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 drugs with a new active ingredient that recently received marketing approval, in consideration of relevant factors including the novelty and priority.
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 |
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Abraxane Partial Change Approval |
paclitaxel | September 2019 | ![]() |
![]() |
Acoalan | antithrombin gamma (genetical recombination) | July 2015 | ![]() |
![]() |
Acofide | acotiamide hydrochloride hydrate | March 2013 | ![]() |
![]() |
Actair | - | March 2015 | ![]() |
![]() ![]() |
Actemra Initial Approval |
tocilizumab (genetical recombination) | April 2008 | ![]() |
![]() ![]() |
Actemra Partial Change Approval |
tocilizumab (genetical recombination) | June 2017 | ![]() |
![]() |
Actemra Partial Change Approval |
tocilizumab (genetical recombination) | August 2017 | ![]() |
![]() |
Actemra Partial Change Approval |
tocilizumab (genetical recombination) | May 2019 | ![]() |
![]() |
Actemra Partial Change Approval |
tocilizumab (genetical recombination) | January 2022 | ![]() |
![]() |
Adcetris Initial Approval |
brentuximab vedotin (genetical recombination) | January 2014 | ![]() |
![]() |
Adcetris Partial Change Approval |
brentuximab vedotin (genetical recombination) | September 2018 | ![]() |
![]() |
Adcetris Partial Change Approval |
brentuximab vedotin (genetical recombination) | December 2019 | ![]() |
![]() |
Adempas | riociguat | January 2014 | ![]() |
![]() |
Adlumiz | anamorelin hydrochloride | January 2021 | ![]() |
![]() |
Adsorbed Cell Culture-derived Influenza Vaccine H5N1 "Kitasato Daiichi Sankyo" | adsorbed cell culture-derived influenza vaccine (H5N1) | March 2016 | ![]() |
![]() |
Adsorbed Influenza Vaccine (H5N1) "HOKKEN" | adsorbed influenza vaccine (H5N1) | October 2007 | ![]() |
![]() ![]() ![]() |
Adsorbed Influenza Vaccine (H5N1) "BIKEN" | adsorbed influenza vaccine (H5N1) | October 2007 | ![]() |
![]() ![]() ![]() |
Adynovate | rurioctocog alfa pegol (genetical recombination) | March 2016 | ![]() |
![]() |
Afstyla | lonoctocog alfa (genetical recombination) | September 2017 | ![]() |
![]() |
Akalux | cetuximab sarotalocan sodium (genetical recombination) | September 2020 | ![]() |
![]() |
Alabel/Alaglio | aminolevulinic acid hydrochloride | March 2013 | ![]() |
![]() |
Alecensa | alectinib hydrochloride | July 2014 | ![]() |
![]() |
Allergen Scratch Extract Positive control "TORII" Histamine Dihydrochloride | histamine dihydrochloride | September 2015 | ![]() |
![]() |
Amenalief | amenamevir | July 2017 | ![]() |
![]() |
Anoro Ellipta | umeclidinium bromide/ vilanterol trifenatate | July 2014 | ![]() |
![]() |
Artist | carvedilol | August 2015 | ![]() |
![]() |
Avastin Initial Approval |
bevacizumab (genetical recombination) | April 2007 | ![]() |
![]() ![]() ![]() ![]() ![]() ![]() |
Avastin Partial Change Approval |
bevacizumab (genetical recombination) | May 2016 | ![]() |
![]() |
Avigan | favipiravir | March 2014 | ![]() |
![]() |
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Cerdartolen | - | January 2014 | ![]() |
![]() |
Cerdelga | eliglustat tartrate | March 2015 | ![]() |
![]() ![]() |
Cervarix | recombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cell) | October 2009 | ![]() |
![]() |
Cibinqo | abrocitinib | September 2021 | ![]() |
![]() |
Clenafin | efinaconazole | July 2014 | ![]() |
![]() |
Clozaril | clozapine | April 2009 | ![]() |
![]() |
Comirnaty** (monovalent, Original) Initial Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran) |
February 2021 | ![]() |
![]() |
Comirnaty** (monovalent, Original) Partial Change Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran) |
November 2021 | ![]() |
![]() |
Comirnaty for 5 to 11 years old** Initial Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran) |
January 2022 | ![]() |
![]() |
Comirnaty for 5 to 11 years old** Partial Change Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran) |
August 2022 | ![]() |
![]() ![]() |
Comirnaty for 6 months to 4 years old** | Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran) |
October 2022 | ![]() |
![]() |
Comirnaty RTU** (bivalent, Original/Omicron BA.1) |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredients: tozinameran and riltozinameran) |
September 2022 | ![]() |
![]() ![]() |
Copegus Partial Change Approval |
ribavirin | March 2015 | ![]() |
![]() |
Copegus Partial Change Approval |
ribavirin | March 2017 | ![]() |
![]() |
Corectim | delgocitinib | January 2020 | ![]() |
![]() |
Cosentyx Initial Approval |
secukinumab (genetical recombination) | December 2014 | ![]() |
![]() |
Cosentyx Partial Change Approval |
secukinumab (genetical recombination) | December 2015 | ![]() |
![]() |
Crysvita | burosumab (genetical recombination) | September 2019 | ![]() |
![]() |
Cymbalta Partial Change Approval |
duloxetine hydrochloride | December 2016 | ![]() |
![]() |
Cyramza Initial Approval |
ramucirumab (genetical recombination) | March 2015 | ![]() |
![]() |
Cyramza Partial Change Approval |
ramucirumab (genetical recombination) | May 2016 | ![]() |
![]() |
Cyramza Partial Change Approval |
ramucirumab (genetical recombination) | June 2016 | ![]() |
![]() |
* Errata sheet. The English translation has been corrected accordingly.
