Wednesday, April 03, 2019

PMDA Japanese drug review reports in English

Japanese drug review reports that were translated for English users by PMDA.
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.

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. This is not a comprehensive drug list and the PMDA, Pharmaceuticals and Medical Devices Agency does not guarantee the translations. When in doubt, always refer to the original documents.
Always refer to the original ducument for clarity, corrections and newly added information


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ABCDEFGHIJKLMNOPQRSTUVWXYZ

EN, English; JP, Japanese
A
NameActive IngredientApproved InPDF
EN
PDF
JP
Acoalanantithrombin gamma (genetical recombination)July 2015PDFPDF
Acofideacotiamide hydrochloride hydrateMarch 2013PDFPDF
Actair-March 2015PDFPDF 1.
PDF 2.
Actemra
Initial Approval
tocilizumab (genetical recombination)April 2008PDFPDF 1.
PDF 2.
Actemra
Partial Change Approval
tocilizumab (genetical recombination)June 2017PDFPDF
Actemra
Partial Change Approval
tocilizumab (genetical recombination)August 2017PDFPDF
Adcetrisbrentuximab vedotin (genetical recombination)January 2014PDFPDF
AdempasriociguatJanuary 2014PDFPDF
Adsorbed Cell Culture-derived Influenza Vaccine H5N1 "Kitasato Daiichi Sankyo"adsorbed cell culture-derived influenza vaccine (H5N1)March 2016PDFPDF
Adsorbed Influenza Vaccine (H5N1)  "HOKKEN"adsorbed influenza vaccine (H5N1)October 2007PDFPDF 1.
PDF 2.
PDF 3.
Adsorbed Influenza Vaccine (H5N1)  "BIKEN"adsorbed influenza vaccine (H5N1)October 2007PDFPDF 1.
PDF 2.
PDF 3.
Adynovaterurioctocog alfa pegol (genetical recombination)March 2016PDFPDF
Alabel/Alaglioaminolevulinic acid hydrochlorideMarch 2013PDFPDF
Alecensaalectinib hydrochlorideJuly 2014PDFPDF
Allergen Scratch Extract Positive control "TORII" Histamine Dihydrochloridehistamine dihydrochlorideSeptember 2015PDFPDF
AmenaliefamenamevirJuly 2017PDFPDF
Anoro Elliptaumeclidinium bromide/ vilanterol trifenatateJuly 2014PDFPDF
ArtistcarvedilolAugust 2015PDFPDF
Avastin
Initial Approval
bevacizumab (genetical recombination)April 2007PDFPDF 1.
PDF 2.
PDF 3.
PDF 4.
PDF 5.
PDF 6.
Avastin
Partial Change Approval
bevacizumab (genetical recombination)May 2016PDFPDF
AviganfavipiravirMarch 2014PDFPDF

B
NameActive IngredientApproved InPDF
EN
PDF
JP
BetanismirabegronJune 2011PDFPDF
Botoxbotulinum toxin type AJune 2015PDFPDF
Bridionsugammadex sodiumJanuary 2010PDFPDF

C
NameActive IngredientApproved InPDF
EN
PDF
JP
Cerdartolen-January 2014PDFPDF
Cerdelgaeliglustat tartrateMarch 2015PDFPDF
PDF*
Cervarixrecombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cell)October 2009PDFPDF
ClenafinefinaconazoleJuly 2014PDFPDF
ClozarilclozapineApril 2009PDFPDF
Copegus
Partial Change Approval
ribavirinMarch 2015PDFPDF
Copegus
Partial Change Approval
ribavirinMarch 2017PDFPDF
Cosentyx
Initial Approval
secukinumab (genetical recombination)December 2014PDFPDF
Cosentyx
Partial Change Approval
secukinumab (genetical recombination)December 2015PDFPDF
Cyramza
Initial Approval
ramucirumab (genetical recombination)March 2015PDFPDF
Cyramza
Partial Change Approval
ramucirumab (genetical recombination)May 2016PDFPDF
Cyramza
Partial Change Approval
ramucirumab (genetical recombination)June 2016PDFPDF
* Errata sheet. The English translation has been corrected accordingly.
D
NameActive IngredientApproved InPDF
EN
PDF
JP
Daklinzadaclatasvir hydrochlorideJuly 2014PDFPDF
DeltybadelamanidJuly 2014PDFPDF
Diquasdiquafosol sodiumApril 2010PDFPDF 1.
PDF 2.
Duacclindamycin phosphate hydrate/benzoyl peroxideMarch 2015PDFPDF

