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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. The PMDA shall not be responsible for any consequence resulting from use of the English versions.
New Drugs
The review reports are 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.
- Pirespa (Pirfenidone) (PDF)
- Thaled Capsule 100 (Thalidomide) (PDF)
- Macugen (Pegaptanib Sodium) (PDF)
- Actemra (Tocilizumab [Genetical Recombination]) (PDF)
- Adsorbed Influenza Vaccine (H5N1) "HOKKEN" (Adsorbed Influenza Vaccine [H5N1]) (PDF)
- Adsorbed Influenza Vaccine (H5N1) "BIKEN" (Adsorbed Influenza Vaccine [H5N1]) (PDF)
- Topina (Topiramate) (PDF)
- Geninax (Garenoxacin Mesilate Hydrate) (PDF)
- Zetia (Ezetimibe) (PDF)
- Myozyme (Alglucosidase Alfa [Genetical Recombination]) (PDF)
- Avastin (Bevacizumab [genetical recombination]) (PDF)