Drug Database
437 PMDA-approved drugs with English review reports
A36 drugs
AbraxanePartial Change Approval
Paclitaxel
September 2019
EN report available
Acenobel
Aceneuramic acid
March 2024
EN report available
Acoalan
Antithrombin gamma (genetical recombination)
July 2015
EN report available
Acofide
Acotiamide hydrochloride hydrate
March 2013
EN report available
Actair
March 2015
EN report available
ActemraInitial Approval
Tocilizumab (genetical recombination)
April 2008
EN report available
ActemraPartial Change Approval
Tocilizumab (genetical recombination)
June 2017
EN report available
ActemraPartial Change Approval
Tocilizumab (genetical recombination)
August 2017
EN report available
ActemraPartial Change Approval
Tocilizumab (genetical recombination)
May 2019
EN report available
ActemraPartial Change Approval
Tocilizumab (genetical recombination)
January 2022
EN report available
AdcetrisInitial Approval
Brentuximab vedotin (genetical recombination)
January 2014
EN report available
AdcetrisPartial Change Approval
Brentuximab vedotin (genetical recombination)
September 2018
EN report available
AdcetrisPartial Change Approval
Brentuximab vedotin (genetical recombination)
December 2019
EN report available
Adempas
Riociguat
January 2014
EN report available
Adlumiz
Anamorelin hydrochloride
January 2021
EN report available
Adsorbed Cell Culture-derived Influenza Vaccine H5N1 "Kitasato Daiichi Sankyo"
Adsorbed cell culture-derived influenza vaccine (H5N1)
March 2016
EN report available
Adsorbed Influenza Vaccine (H5N1) "HOKKEN"
Adsorbed influenza vaccine (H5N1)
October 2007
EN report available
Adsorbed Influenza Vaccine (H5N1) "BIKEN"
Adsorbed influenza vaccine (H5N1)
October 2007
EN report available
Adynovate
Rurioctocog alfa pegol (genetical recombination)
March 2016
EN report available
Adzynma
Apadamtase alfa (genetical recombination)/ cinaxadamtase alfa (genetical recombination)
March 2024
EN report available
Afstyla
Lonoctocog alfa (genetical recombination)
September 2017
EN report available
Airwin
Sotatercept (genetical recombination)
June 2025
EN report available
Akalux
Cetuximab sarotalocan sodium (genetical recombination)
September 2020
EN report available
Alabel/Alaglio
Aminolevulinic acid hydrochloride
March 2013
EN report available
Alecensa
Alectinib hydrochloride
July 2014
EN report available
Alhemo
Concizumab (genetical recombination)
September 2023
EN report available
Allergen Scratch Extract Positive control "TORII" Histamine Dihydrochloride
Histamine dihydrochloride
September 2015
EN report available
Amenalief
Amenamevir
July 2017
EN report available
Andembry
Garadacimab (genetical recombination)
February 2025
EN report available
Anoro Ellipta
Umeclidinium bromide/ vilanterol trifenatate
July 2014
EN report available
Artist
Carvedilol
August 2015
EN report available
Augtyro
Repotrectinib
September 2024
EN report available
AvastinInitial Approval
Bevacizumab (genetical recombination)
April 2007
EN report available
AvastinPartial Change Approval
Bevacizumab (genetical recombination)
May 2016
EN report available
Avigan
Favipiravir
March 2014
EN report available
Awiqli
Insulin icodec (genetical recombination)
June 2024
EN report available
B13 drugs
Bavencio
Avelumab (genetical recombination)
September 2017
EN report available
BenlystaInitial Approval
Belimumab (genetical recombination)
September 2017
EN report available
BenlystaPartial Change Approval
Belimumab (genetical recombination)
September 2019
EN report available
BesponsaPartial Change Approval
Inotuzumab ozogamicin (genetical recombination)
March 2024
EN report available
Betanis
Mirabegron
June 2011
EN report available
Bevespi Aerosphere
Glycopyrronium bromide/
formoterol fumarate hydrate
June 2019
EN report available
Beyonttra
Acoramidis hydrochloride
March 2025
EN report available
Biktarvy
Bictegravir sodium/emtricitabine
/tenofovir alafenamide fumarate
March 2019
EN report available
Botox
Botulinum toxin type A
June 2015
EN report available
BraftoviInitial Approval
Encorafenib
January 2019
EN report available
BraftoviPartial Change Approval
Encorafenib
November 2020
EN report available
Breztri Aerosphere
Budesonide/
glycopyrronium bromide/formoterol fumarate hydrate
June 2019
EN report available
Bridion
Sugammadex sodium
January 2010
EN report available
C29 drugs
Cablivi
Caplacizumab (genetical recombination)
September 2022
EN report available
Camzyos
Mavacamten
March 2025
EN report available
Cerdartolen
January 2014
EN report available
Cerdelga
Eliglustat tartrate
March 2015
EN report available
Cervarix
Recombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cell)
