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Review Reports: Drugs

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.

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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
 

EN, English; JP, Japanese

A
Name Active Ingredient Approved In PDF
EN
PDF
JP
Acoalan antithrombin gamma (genetical recombination) July 2015 PDF PDF
Acofide acotiamide hydrochloride hydrate March 2013 PDF PDF
Actair - March 2015 PDF PDF 1.
PDF 2.
Actemra tocilizumab (genetical recombination) April 2008 PDF PDF 1.
PDF 2.
Adcetris brentuximab vedotin (genetical recombination) January 2014 PDF PDF
Adempas riociguat January 2014 PDF PDF
Adsorbed Cell Culture-derived Influenza Vaccine H5N1 "Kitasato Daiichi Sankyo" adsorbed cell culture-derived influenza vaccine (H5N1) March 2016 PDF PDF
Adsorbed Influenza Vaccine (H5N1)  "HOKKEN" adsorbed influenza vaccine (H5N1) October 2007 PDF PDF 1.
PDF 2.
PDF 3.
Adsorbed Influenza Vaccine (H5N1)  "BIKEN" adsorbed influenza vaccine (H5N1) October 2007 PDF PDF 1.
PDF 2.
PDF 3.
Alabel/Alaglio aminolevulinic acid hydrochloride March 2013 PDF PDF
Alecensa alectinib hydrochloride July 2014 PDF PDF
Allergen Scratch Extract Positive control "TORII" Histamine Dihydrochloride histamine dihydrochloride September 2015 PDF PDF
Anoro Ellipta umeclidinium bromide/ vilanterol trifenatate July 2014 PDF PDF
Artist carvedilol August 2015 PDF PDF
Avastin bevacizumab (genetical recombination) April 2007 PDF PDF 1.
PDF 2.
PDF 3.
PDF 4.
PDF 5.
PDF 6.
Avigan favipiravir March 2014 PDF PDF
 
B
Name Active Ingredient Approved In PDF
EN
PDF
JP
Betanis mirabegron June 2011 PDF PDF
Botox botulinum toxin type A June 2015 PDF PDF
Bridion sugammadex sodium January 2010 PDF PDF
 
C
Name Active Ingredient Approved In PDF
EN
PDF
JP
Cerdartolen - January 2014 PDF PDF
Cerdelga eliglustat tartrate March 2015 PDF PDF
Cervarix recombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cell) October 2009 PDF PDF
Clenafin efinaconazole July 2014 PDF PDF
Clozaril clozapine April 2009 PDF PDF
Copegus ribavirin March 2015 PDF PDF
Cosentyx
Initial Approval
secukinumab (genetical recombination) December 2014 PDF PDF
Cosentyx
Partial Change Approval
secukinumab (genetical recombination) December 2015 PDF PDF
Cyramza ramucirumab (genetical recombination) March 2015 PDF PDF
 
D
Name Active Ingredient Approved In PDF
EN
PDF
JP
Daklinza daclatasvir hydrochloride July 2014 PDF PDF
Deltyba delamanid July 2014 PDF PDF
Diquas diquafosol sodium April 2010 PDF PDF 1.
PDF 2.
 
E
Name Active Ingredient Approved In PDF
EN
PDF
JP
Efient prasugrel hydrochloride March 2014 PDF PDF 1.
PDF 2.
Eliquis apixaban December 2012 PDF PDF
PDF*
Emulsion-adjuvanted Cell-culture Derived Influenza HA Vaccine (Prototype) for Intramuscular Injection "KAKETSUKEN" emulsion-adjuvanted cell-culture derived influenza HA vaccine (prototype) March 2015 PDF PDF
Eylea aflibercept (genetical recombination) June 2015 PDF PDF
* Errata sheet. The English translation has been corrected accordingly.
 
