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
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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EN, English; JP, Japanese
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| 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 | | |
| Adcetris | brentuximab vedotin (genetical recombination) | January 2014 | | |
| Adempas | riociguat | January 2014 | | |
| 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 | | |
| 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 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Betanis | mirabegron | June 2011 | | |
| Botox | botulinum toxin type A | June 2015 | | |
| Bridion | sugammadex sodium | January 2010 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Cerdartolen | - | January 2014 | | |
| Cerdelga | eliglustat tartrate | March 2015 | | * |
| Cervarix | recombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cell) | October 2009 | | |
| Clenafin | efinaconazole | July 2014 | | |
| Clozaril | clozapine | April 2009 | | |
| Copegus Partial Change Approval | ribavirin | March 2015 | | |
| Copegus Partial Change Approval | ribavirin | March 2017 | | |
| Cosentyx Initial Approval | secukinumab (genetical recombination) | December 2014 | | |
| Cosentyx Partial Change Approval | secukinumab (genetical recombination) | December 2015 | | |
| Cyramza Initial Approval | ramucirumab (genetical recombination) | March 2015 | | |
| Cyramza Partial Change Approval | ramucirumab (genetical recombination) | May 2016 | | |
| Cyramza Partial Change Approval | ramucirumab (genetical recombination) | June 2016 | | |
* Errata sheet. The English translation has been corrected accordingly.
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Daklinza | daclatasvir hydrochloride | July 2014 | | |
| Deltyba | delamanid | July 2014 | | |
| Diquas | diquafosol sodium | April 2010 | | 1. 2. |
| Duac | clindamycin phosphate hydrate/benzoyl peroxide | March 2015 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Efient | prasugrel hydrochloride | March 2014 | | 1. 2. |
| Eliquis | apixaban | December 2012 | | * |
| Emulsion-adjuvanted Cell-culture Derived Influenza HA Vaccine (Prototype) for Intramuscular Injection "KAKETSUKEN" | emulsion-adjuvanted cell-culture derived influenza HA vaccine (prototype) | March 2015 | | |
| Epoprostenol ACT Partial Change Approval | epoprostenol sodium | March 2017 | | |
| Erelsa | elbasvir | September 2016 | | |
| Eylea | aflibercept (genetical recombination) | June 2015 | | |
* Errata sheet. The English translation has been corrected accordingly.
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Farydak | panobinostat lactate | July 2015 | | |
| 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 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Geninax | garenoxacin mesilate hydrate | July 2007 | | 1. 2. |
| Genvoya | elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate | June 2016 | | |
| Giotrif | afatinib maleate | January 2014 | | |
| Grazyna | grazoprevir hydrate | September 2016 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Halaven Initial Approval | eribulin mesilate | April 2011 | | |
| Halaven Partial Change Approval | eribulin mesilate | February 2016 | | |
| Harvoni | ledipasvir acetonate/sofosbuvir | July 2015 | | |
| Hemangiol | propranolol hydrochloride | July 2016 | | |
| Humira Partial Change Approval | adalimumab (genetical recombination) | September 2016 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Idelvion | albutrepenonacog alfa (genetical recombination) | September 2016 | | |
| Ilaris Partial Change Approval | canakinumab (genetical recombination) | December 2016 | | |
| Inavir Initial Approval | laninamivir octanoate hydrate | September 2010 | | |
| Inavir Partial Change Approval | laninamivir octanoate hydrate | December 2013 | | |
| Inavir Partial Change Approval | laninamivir octanoate hydrate | August 2016 | | |
| Insulin Glargine BS [Lilly] | insulin glargine (genetical recombination) [insulin glargine biosimilar 1] | December 2014 | | |
| Irribow | ramosetron hydrochloride | May 2015 | | |
| Isentress | raltegravir potassium | June 2008 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Januvia/Glactiv | sitagliptin phosphate hydrate | October 2009 | | 1. 2. |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Kadcyla | trastuzumab emtansine (genetical recombination) | September 2013 | | |
| Kanuma | sebelipase alfa (genetical recombination) | March 2016 | | |
| Kenketu Glovenin-I Partial Change Approval | freeze-dried polyethylene glycol-treated human normal immunoglobulin | November 2015 | | |
| Kenketu Glovenin-I Partial Change Approval | freeze-dried polyethylene glycol-treated human normal immunoglobulin | September 2016 | | |
| Kevzara | sarilumab (genetical recombination) | September 2017 | | |
| Keytruda Initial Approval | pembrolizumab (genetical recombination) | September 2016 | | |
| Keytruda Partial Change Approval | pembrolizumab (genetical recombination) | December 2016 | | |
| Kyprolis | carfilzomib | July 2016 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Laserphyrin | talaporfin sodium | May 2015 | | |
| Lenvima | lenvatinib mesilate | March 2015 | | 1. 2. 3. 4. |
| Livalo | pitavastatin calcium hydrate | June 2015 | | |
| Lixiana | edoxaban | April 2011 | | * |
| Lonsurf | trifluridine and tipiracil hydrochloride | March 2014 | | |
| Loqoa | esflurbiprofen/mentha oil | Sep 2015 | | |
| Lorbrena | lorlatinib | September 2018 | | |
| Lumicef | brodalumab (genetical recombination) | July 2016 | | |
| Lyxumia | lixisenatide | June 2013 | | |
* Errata sheet. The English translation has been corrected accordingly.