E
NameActive IngredientApproved InPDF
EN
PDF
JP
Efientprasugrel hydrochlorideMarch 2014PDFPDF 1.
PDF 2.
EliquisapixabanDecember 2012PDFPDF
PDF*
Emulsion-adjuvanted Cell-culture Derived Influenza HA Vaccine (Prototype) for Intramuscular Injection "KAKETSUKEN"emulsion-adjuvanted cell-culture derived influenza HA vaccine (prototype)March 2015PDFPDF
Epoprostenol ACT
Partial Change Approval
epoprostenol sodiumMarch 2017PDFPDF
ErelsaelbasvirSeptember 2016PDFPDF
Eyleaaflibercept (genetical recombination)June 2015PDFPDF
* Errata sheet. The English translation has been corrected accordingly.

F
NameActive IngredientApproved InPDF
EN
PDF
JP
Farydakpanobinostat lactateJuly 2015PDFPDF
Feburic
Initial Approval
febuxostatJanuary 2011PDFPDF
Feburic
Partial Change Approval
febuxostatMay 2016PDFPDF
Forteoteriparatide (genetical recombination)July 2010PDFPDF
Forxigadapagliflozin propylene glycolate hydrateMarch 2014PDFPDF

G
NameActive IngredientApproved InPDF
EN
PDF
JP
Geninaxgarenoxacin mesilate hydrateJuly 2007PDFPDF 1.
PDF 2.
Genvoyaelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarateJune 2016PDFPDF
Giotrifafatinib maleateJanuary 2014PDFPDF
Grazynagrazoprevir hydrateSeptember 2016PDFPDF

H
NameActive IngredientApproved InPDF
EN
PDF
JP
Halaven
Initial Approval
eribulin mesilateApril 2011PDFPDF
Halaven
Partial Change Approval
eribulin mesilateFebruary 2016PDFPDF
Harvoniledipasvir acetonate/sofosbuvirJuly 2015PDFPDF
Hemangiolpropranolol hydrochlorideJuly 2016PDFPDF
Humira
Partial Change Approval
adalimumab (genetical recombination)September 2016PDFPDF

I
NameActive IngredientApproved InPDF
EN
PDF
JP
Idelvionalbutrepenonacog alfa (genetical recombination)September 2016PDFPDF
Ilaris
Partial Change Approval
canakinumab (genetical recombination)December 2016PDFPDF
Inavir
Initial Approval
laninamivir octanoate hydrateSeptember 2010PDFPDF
Inavir
Partial Change Approval
laninamivir octanoate hydrateDecember 2013PDFPDF
Inavir
Partial Change Approval
laninamivir octanoate hydrateAugust 2016PDFPDF
Insulin Glargine BS [Lilly]insulin glargine (genetical recombination) [insulin glargine biosimilar 1]December 2014PDFPDF
Irribowramosetron hydrochlorideMay 2015PDFPDF
Isentressraltegravir potassiumJune 2008PDFPDF

J
NameActive IngredientApproved InPDF
EN
PDF
JP
Januvia/Glactivsitagliptin phosphate hydrateOctober 2009PDFPDF 1.
PDF 2.