October 2009
EN report available
Cibinqo
Abrocitinib
September 2021
EN report available
Clenafin
Efinaconazole
July 2014
EN report available
Clozaril
Clozapine
April 2009
EN report available
Comirnaty
(monovalent, Original)(Note 2)Initial Approval
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredient: tozinameran)
February 2021
EN report available
Comirnaty
(monovalent, Original)(Note 2)Partial Change Approval
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredient: tozinameran)
November 2021
EN report available
Comirnaty RTU
(bivalent, Original/Omicron BA.1)(Note 2)Partial Change Approval
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredients: tozinameran and riltozinameran)
September 2022
EN report available
Comirnaty RTU
(bivalent, Original/Omicron BA.4-5)(Note 2)Partial Change Approval
Coronavirus (SARS-CoV-2) RNA Vaccine
(active ingredients: tozinameran and famtozinameran)
August 2023
EN report available
Comirnaty for 5 to 11 years old
(monovalent, Original)(Note 2)Initial Approval
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredient: tozinameran)
January 2022
EN report available
Comirnaty for 5 to 11 years old
(monovalent, Original)(Note 2)Partial Change Approval
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredient: tozinameran)
August 2022
EN report available
Comirnaty for 5 to 11 years old
(bivalent, Original/Omicron BA.4-5)(Note 2)Partial Change Approval
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredients: tozinameran and famtozinameran)
February 2023
EN report available
Comirnaty for 5 to 11 years old
(bivalent, Original/Omicron BA.4-5)(Note 2)Partial Change Approval
Coronavirus (SARS-CoV-2) RNA Vaccine
(active ingredients: tozinameran and famtozinameran)
August 2023
EN report available
Comirnaty for 6 months to 4 years old
(monovalent, Original)(Note 2)Initial Approval
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredient: tozinameran)
October 2022
EN report available
Comirnaty for 6 months to 4 years old
(bivalent, Original/Omicron BA.4-5)(Note 2)Partial Change Approval
Coronavirus (SARS-CoV-2) RNA Vaccine
(active ingredients: tozinameran and famtozinameran)
August 2023
EN report available
CopegusPartial Change Approval
Ribavirin
March 2015
EN report available
CopegusPartial Change Approval
Ribavirin
March 2017
EN report available
Corectim
Delgocitinib
January 2020
EN report available
CosentyxInitial Approval
Secukinumab (genetical recombination)
December 2014
EN report available
CosentyxPartial Change Approval
Secukinumab (genetical recombination)
December 2015
EN report available
Covgoze
Recombinant Coronavirus (SARS-CoV-2) Vaccine
June 2024
EN report available
Crysvita
Burosumab (genetical recombination)
September 2019
EN report available
CymbaltaPartial Change Approval
Duloxetine hydrochloride
December 2016
EN report available
CyramzaInitial Approval
Ramucirumab (genetical recombination)
March 2015
EN report available
CyramzaPartial Change Approval
Ramucirumab (genetical recombination)
May 2016
EN report available
CyramzaPartial Change Approval
Ramucirumab (genetical recombination)
June 2016
EN report available
D15 drugs
Daichirona
(monovalent, Original)Initial Approval
Coronavirus (SARS-CoV-2) RNA Vaccine
(active ingredient: ufrenmeran)
August 2023
EN report available
Daichirona
(monovalent, Omicron XBB.1.5)Partial Change Approval
Coronavirus (SARS-CoV-2) RNA Vaccine
(active ingredient: MAFB-7256a)
November 2023
EN report available
DaichironaPartial Change Approval
Coronavirus (SARS-CoV-2) RNA Vaccine
March 2025
EN report available
Daklinza
Daclatasvir hydrochloride
July 2014
EN report available
Darvias
Darinaparsin
June 2022
EN report available
DarzalexInitial Approval
Daratumumab (genetical recombination)
September 2017
EN report available
DarzalexPartial Change Approval
Daratumumab (genetical recombination)
August 2019
EN report available
Datroway
Datopotamab deruxtecan (genetical recombination)
December 2024
EN report available
Dayvigo
Lemborexant
January 2020
EN report available
Deltyba
Delamanid
July 2014
EN report available
Diquas
Diquafosol sodium
April 2010
EN report available
Duac
Clindamycin phosphate hydrate/benzoyl peroxide
March 2015
EN report available
DupixentInitial Approval
Dupilumab (genetical recombination)
January 2018
EN report available
DupixentPartial Change Approval
Dupilumab (genetical recombination)
February 2024
EN report available
Dysval
Valbenazine tosilate
March 2022
EN report available
E20 drugs
Ebglyss
Lebrikizumab (genetical recombination)
January 2024
EN report available
Efient
Prasugrel hydrochloride
March 2014