** Special Approval for Emergency
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Daklinza | daclatasvir hydrochloride | July 2014 | ![]() |
![]() |
Darzalex Initial Approval |
daratumumab (genetical recombination) | September 2017 | ![]() |
![]() |
Darzalex Partial Change Approval |
daratumumab (genetical recombination) | August 2019 | ![]() |
![]() |
Dayvigo | lemborexant | January 2020 | ![]() |
![]() ![]() |
Deltyba | delamanid | July 2014 | ![]() |
![]() |
Diquas | diquafosol sodium | April 2010 | ![]() |
![]() ![]() |
Duac | clindamycin phosphate hydrate/benzoyl peroxide | March 2015 | ![]() |
![]() |
Dupixent |
dupilumab (genetical recombination) | January 2018 | ![]() |
![]() |
Dysval | valbenazine tosilate | March 2022 | ![]() |
![]() |
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Efient | prasugrel hydrochloride | March 2014 | ![]() |
![]() ![]() |
Eliquis | apixaban | December 2012 | ![]() |
![]() ![]() |
Emgality | galcanezumab (genetical recombination) | January 2021 | ![]() |
![]() |
Empliciti | elotuzumab (genetical recombination) | September 2016 | ![]() |
![]() |
Emulsion-adjuvanted Cell-culture Derived Influenza HA Vaccine (Prototype) for Intramuscular Injection "KAKETSUKEN" | emulsion-adjuvanted cell-culture derived influenza HA vaccine (prototype) | March 2015 | ![]() |
![]() |
Enaroy | enarodustat | September 2020 | ![]() |
![]() |
Enhertu Initial Approval |
trastuzumab deruxtecan (genetical recombination) | March 2020 | ![]() |
![]() |
Enhertu Partial Change Approval |
trastuzumab deruxtecan (genetical recombination) | September 2020 | ![]() |
![]() |
Enspryng | satralizumab (genetical recombination) | June 2020 | ![]() |
![]() ![]() |
Epoprostenol ACT Partial Change Approval |
epoprostenol sodium | March 2017 | ![]() |
![]() |
Erelsa | elbasvir | September 2016 | ![]() |
![]() |
Erleada | apalutamide | March 2019 | ![]() |
![]() |
Evenity | romosozumab (genetical recombination) | January 2019 | ![]() |
![]() |
Evrenzo | roxadustat | September 2019 | ![]() |
![]() |
Evusheld** | tixagevimab (genetical recombination) and cilgavimab (genetical recombination) | August 2022 | ![]() |
![]() |
Eylea | aflibercept (genetical recombination) | June 2015 | ![]() |
![]() |
* Errata sheet. The English translation has been corrected accordingly.
** Special Approval for Emergency
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Galafold | migalastat hydrochloride | March 2018 | ![]() |
![]() |
Geninax | garenoxacin mesilate hydrate | July 2007 | ![]() |
![]() ![]() |
Genvoya | elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate | June 2016 | ![]() |
![]() |
Giotrif | afatinib maleate | January 2014 | ![]() |
![]() |
Goofice | elobixibat hydrate | January 2018 | ![]() |
![]() ![]() |
Grazyna | grazoprevir hydrate | September 2016 | ![]() |
![]() |
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Halaven Initial Approval |
eribulin mesilate | April 2011 | ![]() |
![]() |
Halaven Partial Change Approval |
eribulin mesilate | February 2016 | ![]() |
![]() |
Harvoni | ledipasvir acetonate/sofosbuvir | July 2015 | ![]() |
![]() |
Hemangiol | propranolol hydrochloride | July 2016 | ![]() |
![]() |
Hemlibra | emicizumab (genetical recombination) | March 2018 | ![]() |
![]() |
Hiyasta | tucidinostat | June 2021 | ![]() |
![]() ![]() ![]() |
Humira Partial Change Approval |
adalimumab (genetical recombination) | September 2016 | ![]() |
![]() |
* Errata sheet. The English translation has been corrected accordingly.
