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.
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 |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Abraxane Partial Change Approval |
Paclitaxel | September 2019 | English [409.55 KB] | Japanese [583.10 KB] |
| Acenobel | Aceneuramic acid | March 2024 | English [860.33 KB] | Japanese [1.88 MB] |
| Acoalan | Antithrombin gamma (genetical recombination) | July 2015 | English [455.67 KB] | Japanese [606.42 KB] |
| Acofide | Acotiamide hydrochloride hydrate | March 2013 | English [594.70 KB] | Japanese [838.03 KB] |
| Actair | - | March 2015 | English [489.96 KB] | Japanese No.1 [7.79 MB] Japanese No.2 [8.67 MB] |
| Actemra Initial Approval |
Tocilizumab (genetical recombination) | April 2008 | English [1.01 MB] | Japanese No.1 [8.21 KB] Japanese No.2 [944.01 KB] |
| Actemra Partial Change Approval |
Tocilizumab (genetical recombination) | June 2017 | English [352.73 KB] | Japanese [379.25 KB] |
| Actemra Partial Change Approval |
Tocilizumab (genetical recombination) | August 2017 | English [740.12 KB] | Japanese [379.25 KB] |
| Actemra Partial Change Approval |
Tocilizumab (genetical recombination) | May 2019 | English [652.06 KB] | Japanese [822.87 KB] |
| Actemra Partial Change Approval |
Tocilizumab (genetical recombination) | January 2022 | English [945.24 KB] | Japanese [1.22 MB] |
| Adcetris Initial Approval |
Brentuximab vedotin (genetical recombination) | January 2014 | English [930.00 KB] | Japanese [7.30 MB] |
| Adcetris Partial Change Approval |
Brentuximab vedotin (genetical recombination) | September 2018 | English [463.17 KB] | Japanese [3.60 MB] |
| Adcetris Partial Change Approval |
Brentuximab vedotin (genetical recombination) | December 2019 | English [1.26 MB] | Japanese [2.76 MB] |
| Adempas | Riociguat | January 2014 | English [1.06 MB] | Japanese [860.65 KB] |
| Adlumiz | Anamorelin hydrochloride | January 2021 | English [1.11 MB] | Japanese [8.02 MB] |
| Adsorbed Cell Culture-derived Influenza Vaccine H5N1 "Kitasato Daiichi Sankyo" | Adsorbed cell culture-derived influenza vaccine (H5N1) | March 2016 | English [250.29 KB] | Japanese [1.02 MB] |
| Adsorbed Influenza Vaccine (H5N1) "HOKKEN" | Adsorbed influenza vaccine (H5N1) | October 2007 | English [405.57 KB] | Japanese No.1 [732.80 KB] Japanese No.2 [922.96 KB] Japanese No.3 [864.60 KB] |
| Adsorbed Influenza Vaccine (H5N1) "BIKEN" | Adsorbed influenza vaccine (H5N1) | October 2007 | English [901.90 KB] | Japanese No.1 [969.12 KB] Japanese No.2 [1.01 MB] Japanese No.3 [529.68 KB] |
| Adynovate | Rurioctocog alfa pegol (genetical recombination) | March 2016 | English [391.27 KB] | Japanese [593.93 KB] |
| Adzynma | Apadamtase alfa (genetical recombination)/ cinaxadamtase alfa (genetical recombination) | March 2024 | English [1.20 MB] | Japanese [1.75 MB] |
| Afstyla | Lonoctocog alfa (genetical recombination) | September 2017 | English [337.72 KB] | Japanese [6.00 MB] |
| Akalux | Cetuximab sarotalocan sodium (genetical recombination) | September 2020 | English [1.09 MB] | Japanese [1.15 MB] |
| Alabel/Alaglio | Aminolevulinic acid hydrochloride | March 2013 | English [398.29 KB] | Japanese [1,016.30 KB] |
| Alecensa | Alectinib hydrochloride | July 2014 | English [444.56 KB] | Japanese [3.89 MB] |
| Alhemo | Concizumab (genetical recombination) | September 2023 | English [1.24 MB] | Japanese [2.61 MB] |
| Allergen Scratch Extract Positive control "TORII" Histamine Dihydrochloride | Histamine dihydrochloride | September 2015 | English [222.78 KB] | Japanese [575.91 KB] |
| Amenalief | Amenamevir | July 2017 | English [1.10 MB] | Japanese [1.55 MB] |
| Anoro Ellipta | Umeclidinium bromide/ vilanterol trifenatate | July 2014 | English [1.51 MB] | Japanese [1.75 MB] |
| Artist | Carvedilol | August 2015 | English [199.50 KB] | Japanese [524.78 KB] |
| Avastin Initial Approval |
Bevacizumab (genetical recombination) | April 2007 | English [7.11 MB] | Japanese No.1 [448.40 KB] Japanese No.2 [979.89 KB] Japanese No.3 [571.42 KB] Japanese No.4 [995.20 KB] Japanese No.5 [707.06 KB] Japanese No.6 [350.46 KB] |
| Avastin Partial Change Approval |
Bevacizumab (genetical recombination) | May 2016 | English [602.27 KB] | Japanese [868.58 KB] |
| Avigan | Favipiravir | March 2014 | English [1.15 MB] | Japanese [2.98 MB] |
| Awiqli | Insulin icodec (genetical recombination) | June 2024 | English [2.68 MB] | Japanese [4.08 MB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Bavencio | Avelumab (genetical recombination) | September 2017 | English [669.08 KB] | Japanese [1.00 MB] |
| Benlysta Initial Approval |
Belimumab (genetical recombination) | September 2017 | English [2.35 MB] | Japanese [1.89 MB] |
| Benlysta Partial Change Approval |
Belimumab (genetical recombination) | September 2019 | English [334.07 KB] | Japanese [864.60 KB] |
| Besponsa Partial Change Approval |
Inotuzumab ozogamicin (genetical recombination) | March 2024 | English [656.60 KB] | Japanese [909.09 KB] |
| Betanis | Mirabegron | June 2011 | English [1.78 MB] | Japanese [8.52 MB] |
| Bevespi Aerosphere | Glycopyrronium bromide/ formoterol fumarate hydrate |
June 2019 | English [1.78 MB] | Japanese [2.32 MB] |
| Biktarvy | Bictegravir sodium/emtricitabine /tenofovir alafenamide fumarate |
March 2019 | English [1.78 MB] | Japanese [2.32 MB] |
| Botox | Botulinum toxin type A | June 2015 | English [264.21 KB] | Japanese [521.85 KB] |
| Braftovi Initial Approval |
Encorafenib | January 2019 | English [1.21 MB] | Japanese [10.25 MB] |
| Braftovi Partial Change Approval |
Encorafenib | November 2020 | English [1.21 MB] | Japanese [10.25 MB] |
| Breztri Aerosphere | Budesonide/ glycopyrronium bromide/formoterol fumarate hydrate |
June 2019 | English [1.81 MB] | Japanese [1.77 MB] |
| Bridion | Sugammadex sodium | January 2010 | English [817.70 KB] | Japanese [1.15 MB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Cablivi | Caplacizumab (genetical recombination) | September 2022 | English [1.27 MB] | Japanese [3.98 MB] |
| Cerdartolen | - | January 2014 | English [505.51 KB] | Japanese [648.31 KB] |
| Cerdelga | Eliglustat tartrate | March 2015 | English [679.13 KB] | Japanese [8.26 MB] Errata sheet (JP) [42.36 KB] (Note 1) |
| Cervarix | Recombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cell) | October 2009 | English [1.07 MB] | Japanese [823.83 KB] |
| Cibinqo | Abrocitinib | September 2021 | English [2.93 MB] | Japanese [2.86 MB] |
| Clenafin | Efinaconazole | July 2014 | English [916.67 KB] | Japanese [1.08 MB] |
| Clozaril | Clozapine | April 2009 | English [2.23 MB] | Japanese [1.52 MB] |