EN report available
Eliquis
Apixaban
December 2012
EN report available
Emgality
Galcanezumab (genetical recombination)
January 2021
EN report available
Empliciti
Elotuzumab (genetical recombination)
September 2016
EN report available
Emulsion-adjuvanted Cell-culture Derived Influenza HA Vaccine (Prototype) for Intramuscular Injection "KAKETSUKEN"
Emulsion-adjuvanted cell-culture derived influenza HA vaccine (prototype)
March 2015
EN report available
Enaroy
Enarodustat
September 2020
EN report available
EnhertuInitial Approval
Trastuzumab deruxtecan (genetical recombination)
March 2020
EN report available
EnhertuPartial Change Approval
Trastuzumab deruxtecan (genetical recombination)
September 2020
EN report available
Enspryng
Satralizumab (genetical recombination)
June 2020
EN report available
Epoprostenol ACTPartial Change Approval
Epoprostenol sodium
March 2017
EN report available
Erelsa
Elbasvir
September 2016
EN report available
Erleada
Apalutamide
March 2019
EN report available
Evenity
Romosozumab (genetical recombination)
January 2019
EN report available
Evrenzo
Roxadustat
September 2019
EN report available
Evusheld(Note 2)
Tixagevimab (genetical recombination) and cilgavimab (genetical recombination)
August 2022
EN report available
EyleaPartial Change Approval
Aflibercept (genetical recombination)
June 2015
EN report available
EyleaPartial Change Approval
Aflibercept (genetical recombination)
September 2022
EN report available
EzharmiaInitial Approval
Valemetostat tosilate
September 2022
EN report available
EzharmiaPartial Change Approval
Valemetostat tosilate
June 2024
EN report available
F10 drugs
Fabhalta
Iptacopan hydrochloride hydrate
June 2024
EN report available
Farydak
Panobinostat lactate
July 2015
EN report available
FasenraInitial Approval
Benralizumab (genetical recombination)
January 2018
EN report available
FasenraPartial Change Approval
Benralizumab (genetical recombination)
March 2024
EN report available
FeburicInitial Approval
Febuxostat
January 2011
EN report available
FeburicPartial Change Approval
Febuxostat
May 2016
EN report available
Forteo
Teriparatide (genetical recombination)
July 2010
EN report available
ForxigaInitial Approval
Dapagliflozin propylene glycolate hydrate
March 2014
EN report available
ForxigaPartial Change Approval
Dapagliflozin propylene glycolate hydrate
November 2020
EN report available
Freeze-dried Smallpox Vaccine Prepared in Cell Culture LC16 “KMB”Partial Change Approval
Freeze-dried smallpox vaccine prepared in cell culture
August 2022
EN report available
G6 drugs
Galafold
Migalastat hydrochloride
March 2018
EN report available
Geninax
Garenoxacin mesilate hydrate
July 2007
EN report available
Genvoya
Elvitegravir/cobicistat/
emtricitabine/tenofovir alafenamide fumarate
June 2016
EN report available
Giotrif
Afatinib maleate
January 2014
EN report available
Goofice
Elobixibat hydrate
January 2018
EN report available
Grazyna
Grazoprevir hydrate
September 2016
EN report available
H9 drugs
HalavenInitial Approval
Eribulin mesilate
April 2011
EN report available
HalavenPartial Change Approval
Eribulin mesilate
February 2016
EN report available
Harvoni
Ledipasvir acetonate/sofosbuvir
July 2015
EN report available
Hemangiol
Propranolol hydrochloride
July 2016
EN report available
Hemlibra
Emicizumab (genetical recombination)
March 2018
EN report available
HerceptinPartial Change Approval
Trastuzumab (genetical recombination)
March 2022
EN report available
Hiyasta
Tucidinostat
June 2021
EN report available
HumiraPartial Change Approval
Adalimumab (genetical recombination)
September 2016
EN report available
Hympavzi
Marstacimab (genetical recombination)
December 2024
EN report available
I15 drugs
Idelvion
Albutrepenonacog alfa (genetical recombination)
September 2016
EN report available
IlarisPartial Change Approval
Canakinumab (genetical recombination)
December 2016
EN report available
ImbruvicaPartial Change Approval
Ibrutinib
February 2023
EN report available
ImfinziInitial Approval
Durvalumab (genetical recombination)
July 2018
EN report available
ImfinziPartial Change Approval
Durvalumab (genetical recombination)
August 2020
EN report available
InavirInitial Approval
Laninamivir octanoate hydrate
September 2010
EN report available
InavirPartial Change Approval
Laninamivir octanoate hydrate
December 2013
EN report available
InavirPartial Change Approval
Laninamivir octanoate hydrate
August 2016
EN report available
InavirPartial Change Approval
Laninamivir octanoate hydrate
June 2019
EN report available
Insulin Glargine BS [Lilly]
Insulin glargine (genetical recombination) [insulin glargine biosimilar 1]