K
NameActive IngredientApproved InPDF
EN
PDF
JP
Kadcylatrastuzumab emtansine (genetical recombination)September 2013PDFPDF
Kanumasebelipase alfa (genetical recombination)March 2016PDFPDF
Kenketu Glovenin-I
Partial Change Approval
freeze-dried polyethylene glycol-treated human normal immunoglobulinNovember 2015PDFPDF
Kenketu Glovenin-I
Partial Change Approval
freeze-dried polyethylene glycol-treated human normal immunoglobulinSeptember 2016PDFPDF
Kevzarasarilumab (genetical recombination)September 2017PDFPDF
Keytruda
Initial Approval
pembrolizumab (genetical recombination)September 2016PDFPDF
Keytruda
Partial Change Approval
pembrolizumab (genetical recombination)December 2016PDFPDF
KyproliscarfilzomibJuly 2016PDFPDF

L
NameActive IngredientApproved InPDF
EN
PDF
JP
Laserphyrintalaporfin sodiumMay 2015PDFPDF
Lenvimalenvatinib mesilateMarch 2015PDFPDF 1.
PDF 2.
PDF 3.
PDF 4.
Livalopitavastatin calcium hydrateJune 2015PDFPDF
LixianaedoxabanApril 2011PDFPDF
PDF*
Lonsurftrifluridine and tipiracil hydrochlorideMarch 2014PDFPDF
Loqoaesflurbiprofen/mentha oilSep 2015PDFPDF
LorbrenalorlatinibSeptember 2018PDFPDF
Lumicefbrodalumab (genetical recombination)July 2016PDFPDF
LyxumialixisenatideJune 2013PDFPDF
 * Errata sheet. The English translation has been corrected accordingly.
M
NameActive IngredientApproved InPDF
EN
PDF
JP
Macugenpegaptanib sodiumJuly 2008PDFPDF
Mekinisttrametinib dimethyl sulfoxideMarch 2016PDFPDF
Memarymemantine hydrochlorideJanuary 2011PDFPDF
Metreleptinmetreleptin (genetical recombination)March 2013PDFPDF
Mikelunacarteolol hydrochloride/ latanoprostSeptember 2016PDFPDF
Miticure-September 2015PDFPDF
MulpletalusutrombopagSeptember 2015PDFPDF 1.
PDF 2.
Mundesineforodesine hydrochlorideMarch 2017PDFPDF
Myozymealglucosidase alfa (genetical recombination)April 2007PDFPDF 1.
PDF 2.

N
NameActive IngredientApproved InPDF
EN
PDF
JP
Ninlaroixazomib citrateMarch 2017PDFPDF
Nopicornalfurafine hydrochlorideDecember 2014PDFPDF
NouriastistradefyllineMarch 2013PDFPDF
NovoEightturoctocog alfa (genetical recombination)January 2014PDFPDF
NovoThirteencatridecacog (genetical recombination)March 2015PDFPDF
Nucalamepolizumab (genetical recombination)March 2016PDFPDF

O
NameActive IngredientApproved InPDF
EN
PDF
JP
Ofevnintedanib ethanesulfonateJuly 2015PDFPDF
Olanedineolanexidine gluconateJuly 2015PDFPDF
OlumiantbaricitinibJuly 2017PDFPDF
Opdivo
Initial Approval
nivolumab (genetical recombination)July 2014PDFPDF
Opdivo
Partial Change Approval
nivolumab (genetical recombination)December 2015PDFPDF
Opdivo
Partial Change Approval
nivolumab (genetical recombination)August 2016PDFPDF
Opdivo
Partial Change Approval
nivolumab (genetical recombination)December 2016PDFPDF
Opdivo
Partial Change Approval
nivolumab (genetical recombination)March 2017PDFPDF
Opdivo
Partial Change Approval
nivolumab (genetical recombination)September 2017PDFPDF
Orenciaabatacept (genetical recombination)July 2010PDFPDF
OrfadinnitisinoneDecember 2014PDFPDF

