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.

EN: English, JP: Japanese   

Name Active Ingredient Approved In PDF
EN
PDF
JP
Acofide acotiamide hydrochloride hydrate Mar. 2013 PDF PDF
Actemra tocilizumab (genetical recombination) Apr. 2008 PDF *
Adsorbed Influenza Vaccine (H5N1)  "HOKKEN" adsorbed influenza vaccine (H5N1) Oct. 2007 PDF PDF 1.
PDF 2.
PDF 3.
Adsorbed Influenza Vaccine (H5N1)  "BIKEN" adsorbed influenza vaccine (H5N1) Oct. 2007 PDF PDF 1.
PDF 2.
PDF 3.
Alabel/Alaglio aminolevulinic acid hydrochloride Mar. 2013 PDF PDF
Avastin bevacizumab (genetical recombination) Apr. 2007 PDF PDF 1.
PDF 2.
PDF 3.
PDF 4.
PDF 5.
PDF 6.
Bridion sugammadex sodium Jan. 2010 PDF PDF
Cervarix recombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cell) Oct. 2009 PDF PDF
Clozaril clozapine Apr. 2009 PDF *
Diquas diquafosol sodium Apr. 2010 PDF PDF 1.
PDF 2.
Geninax garenoxacin mesilate hydrate July 2007 PDF PDF 1.
PDF 2.
Isentress raltegravir potassium June 2008 PDF PDF
Januvia/Glactiv sitagliptin phosphate hydrate Oct. 2009 PDF PDF 1.
PDF 2.
Lixiana edoxaban Apr. 2011 PDF PDF
Lyxumia lixisenatide June 2013 PDF PDF
Macugen pegaptanib sodium July 2008 PDF PDF
Metreleptin metreleptin (genetical recombination) Mar. 2013 PDF PDF
Myozyme alglucosidase alfa (genetical recombination) Apr. 2007 PDF PDF 1.
PDF 2.
Nouriast istradefylline Mar. 2013 PDF PDF
Orencia abatacept (genetical recombination) July 2010 PDF PDF
Perjeta pertuzumab (genetical recombination) June 2013 PDF PDF
Pirespa pirfenidone Oct. 2008 PDF *
Poteligeo mogamulizumab (genetical recombination) Mar. 2012 PDF PDF
Quattrovac adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine July 2012 PDF PDF 1.
PDF 2.
Rapiacta peramivir hydrate Jan. 2010 PDF PDF
Rasilez aliskiren fumarate July 2009
PDF *
Rasuritek rasburicase (genetical recombination) Oct. 2009
PDF PDF
Remitch nalfurafine hydrochloride Jan. 2009 PDF PDF
Rozerem ramelteon Apr. 2010 PDF *
Ryzodeg insulin degludec (genetical recombination) / insulin aspart (genetical recombination) Dec. 2012 PDF PDF
Seebri glycopyrronium bromide Sep. 2012 PDF PDF
Soliris eculizumab (general recombination) Apr. 2010 PDF PDF
Sovriad simeprevir sodium Sep. 2013 PDF PDF
Stivarga regorafenib hydrate Mar. 2013 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 Oct. 2008 PDF PDF
Topiloric/Uriadec topiroxostat June 2013 PDF PDF
Topina topiramate July 2007 PDF PDF
Tresiba insulin degludec (genetical recombination) Sep. 2012 PDF PDF
Victoza liraglutide (genetical recombination) Jan. 2010 PDF PDF
Votrient pazopanib hydrochloride Sep. 2012 PDF PDF
Vyndaqel tafamidis meglumine Sep. 2013 PDF PDF
Xalkori crizotinib Mar. 2012 PDF PDF
Xeljanz tofacitinib citrate Mar. 2013 PDF PDF
Xolair omalizumab (genetical recombination) Jan. 2009 PDF PDF
Zetia ezetimibe Apr. 2007 PDF *

*: PDF to be posted soon.