ReportontheDeliberationResults

December28,2009

EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau

MinistryofHealth,LabourandWelfare

[Brandname]Rapiacta300mgbagforintravenousdripinfusion

Rapiacta150mgvialforintravenousdripinfusion

[Non-proprietaryname]PeramivirHydrate(JAN*)

[Applicant]ShionogiCo.,Ltd.

[Dateofapplication]October30,2009

[Resultsofdeliberation]

InthemeetingheldonDecember26,2009,theSecondCommitteeonNewDrugsconcluded

thattheproductmaybeapprovedandthatthisresultshouldbereportedtothePharmaceutical

AffairsDepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct,the

re-examinationperiodis8years,andneitherthedrugsubstancenorthedrugproductis

classifiedasapoisonousdrugorapowerfuldrug.

Thedosageandadministrationstatementofthepackageinsertshouldbemodifiedasfollows:

“Usually,foradults,300mgofperamivirshouldbeadministeredasasingleintravenous

infusionoveratleast15minutes.

Forpatientsathighriskforsevereinfluenzacomplicationsetc.,600mgofperamivirshouldbe

administeredasasingleintravenousinfusionoveratleast15minutes.Once-dailymultiple

dosesof600mgmaybeadministeredaccordingtothepatient’ssymptoms.

Thedosageshouldbereduced,asappropriate,accordingtothepatient’sageandsymptoms.”

(Theunderlinedtextrepresentsaddition.)

This