| Comirnaty (Note 2) (monovalent, Original) Initial Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran) |
February 2021 | English [1.77 MB] | Japanese [1.85 MB] |
| Comirnaty (Note 2) (monovalent, Original) Partial Change Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran) |
November 2021 | English [944.38 KB] | Japanese [920.15 KB] |
| Comirnaty RTU (Note 2) (bivalent, Original/Omicron BA.1) Partial Change Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredients: tozinameran and riltozinameran) |
September 2022 | English [540.03 KB] | Japanese [754.50 KB] Errata sheet (JP) [120.93 KB] (Note 1) |
| Comirnaty RTU (Note 2) (bivalent, Original/Omicron BA.4-5) Partial Change Approval |
Coronavirus (SARS-CoV-2) RNA Vaccine (active ingredients: tozinameran and famtozinameran) |
August 2023 | English [503.88 KB] | Japanese [579.63 KB] Errata sheet (JP) [111.72 KB] (Note 1) |
| Comirnaty for 5 to 11 years old (Note 2) (monovalent, Original) Initial Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran) |
January 2022 | English [336.41 KB] | Japanese [858.51 KB] |
| Comirnaty for 5 to 11 years old (Note 2) (monovalent, Original) Partial Change Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran) |
August 2022 | English [397.41 KB] | Japanese [590.63 KB] Errata sheet (JP) [121.42 KB] (Note 1) |
| Comirnaty for 5 to 11 years old (Note 2) (bivalent, Original/Omicron BA.4-5) Partial Change Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredients: tozinameran and famtozinameran) |
February 2023 | English [502.20 KB] | Japanese [646.51 KB] |
| Comirnaty for 5 to 11 years old (Note 2) (bivalent, Original/Omicron BA.4-5) Partial Change Approval |
Coronavirus (SARS-CoV-2) RNA Vaccine (active ingredients: tozinameran and famtozinameran) |
August 2023 | English [503.88 KB] | Japanese [579.63 KB] Errata sheet (JP) [111.72 KB] (Note 1) |
| Comirnaty for 6 months to 4 years old (Note 2) (monovalent, Original) Initial Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran) |
October 2022 | English [652.23 KB] | Japanese [1.17 MB] |
| Comirnaty for 6 months to 4 years old (Note 2) (bivalent, Original/Omicron BA.4-5) Partial Change Approval |
Coronavirus (SARS-CoV-2) RNA Vaccine (active ingredients: tozinameran and famtozinameran) |
August 2023 | English [503.88 KB] | Japanese [579.63 KB] Errata sheet (JP) [111.72 KB] (Note 1) |
| Copegus Partial Change Approval |
Ribavirin | March 2015 | English [660.72 KB] | Japanese [1.81 MB] |
| Copegus Partial Change Approval |
Ribavirin | March 2017 | English [381.90 KB] | Japanese [886.23 KB] |
| Corectim | Delgocitinib | January 2020 | English [1.24 MB] | Japanese [896.65 KB] |
| Cosentyx Initial Approval |
Secukinumab (genetical recombination) | December 2014 | English [1.81 MB] | Japanese [2.40 MB] |
| Cosentyx Partial Change Approval |
Secukinumab (genetical recombination) | December 2015 | English [293.19 KB] | Japanese [528.81 KB] |
| Crysvita | Burosumab (genetical recombination) | September 2019 | English [1,009.11 KB] | Japanese [1.32 MB] |
| Cymbalta Partial Change Approval |
Duloxetine hydrochloride | December 2016 | English [592.64 KB] | Japanese [17.58 MB] |
| Cyramza Initial Approval |
Ramucirumab (genetical recombination) | March 2015 | English [926.07 KB] | Japanese [1.90 MB] |
| Cyramza Partial Change Approval |
Ramucirumab (genetical recombination) | May 2016 | English [423.79 KB] | Japanese [1.61 MB] |
| Cyramza Partial Change Approval |
Ramucirumab (genetical recombination) | June 2016 | English [381.51 KB] | Japanese [1.38 MB] |
Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Daichirona (monovalent, Original) Initial Approval |
Coronavirus (SARS-CoV-2) RNA Vaccine (active ingredient: ufrenmeran) |
August 2023 | English [1.89 MB] | Japanese [1.73 MB] |
| Daichirona (monovalent, Omicron XBB.1.5) Partial Change Approval |
Coronavirus (SARS-CoV-2) RNA Vaccine (active ingredient: MAFB-7256a) |
November 2023 | English [595.71 KB] | Japanese [494.45 KB] |
| Daklinza | Daclatasvir hydrochloride | July 2014 | English [2.20 MB] | Japanese [1.62 MB] |
| Darvias | Darinaparsin | June 2022 | English [839.47 KB] | Japanese [1.17 MB] |
| Darzalex Initial Approval |
Daratumumab (genetical recombination) | September 2017 | English [855.52 KB] | Japanese [955.91 KB] |
| Darzalex Partial Change Approval |
Daratumumab (genetical recombination) | August 2019 | English [714.44 KB] | Japanese [507.65 KB] |
| Dayvigo | Lemborexant | January 2020 | English [1.33 MB] | Japanese1. [9.50 MB] Japanese2. [9.79 MB] |
| Deltyba | Delamanid | July 2014 | English [648.00 KB] | Japanese [3.37 MB] |
| Diquas | Diquafosol sodium | April 2010 | English [454.87 KB] | Japanese No.1 [1.49 MB] Japanese No.2 [97.96 KB] |
| Duac | Clindamycin phosphate hydrate/benzoyl peroxide | March 2015 | English [461.59 KB] | Japanese [2.57 MB] |
|
Dupixent |
Dupilumab (genetical recombination) | January 2018 | English [2.16 MB] | Japanese [2.62 MB] |
| Dupixent Partial Change Approval |
Dupilumab (genetical recombination) | February 2024 | English [630.85 KB] | Japanese [1.49 MB] |
| Dysval | Valbenazine tosilate | March 2022 | English [1.76 MB] | Japanese [9.08 MB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Ebglyss | Lebrikizumab (genetical recombination) | January 2024 | English [1.85 MB] | Japanese [4.01 MB] |
| Efient | Prasugrel hydrochloride | March 2014 | English [890.80 KB] | Japanese No.1 [6.00 MB] Japanese No.2 [5.88 MB] |
| Eliquis | Apixaban | December 2012 | English [937.80 KB] | Japanese [4.80 MB] Errata sheet (JP) [115.85 KB] (Note 1) |
| Emgality | Galcanezumab (genetical recombination) | January 2021 | English [2.30 MB] | Japanese [2.73 MB] |
| Empliciti | Elotuzumab (genetical recombination) | September 2016 | English [2.15 MB] | Japanese [2.04 MB] |
| Emulsion-adjuvanted Cell-culture Derived Influenza HA Vaccine (Prototype) for Intramuscular Injection "KAKETSUKEN" | Emulsion-adjuvanted cell-culture derived influenza HA vaccine (prototype) | March 2015 | English [325.35 KB] | Japanese [903.12 KB] |
| Enaroy | Enarodustat | September 2020 | English [1.82 MB] | Japanese [2.64 MB] |
| Enhertu Initial Approval |
Trastuzumab deruxtecan (genetical recombination) | March 2020 | English [860.46 KB] | Japanese [1.75 MB] |
| Enhertu Partial Change Approval |
Trastuzumab deruxtecan (genetical recombination) | September 2020 | English [390.57 KB] | Japanese [681.54 KB] |
| Enspryng | Satralizumab (genetical recombination) | June 2020 | English [873.44 KB] | Japanese [2.44 MB] Errata sheet (JP) [76.57 KB] (Note 1) |
| Epoprostenol ACT Partial Change Approval |
Epoprostenol sodium | March 2017 | English [312.62 KB] | Japanese [646.08 KB] |
