详细信息
PMDA药品审评报告，英文版本。
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.
| 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 | | 1. 2. |
| Actemra Initial Approval | tocilizumab (genetical recombination) | April 2008 | | 1. 2. |
| 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 | | |
| 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 | | 1. 2. 3. |
| Adsorbed Influenza Vaccine (H5N1) "BIKEN" | adsorbed influenza vaccine (H5N1) | October 2007 | | 1. 2. 3. |
| 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 | | 1. 2. 3. 4. 5. 6. |
| Avastin Partial Change Approval | bevacizumab (genetical recombination) | May 2016 | | |
| Avigan | favipiravir | March 2014 | | |
Brand NameNon-proprietary NameApproved InEnglishJapaneseBavencioavelumab (genetical recombination)September 2017Benlysta
Initial Approvalbelimumab (genetical recombination)September 2017Benlysta
Partial Change Approvalbelimumab (genetical recombination)September 2019BetanismirabegronJune 2011Bevespi Aerosphereglycopyrronium bromide/formoterol fumarate hydrateJune 2019Biktarvybictegravir sodium/emtricitabine/tenofovir alafenamide fumarateMarch 2019Botoxbotulinum toxin type AJune 2015Braftovi
Initial ApprovalencorafenibJanuary 2019Braftovi
Partial Change ApprovalencorafenibNovember 2020Breztri Aerospherebudesonide/glycopyrronium bromide/formoterol fumarate hydrateJune 2019Bridionsugammadex sodiumJanuary 2010
Brand NameNon-proprietary NameApproved InEnglishJapaneseCerdartolen-January 2014Cerdelgaeliglustat tartrateMarch 2015*Cervarixrecombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cell)October 2009ClenafinefinaconazoleJuly 2014ClozarilclozapineApril 2009Comirnaty
(Report on Special Approval for Emergency)
Initial ApprovalCoronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredient: tozinameran)February 2021Comirnaty
(Report on Special Approval for Emergency)
Partial Change ApprovalCoronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredient: tozinameran)November 2021Copegus
Partial Change ApprovalribavirinMarch 2015Copegus
Partial Change ApprovalribavirinMarch 2017CorectimdelgocitinibJanuary 2020Cosentyx
Initial Approvalsecukinumab (genetical recombination)December 2014Cosentyx
Partial Change Approvalsecukinumab (genetical recombination)December 2015Crysvitaburosumab (genetical recombination)September 2019Cymbalta
Partial Change Approvalduloxetine hydrochlorideDecember 2016Cyramza
Initial Approvalramucirumab (genetical recombination)March 2015Cyramza
Partial Change Approvalramucirumab (genetical recombination)May 2016Cyramza
Partial Change Approvalramucirumab (genetical recombination)June 2016
* Errata sheet. The English translation has been corrected accordingly.
Brand NameNon-proprietary NameApproved InEnglishJapaneseDaklinzadaclatasvir hydrochlorideJuly 2014Darzalex
Initial Approvaldaratumumab (genetical recombination)September 2017Darzalex
Partial Change Approvaldaratumumab (genetical recombination)August 2019DayvigolemborexantJanuary 20201.2.DeltybadelamanidJuly 2014Diquasdiquafosol sodiumApril 2010 1. 2.Duacclindamycin phosphate hydrate/benzoyl peroxideMarch 2015Dupixentdupilumab (genetical recombination)January 2018
Brand NameNon-proprietary NameApproved InEnglishJapaneseEfientprasugrel hydrochlorideMarch 2014 1. 2.EliquisapixabanDecember 2012*Emplicitielotuzumab (genetical recombination)September 2016Emulsion-adjuvanted Cell-culture Derived Influenza HA Vaccine (Prototype) for Intramuscular Injection "KAKETSUKEN"emulsion-adjuvanted cell-culture derived influenza HA vaccine (prototype)March 2015EnaroyenarodustatSeptember 2020Enhertu
Initial Approvaltrastuzumab deruxtecan (genetical recombination)March 2020Enhertu
Partial Change Approvaltrastuzumab deruxtecan (genetical recombination)September 2020Enspryngsatralizumab (genetical recombination)June 2020*Epoprostenol ACT
Partial Change Approvalepoprostenol sodiumMarch 2017ErelsaelbasvirSeptember 2016ErleadaapalutamideMarch 2019Evenityromosozumab (genetical recombination)January 2019EvrenzoroxadustatSeptember 2019Eyleaaflibercept (genetical recombination)June 2015
* Errata sheet. The English translation has been corrected accordingly.
| Brand Name | Non-proprietary Name | Approved In | English | Japanese |
|---|---|---|---|---|
| Farydak | panobinostat lactate | July 2015 | | |
| Fasenra | benralizumab (genetical recombination) | January 2018 | | |
| Feburic Initial Approval | febuxostat | January 2011 | | |
| Feburic Partial Change Approval | febuxostat | May 2016 | | |
| Forteo | teriparatide (genetical recombination) | July 2010 | | |
| Forxiga | dapagliflozin propylene glycolate hydrate | March 2014 | | |
Brand NameNon-proprietary NameApproved InEnglishJapaneseGalafoldmigalastat hydrochlorideMarch 2018Geninaxgarenoxacin mesilate hydrateJuly 2007 1. 2.Genvoyaelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarateJune 2016Giotrifafatinib maleateJanuary 2014Gooficeelobixibat hydrateJanuary 2018 1. 2.Grazynagrazoprevir hydrateSeptember 2016
Brand NameNon-proprietary NameApproved InEnglishJapaneseHalaven
Initial Approvaleribulin mesilateApril 2011Halaven
Partial Change Approvaleribulin mesilateFebruary 2016Harvoniledipasvir acetonate/sofosbuvirJuly 2015Hemangiolpropranolol hydrochlorideJuly 2016Hemlibraemicizumab (genetical recombination)March 2018Humira
Partial Change Approvaladalimumab (genetical recombination)September 2016
Brand NameNon-proprietary NameApproved InEnglishJapaneseIdelvionalbutrepenonacog alfa (genetical recombination)September 2016Ilaris
Partial Change Approvalcanakinumab (genetical recombination)December 2016Imfinzi
Initial Approvaldurvalumab (genetical recombination)July 2018Imfinzi
Partial Change Approvaldurvalumab (genetical recombination)August 2020Inavir
Initial Approvallaninamivir octanoate hydrateSeptember 2010Inavir
Partial Change Approvallaninamivir octanoate hydrateDecember 2013Inavir
Partial Change Approvallaninamivir octanoate hydrateAugust 2016Inavir
Partial Change Approvallaninamivir octanoate hydrateJune 2019Insulin Glargine BS [Lilly]insulin glargine (genetical recombination) [insulin glargine biosimilar 1]December 2014Intuniv
Partial Change Approvalguanfacine hydrochlorideJune 2019