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Peginterferon alfa-2b
Product Approval Information - Licensing Action
Proper name: Peginterferon alfa-2b
Tradename: PEG-Intron
Manufacturer: Schering Corp, Kenilworth, NJ, License #0994
Indication for Use: Treatment of chronic hepatitis C in patients not previously treated with interferon alfa who have compensated liver disease and are at least 18 years of age
Approval Date: 1/19/2001
Type of submission: Biologics license application
Approval Letter (Text),
(PDF)
Label (PDF)
Medication Guide (PDF)
Summary Review (PDF)
Pharmacology Review (PDF)
Clinical Review (PDF)
Toxicologist's Review (PDF)
Clinical Review (PDF)
Last Updated: 8/5/2003
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Updated: September 25, 2003 |