| Erelsa | Elbasvir | September 2016 | English [1.07 MB] | Japanese [1.63 MB] |
| Erleada | Apalutamide | March 2019 | English [1.61 MB] | Japanese [935.32 KB] |
| Evenity | Romosozumab (genetical recombination) | January 2019 | English [1.29 MB] | Japanese [1.39 MB] |
| Evrenzo | Roxadustat | September 2019 | English [1.96 MB] | Japanese [2.68 MB] |
| Evusheld (Note 2) | Tixagevimab (genetical recombination) and cilgavimab (genetical recombination) | August 2022 | English [1.44 MB] | Japanese [2.57 MB] |
| Eylea Partial Change Approval |
Aflibercept (genetical recombination) | June 2015 | English [317.54 KB] | Japanese [449.08 KB] |
| Eylea Partial Change Approval |
Aflibercept (genetical recombination) | September 2022 | English [678.48 KB] | Japanese [1.64 MB] |
| Ezharmia Initial Approval |
Valemetostat tosilate | September 2022 | English [967.36 KB] | Japanese [2.07 MB] |
| Ezharmia Partial Change Approval |
Valemetostat tosilate | June 2024 | English [590.71 KB] | Japanese [692.00 KB] |
Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Farydak | Panobinostat lactate | July 2015 | English [804.49 KB] | Japanese [6.02 MB] |
| Fasenra Initial Approval |
Benralizumab (genetical recombination) | January 2018 | English [919.09 KB] | Japanese [1.67 MB] |
| Fasenra Partial Change Approval |
Benralizumab (genetical recombination) | March 2024 | English [352.35KB] | Japanese [489.97 KB] |
| Feburic Initial Approval |
Febuxostat | January 2011 | English [1.08 MB] | Japanese [5.84 MB] |
| Feburic Partial Change Approval |
Febuxostat | May 2016 | English [382.63 KB] | Japanese [458.62 KB] |
| Forteo | Teriparatide (genetical recombination) | July 2010 | English [1.28 MB] | Japanese [1.73 MB] |
| Forxiga Initial Approval |
Dapagliflozin propylene glycolate hydrate | March 2014 | English [1.53 MB] | Japanese [1.03 MB] |
| Forxiga Partial Change Approval |
Dapagliflozin propylene glycolate hydrate | November 2020 | English [642.63 KB] | Japanese [1.29 MB] |
| Freeze-dried Smallpox Vaccine Prepared in Cell Culture LC16 “KMB” Partial Change Approval |
Freeze-dried smallpox vaccine prepared in cell culture | August 2022 | English [286.30 KB] | Japanese [588.37 KB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Galafold | Migalastat hydrochloride | March 2018 | English [770.50 KB] | Japanese [1.01 MB] |
| Geninax | Garenoxacin mesilate hydrate | July 2007 | English [987.19 KB] | Japanese No.1 [816.85 KB] Japanese No.2 [810.63 KB] |
| Genvoya | Elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate |
June 2016 | English [665.87 KB] | Japanese [1.44 MB] |
| Giotrif | Afatinib maleate | January 2014 | English [1.62 MB] | Japanese [2.11 MB] |
| Goofice | Elobixibat hydrate | January 2018 | English [466.44 KB] | Japanese No.1 [8.47 MB] Japanese No.2 [3.05 MB] |
| Grazyna | Grazoprevir hydrate | September 2016 | English [1.08 MB] | Japanese [1.63 MB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Halaven Initial Approval |
Eribulin mesilate | April 2011 | English [1.30 MB] | Japanese [940.89 KB] |
| Halaven Partial Change Approval |
Eribulin mesilate | February 2016 | English [522.36 KB] | Japanese [2.51 MB] |
| Harvoni | Ledipasvir acetonate/sofosbuvir | July 2015 | English [571.76 KB] | Japanese [1.63 MB] |
| Hemangiol | Propranolol hydrochloride | July 2016 | English [289.05 KB] | Japanese [1.45 MB] |
| Hemlibra | Emicizumab (genetical recombination) | March 2018 | English [1.31 MB] | Japanese [3.32 MB] |
| Herceptin Partial Change Approval |
Trastuzumab (genetical recombination) | March 2022 | English [396.90 KB] | Japanese [841.31 KB] Errata sheet (JP) [70.02 KB] (Note 1) |
| Hiyasta | Tucidinostat | June 2021 | English [854.18 KB] | Japanese1. [673.45 KB] Japanese2. [9.76 MB] Errata sheet (JP) [91.46 KB] (Note 1) |
| Humira Partial Change Approval |
Adalimumab (genetical recombination) | September 2016 | English [461.13 KB] | Japanese [618.55 KB] |
Note 1 The English translation has been corrected accordingly.
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Idelvion | Albutrepenonacog alfa (genetical recombination) | September 2016 | English [554.78 KB] | Japanese [8.37 MB] |
| Ilaris Partial Change Approval |
Canakinumab (genetical recombination) | December 2016 | English [479.37 KB] | Japanese [659.97 KB] |
| Imbruvica Partial Change Approval |
Ibrutinib | February 2023 | English [799.91 KB] | Japanese [1.53 MB] |
| Imfinzi Initial Approval |
Durvalumab (genetical recombination) | July 2018 | English [1.51 MB] | Japanese [1.73 MB] |
| Imfinzi Partial Change Approval |
Durvalumab (genetical recombination) | August 2020 | English [1.15 MB] | Japanese [1.16 MB] |
| Inavir Initial Approval |
Laninamivir octanoate hydrate | September 2010 | English [758.82 KB] | Japanese [3.03 MB] |
| Inavir Partial Change Approval |
Laninamivir octanoate hydrate | December 2013 | English [356.81 KB] | Japanese [2.27 MB] |
| Inavir Partial Change Approval |
Laninamivir octanoate hydrate | August 2016 | English [239.59 KB] | Japanese [1.04 MB] |
| Inavir Partial Change Approval |
Laninamivir octanoate hydrate | June 2019 | English [911.09 KB] | Japanese [4.09 MB] |
| Insulin Glargine BS [Lilly] | Insulin glargine (genetical recombination) [insulin glargine biosimilar 1] | December 2014 | English [681.40 KB] | Japanese [526.48 MB] |
| Intuniv Partial Change Approval |
Guanfacine hydrochloride | June 2019 | English [355.07 KB] | Japanese [1.06 MB] |
| Irribow | Ramosetron hydrochloride | May 2015 | English [378.29 KB] | Japanese [834.83 KB] |
| Isentress | Raltegravir potassium | June 2008 | English [810.64 KB] | Japanese [778.89 KB] |
| Istodax | Romidepsin | July 2017 | English [482.85 KB] | Japanese [1.43 MB] |
| Izcargo | Pabinafusp alfa (genetical recombination) | March 2021 | English [1.61 MB] | Japanese [7.09 MB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Januvia/Glactiv | Sitagliptin phosphate hydrate | October 2009 | English [1.23 MB] | Japanese No.1 [5.19 MB] Japanese No.2 [114.27 KB] |
| Jaypirca | Pirtobrutinib | June 2024 | English [919.53 KB] | Japanese [1.27 MB] |
| Jcovden | COVID-19 (SARS-CoV-2) Vaccine (recombinant adenovirus vector) | June 2022 | English [1.78 MB] | Japanese [1.13 MB] Errata sheet (JP) [93.42 KB] (Note 1) |
| Jeselhy | Pimitespib | June 2022 | English [1.59 MB] | Japanese [1.41 MB] |
| Jivi | Damoctocog alfa pegol (genetical recombination) | September 2018 | English [987.64 KB] | Japanese [663.67 KB] |
| Jyseleca | Filgotinib maleate | September 2020 | English [2.11 MB] | Japanese [3.59 MB] |
Note 1 The English translation has been corrected accordingly.
