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U.S. Department of Health and Human Services


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Interferon beta-1b Product Approval Information - Licensing Action 3/14/03

Proper name: Interferon beta-1b
Tradename: Betaseron
Manufacturer: Chiron Corp, Emeryville, CA, License #1106
Revised Package Insert: Revised the Clinical Studies section, Adverse Reactions and Warnings sections, and provided a Medication Guide
Approval Date: 3/14/2003
Type of submission: Biologics license application supplement


Label (PDF)

Medication Guide (PDF)

Clinical Reviews (PDF)

Statistical Review (PDF)