P
NameActive IngredientApproved InPDF
EN
PDF
JP
ParmodiapemafibrateJuly 2017PDFPDF
Parsabivetelcalcetide hydrochlorideDecember 2016PDFPDF
Perjetapertuzumab (genetical recombination)June 2013PDFPDF
PDF*
PirespapirfenidoneOctober 2008PDFPDF
PomalystpomalidomideMarch 2015PDFPDF
Poteligeomogamulizumab (genetical recombination)March 2012PDFPDF
Pradaxadabigatran etexilate methanesulfonateJanuary 2011PDFPDF
Pralia
Partial Change Approval
denosumab (genetical recombination)July 2017PDFPDF
Praluentalirocumab (genetical recombination)July 2016PDFPDF
PDF*
Prizbindidarucizumab (genetical recombination)September 2016PDFPDF
Proemendfosaprepitant meglumineMarch 2016PDFPDF
* Errata sheet. The English translation has been corrected accordingly.

Q
NameActive IngredientApproved InPDF
EN
PDF
JP
Quattrovacadsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccineJuly 2012PDFPDF 1.
PDF 2.

R
NameActive IngredientApproved InPDF
EN
PDF
JP
RadicutedaravoneJune 2015PDFPDF
Rapalimus
(tablet)
sirolimusJuly 2014PDFPDF
Rapalimus
(topical gel)
sirolimusMarch 2018PDFPDF
Rapiactaperamivir hydrateJanuary 2010PDFPDF
Rasilezaliskiren fumarateJuly 2009PDFPDF
Rasuritekrasburicase (genetical recombination)October 2009PDFPDF
Rebetol
Partial Change Approval
ribavirinSeptember 2016PDFPDF
Rebetol
Partial Change Approval
ribavirinMarch 2017PDFPDF
Regrothtrafermin (genetical recombination)September 2016PDFPDF
Remicadeinfliximab (genetical recombination)August 2015PDFPDF
Remitchnalfurafine hydrochlorideJanuary 2009PDFPDF
Repathaevolocumab (genetical recombination)January 2016PDFPDF
Revlimid
Partial Change Approval
lenalidomide hydrateMarch 2017PDFPDF
Revoladeeltrombopag olamineOctober 2010PDFPDF
RisperdalrisperidoneFebruary 2016PDFPDF
Rituxanrituximab (genetical recombination)August 2014PDFPDF
Romiplateromiplostim (genetical recombination)January 2011PDFPDF
RozeremramelteonApril 2010PDFPDF
Ryzodeginsulin degludec (genetical recombination) / insulin aspart (genetical recombination)December 2012PDFPDF

S
NameActive IngredientApproved InPDF
EN
PDF
JP
SamscatolvaptanMarch 2014PDFPDF
Seebriglycopyrronium bromideSeptember 2012PDFPDF
Soliriseculizumab (genetical recombination)April 2010PDFPDF
Sovaldi
Initial Approval
sofosbuvirMarch 2015PDFPDF
Sovaldi
Partial Change Approval
sofosbuvirMarch 2017PDFPDF
Sovriadsimeprevir sodiumSeptember 2013PDFPDF
Spinraza
Initial Approval
nusinersen sodiumJuly 2017PDFPDF
Spinraza
Partial Change Approval
nusinersen sodiumSeptember 2017PDFPDF
Spioltotiotropium bromide hydrate/olodaterol hydrochlorideSeptember 2015PDFPDF
Squarekidsadsorbed diphtheria-purified pertussis-tetanus-inactivated polio (salk vaccine) combined vaccineJuly 2014PDFPDF
Stelara
Initial Approval
ustekinumab (genetical recombination)December 2010PDFPDF
Stelara
Partial Change Approval
ustekinumab (genetical recombination)March 2017PDFPDF
Stivarga
Initial Approval
regorafenib hydrateMarch 2013PDFPDF
Stivarga
Partial Change Approval
regorafenib hydrateJune 2017PDFPDF
Strensiqasfotase alfa (genetical recombination)July 2015PDFPDF
Stribildelvitegravir/cobicistat/
emtricitabine/tenofovir disoproxil fumarate
March 2013PDFPDF
Suglatipragliflozin L-prolineJanuary 2014PDFPDF
SuinyanagliptinDecember 2015PDFPDF
SunvepraasunaprevirJuly 2014PDFPDF
Symproicnaldemedine tosilateMarch 2017PDFPDF
Synflorixpneumococcal 10-valent conjugate vaccine adsorbed (non-typeable haemophilus influenzae [NTHi] protein D, diphtheria or tetanus toxoid conjugates)March 2015PDFPDF