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Kadcyla | Trastuzumab emtansine (genetical recombination) | September 2013 | English [1.56 MB] | Japanese [2.22 MB] |
| Kanuma | Sebelipase alfa (genetical recombination) | March 2016 | English [607.06 KB] | Japanese [999.22 KB] |
| Kenketu Glovenin-I Partial Change Approval |
Freeze-dried polyethylene glycol-treated human normal immunoglobulin | November 2015 | English [275.79 KB] | Japanese [3.77 MB] |
| Kenketu Glovenin-I Partial Change Approval |
Freeze-dried polyethylene glycol-treated human normal immunoglobulin | September 2016 | English [247.76 KB] | Japanese [4.81 MB] |
| Kerendia | Finerenone | March 2022 | English [1.76 MB] | Japanese [2.90 MB] |
| Kevzara | Sarilumab (genetical recombination) | September 2017 | English [745.43 KB] | Japanese [2.16 MB] |
| Keytruda Initial Approval |
Pembrolizumab (genetical recombination) | September 2016 | English [1.28 MB] | Japanese [2.37 MB] |
| Keytruda Partial Change Approval |
Pembrolizumab (genetical recombination) | December 2016 | English [815.41 KB] | Japanese [1.25 MB] |
| Keytruda Partial Change Approval |
Pembrolizumab (genetical recombination) | December 2018 | English [1.56 MB] | Japanese [5.01 MB] |
| Keytruda Partial Change Approval |
Pembrolizumab (genetical recombination) | August 2020 | English [1.42 MB] | Japanese [3.51 MB] Errata sheet (JP) [77.68 KB] (Note 1) |
| Kostaive | Coronavirus (SARS-CoV-2) RNA Vaccine | November 2023 | English [1.33 MB] | Japanese [1.67 MB] |
| Kyprolis | Carfilzomib | July 2016 | English [1.35 MB] | Japanese [1.61 MB] |
Note 1 The English translation has been corrected accordingly.
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Lagevrio (Note 2) | Molnupiravir | December 2021 | English [391.72 KB] | Japanese [1.04 MB] |
| Laserphyrin | Talaporfin sodium | May 2015 | English [471.76 KB] | Japanese [600.20 KB] |
| Lenvima Initial Approval |
Lenvatinib mesilate | March 2015 | English [1.36 MB] | Japanese No.1 [9.21 MB] Japanese No.2 [9.03 MB] Japanese No.3 [8.86 MB] Japanese No.4 [7.53 MB] |
| Lenvima Partial Change Approval |
Lenvatinib mesilate | March 2018 | English [458.00 KB] | Japanese1. [8.68 MB] Japanese2. [2.73 MB] |
| Lenvima Partial Change Approval |
Lenvatinib mesilate | March 2021 | English [580.79 KB] | Japanese [7.80 MB] |
| Leqembi | Lecanemab (genetical recombination) | September 2023 | English [1.99 MB] | Japanese No.1 [9.22 MB] Japanese No.2 [9.05 MB] Japanese No.3 [9.31 MB] Japanese No.4 [2.08 MB] |
| Libtayo | Cemiplimab (genetical recombination) | December 2022 | English [1.40 MB] | Japanese [7.95 MB] |
| Litfulo | Ritlecitinib tosilate | June 2023 | English [1.93 MB] | Japanese [1.96 MB] |
| Livalo | Pitavastatin calcium hydrate | June 2015 | English [455.95 KB] | Japanese [735.40 KB] |
| Lixiana | Edoxaban | April 2011 | English [863.11 KB] | Japanese [1.65 MB] Errata sheet (JP) [84.36 KB] (Note 1) |
| Lonasen Partial Change Approval |
Blonanserin | March 2021 | English [799.96 KB] | Japanese [5.72 MB] |
| Lonsurf Initial Approval |
Trifluridine and tipiracil hydrochloride | March 2014 | English [650.96 KB] | Japanese [3.49 MB] |
| Lonsurf Partial Change Approval |
Trifluridine and tipiracil hydrochloride | August 2019 | English [281.63 KB] | Japanese [697.41 KB] |
| Loqoa | Esflurbiprofen/mentha oil | September 2015 | English [926.55 KB] | Japanese [6.67 MB] |
| Lorbrena | Lorlatinib | September 2018 | English [746.90 KB] | Japanese [1.13 MB] |
| Lumicef | Brodalumab (genetical recombination) | July 2016 | English [1.37 MB] | Japanese [2.31 MB] |
| Lyfnua | Gefapixant citrate | January 2022 | English [1.11 MB] | Japanese1. [8.58 MB] Japanese2. [8.30 MB] |
| Lynparza Partial Change Approval |
Olaparib | August 2023 | English [1.58 MB] | Japanese [1.32 MB] |
| Lytgobi | Futibatinib | June 2023 | English [1.26 MB] | Japanese [1.46 MB] |
| Lyxumia | Lixisenatide | June 2013 | English [1.48 MB] | Japanese [1.04 MB] |
Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Macugen | Pegaptanib sodium | July 2008 | English [952.29 KB] | Japanese [4.47 MB] |
| Maviret | Glecaprevir hydrate/pibrentasvir | September 2017 | English [897.90 KB] | Japanese [4.16 MB] |
| Mayzent | Siponimod fumaric acid | June 2020 | English [1.96 MB] | Japanese [5.68 MB] Errata sheet (JP) [231.69 KB] (Note 1) |
| Mekinist Initial Approval |
Trametinib dimethyl sulfoxide | March 2016 | English [938.91 KB] | Japanese [1.55 MB] |
| Mekinist Partial Change Approval |
Trametinib dimethyl sulfoxide | March 2018 | English [287.40 KB] | Japanese [1.24 MB] |
| Mekinist Partial Change Approval |
Trametinib dimethyl sulfoxide | July 2018 | English [376.11 KB] | Japanese [421.19 KB] |
| Mektovi Initial Approval |
Binimetinib | January 2019 | English [1.21 MB] | Japanese [10.22 MB] |
| Mektovi Partial Change Approval |
Binimetinib | November 2020 | English [837.06 KB] | Japanese [1.97 MB] |
| Memary | Memantine hydrochloride | January 2011 | English [600.77 KB] | Japanese [2.33 MB] |
| Metreleptin | Metreleptin (genetical recombination) | March 2013 | English [579.48 KB] | Japanese [930.31 KB] |
| Mikeluna | Carteolol hydrochloride/ latanoprost | September 2016 | English [453.05 KB] | Japanese [437.08 KB] |
| Minnebro | Esaxerenone | January 2019 | English [472.53 KB] | Japanese [11.80 MB] |
| Mitchga | Nemolizumab (genetical recombination) | March 2022 | English [1.12 MB] | Japanese [8.37 MB] |
| Miticure | - | September 2015 | English [200.67 KB] | Japanese [724.07 KB] |
| Moizerto | Difamilast | September 2021 | English [1.02 MB] | Japanese [1.71 MB] |
| Mulpleta | Lusutrombopag | September 2015 | English [899.37 KB] | Japanese No.1 [9.78 MB] Japanese No.2 [10.09 MB] |
| Mundesine | Forodesine hydrochloride | March 2017 | English [441.01 KB] | Japanese [979.42 KB] |
| Myozyme | Alglucosidase alfa (genetical recombination) | April 2007 | English [918.40 KB] | Japanese No.1 [196.92 KB] Japanese No.2 [4.22 MB] |
Note 1 The English translation has been corrected accordingly.