December 2014
EN report available
IntunivPartial Change Approval
Guanfacine hydrochloride
June 2019
EN report available
Irribow
Ramosetron hydrochloride
May 2015
EN report available
Isentress
Raltegravir potassium
June 2008
EN report available
Istodax
Romidepsin
July 2017
EN report available
Izcargo
Pabinafusp alfa (genetical recombination)
March 2021
EN report available
J6 drugs
Januvia/Glactiv
Sitagliptin phosphate hydrate
October 2009
EN report available
Jaypirca
Pirtobrutinib
June 2024
EN report available
Jcovden
COVID-19 (SARS-CoV-2) Vaccine (recombinant adenovirus vector)
June 2022
EN report available
Jeselhy
Pimitespib
June 2022
EN report available
Jivi
Damoctocog alfa pegol (genetical recombination)
September 2018
EN report available
Jyseleca
Filgotinib maleate
September 2020
EN report available
K15 drugs
Kadcyla
Trastuzumab emtansine (genetical recombination)
September 2013
EN report available
Kanuma
Sebelipase alfa (genetical recombination)
March 2016
EN report available
Kavigale
Sipavibart (genetical recombination)
December 2024
EN report available
Kenketu Glovenin-IPartial Change Approval
Freeze-dried polyethylene glycol-treated human normal immunoglobulin
November 2015
EN report available
Kenketu Glovenin-IPartial Change Approval
Freeze-dried polyethylene glycol-treated human normal immunoglobulin
September 2016
EN report available
Kerendia
Finerenone
March 2022
EN report available
Kevzara
Sarilumab (genetical recombination)
September 2017
EN report available
KeytrudaInitial Approval
Pembrolizumab (genetical recombination)
September 2016
EN report available
KeytrudaPartial Change Approval
Pembrolizumab (genetical recombination)
December 2016
EN report available
KeytrudaPartial Change Approval
Pembrolizumab (genetical recombination)
December 2018
EN report available
KeytrudaPartial Change Approval
Pembrolizumab (genetical recombination)
August 2020
EN report available
Kisunla
Donanemab (genetical recombination)
September 2024
EN report available
KostaiveInitial Approval
Coronavirus (SARS-CoV-2) RNA Vaccine
November 2023
EN report available
KostaivePartial Change Approval
Coronavirus (SARS-CoV-2) RNA Vaccine
September 2024
EN report available
Kyprolis
Carfilzomib
July 2016
EN report available
L24 drugs
Lagevrio(Note 2)
Molnupiravir
December 2021
EN report available
Laserphyrin
Talaporfin sodium
May 2015
EN report available
Lazcluze
Lazertinib mesilate hydrate
March 2025
EN report available
LenvimaInitial Approval
Lenvatinib mesilate
March 2015
EN report available
LenvimaPartial Change Approval
Lenvatinib mesilate
March 2018
EN report available
LenvimaPartial Change Approval
Lenvatinib mesilate
March 2021
EN report available
Leqembi
Lecanemab (genetical recombination)
September 2023
EN report available
LialdaPartial Change Approval
Mesalazine
June 2025
EN report available
Libtayo
Cemiplimab (genetical recombination)
December 2022
EN report available
Litfulo
Ritlecitinib tosilate
June 2023
EN report available
Livalo
Pitavastatin calcium hydrate
June 2015
EN report available
Livtencity
Maribavir
June 2024
EN report available
Lixiana
Edoxaban
April 2011
EN report available
LonasenPartial Change Approval
Blonanserin
March 2021
EN report available
LonsurfInitial Approval
Trifluridine and tipiracil hydrochloride
March 2014
EN report available
LonsurfPartial Change Approval
Trifluridine and tipiracil hydrochloride
August 2019
EN report available
Loqoa
Esflurbiprofen/mentha oil
September 2015
EN report available
Lorbrena
Lorlatinib
September 2018
EN report available
Lumicef
Brodalumab (genetical recombination)
July 2016
EN report available
Lupkynis
Voclosporin
September 2024
EN report available
Lyfnua
Gefapixant citrate
January 2022
EN report available
LynparzaPartial Change Approval
Olaparib
August 2023
EN report available
Lytgobi
Futibatinib
June 2023
EN report available
Lyxumia
Lixisenatide
June 2013
EN report available
M18 drugs
Macugen
Pegaptanib sodium
July 2008
EN report available
Maviret
Glecaprevir hydrate/pibrentasvir
September 2017
EN report available
Mayzent
Siponimod fumaric acid
June 2020
EN report available
MekinistInitial Approval
Trametinib dimethyl sulfoxide
March 2016
EN report available
MekinistPartial Change Approval
Trametinib dimethyl sulfoxide
March 2018
EN report available
MekinistPartial Change Approval
Trametinib dimethyl sulfoxide
July 2018
EN report available
MektoviInitial Approval
Binimetinib
January 2019
EN report available
MektoviPartial Change Approval
Binimetinib
November 2020
EN report available
Memary
Memantine hydrochloride
January 2011
EN report available
Metreleptin