T
NameActive IngredientApproved InPDF
EN
PDF
JP
Tafinlardabrafenib mesilateMarch 2016PDFPDF
Tagrissoosimertinib mesilateMarch 2016PDFPDF
Takecabvonoprazan fumarateDecember 2014PDFPDF
Takeldaaspirin/lansoprazoleMarch 2014PDFPDF
Talionbepotastine besilateMay 2015PDFPDF
Taltzixekizumab (genetical recombination)July 2016PDFPDF
Teneliateneligliptin hydrobromide hydrateJune 2012PDFPDF
Tetrabikadsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccineJuly 2012PDFPDF 1.
PDF 2.
ThaledthalidomideOctober 2008PDFPDF
Tivicaydolutegravir sodiumMarch 2014PDFPDF
Topiloric/UriadectopiroxostatJune 2013PDFPDF
TopinatopiramateJuly 2007PDFPDF
Tracleer (pediatric dispersible tablets)bosentan hydrateSeptember 2015PDFPDF
Treakisym
Partial Change Approval
bendamustine hydrochlorideDecember 2016PDFPDF
Tresiba
Initial Approval
insulin degludec (genetical recombination)September 2012PDFPDF
Tresiba
Partial Change Approval
insulin degludec (genetical recombination)August 2015PDFPDF

U
NameActive IngredientApproved InPDF
EN
PDF
JP
UptraviselexipagSeptember 2016PDFPDF

V
NameActive IngredientApproved InPDF
EN
PDF
JP
Vemlidytenofovir alafenamide fumarateDecember 2016PDFPDF
Victozaliraglutide (genetical recombination)January 2010PDFPDF
Viekirax
Initial Approval
ombitasvir hydrate/paritaprevir hydrate/ritonavirSeptember 2015PDFPDF
Viekirax
Partial Change Approval
ombitasvir hydrate/paritaprevir hydrate/ritonavirSeptember 2016PDFPDF
Votrientpazopanib hydrochlorideSeptember 2012PDFPDF
Vyndaqeltafamidis meglumineSeptember 2013PDFPDF

W
NameActive IngredientApproved InPDF
EN
PDF
JP

X
NameActive IngredientApproved InPDF
EN
PDF
JP
Xalkori
Initial Approval
crizotinibMarch 2012PDFPDF
Xalkori
Partial Change Approval
crizotinibMay 2017PDFPDF
Xeljanztofacitinib citrateMarch 2013PDFPDF
Xiaflexcollagenase (clostridium histolyticum)July 2015PDFPDF
Ximencydaclatasvir hydrochloride/asunaprevir/beclabuvir hydrochlorideDecember 2016PDFPDF
Xofluzabaloxavir marboxilFebruary 2018PDFPDF1.
PDF2.
PDF3.
Xolairomalizumab (genetical recombination)January 2009PDFPDF
Xospatagilteritinib fumarateSeptember 2018PDFPDF

Y
NameActive IngredientApproved InPDF
EN
PDF
JP
Yervoyipilimumab (genetical recombination)July 2015PDFPDF
YondelistrabectedinSeptember 2015PDFPDF

Z
NameActive IngredientApproved InPDF
EN
PDF
JP
Zafatektrelagliptin succinateMarch 2015PDFPDF
ZagallodutasterideSeptember 2015PDFPDF
ZetiaezetimibeApril 2007PDFPDF
ZykadiaceritinibMarch 2016PDFPDF
Zyprexa/OlanzapineolanzapineDecember 2017PDFPDF

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