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Macugen | pegaptanib sodium | July 2008 | | |
| Mekinist | trametinib dimethyl sulfoxide | March 2016 | | |
| Memary | memantine hydrochloride | January 2011 | | |
| Metreleptin | metreleptin (genetical recombination) | March 2013 | | |
| Mikeluna | carteolol hydrochloride/ latanoprost | September 2016 | | |
| Miticure | - | September 2015 | | |
| Mulpleta | lusutrombopag | September 2015 | | 1. 2. |
| Mundesine | forodesine hydrochloride | March 2017 | | |
| Myozyme | alglucosidase alfa (genetical recombination) | April 2007 | | 1. 2. |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Ninlaro | ixazomib citrate | March 2017 | | |
| Nopicor | nalfurafine hydrochloride | December 2014 | | |
| Nouriast | istradefylline | March 2013 | | |
| NovoEight | turoctocog alfa (genetical recombination) | January 2014 | | |
| NovoThirteen | catridecacog (genetical recombination) | March 2015 | | |
| Nucala | mepolizumab (genetical recombination) | March 2016 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Ofev | nintedanib ethanesulfonate | July 2015 | | |
| Olanedine | olanexidine gluconate | July 2015 | | |
| Olumiant | baricitinib | July 2017 | | |
| Opdivo Initial Approval | nivolumab (genetical recombination) | July 2014 | | |
| Opdivo Partial Change Approval | nivolumab (genetical recombination) | December 2015 | | |
| Opdivo Partial Change Approval | nivolumab (genetical recombination) | August 2016 | | |
| Opdivo Partial Change Approval | nivolumab (genetical recombination) | December 2016 | | |
| Opdivo Partial Change Approval | nivolumab (genetical recombination) | March 2017 | | |
| Opdivo Partial Change Approval | nivolumab (genetical recombination) | September 2017 | | |
| Orencia | abatacept (genetical recombination) | July 2010 | | |
| Orfadin | nitisinone | December 2014 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Parmodia | pemafibrate | July 2017 | | |
| Parsabiv | etelcalcetide hydrochloride | December 2016 | | |
| Perjeta | pertuzumab (genetical recombination) | June 2013 | | * |
| Pirespa | pirfenidone | October 2008 | | |
| Pomalyst | pomalidomide | March 2015 | | |
| Poteligeo | mogamulizumab (genetical recombination) | March 2012 | | |
| Pradaxa | dabigatran etexilate methanesulfonate | January 2011 | | |
| Pralia Partial Change Approval | denosumab (genetical recombination) | July 2017 | | |
| Praluent | alirocumab (genetical recombination) | July 2016 | | * |
| Prizbind | idarucizumab (genetical recombination) | September 2016 | | |
| Proemend | fosaprepitant meglumine | March 2016 | | |
* Errata sheet. The English translation has been corrected accordingly.