F
Name Active Ingredient Approved In PDF
EN
PDF
JP
Farydak panobinostat lactate July 2015 PDF PDF
Forteo teriparatide (genetical recombination) July 2010 PDF PDF
Forxiga dapagliflozin propylene glycolate hydrate March 2014 PDF PDF
 
G
Name Active Ingredient Approved In PDF
EN
PDF
JP
Geninax garenoxacin mesilate hydrate July 2007 PDF PDF 1.
PDF 2.
Giotrif afatinib maleate January 2014 PDF PDF
 
H
Name Active Ingredient Approved In PDF
EN
PDF
JP
Harvoni ledipasvir acetonate/sofosbuvir July 2015 PDF PDF
 
I
Name Active Ingredient Approved In PDF
EN
PDF
JP
Inavir
Initial Approval
laninamivir octanoate hydrate September 2010 PDF PDF
Inavir
Partial Change Approval
laninamivir octanoate hydrate December 2013 PDF PDF
Insulin Glargine BS [Lilly] insulin glargine (genetical recombination) [insulin glargine biosimilar 1] December 2014 PDF PDF
Irribow ramosetron hydrochloride May 2015 PDF PDF
Isentress raltegravir potassium June 2008 PDF PDF
 
J
Name Active Ingredient Approved In PDF
EN
PDF
JP
Januvia/Glactiv sitagliptin phosphate hydrate October 2009 PDF PDF 1.
PDF 2.
 
K
Name Active Ingredient Approved In PDF
EN
PDF
JP
Kadcyla trastuzumab emtansine (genetical recombination) September 2013 PDF PDF
Kenketu Glovenin-I freeze-dried polyethylene glycol treated human normal immunoglobulin November 2015 PDF PDF
 
L
Name Active Ingredient Approved In PDF
EN
PDF
JP
Laserphyrin talaporfin sodium May 2015 PDF PDF
Lenvima lenvatinib mesilate March 2015 PDF PDF 1.
PDF 2.
PDF 3.
PDF 4.
Lixiana edoxaban April 2011 PDF PDF
Lonsurf trifluridine and tipiracil hydrochloride March 2014 PDF PDF
Lyxumia lixisenatide June 2013 PDF PDF
 
M
Name Active Ingredient Approved In PDF
EN
PDF
JP
Macugen pegaptanib sodium July 2008 PDF PDF
Memary memantine hydrochloride January 2011 PDF PDF
Metreleptin metreleptin (genetical recombination) March 2013 PDF PDF
Miticure - September 2015 PDF PDF
Mulpleta lusutrombopag September 2015 PDF PDF 1.
PDF 2.
Myozyme alglucosidase alfa (genetical recombination) April 2007 PDF PDF 1.
PDF 2.
 
N
Name Active Ingredient Approved In PDF
EN
PDF
JP
Nopicor nalfurafine hydrochloride December 2014 PDF PDF
Nouriast istradefylline March 2013 PDF PDF
NovoEight turoctocog alfa (genetical recombination) January 2014 PDF PDF
NovoThirteen catridecacog (genetical recombination) March 2015 PDF PDF
 
O
Name Active Ingredient Approved In PDF
EN
PDF
JP
Ofev nintedanib ethanesulfonate July 2015 PDF PDF
Olanedine olanexidine gluconate July 2015 PDF PDF
Opdivo
Initial Approval
nivolumab (genetical recombination) July 2014 PDF PDF
Opdivo
Partial Change Approval
nivolumab (genetical recombination) December 2015 PDF PDF
Orencia abatacept (genetical recombination) July 2010 PDF PDF
Orfadin nitisinone December 2014 PDF PDF
 
P
Name Active Ingredient Approved In PDF
EN
PDF
JP
Perjeta pertuzumab (genetical recombination) June 2013 PDF PDF
PDF*
Pirespa pirfenidone October 2008 PDF PDF
Pomalyst pomalidomide March 2015 PDF PDF
Poteligeo mogamulizumab (genetical recombination) March 2012 PDF PDF
Pradaxa dabigatran etexilate methanesulfonate January 2011 PDF PDF
* Errata sheet. The English translation has been corrected accordingly.
 
Q
Name Active Ingredient Approved In PDF
EN
PDF
JP
Quattrovac adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine July 2012 PDF PDF 1.
PDF 2.
 
