Cysview

Product manufactured by Photocure Asa

Application Nr Approved Date Route Status External Links
NDA022555 None None None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Cysview Is Indicated For Use In The Cystoscopic Detection Of Carcinoma Of The Bladder, Including Carcinoma In Situ (Cis), Among Patients Suspected Or Known To Have Lesion(S) On The Basis Of A Prior Cystoscopy, Or In Patients Undergoing Surveillance Cystoscopy For Carcinoma Of The Bladder. Cysview Is Used With The Karl Storz D-Light C Photodynamic Diagnostic (Pdd) System To Perform Blue Light Cystoscopy (Blcâ„¢) As An Adjunct To The White Light Cystoscopy. Cysview Is An Optical Imaging Agent Indicated For Use In The Cystoscopic Detection Of Carcinoma Of The Bladder, Including Carcinoma In Situ (Cis), Among Patients Suspected Or Known To Have Lesion(S) On The Basis Of A Prior Cystoscopy, Or In Patients Undergoing Surveillance Cystoscopy For Carcinoma Of The Bladder. Cysview Is Used With The Karl Storz D-Light C Photodynamic Diagnostic (Pdd) System To Perform Blue Light Cystoscopy (Blcâ„¢) As An Adjunct To The White Light Cystoscopy. Important Limitations Of Use: Not A Replacement For Random Bladder Biopsies Or Other Procedures Used In The Detection Of Bladder Cancer. ( 1.1 , 5.2 ) 1.1 Limitations Of Use Cysview Is Not A Replacement For Random Bladder Biopsies Or Other Procedures Used In The Detection Of Bladder Cancer [ See Warnings And Precautions (5.2) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Hexaminolevulinate Hydrochloride HEXAMINOLEVULINATE HYDROCHLORIDE ZINC1554392

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