Metreleptin (genetical recombination)
March 2013
EN report available
Mikeluna
Carteolol hydrochloride/ latanoprost
September 2016
EN report available
Minnebro
Esaxerenone
January 2019
EN report available
Mitchga
Nemolizumab (genetical recombination)
March 2022
EN report available
Miticure
September 2015
EN report available
Moizerto
Difamilast
September 2021
EN report available
Mulpleta
Lusutrombopag
September 2015
EN report available
Mundesine
Forodesine hydrochloride
March 2017
EN report available
Myozyme
Alglucosidase alfa (genetical recombination)
April 2007
EN report available
N11 drugs
Nexviazyme
Avalglucosidase alfa (genetical recombination)
September 2021
EN report available
Ninlaro
Ixazomib citrate
March 2017
EN report available
Nopicor
Nalfurafine hydrochloride
December 2014
EN report available
Nouriast
Istradefylline
March 2013
EN report available
NovoEight
Turoctocog alfa (genetical recombination)
January 2014
EN report available
NovoSevenPartial Change Approval
Eptacog alfa (activated) (genetical recombination)
September 2024
EN report available
NovoThirteen
Catridecacog (genetical recombination)
March 2015
EN report available
Nubeqa
Darolutamide
January 2020
EN report available
Nucala
Mepolizumab (genetical recombination)
March 2016
EN report available
NuvaxovidInitial Approval
Recombinant Coronavirus (SARS-CoV-2) Vaccine
April 2022
EN report available
NuvaxovidPartial Change Approval
Recombinant Coronavirus (SARS-CoV-2) Vaccine
September 2024
EN report available
O26 drugs
OfevInitial Approval
Nintedanib ethanesulfonate
July 2015
EN report available
OfevPartial Change Approval
Nintedanib ethanesulfonate
May 2020
EN report available
Olanedine
Olanexidine gluconate
July 2015
EN report available
OlumiantInitial Approval
Baricitinib
July 2017
EN report available
OlumiantPartial Change Approval
Baricitinib
December 2020
EN report available
OlumiantPartial Change Approval
Baricitinib
April 2021
EN report available
Omvoh
Mirikizumab (genetical recombination)
March 2023
EN report available
Ongentys
Opicapone
June 2020
EN report available
OpdivoInitial Approval
Nivolumab (genetical recombination)
July 2014
EN report available
OpdivoPartial Change Approval
Nivolumab (genetical recombination)
December 2015
EN report available
OpdivoPartial Change Approval
Nivolumab (genetical recombination)
August 2016
EN report available
OpdivoPartial Change Approval
Nivolumab (genetical recombination)
December 2016
EN report available
OpdivoPartial Change Approval
Nivolumab (genetical recombination)
March 2017
EN report available
OpdivoPartial Change Approval
Nivolumab (genetical recombination)
September 2017
EN report available
OpdivoPartial Change Approval
Nivolumab (genetical recombination)
May 2018
EN report available
OpdivoPartial Change Approval
Nivolumab (genetical recombination)
August 2018
EN report available
OpdivoPartial Change Approval
Nivolumab (genetical recombination)
February 2020
EN report available
OpdivoPartial Change Approval
Nivolumab (genetical recombination)
September 2020
EN report available
OpdivoPartial Change Approval
Nivolumab (genetical recombination)
November 2021
EN report available
Orencia
Abatacept (genetical recombination)
July 2010
EN report available
Orfadin
Nitisinone
December 2014
EN report available
OrkediaInitial Approval
Evocalcet
March 2018
EN report available
OrkediaPartial Change Approval
Evocalcet
December 2019
EN report available
Orladeyo
Berotralstat hydrochloride
January 2021
EN report available
Ostabalo
Abaloparatide acetate
March 2021
EN report available
Otezla
Apremilast
December 2016
EN report available
P20 drugs
Parmodia
Pemafibrate
July 2017
EN report available
Parmodia XR
Pemafibrate
June 2023
EN report available
Parsabiv
Etelcalcetide hydrochloride
December 2016
EN report available
Paxlovid(Note 2)
Nirmatrelvir and ritonavir
February 2022
EN report available
PerjetaInitial Approval
Pertuzumab (genetical recombination)
June 2013
EN report available
PerjetaPartial Change Approval
Pertuzumab (genetical recombination)
March 2022
EN report available
Phozevel
Tenapanor hydrochloride
September 2023
EN report available
Piasky
Crovalimab (genetical recombination)
March 2024
EN report available
Pirespa
Pirfenidone
October 2008
EN report available
Pivlaz
Clazosentan sodium
January 2022
EN report available
Pomalyst
Pomalidomide
March 2015
EN report available
PoteligeoInitial Approval
Mogamulizumab (genetical recombination)
March 2012
EN report available
PoteligeoPartial Change Approval
Mogamulizumab (genetical recombination)
August 2018
EN report available
Pradaxa
Dabigatran etexilate methanesulfonate