R
Name Active Ingredient Approved In PDF
EN
PDF
JP
Radicut edaravone June 2015 PDF PDF
Rapalimus sirolimus July 2014 PDF PDF
Rapiacta peramivir hydrate January 2010 PDF PDF
Rasilez aliskiren fumarate July 2009 PDF PDF
Rasuritek rasburicase (genetical recombination) October 2009 PDF PDF
Remicade infliximab (genetical recombination) August 2015 PDF PDF
Remitch nalfurafine hydrochloride January 2009 PDF PDF
Revolade eltrombopag olamine October 2010 PDF PDF
Rituxan rituximab (genetical recombination) August 2014 PDF PDF
Romiplate romiplostim (genetical recombination) January 2011 PDF PDF
Rozerem ramelteon April 2010 PDF PDF
Ryzodeg insulin degludec (genetical recombination) / insulin aspart (genetical recombination) December 2012 PDF PDF
 
S
Name Active Ingredient Approved In PDF
EN
PDF
JP
Samsca tolvaptan March 2014 PDF PDF
Seebri glycopyrronium bromide September 2012 PDF PDF
Soliris eculizumab (genetical recombination) April 2010 PDF PDF
Sovaldi sofosbuvir March 2015 PDF PDF
Sovriad simeprevir sodium September 2013 PDF PDF
Spiolto tiotropium bromide hydrate/olodaterol hydrochloride September 2015 PDF PDF
Squarekids adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (salk vaccine) combined vaccine July 2014 PDF PDF
Stelara ustekinumab (genetical recombination) December 2010 PDF PDF
Stivarga regorafenib hydrate March 2013 PDF PDF
Strensiq asfotase alfa (genetical recombination) July 2015 PDF PDF
Stribild elvitegravir/cobicistat/
emtricitabine/tenofovir disoproxil fumarate
March 2013 PDF PDF
Suglat ipragliflozin L-proline January 2014 PDF PDF
Sunvepra asunaprevir July 2014 PDF PDF
Synflorix pneumococcal 10-valent conjugate vaccine adsorbed (non-typeable haemophilus influenzae [NTHi] protein D, diphtheria or tetanus toxoid conjugates) March 2015 PDF PDF
 
T
Name Active Ingredient Approved In PDF
EN
PDF
JP
Takecab vonoprazan fumarate December 2014 PDF PDF
Takelda aspirin/lansoprazole March 2014 PDF PDF
Talion bepotastine besilate May 2015 PDF PDF
Tenelia teneligliptin hydrobromide hydrate June 2012 PDF PDF
Tetrabik adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine July 2012 PDF PDF 1.
PDF 2.
Thaled thalidomide October 2008 PDF PDF
Tivicay dolutegravir sodium March 2014 PDF PDF
Topiloric/Uriadec topiroxostat June 2013 PDF PDF
Topina topiramate July 2007 PDF PDF
Tresiba
Initial Approval
insulin degludec (genetical recombination) September 2012 PDF PDF
Tresiba
Partial Change Approval
insulin degludec (genetical recombination) August 2015 PDF PDF
 
U
Name Active Ingredient Approved In PDF
EN
PDF
JP
 
V
Name Active Ingredient Approved In PDF
EN
PDF
JP
Victoza liraglutide (genetical recombination) January 2010 PDF PDF
Viekirax ombitasvir hydrate/paritaprevir hydrate/ritonavir September 2015 PDF PDF
Votrient pazopanib hydrochloride September 2012 PDF PDF
Vyndaqel tafamidis meglumine September 2013 PDF PDF
 
W
Name Active Ingredient Approved In PDF
EN
PDF
JP
 
X
Name Active Ingredient Approved In PDF
EN
PDF
JP
Xalkori crizotinib March 2012 PDF PDF
Xeljanz tofacitinib citrate March 2013 PDF PDF
Xiaflex collagenase (clostridium histolyticum) July 2015 PDF PDF
Xolair omalizumab (genetical recombination) January 2009 PDF PDF
 
Y
Name Active Ingredient Approved In PDF
EN
PDF
JP
Yervoy ipilimumab (genetical recombination) July 2015 PDF PDF
Yondelis trabectedin September 2015 PDF PDF
 
Z
Name Active Ingredient Approved In PDF
EN
PDF
JP
Zafatek trelagliptin succinate March 2015 PDF PDF
Zetia ezetimibe April 2007 PDF PDF

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Review Reports: Drugs
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