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Interferon beta-1b
Product Approval Information - Licensing Action
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
Approval Letter
(Text)
Label
(PDF)
Medication Guide
(PDF)
Clinical Reviews
(PDF)
(PDF)
Statistical Review
(PDF)
Updated July 17, 2003
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Date created: September 23, 2003 |
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