[SHINSA]English Translation of Review Report: Jivi (Partial Change Approval)

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.

The review report contains contents for which the marketing authorization holder holds copyright and other rights.
In addition, the Ministry of Health, Labour and Welfare holds copyright and other rights for the report on the deliberation results.
You are responsible for confirming any rights relevant to your intended use of the Content.

Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency

Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency

Note 1 The English translation has been corrected accordingly.

Note 1 The English translation has been corrected accordingly.

Note 1 The English translation has been corrected accordingly.

Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency

Note 1 The English translation has been corrected accordingly.

Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency

Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency

Note 1 The English translation has been corrected accordingly.
Note 2 Special Approval for Emergency