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Nexviazyme | Avalglucosidase alfa (genetical recombination) | September 2021 | English [1.37 MB] | Japanese [3.65 MB] |
| Ninlaro | Ixazomib citrate | March 2017 | English [1.25 MB] | Japanese [4.78 MB] |
| Nopicor | Nalfurafine hydrochloride | December 2014 | English [647.48 KB] | Japanese [993.04 KB] |
| Nouriast | Istradefylline | March 2013 | English [1.38 MB] | Japanese [960.38 KB] |
| NovoEight | Turoctocog alfa (genetical recombination) | January 2014 | English [682.94 KB] | Japanese [1.22 MB] |
| NovoThirteen | Catridecacog (genetical recombination) | March 2015 | English [807.25 KB] | Japanese [1.03 MB] |
| Nubeqa | Darolutamide | January 2020 | English [734.29 KB] | Japanese [1.19 MB] |
| Nucala | Mepolizumab (genetical recombination) | March 2016 | English [1.26 MB] | Japanese [1.55 MB] |
| Nuvaxovid | Recombinant Coronavirus (SARS-CoV-2) Vaccine | April 2022 | English [1.75 MB] | Japanese [2.22 MB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Ofev Initial Approval |
Nintedanib ethanesulfonate | July 2015 | English [695.44 KB] | Japanese [1.49 MB] |
| Ofev Partial Change Approval |
Nintedanib ethanesulfonate | May 2020 | English [626.02 KB] | Japanese [909.21 KB] |
| Olanedine | Olanexidine gluconate | July 2015 | English [1.09 MB] | Japanese [2.08 MB] |
| Olumiant Initial Approval |
Baricitinib | July 2017 | English [1.96 MB] | Japanese [2.96 MB] |
| Olumiant Partial Change Approval |
Baricitinib | December 2020 | English [1.36 MB] | Japanese [1.91 MB] |
| Olumiant Partial Change Approval |
Baricitinib | April 2021 | English [1.13 MB] | Japanese [1.41 MB] |
| Omvoh | Mirikizumab (genetical recombination) | March 2023 | English [1.45 MB] | Japanese [3.01 MB] |
| Ongentys | Opicapone | June 2020 | English [1.17 MB] | Japanese [2.49 MB] |
| Opdivo Initial Approval |
Nivolumab (genetical recombination) | July 2014 | English [529.98 KB] | Japanese [3.60 MB] |
| Opdivo Partial Change Approval |
Nivolumab (genetical recombination) | December 2015 | English [553.41 KB] | Japanese [2.78 MB] |
| Opdivo Partial Change Approval |
Nivolumab (genetical recombination) | August 2016 | English [614.57 KB] | Japanese [2.34 MB] |
| Opdivo Partial Change Approval |
Nivolumab (genetical recombination) | December 2016 | English [339.34 KB] | Japanese [2.16 MB] |
| Opdivo Partial Change Approval |
Nivolumab (genetical recombination) | March 2017 | English [560.03 KB] | Japanese [1.61 MB] |
| Opdivo Partial Change Approval |
Nivolumab (genetical recombination) | September 2017 | English [344.98 KB] | Japanese [484.87 KB] |
| Opdivo Partial Change Approval |
Nivolumab (genetical recombination) | May 2018 | English [673.65 KB] | Japanese [695.72 KB] |
| Opdivo Partial Change Approval |
Nivolumab (genetical recombination) | August 2018 | English [1.02 MB] | Japanese [4.58 MB] |
| Opdivo Partial Change Approval |
Nivolumab (genetical recombination) | February 2020 | English [654.58 KB] | Japanese [3.00 MB] |
| Opdivo Partial Change Approval |
Nivolumab (genetical recombination) | September 2020 | English [687.82 KB] | Japanese [768.82 KB] |
| Opdivo Partial Change Approval |
Nivolumab (genetical recombination) | November 2021 | English [1.27 MB] | Japanese [9.52 MB] |
| Orencia | Abatacept (genetical recombination) | July 2010 | English [1.10 MB] | Japanese [1.11 MB] |
| Orfadin | Nitisinone | December 2014 | English [531.74 KB] | Japanese [925.12 KB] |
| Orkedia Initial Approval |
Evocalcet | March 2018 | English [1.10 MB] | Japanese [4.32 MB] |
| Orkedia Partial Change Approval |
Evocalcet | December 2019 | English [410.05 KB] | Japanese [624.44 KB] |
| Orladeyo | Berotralstat hydrochloride | January 2021 | English [2.05 MB] | Japanese [2.41 MB] |
| Ostabalo | Abaloparatide acetate | March 2021 | English [2.88 MB] | Japanese [3.18 MB] |
| Otezla | Apremilast | December 2016 | English [1,003.72 KB] | Japanese [1.22 MB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Parmodia | Pemafibrate | July 2017 | English [672.04 KB] | Japanese [1.22 MB] |
| Parmodia XR | Pemafibrate | June 2023 | English [560.84 KB] | Japanese [461.03 KB] |
| Parsabiv | Etelcalcetide hydrochloride | December 2016 | English [447.10 KB] | Japanese [2.95 MB] |
| Paxlovid (Note 2) | Nirmatrelvir and ritonavir | February 2022 | English [285.69 KB] | Japanese [978.83 KB] |
| Perjeta Initial Approval |
Pertuzumab (genetical recombination) | June 2013 | English [1.59 MB] | Japanese [2.10 MB] Errata sheet (JP) [39.18 KB] (Note 1) |
| Perjeta Partial Change Approval |
Pertuzumab (genetical recombination) | March 2022 | English [395.33 KB] | Japanese [840.84 KB] Errata sheet (JP) [72.42 KB] (Note 1) |
| Phozevel | Tenapanor hydrochloride | September 2023 | English [1.66 MB] | Japanese [3.32 MB] |
| Piasky | Crovalimab (genetical recombination) | March 2024 | English [2.23 MB] | Japanese [1.57 MB] |
| Pirespa | Pirfenidone | October 2008 | English [862.11 KB] | Japanese [3.99 MB] |
| Pivlaz | Clazosentan sodium | January 2022 | English [1.24 MB] | Japanese [1.22 MB] |
| Pomalyst | Pomalidomide | March 2015 | English [701.64 KB] | Japanese [2.79 MB] |
| Poteligeo Initial Approval |
Mogamulizumab (genetical recombination) | March 2012 | English [949.15 KB] | Japanese [871.35 KB] |
| Poteligeo Partial Change Approval |
Mogamulizumab (genetical recombination) | August 2018 | English [761.27 KB] | Japanese [806.23 KB] |
| Pradaxa | Dabigatran etexilate methanesulfonate | January 2011 | English [734.43 KB] | Japanese [17.63 MB] |
| Pralia Partial Change Approval |
Denosumab (genetical recombination) | July 2017 | English [515.69 KB] | Japanese [1.53 MB] |
| Praluent | Alirocumab (genetical recombination) | July 2016 | English [1.04 MB] | Japanese [2.00 MB] Errata sheet (JP) [89.87 KB] (Note 1) |
| Precedex Partial Change Approval |
Dexmedetomidine hydrochloride | February 2023 | English [864.25 KB] | Japanese [930.79 KB] Errata sheet (JP) [94.78 KB] (Note 1) |
| Prevymis | Letermovir | March 2018 | English [749.71 KB] | Japanese [2.41 MB] |
| Prizbind | Idarucizumab (genetical recombination) | September 2016 | English [1.10 MB] | Japanese [1.20 MB] |
| Proemend | Fosaprepitant meglumine | March 2016 | English [268.35 KB] | Japanese [1.84 MB] |
Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Quattrovac | Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine | July 2012 | English [847.54 KB] | Japanese No.1 [971.29 KB] Japanese No.2 [3.76 MB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Radicut | Edaravone | June 2015 | English [620.18 KB] | Japanese [1.13 MB] |
| Rapalimus Initial Approval |
Sirolimus | July 2014 | English [1.14 MB] | Japanese [861.09 KB] |
| Rapalimus Partial Change Approval |
Sirolimus | January 2024 | English [556.68 KB] | Japanese [748.83 KB] |
| Rapalimus Initial Approval |
Sirolimus | March 2018 | English [428.49 KB] | Japanese [1.33 MB] |
| Rapiacta | Peramivir hydrate | January 2010 | English [1.37 MB] | Japanese [1.20 MB] |
| Rasilez | Aliskiren fumarate | July 2009 | English [904.49 KB] | Japanese [1.71 MB] |
| Rasuritek | Rasburicase (genetical recombination) | October 2009 | English [1.73 MB] | Japanese [5.35 MB] |
| Rebetol Partial Change Approval |
Ribavirin | September 2016 | English [417.05 KB] | Japanese [1.99 MB] |
| Rebetol Partial Change Approval |
Ribavirin | March 2017 | English [381.88 KB] | Japanese [886.23 KB] |
| Refixia | Nonacog beta pegol (genetical recombination) | July 2018 | English [496.49 KB] | Japanese [950.09 KB] |
| Regroth | Trafermin (genetical recombination) | September 2016 | English [576.77 KB] | Japanese [1.07 MB] |
| Relumina | Relugolix | January 2019 | English [1.59 MB] | Japanese [4.30 MB] |
| Remicade | Infliximab (genetical recombination) | August 2015 | English [267.31 KB] | Japanese [1.82 MB] |
| Remitch | Nalfurafine hydrochloride | January 2009 | English [940.49 KB] | Japanese [735.06 KB] |
| Repatha | Evolocumab (genetical recombination) | January 2016 | English [552.85 KB] | Japanese [1.10 MB] |
| Revcovi | Elapegademase (genetical recombination) | March 2019 | English [496.20 KB] | Japanese [7.03 MB] |
| Revlimid Partial Change Approval |
Lenalidomide hydrate | March 2017 | English [281.87 KB] | Japanese [846.63 KB] |
| Revolade Initial Approval |
Eltrombopag olamine | October 2010 | English [728.23 KB] | Japanese [1.40 MB] |
| Revolade Partial Change Approval |
Eltrombopag olamine | August 2017 | English [434.19 KB] | Japanese [871.97 KB] |
| Rexulti Partial Change Approval |
Brexpiprazole | December 2023 | English [719.04 KB] | Japanese [878.29 KB] |
| Rinvoq Partial Change Approval |
Upadacitinib hydrate | September 2021 | English [1.13 MB] | Japanese [10.67 MB] |
| Risperdal | Risperidone | February 2016 | English [586.18 KB] | Japanese [792.82 KB] |
| Rituxan Partial Change Approval |
Rituximab (genetical recombination) | August 2014 | English [777.56 KB] | Japanese [902.27 KB] |
| Rituxan Partial Change Approval |
Rituximab (genetical recombination) | June 2022 | English [440.45 KB] | Japanese [867.98 KB] |
| Romiplate Initial Approval |
Romiplostim (genetical recombination) | January 2011 | English [1.71 MB] | Japanese [1.21 MB] |
| Romiplate Partial Change Approval |
Romiplostim (genetical recombination) | June 2019 | English [317.45 KB] | Japanese [989.97 KB] |
| Ronapreve (Note 2) Initial Approval |
Casirivimab (genetical recombination) and imdevimab (genetical recombination) | July 2021 | English [1.64 MB] | Japanese [1.60 MB] |
| Ronapreve (Note 2) Partial Change Approval |
Casirivimab (genetical recombination) and imdevimab (genetical recombination) | November 2021 | English [1.01 MB] | Japanese [1.43 MB] |
| Rosuzet | Ezetimibe / rosuvastatin calcium | March 2019 | English [521.96 KB] | Japanese [843.74 KB] |
| Rozerem | Ramelteon | April 2010 | English [3.30 MB] | Japanese [6.45 MB] |
| Rozlytrek | Entrectinib | June 2019 | English [796.10 KB] | Japanese [1.36 MB] |
| Ryzodeg | Insulin degludec (genetical recombination) / insulin aspart (genetical recombination) | December 2012 | English [819.06 KB] | Japanese [957.43 KB] |
Note 2 Special Approval for Emergency
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Samsca | Tolvaptan | March 2014 | English [786.58 KB] | Japanese [997.89 KB] |
| Samtasu | Tolvaptan sodium phosphate | March 2022 | English [1.04 MB] | Japanese [2.21 MB] |
| Sarclisa | Isatuximab (genetical recombination) | June 2020 | English [1.09 MB] | Japanese [2.11 MB] |
| Sargmalin | Sargramostim (genetical recombination) | March 2024 | English [602.18 KB] | Japanese [3.17 MB] |
| Seebri | Glycopyrronium bromide | September 2012 | English [813.96 KB] | Japanese [7.43 MB] |
| Shingrix | Dried recombinant herpes zoster vaccine (derived from Chinese hamster ovary cells) | March 2018 | English [588.70 KB] | Japanese [1.34 MB] |
| Signifor Partial Change Approval |
Pasireotide pamoate | March 2018 | English [453.56 KB] | Japanese [1.53 MB] |
| Skyrizi | Risankizumab (genetical recombination) | March 2019 | English [2.10 MB] | Japanese [7.37 MB] |
| Smyraf | Peficitinib hydrobromide | March 2019 | English [1,005.98 KB] | Japanese [3.53 MB] |
| Soliris
Initial Approval |
Eculizumab (genetical recombination) | April 2010 | English [673.96 KB] | Japanese [5.61 MB] |
| Soliris Partial Change Approval |
Eculizumab (genetical recombination) | December 2017 | English [577.51 KB] | Japanese [1.92 MB] |
| Sovaldi Initial Approval |
Sofosbuvir | March 2015 | English [661.86 KB] | Japanese [1.81 MB] |
| Sovaldi Partial Change Approval |
Sofosbuvir | March 2017 | English [383.01 KB] | Japanese [1,022.48 KB] |
| Sovriad | Simeprevir sodium | September 2013 | English [1.01 MB] | Japanese [1.74 MB] |
| Spikevax (previously COVID-19 Vaccine Moderna) (Note 2) (monovalent, Original) Initial Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: elasomeran) |
May 2021 | English [723.93 KB] | Japanese [1.42 MB] |
| Spikevax (previously COVID-19 Vaccine Moderna) (Note 2) (monovalent, Original) Partial Change Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: elasomeran) |
December 2021 | English [661.20 KB] | Japanese [669.45 KB] |
| Spikevax (Note 2) (bivalent, Original/Omicron BA.1) Partial Change Approval |
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredients: elasomeran and imelasomeran) |
September 2022 | English [548.93 KB] | Japanese [731.89 KB] Errata sheet (JP) [118.67 KB] (Note 1) |
| Spikevax (Note 2) (bivalent, Original/Omicron BA.4-5) Partial Change Approval |
Coronavirus (SARS-CoV-2) RNA Vaccine (active ingredients: elasomeran and davesomeran) |
