 KB] |
| JACE Partial Change Approval |
Human (autologous) epidermal cell sheet | September 2016 | English [339.23 KB] | Japanese [4.61 MB] |
| JACE Partial Change Approval |
Human (autologous) epidermal cell sheet | December 2018 | English [301.95 KB] | Japanese [2.57 MB] |
| JACEMIN | Melanocyte-containing human (autologous) epidermis-derived cell sheet | March 2023 | English [608.59 KB] | Japanese [1.52 MB] |
Note 1 This product was approved as a medical device under the previous regulatory framework.
K
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| Kymriah Initial Approval |
Tisagenlecleucel | March 2019 | English [2.31 MB] | Japanese No.1 [9.55 MB] Japanese No.2 [4.36 MB] |
| Kymriah Partial Change Approval |
Tisagenlecleucel | August 2022 | English [398.09 KB] | Japanese [572.33 KB] |
L
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| Luxturna | Voretigene neparvovec | June 2023 | English [1.38 MB] | Japanese [1.74 MB] |
N
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| Nepic | Human (autologous) corneal limbus-derived corneal epithelial cell sheet | March 2020 | English [1.19 MB] | Japanese [2.22 MB] |
O
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| Ocural | Human (autologous) oral mucosa-derived epithelial cell sheet | June 2021 | English [1.05 MB] | Japanese [1.43 MB] |
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 | English [737.66 KB] | Japanese [2.15 MB] |
| Stemirac | Human (autologous) bone marrow-derived mesenchymal stem cells | December 2018 (Conditional and time-limited approval) |
English [479.74 KB] | Japanese [2.66 MB] |
T
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| Temcell | Human (allogeneic) bone marrow-derived mesenchymal stem cells | September 2015 | English [461.86 KB] | Japanese [3.26 MB] |
V
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| Vyznova | Neltependocel | March 2023 | English [629.58 KB] | Japanese [1.45 MB] |
Y
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| YESCARTA Initial Approval |
Axicabtagene ciloleucel | January 2021 | English [1.97 MB] | Japanese [2.17 MB] |
| YESCARTA Partial Change Approval |
Axicabtagene ciloleucel | December 2022 | English [869.55 KB] | Japanese [753.85 KB] |
Z
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| ZOLGENSMA | Onasemnogene abeparvovec | March 2020 | English [1.31 MB] Errata sheet (EN) [384.77 KB] (Note 2) |
Japanese [8.48 MB] Errata sheet (JP) [506.82 KB] (Note 2) |
Note 2 Errata sheet. The English translation has been corrected accordingly.