January 2011
EN report available
PraliaPartial Change Approval
Denosumab (genetical recombination)
July 2017
EN report available
Praluent
Alirocumab (genetical recombination)
July 2016
EN report available
PrecedexPartial Change Approval
Dexmedetomidine hydrochloride
February 2023
EN report available
Prevymis
Letermovir
March 2018
EN report available
Prizbind
Idarucizumab (genetical recombination)
September 2016
EN report available
Proemend
Fosaprepitant meglumine
March 2016
EN report available
Q2 drugs
R36 drugs
Radicut
Edaravone
June 2015
EN report available
RapalimusInitial Approval
Sirolimus
July 2014
EN report available
RapalimusPartial Change Approval
Sirolimus
January 2024
EN report available
RapalimusInitial Approval
Sirolimus
March 2018
EN report available
Rapiacta
Peramivir hydrate
January 2010
EN report available
Rasilez
Aliskiren fumarate
July 2009
EN report available
Rasuritek
Rasburicase (genetical recombination)
October 2009
EN report available
RebetolPartial Change Approval
Ribavirin
September 2016
EN report available
RebetolPartial Change Approval
Ribavirin
March 2017
EN report available
Refixia
Nonacog beta pegol (genetical recombination)
July 2018
EN report available
Regroth
Trafermin (genetical recombination)
September 2016
EN report available
Relumina
Relugolix
January 2019
EN report available
Remicade
Infliximab (genetical recombination)
August 2015
EN report available
Remitch
Nalfurafine hydrochloride
January 2009
EN report available
Repatha
Evolocumab (genetical recombination)
January 2016
EN report available
Revcovi
Elapegademase (genetical recombination)
March 2019
EN report available
RevlimidPartial Change Approval
Lenalidomide hydrate
March 2017
EN report available
RevoladeInitial Approval
Eltrombopag olamine
October 2010
EN report available
RevoladePartial Change Approval
Eltrombopag olamine
August 2017
EN report available
RexultiPartial Change Approval
Brexpiprazole
December 2023
EN report available
RinvoqPartial Change Approval
Upadacitinib hydrate
September 2021
EN report available
Risperdal
Risperidone
February 2016
EN report available
RituxanPartial Change Approval
Rituximab (genetical recombination)
August 2014
EN report available
RituxanPartial Change Approval
Rituximab (genetical recombination)
June 2022
EN report available
RomiplateInitial Approval
Romiplostim (genetical recombination)
January 2011
EN report available
RomiplatePartial Change Approval
Romiplostim (genetical recombination)
June 2019
EN report available
Ronapreve(Note 2)Initial Approval
Casirivimab (genetical recombination) and imdevimab (genetical recombination)
July 2021
EN report available
Ronapreve(Note 2)Partial Change Approval
Casirivimab (genetical recombination) and imdevimab (genetical recombination)
November 2021
EN report available
Rosuzet
Ezetimibe / rosuvastatin calcium
March 2019
EN report available
Rozebalamin
Mecobalamin
September 2024
EN report available
Rozerem
Ramelteon
April 2010
EN report available
Rozlytrek
Entrectinib
June 2019
EN report available
RybrevantInitial Approval
Amivantamab (genetical recombination)
September 2024
EN report available
RybrevantPartial Change Approval
Amivantamab (genetical recombination)
March 2025
EN report available
Ryjusea Mini
Atropine sulfate hydrate
December 2024
EN report available
Ryzodeg
Insulin degludec (genetical recombination) / insulin aspart (genetical recombination)
December 2012
EN report available
S37 drugs
Samsca
Tolvaptan
March 2014
EN report available
Samtasu
Tolvaptan sodium phosphate
March 2022
EN report available
Sarclisa
Isatuximab (genetical recombination)
June 2020
EN report available
Sargmalin
Sargramostim (genetical recombination)
March 2024
EN report available
Seebri
Glycopyrronium bromide
September 2012
EN report available
Shingrix
Dried recombinant herpes zoster vaccine (derived from Chinese hamster ovary cells)
March 2018
EN report available
SigniforPartial Change Approval
Pasireotide pamoate
March 2018
EN report available
Skyrizi
Risankizumab (genetical recombination)
March 2019
EN report available
Smyraf
Peficitinib hydrobromide
March 2019
EN report available
SolirisInitial Approval
Eculizumab (genetical recombination)
April 2010
EN report available
SolirisPartial Change Approval
Eculizumab (genetical recombination)
December 2017
EN report available
SovaldiInitial Approval
Sofosbuvir
March 2015
EN report available
SovaldiPartial Change Approval
Sofosbuvir
March 2017
EN report available
Sovriad
Simeprevir sodium
September 2013
EN report available
Spikevax (previously COVID-19 Vaccine Moderna)
(monovalent, Original)(Note 2)Initial Approval