August 2023 | English [832.26 KB] | Japanese [709.97 KB] |
| Spikevax (Note 2) (bivalent, Original/Omicron BA.1) (bivalent, Original/Omicron BA.4-5) (monovalent, Omicron XBB.1.5) Partial Change Approval |
Coronavirus (SARS-CoV-2) RNA Vaccine (active ingredients of bivalent Original/Omicron BA.1 vaccine: elasomeran and imelasomeran) (active ingredients of bivalent Original/Omicron BA.4-5 vaccine: elasomeran and davesomeran) (active ingredient of monovalent Omicron XBB.1.5 vaccine: andusomeran) |
October 2023 | English [661.87 KB] | Japanese [773.31 KB] |
| Spinraza Initial Approval |
Nusinersen sodium | July 2017 | English [1,000.46 KB] | Japanese [2.01 MB] |
| Spinraza Partial Change Approval |
Nusinersen sodium | September 2017 | English [490.71 KB] | Japanese [911.59 KB] |
| Spiolto | Tiotropium bromide hydrate/olodaterol hydrochloride | September 2015 | English [595.38 KB] | Japanese [1.21 MB] |
| Squarekids | Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (salk vaccine) combined vaccine | July 2014 | English [568.16 KB] | Japanese [4.88 MB] |
| Steboronine | Borofalan (10B) | March 2020 | English [1.30 MB] | Japanese [938.25 KB] |
| Stelara Initial Approval |
Ustekinumab (genetical recombination) | December 2010 | English [745.13 KB] | Japanese [3.23 MB] |
| Stelara Partial Change Approval |
Ustekinumab (genetical recombination) | March 2017 | English [1.43 MB] | Japanese [734.45 KB] |
| Stivarga Initial Approval |
Regorafenib hydrate | March 2013 | English [844.24 KB] | Japanese [1.36 MB] |
| Stivarga Partial Change Approval |
Regorafenib hydrate | June 2017 | English [368.18 KB] | Japanese [517.21 KB] |
| Strensiq | Asfotase alfa (genetical recombination) | July 2015 | English [693.96 KB] | Japanese [2.47 MB] |
| Stribild | Elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate |
March 2013 | English [493.80 KB] | Japanese [859.58 KB] |
| Suglat Initial Approval |
Ipragliflozin L-proline | January 2014 | English [1.80 MB] | Japanese [2.25 MB] |
| Suglat Partial Change Approval |
Ipragliflozin L-proline | December 2018 | English [1.08 MB] | Japanese [1.39 MB] |
| Suiny | Anagliptin | December 2015 | English [729.59 KB] | Japanese [963.66 KB] |
| Sunvepra | Asunaprevir | July 2014 | English [2.20 MB] | Japanese [1.62 MB] |
| Symproic | Naldemedine tosilate | March 2017 | English [1.03 MB] | Japanese [2.05 MB] |
| Synflorix | Pneumococcal 10-valent conjugate vaccine adsorbed (non-typeable haemophilus influenzae [NTHi] protein D, diphtheria or tetanus toxoid conjugates) | March 2015 | English [589.78 KB] | Japanese [815.85 KB] |
Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Tabrecta | Capmatinib hydrochloride hydrate | June 2020 | English [1.24 MB] | Japanese [7.33 MB] |
| Tafinlar Initial Approval |
Dabrafenib mesilate | March 2016 | English [992.67 KB] | Japanese [1.14 MB] |
| Tafinlar Partial Change Approval |
Dabrafenib mesilate | March 2018 | English [288.01 KB] | Japanese [1.24 MB] |
| Tafinlar Partial Change Approval |
Dabrafenib mesilate | July 2018 | English [376.46 KB] | Japanese [421.54 KB] |
| Tagrisso | Osimertinib mesilate | March 2016 | English [532.36 KB] | Japanese [1.11 MB] |
| Takecab | Vonoprazan fumarate | December 2014 | English [759.00 KB] | Japanese [6.94 MB] |
| Takelda | Aspirin/lansoprazole | March 2014 | English [143.53 KB] | Japanese [1.04 MB] |
| Talion | Bepotastine besilate | May 2015 | English [224.23 KB] | Japanese [564.82 KB] |
| Taltz | Ixekizumab (genetical recombination) | July 2016 | English [1.18 MB] | Japanese [1.68 MB] |
| Talzenna | Talazoparib tosilate | January 2024 | English [2.65 MB] | Japanese [2.52 MB] |
| Tavneos | Avacopan | September 2021 | English [1.38 MB] | Japanese [1.90 MB] |
| Tazverik | Tazemetostat hydrobromide | June 2021 | English [1.28 MB] | Japanese No.1 [9.62 MB] Japanese No.2 [10.01 MB] Japanese No.3 [5.83 MB] |
| Tecentriq Initial Approval |
Atezolizumab (genetical recombination) | January 2018 | English [1.28 MB] | Japanese [2.12 MB] |
| Tecentriq Partial Change Approval |
Atezolizumab (genetical recombination) | August 2019 | English [507.88 KB] | Japanese [673.15 KB] |
| Tecentriq Partial Change Approval |
Atezolizumab (genetical recombination) | September 2019 | English [629.76 KB] | Japanese [748.85 KB] |
| Tecentriq Partial Change Approval |
Atezolizumab (genetical recombination) | November 2019 | English [955.61 KB] | Japanese [1.09 MB] |
| Tenelia | Teneligliptin hydrobromide hydrate | June 2012 | English [1.18 MB] | Japanese [5.91 MB] |
| Tepmetko | Tepotinib hydrochloride hydrate | March 2020 | English [1.01 MB] | Japanese [1.68 MB] |
| Tetrabik | Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine | July 2012 | English [732.77 KB] | Japanese No.1 [2.43 MB] Japanese No.2 [3.76 MB] |
| Thaled Initial Approval |
Thalidomide | October 2008 | English [1.04 MB] | Japanese [3.59 MB] |
| Thaled Partial Change Approval |
Thalidomide | February 2021 | English [588.02 KB] | Japanese [1.06 MB] |
| Tivicay | Dolutegravir sodium | March 2014 | English [1.12 M KB] | Japanese [2.15 MB] |
| Topiloric/Uriadec | Topiroxostat | June 2013 | English [2.44 MB] | Japanese [9.50 MB] |
| Topina | Topiramate | July 2007 | English [1.26 MB] | Japanese [782.20 KB] |
| Tracleer (pediatric dispersible tablets) | Bosentan hydrate | September 2015 | English [312.95 KB] | Japanese [4.91 MB] |
| Treakisym Partial Change Approval |
Bendamustine hydrochloride | December 2016 | English [677.52 KB] | Japanese [968.82 KB] |
| Tremfya | Guselkumab (genetical recombination) | March 2018 | English [775.90 KB] | Japanese [774.81 KB] |
| Trerief Initial Approval |
Zonisamide | January 2009 | English [1.26 MB] | Japanese [3.26 MB] |
| Trerief Partial Change Approval |
Zonisamide | July 2018 | English [806.54 KB] | Japanese [2.31 MB] |
| Tresiba Initial Approval |
Insulin degludec (genetical recombination) | September 2012 | English [805.50 KB] | Japanese [1.46 MB] |
| Tresiba Partial Change Approval |
Insulin degludec (genetical recombination) | August 2015 | English [1.20 MB] | Japanese [716.84 KB] |
| TS-1 Partial Change Approval |
Tegafur/gimeracil /oteracil potassium |
November 2022 | English [669.67 KB] | Japanese [785.52 KB] |
