Interferon beta-1a
Product Approval Information - Licensing Action
Proper name: Interferon beta-1a
Tradename: Rebif
Manufacturer: Serono, Inc, Rockland, MA, License #1574
Indication for Use: Treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability
Approval Date: 3/7/2002
Type of submission: Biologics license application
Approval Letter
(Text),
(PDF)
Comparative Study - (PDF)
Office of Orphan Products Development Analysis - (PDF)
Medical Officer's Review - (PDF)
Medical Officer's Clinical Review - (PDF)
Consult Review - (PDF)
Stability Review - (PDF)
Stability Review (addendum) - (PDF)
CMC Review 1 - (PDF)
CMC Review 2 - (PDF)
CMC Review 3 - (PDF)
Statistical Review - (PDF)
Statistical Review 2 - (PDF)
Toxicology Review - (PDF)
Immunogenicity Review - (PDF)
Label - (PDF)
Medication Guide - (PDF)
Last Updated: 4/3/2002
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Date created: September 23, 2003 |