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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 |
|---|---|---|---|---|
| Actemra | tocilizumab (genetical recombination) | Apr. 2008 |  |
|
| Adsorbed Influenza Vaccine (H5N1) "HOKKEN" | adsorbed influenza vaccine (H5N1) | Oct. 2007 | |
|
| Adsorbed Influenza Vaccine (H5N1) "BIKEN" | adsorbed influenza vaccine (H5N1) | Oct. 2007 | |
|
| Avastin | bevacizumab (genetical recombination) | Apr. 2007 | |
|
| Bridion | sugammadex sodium | Jan. 2010 | |
|
| Cervarix | recombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cell) | Oct. 2009 | |
|
| Clozaril | clozapine | Apr. 2009 | |
|
| Diquas | diquafosol sodium | Apr. 2010 | |
1. 2. |
| Geninax | garenoxacin mesilate hydrate | July 2007 | |
1. 2. |
| Isentress | raltegravir potassium | June 2008 | |
|
| Januvia/Glactiv | sitagliptin phosphate hydrate | Oct. 2009 | |
|
| Macugen | pegaptanib sodium | July 2008 | |
|
| Myozyme | alglucosidase alfa (genetical recombination) | Apr. 2007 | |
|
| Pirespa | pirfenidone | Oct. 2008 | |
|
| Poteligeo | mogamulizumab (genetical recombination) | Mar. 2012 | |
|
| Quattrovac | adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine | July 2012 | |
1. 2. |
| Rapiacta | peramivir hydrate | Jan. 2010 | |
|
| Rasilez | aliskiren fumarate | July 2009 |
|
|
| Rasuritek | rasburicase (genetical recombination) | Oct. 2009 |
|
|
| Remitch | nalfurafine hydrochloride | Jan. 2009 | |
|
| Rozerem | ramelteon | Apr. 2010 | |
|
| Soliris | eculizumab (general recombination) | Apr. 2010 | |
|
| Tetrabik | adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine | July 2012 | |
1. 2. |
| Thaled | thalidomide | Oct. 2008 | |
|
| Topina | topiramate | July 2007 | |
|
| Victoza | liraglutide (genetical recombination) | Jan. 2010 | |
|
| Xolair | omalizumab (genetical recombination) | Jan. 2009 | |
|
| Zetia | ezetimibe | Apr. 2007 | |
|