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Januvia/Glactiv | sitagliptin phosphate hydrate | October 2009 | ![]() |
![]() ![]() |
Jcovden | COVID-19 (SARS-CoV-2) Vaccine (recombinant adenovirus vector) | June 2022 | ![]() |
![]() ![]() |
Jeselhy | pimitespib | June 2022 | ![]() |
![]() |
Jivi | damoctocog alfa pegol (genetical recombination) | September 2018 | ![]() |
![]() |
Jyseleca | filgotinib maleate | September 2020 | ![]() |
![]() |
* Errata sheet. The English translation has been corrected accordingly.
* Errata sheet. The English translation has been corrected accordingly.
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Lagevrio** | molnupiravir | December 2021 | ![]() |
![]() |
Laserphyrin | talaporfin sodium | May 2015 | ![]() |
![]() |
Lenvima Initial Approval |
lenvatinib mesilate | March 2015 | ![]() |
![]() ![]() ![]() ![]() |
Lenvima Partial Change Approval |
lenvatinib mesilate | March 2018 | ![]() |
![]() ![]() |
Lenvima Partial Change Approval |
lenvatinib mesilate | March 2021 | ![]() |
![]() |
Livalo | pitavastatin calcium hydrate | June 2015 | ![]() |
![]() |
Lixiana | edoxaban | April 2011 | ![]() |
![]() ![]() |
Lonasen Partial Change Approval |
blonanserin | March 2021 | ![]() |
![]() |
Lonsurf Initial Approval |
trifluridine and tipiracil hydrochloride | March 2014 | ![]() |
![]() |
Lonsurf Partial Change Approval |
trifluridine and tipiracil hydrochloride | August 2019 | ![]() |
![]() |
Loqoa | esflurbiprofen/mentha oil | September 2015 | ![]() |
![]() |
Lorbrena | lorlatinib | September 2018 | ![]() |
![]() |
Lumicef | brodalumab (genetical recombination) | July 2016 | ![]() |
![]() |
Lyxumia | lixisenatide | June 2013 | ![]() |
![]() |
* Errata sheet. The English translation has been corrected accordingly.
** Special Approval for Emergency
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Macugen | pegaptanib sodium | July 2008 | ![]() |
![]() |
Maviret | glecaprevir hydrate/pibrentasvir | September 2017 | ![]() |
![]() |
Mayzent | siponimod fumaric acid | June 2020 | ![]() |
![]() ![]() |
Mekinist Initial Approval |
trametinib dimethyl sulfoxide | March 2016 | ![]() |
![]() |
Mekinist Partial Change Approval |
trametinib dimethyl sulfoxide | March 2018 | ![]() |
![]() |
Mekinist Partial Change Approval |
trametinib dimethyl sulfoxide | July 2018 | ![]() |
![]() |
Mektovi Initial Approval |
binimetinib | January 2019 | ![]() |
![]() |
Mektovi Partial Change Approval |
binimetinib | November 2020 | ![]() |
![]() |
Memary | memantine hydrochloride | January 2011 | ![]() |
![]() |
Metreleptin | metreleptin (genetical recombination) | March 2013 | ![]() |
![]() |
Mikeluna | carteolol hydrochloride/ latanoprost | September 2016 | ![]() |
![]() |
Minnebro | esaxerenone | January 2019 | ![]() |
![]() |
Miticure | - | September 2015 | ![]() |
![]() |
Moizerto | difamilast | September 2021 | ![]() |
![]() |
Mulpleta | lusutrombopag | September 2015 | ![]() |
![]() ![]() |
Mundesine | forodesine hydrochloride | March 2017 | ![]() |
![]() |
Myozyme | alglucosidase alfa (genetical recombination) | April 2007 | ![]() |
![]() ![]() |
* Errata sheet. The English translation has been corrected accordingly.
* Errata sheet. The English translation has been corrected accordingly.
** Special Approval for Emergency
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Quattrovac | adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine | July 2012 | ![]() |
![]() ![]() |
** Special Approval for Emergency
* Errata sheet. The English translation has been corrected accordingly.