| Twymeeg | Imeglimin hydrochloride | June 2021 | English [1.72 MB] | Japanese [6.87 MB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Uptravi | Selexipag | September 2016 | English [1.04 MB] | Japanese [1.69 MB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Vafseo | Vadadustat | June 2020 | English [2.53 MB] | Japanese [10.39 MB] |
| Valixa Partial Change Approval |
Valganciclovir hydrochloride | March 2023 | English [480.11 KB] | Japanese [861.40 KB] |
| Vanflyta | Quizartinib hydrochloride | June 2019 | English [1.62 MB] | Japanese [1.33 MB] |
| Vaxzevria (Note 2) | COVID-19 (SARS-CoV-2) Vaccine (recombinant chimpanzee adenovirus vector) | May 2021 | English [1.97 MB] | Japanese [1.84 MB] Errata sheet (JP) [117.51 KB] (Note 1) |
| Veklury (Note 2) | Remdesivir | May 2020 | English [649.59 KB] | Japanese [806.20 KB] Errata sheet (JP) [163.66 KB] (Note 1) |
| Velcade Partial Change Approval |
Bortezomib | August 2019 | English [685.30 KB] | Japanese [461.52 KB] |
| Velexbru Initial Approval |
Tirabrutinib hydrochloride | March 2020 | English [1.21 MB] | Japanese [1.56 MB] |
| Velexbru Partial Change Approval |
Tirabrutinib hydrochloride | August 2020 | English [747.13 KB] | Japanese [1.14 MB] Errata sheet (JP) [93.54 KB] (Note 1) |
| Vemlidy | Tenofovir alafenamide fumarate | December 2016 | English [438.08 KB] | Japanese [1.00 MB] |
| Verquvo | Vericiguat | June 2021 | English [1.37 MB] | Japanese [1.71 MB] |
| Victoza | Liraglutide (genetical recombination) | January 2010 | English [1.30 MB] | Japanese [4.41 MB] |
| Viekirax Initial Approval |
Ombitasvir hydrate/paritaprevir hydrate/ritonavir | September 2015 | English [1.43 MB] | Japanese [4.72 MB] |
| Viekirax Partial Change Approval |
Ombitasvir hydrate/paritaprevir hydrate/ritonavir | September 2016 | English [447.72 KB] | Japanese [1.91 MB] |
| Viltepso | Viltolarsen | March 2020 | English [1.56 MB] | Japanese [2.33 MB] |
| Vizimpro | Dacomitinib hydrate | January 2019 | English [813.93 KB] | Japanese [1.34 MB] |
| Volibris Partial Change Approval |
Ambrisentan | March 2021 | English [741.91 KB] | Japanese [994.92 KB] |
| Votrient | Pazopanib hydrochloride | September 2012 | English [1.68 MB] | Japanese [2.64 MB] |
| Voydeya | Danicopan | January 2024 | English [1.08 MB] | Japanese [1.07 MB] |
| Vyloy | Zolbetuximab (genetical recombination) | March 2024 | English [2.24 MB] | Japanese [2.12 MB] |
| Vyndaqel Initial Approval |
Tafamidis meglumine | September 2013 | English [756.15 KB] | Japanese [1.13 MB] |
| Vyndaqel Partial Change Approval |
Tafamidis meglumine | March 2019 | English [957.70 KB] | Japanese [1.21 MB] Errata sheet (JP) [163.38 KB] (Note 1) |
| Vyvgart Initial Approval |
Efgartigimod alfa (genetical recombination) | January 2022 | English [1.21 MB] | Japanese [2.19 MB] |
| Vyvgart Partial Change Approval |
Efgartigimod alfa (genetical recombination) | March 2024 | English [1.18 MB] | Japanese [1.32 MB] |
Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Wegovy | Semaglutide (genetical recombination) | March 2023 | English [1.22 MB] | Japanese [1.38 MB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Xalkori Initial Approval |
Crizotinib | March 2012 | English [666.24 KB] | Japanese [6.60 MB] |
| Xalkori Partial Change Approval |
Crizotinib | May 2017 | English [888.94 KB] | Japanese [605.31 KB] |
| Xarelto Partial Change Approval |
Rivaroxaban | January 2021 | English [1.13 MB] | Japanese [2.07 MB] |
| Xeljanz Initial Approval |
Tofacitinib citrate | March 2013 | English [988.53 KB] | Japanese [4.89 MB] |
| Xeljanz Partial Change Approval |
Tofacitinib citrate | May 2018 | English [572.88 KB] | Japanese [1.17 MB] |
| Xenpozyme | Olipudase alfa (genetical recombination) | March 2022 | English [1.10 MB] | Japanese [2.12 MB] |
| Xevudy (Note 2) | Sotrovimab (genetical recombination) | September 2021 | English [462.64 KB] | Japanese [1.44 MB] Errata sheet (JP) [108.86 KB] (Note 1) |
| Xiaflex | Collagenase (clostridium histolyticum) | July 2015 | English [532.44 KB] | Japanese [1.85 MB] |
| Ximency | Daclatasvir hydrochloride/ asunaprevir/beclabuvir hydrochloride |
December 2016 | English [1,012.27 KB] | Japanese [3.31 MB] |
| Xocova (Note 3) | Ensitrelvir fumaric acid | November 2022 | English [2.84 MB] | Japanese [8.39 MB] |
| Xocova | Ensitrelvir fumaric acid | March 2024 | English [1.04 MB] | Japanese [2.45 MB] |
| Xofluza Initial Approval |
Baloxavir marboxil | February 2018 | English [1.53 MB] | Japanese1. [10.34 MB] Japanese2. [10.71 MB] Japanese3. [6.98 MB] |
| Xofluza Partial Change Approval |
Baloxavir marboxil | November 2020 | English [1.28 MB] | Japanese [3.06 MB] |
| Xolair | Omalizumab (genetical recombination) | January 2009 | English [704.06 KB] | Japanese [3.80 MB] |
| Xospata | Gilteritinib fumarate | September 2018 | English [1.54 MB] | Japanese [1.67 MB] |
Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency
Note 3 Emergency Approval
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Yervoy Initial Approval |
Ipilimumab (genetical recombination) | July 2015 | English [1.41 MB] | Japanese [1.63 MB] |
| Yervoy Partial Change Approval |
Ipilimumab (genetical recombination) | May 2018 | English [670.86 KB] | Japanese [696.51 KB] |
| Yervoy Partial Change Approval |
Ipilimumab (genetical recombination) | August 2018 | English [1.01 MB] | Japanese [2.31 MB] |
| Yervoy Partial Change Approval |
Ipilimumab (genetical recombination) | September 2020 | English [684.99 KB] | Japanese [762.76 KB] |
| Yondelis | Trabectedin | September 2015 | English [1.21 MB] | Japanese [11.33 MB] |
| Brand Name | Non-proprietary Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Zafatek | Trelagliptin succinate | March 2015 | English [575.72 KB] | Japanese [6.18 MB] |
| Zagallo | Dutasteride | September 2015 | English [410.21 KB] | Japanese [1.05 MB] |
| Zejula | Niraparib tosilate hydrate | September 2020 | English [2.28 MB] | Japanese No.1[9.62 MB] Japanese No.2[9.46 MB] Japanese No.3[10.21 MB] |
| Zetia | Ezetimibe | April 2007 | English [896.35 KB] | Japanese [5.22 MB] |
| Zilbrysq | Zilucoplan sodium | September 2023 | English [1.35 MB] | Japanese [1.78 MB] |
| Zykadia | Ceritinib | March 2016 | English [569.87 KB] | Japanese [876.27 KB] |
| Zyprexa/Olanzapine | Olanzapine | December 2017 | English [119.04 KB] | Japanese [216.21 KB] |