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredient: elasomeran)
May 2021
EN report available
Spikevax (previously COVID-19 Vaccine Moderna)
(monovalent, Original)(Note 2)Partial Change Approval
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredient: elasomeran)
December 2021
EN report available
Spikevax
(bivalent, Original/Omicron BA.1)(Note 2)Partial Change Approval
Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredients: elasomeran and imelasomeran)
September 2022
EN report available
Spikevax
(bivalent, Original/Omicron BA.4-5)(Note 2)Partial Change Approval
Coronavirus (SARS-CoV-2) RNA Vaccine
(active ingredients: elasomeran and davesomeran)
August 2023
EN report available
Spikevax
(bivalent, Original/Omicron BA.1)
(bivalent, Original/Omicron BA.4-5)
(monovalent, Omicron XBB.1.5)(Note 2)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
EN report available
SpikevaxPartial Change Approval
Coronavirus (SARS-CoV-2) RNA Vaccine
May 2025
EN report available
SpinrazaInitial Approval
Nusinersen sodium
July 2017
EN report available
SpinrazaPartial Change Approval
Nusinersen sodium
September 2017
EN report available
Spiolto
Tiotropium bromide hydrate/olodaterol hydrochloride
September 2015
EN report available
Squarekids
Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (salk vaccine) combined vaccine
July 2014
EN report available
Steboronine
Borofalan (10B)
March 2020
EN report available
StelaraInitial Approval
Ustekinumab (genetical recombination)
December 2010
EN report available
StelaraPartial Change Approval
Ustekinumab (genetical recombination)
March 2017
EN report available
StivargaInitial Approval
Regorafenib hydrate
March 2013
EN report available
StivargaPartial Change Approval
Regorafenib hydrate
June 2017
EN report available
Strensiq
Asfotase alfa (genetical recombination)
July 2015
EN report available
Stribild
Elvitegravir/cobicistat/
emtricitabine/tenofovir disoproxil fumarate
March 2013
EN report available
SuglatInitial Approval
Ipragliflozin L-proline
January 2014
EN report available
SuglatPartial Change Approval
Ipragliflozin L-proline
December 2018
EN report available
Suiny
Anagliptin
December 2015
EN report available
Sunvepra
Asunaprevir
July 2014
EN report available
Symproic
Naldemedine tosilate
March 2017
EN report available
Synflorix
Pneumococcal 10-valent conjugate vaccine adsorbed (non-typeable haemophilus influenzae [NTHi] protein D, diphtheria or tetanus toxoid conjugates)
March 2015
EN report available
T36 drugs
Tabrecta
Capmatinib hydrochloride hydrate
June 2020
EN report available
TafinlarInitial Approval
Dabrafenib mesilate
March 2016
EN report available
TafinlarPartial Change Approval
Dabrafenib mesilate
March 2018
EN report available
TafinlarPartial Change Approval
Dabrafenib mesilate
July 2018
EN report available
Tagrisso
Osimertinib mesilate
March 2016
EN report available
Takecab
Vonoprazan fumarate
December 2014
EN report available
Takelda
Aspirin/lansoprazole
March 2014
EN report available
Talion
Bepotastine besilate
May 2015
EN report available
Taltz
Ixekizumab (genetical recombination)
July 2016
EN report available
Talzenna
Talazoparib tosilate
January 2024
EN report available
Tasfygo
Tasurgratinib succinate
September 2024
EN report available
Tauvid
Flortaucipir (18F)
December 2024
EN report available
Tavneos
Avacopan
September 2021
EN report available
Tazverik
Tazemetostat hydrobromide
June 2021
EN report available
TecentriqInitial Approval
Atezolizumab (genetical recombination)
January 2018
EN report available
TecentriqPartial Change Approval
Atezolizumab (genetical recombination)
August 2019
EN report available
Tecentriq
Partial Change Approval
Atezolizumab (genetical recombination)
September 2019
EN report available
TecentriqPartial Change Approval
Atezolizumab (genetical recombination)
November 2019
EN report available
Tenelia
Teneligliptin hydrobromide hydrate
June 2012
EN report available
Tepmetko
Tepotinib hydrochloride hydrate
March 2020
EN report available
Tepoxx
Tecovirimat hydrate
December 2024
EN report available
Tetrabik
Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine
July 2012
EN report available
ThaledInitial Approval
Thalidomide
October 2008
EN report available
ThaledPartial Change Approval
Thalidomide
February 2021
EN report available
Tivicay
Dolutegravir sodium
March 2014
EN report available
Topiloric/Uriadec
Topiroxostat
June 2013
EN report available
Topina
Topiramate
July 2007
EN report available
Tracleer (pediatric dispersible tablets)
Bosentan hydrate
September 2015
EN report available
TreakisymPartial Change Approval
Bendamustine hydrochloride
December 2016
