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 Interferon beta-1a

Product 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


Approval Letter (Text)

Label (PDF)

Clinical Review (PDF)

Statistical Review (PDF)

Updated August 5, 2003

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Date created: September 24, 2003

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