** Special Approval for Emergency
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Tabrecta | capmatinib hydrochloride hydrate | June 2020 | ![]() |
![]() |
Tafinlar Initial Approval |
dabrafenib mesilate | March 2016 | ![]() |
![]() |
Tafinlar Partial Change Approval |
dabrafenib mesilate | March 2018 | ![]() |
![]() |
Tafinlar Partial Change Approval |
dabrafenib mesilate | July 2018 | ![]() |
![]() |
Tagrisso | osimertinib mesilate | March 2016 | ![]() |
![]() |
Takecab | vonoprazan fumarate | December 2014 | ![]() |
![]() |
Takelda | aspirin/lansoprazole | March 2014 | ![]() |
![]() |
Talion | bepotastine besilate | May 2015 | ![]() |
![]() |
Taltz | ixekizumab (genetical recombination) | July 2016 | ![]() |
![]() |
Tavneos | avacopan | September 2021 | ![]() |
![]() |
Tazverik | tazemetostat hydrobromide | June 2021 | ![]() |
![]() ![]() ![]() |
Tecentriq Initial Approval |
atezolizumab (genetical recombination) | January 2018 | ![]() |
![]() |
Tecentriq Partial Change Approval |
atezolizumab (genetical recombination) | August 2019 | ![]() |
![]() |
Tecentriq Partial Change Approval |
atezolizumab (genetical recombination) | September 2019 | ![]() |
![]() |
Tecentriq Partial Change Approval |
atezolizumab (genetical recombination) | November 2019 | ![]() |
![]() |
Tenelia | teneligliptin hydrobromide hydrate | June 2012 | ![]() |
![]() |
Tepmetko | tepotinib hydrochloride hydrate | March 2020 | ![]() |
![]() |
Tetrabik | adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine | July 2012 | ![]() |
![]() ![]() |
Thaled Initial Approval |
thalidomide | October 2008 | ![]() |
![]() |
Thaled Partial Change Approval |
thalidomide | February 2021 | ![]() |
![]() |
Tivicay | dolutegravir sodium | March 2014 | ![]() |
![]() |
Topiloric/Uriadec | topiroxostat | June 2013 | ![]() |
![]() |
Topina | topiramate | July 2007 | ![]() |
![]() |
Tracleer (pediatric dispersible tablets) | bosentan hydrate | September 2015 | ![]() |
![]() |
Treakisym Partial Change Approval |
bendamustine hydrochloride | December 2016 | ![]() |
![]() |
Tremfya | guselkumab (genetical recombination) | March 2018 | ![]() |
![]() |
Trerief Initial Approval |
zonisamide | January 2009 | ![]() |
![]() |
Trerief Partial Change Approval |
zonisamide | July 2018 | ![]() |
![]() |
Tresiba Initial Approval |
insulin degludec (genetical recombination) | September 2012 | ![]() |
![]() |
Tresiba Partial Change Approval |
insulin degludec (genetical recombination) | August 2015 | ![]() |
![]() |
Twymeeg | imeglimin hydrochloride | June 2021 | ![]() |
![]() |
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Uptravi | selexipag | September 2016 | ![]() |
![]() |
* Errata sheet. The English translation has been corrected accordingly.
** Special Approval for Emergency
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|
Brand Name | Non-proprietary Name | Approved In | English | Japanese |
---|---|---|---|---|
Xalkori Initial Approval |
crizotinib | March 2012 | ![]() |
![]() |
Xalkori Partial Change Approval |
crizotinib | May 2017 | ![]() |
![]() |
Xarelto Partial Change Approval |
rivaroxaban | January 2021 | ![]() |
![]() |
Xeljanz Initial Approval |
tofacitinib citrate | March 2013 | ![]() |
![]() |
Xeljanz Partial Change Approval |
tofacitinib citrate | May 2018 | ![]() |
![]() |
Xenpozyme | olipudase alfa (genetical recombination) | March 2022 | ![]() |
![]() |
Xevudy** | sotrovimab (genetical recombination) | September 2021 | ![]() |
![]() ![]() |
Xiaflex | collagenase (clostridium histolyticum) | July 2015 | ![]() |
![]() |
Ximency | daclatasvir hydrochloride/asunaprevir/beclabuvir hydrochloride | December 2016 | ![]() |
![]() |
Xocova*** | ensitrelvir fumaric acid | November 2022 | ![]() |
![]() |
Xofluza Initial Approval |
baloxavir marboxil | February 2018 | ![]() |
![]() ![]() ![]() |
Xofluza Partial Change Approval |
baloxavir marboxil | November 2020 | ![]() |
![]() |
Xolair | omalizumab (genetical recombination) | January 2009 | ![]() |
![]() |
Xospata | gilteritinib fumarate | September 2018 | ![]() |
![]() |
* Errata sheet. The English translation has been corrected accordingly.
** Special Approval for Emergency
*** Emergency Approval