EN report available
Tremfya
Guselkumab (genetical recombination)
March 2018
EN report available
TreriefInitial Approval
Zonisamide
January 2009
EN report available
TreriefPartial Change Approval
Zonisamide
July 2018
EN report available
TresibaInitial Approval
Insulin degludec (genetical recombination)
September 2012
EN report available
TresibaPartial Change Approval
Insulin degludec (genetical recombination)
August 2015
EN report available
TS-1Partial Change Approval
Tegafur/gimeracil
/oteracil potassium
November 2022
EN report available
Twymeeg
Imeglimin hydrochloride
June 2021
EN report available
U1 drug
V23 drugs
Vafseo
Vadadustat
June 2020
EN report available
ValixaPartial Change Approval
Valganciclovir hydrochloride
March 2023
EN report available
Vanflyta
Quizartinib hydrochloride
June 2019
EN report available
Vaxzevria(Note 2)
COVID-19 (SARS-CoV-2) Vaccine (recombinant chimpanzee adenovirus vector)
May 2021
EN report available
Veklury(Note 2)
Remdesivir
May 2020
EN report available
VelcadePartial Change Approval
Bortezomib
August 2019
EN report available
VelexbruInitial Approval
Tirabrutinib hydrochloride
March 2020
EN report available
VelexbruPartial Change Approval
Tirabrutinib hydrochloride
August 2020
EN report available
Vemlidy
Tenofovir alafenamide fumarate
December 2016
EN report available
Verquvo
Vericiguat
June 2021
EN report available
Victoza
Liraglutide (genetical recombination)
January 2010
EN report available
ViekiraxInitial Approval
Ombitasvir hydrate/paritaprevir hydrate/ritonavir
September 2015
EN report available
ViekiraxPartial Change Approval
Ombitasvir hydrate/paritaprevir hydrate/ritonavir
September 2016
EN report available
Viltepso
Viltolarsen
March 2020
EN report available
Vizimpro
Dacomitinib hydrate
January 2019
EN report available
VolibrisPartial Change Approval
Ambrisentan
March 2021
EN report available
Votrient
Pazopanib hydrochloride
September 2012
EN report available
Voydeya
Danicopan
January 2024
EN report available
Vyloy
Zolbetuximab (genetical recombination)
March 2024
EN report available
VyndaqelInitial Approval
Tafamidis meglumine
September 2013
EN report available
VyndaqelPartial Change Approval
Tafamidis meglumine
March 2019
EN report available
VyvgartInitial Approval
Efgartigimod alfa (genetical recombination)
January 2022
EN report available
VyvgartPartial Change Approval
Efgartigimod alfa (genetical recombination)
March 2024
EN report available
W1 drug
X15 drugs
XalkoriInitial Approval
Crizotinib
March 2012
EN report available
XalkoriPartial Change Approval
Crizotinib
May 2017
EN report available
XareltoPartial Change Approval
Rivaroxaban
January 2021
EN report available
XeljanzInitial Approval
Tofacitinib citrate
March 2013
EN report available
XeljanzPartial Change Approval
Tofacitinib citrate
May 2018
EN report available
Xenpozyme
Olipudase alfa (genetical recombination)
March 2022
EN report available
Xevudy(Note 2)
Sotrovimab (genetical recombination)
September 2021
EN report available
Xiaflex
Collagenase (clostridium histolyticum)
July 2015
EN report available
Ximency
Daclatasvir hydrochloride/
asunaprevir/beclabuvir hydrochloride
December 2016
EN report available
Xocova(Note 3)
Ensitrelvir fumaric acid
November 2022
EN report available
Xocova
Ensitrelvir fumaric acid
March 2024
EN report available
XofluzaInitial Approval
Baloxavir marboxil
February 2018
EN report available
XofluzaPartial Change Approval
Baloxavir marboxil
November 2020
EN report available
Xolair
Omalizumab (genetical recombination)
January 2009
EN report available
Xospata
Gilteritinib fumarate
September 2018
EN report available
Y5 drugs
YervoyInitial Approval
Ipilimumab (genetical recombination)
July 2015
EN report available
YervoyPartial Change Approval
Ipilimumab (genetical recombination)
May 2018
EN report available
YervoyPartial Change Approval
Ipilimumab (genetical recombination)
August 2018
EN report available
YervoyPartial Change Approval
Ipilimumab (genetical recombination)
September 2020
EN report available
Yondelis
Trabectedin
September 2015
EN report available
Z8 drugs
Zafatek
Trelagliptin succinate
March 2015
EN report available
Zagallo
Dutasteride
September 2015
EN report available
Zejula
Niraparib tosilate hydrate
September 2020
EN report available
Zepbound
Tirzepatide
December 2024
EN report available
Zetia
Ezetimibe
April 2007
EN report available
Zilbrysq
Zilucoplan sodium
September 2023
EN report available
Zykadia
Ceritinib
March 2016
EN report available
Zyprexa/Olanzapine
Olanzapine
December 2017
EN report available
Source: PMDA Website. Data provided under Japan's Public Data License v1.0.