Drug Approval Package
Tysabri (Natalizumab)
Company: Biogen
Application No.: 125104
Approval Date: 11/23/2004
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)
Part 6 (PDF) -
Statistical Review(s) (PDF)
Date created: March 082005
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