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U.S. Department of Health and Human Services


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Interferon beta-1a Approval Information - Licensing Action

Proper name: Interferon beta-1a
Tradename: Rebif
Manufacturer: Serono, Inc, Rockland, MA, License #1574
Revised Package Insert: Final pivotal study report that confirms the results of 48 week data 
Approval Date: 5/2/2003
Type of submission: Biologics license application supplement


Label (PDF)

Clinical Review (PDF)

Statistical Review (PDF)