FDA Logo links to FDA home page
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

horizontal rule
CBER links to product areas
CBER links
horizontal rule

Product Approval Information - Licensing Action

horizontal rule

Proper name: BCG, Live
Tradename: PACIS
Manufacturer: BioChem Pharma Inc, Sainte-Foy, Quebec, Canada, License #1283
Indication for Use: Treatment of carcinoma-in-situ (CIS) in the absence of associated invasive cancer of the bladder
Approval Date: 3/9/2000
Type of submission: Biologics license application

horizontal rule

Approval Letter - (PDF), (Text)

Label - (PDF)

 

Updated March 5, 2001
 
horizontal rule

CBER Home Page | CBER A-Z Index | CBER Search | Contact CBER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA / Center for Biologics Evaluation and Research