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Quattrovac | adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine | July 2012 | | 1. 2. |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Radicut | edaravone | June 2015 | | |
| Rapalimus (tablet) | sirolimus | July 2014 | | |
| Rapalimus (topical gel) | sirolimus | March 2018 | | |
| Rapiacta | peramivir hydrate | January 2010 | | |
| Rasilez | aliskiren fumarate | July 2009 | | |
| Rasuritek | rasburicase (genetical recombination) | October 2009 | | |
| Rebetol Partial Change Approval | ribavirin | September 2016 | | |
| Rebetol Partial Change Approval | ribavirin | March 2017 | | |
| Regroth | trafermin (genetical recombination) | September 2016 | | |
| Remicade | infliximab (genetical recombination) | August 2015 | | |
| Remitch | nalfurafine hydrochloride | January 2009 | | |
| Repatha | evolocumab (genetical recombination) | January 2016 | | |
| Revlimid Partial Change Approval | lenalidomide hydrate | March 2017 | | |
| Revolade | eltrombopag olamine | October 2010 | | |
| Risperdal | risperidone | February 2016 | | |
| Rituxan | rituximab (genetical recombination) | August 2014 | | |
| Romiplate | romiplostim (genetical recombination) | January 2011 | | |
| Rozerem | ramelteon | April 2010 | | |
| Ryzodeg | insulin degludec (genetical recombination) / insulin aspart (genetical recombination) | December 2012 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Samsca | tolvaptan | March 2014 | | |
| Seebri | glycopyrronium bromide | September 2012 | | |
| Soliris | eculizumab (genetical recombination) | April 2010 | | |
| Sovaldi Initial Approval | sofosbuvir | March 2015 | | |
| Sovaldi Partial Change Approval | sofosbuvir | March 2017 | | |
| Sovriad | simeprevir sodium | September 2013 | | |
| Spinraza Initial Approval | nusinersen sodium | July 2017 | | |
| Spinraza Partial Change Approval | nusinersen sodium | September 2017 | | |
| Spiolto | tiotropium bromide hydrate/olodaterol hydrochloride | September 2015 | | |
| Squarekids | adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (salk vaccine) combined vaccine | July 2014 | | |
| Stelara Initial Approval | ustekinumab (genetical recombination) | December 2010 | | |
| Stelara Partial Change Approval | ustekinumab (genetical recombination) | March 2017 | | |
| Stivarga Initial Approval | regorafenib hydrate | March 2013 | | |
| Stivarga Partial Change Approval | regorafenib hydrate | June 2017 | | |
| Strensiq | asfotase alfa (genetical recombination) | July 2015 | | |
| Stribild | elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate | March 2013 | | |
| Suglat | ipragliflozin L-proline | January 2014 | | |
| Suiny | anagliptin | December 2015 | | |
| Sunvepra | asunaprevir | July 2014 | | |
| Symproic | naldemedine tosilate | March 2017 | | |
| Synflorix | pneumococcal 10-valent conjugate vaccine adsorbed (non-typeable haemophilus influenzae [NTHi] protein D, diphtheria or tetanus toxoid conjugates) | March 2015 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Tafinlar | dabrafenib mesilate | March 2016 | | |
| Tagrisso | osimertinib mesilate | March 2016 | | |
| Takecab | vonoprazan fumarate | December 2014 | | |
| Takelda | aspirin/lansoprazole | March 2014 | | |
| Talion | bepotastine besilate | May 2015 | | |
| Taltz | ixekizumab (genetical recombination) | July 2016 | | |
| Tenelia | teneligliptin hydrobromide hydrate | June 2012 | | |
| Tetrabik | adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine | July 2012 | | 1. 2. |
| Thaled | thalidomide | October 2008 | | |
| Tivicay | dolutegravir sodium | March 2014 | | |
| Topiloric/Uriadec | topiroxostat | June 2013 | | |
| Topina | topiramate | July 2007 | | |
| Tracleer (pediatric dispersible tablets) | bosentan hydrate | September 2015 | | |
| Treakisym Partial Change Approval | bendamustine hydrochloride | December 2016 | | |
| Tresiba Initial Approval | insulin degludec (genetical recombination) | September 2012 | | |
| Tresiba Partial Change Approval | insulin degludec (genetical recombination) | August 2015 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Uptravi | selexipag | September 2016 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Vemlidy | tenofovir alafenamide fumarate | December 2016 | | |
| Victoza | liraglutide (genetical recombination) | January 2010 | | |
| Viekirax Initial Approval | ombitasvir hydrate/paritaprevir hydrate/ritonavir | September 2015 | | |
| Viekirax Partial Change Approval | ombitasvir hydrate/paritaprevir hydrate/ritonavir | September 2016 | | |
| Votrient | pazopanib hydrochloride | September 2012 | | |
| Vyndaqel | tafamidis meglumine | September 2013 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Xalkori Initial Approval | crizotinib | March 2012 | | |
| Xalkori Partial Change Approval | crizotinib | May 2017 | | |
| Xeljanz | tofacitinib citrate | March 2013 | | |
| Xiaflex | collagenase (clostridium histolyticum) | July 2015 | | |
| Ximency | daclatasvir hydrochloride/asunaprevir/beclabuvir hydrochloride | December 2016 | | |
| Xofluza | baloxavir marboxil | February 2018 | | 1.2.3. |
| Xolair | omalizumab (genetical recombination) | January 2009 | | |
| Xospata | gilteritinib fumarate | September 2018 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Yervoy | ipilimumab (genetical recombination) | July 2015 | | |
| Yondelis | trabectedin | September 2015 | | |
| Name | Active Ingredient | Approved In | PDF EN | PDF JP |
|---|---|---|---|---|
| Zafatek | trelagliptin succinate | March 2015 | | |
| Zagallo | dutasteride | September 2015 | | |
| Zetia | ezetimibe | April 2007 | | |
| Zykadia | ceritinib | March 2016 | | |
| Zyprexa/Olanzapine | olanzapine | December 2017 | | |
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