Drug Approval Package

Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Injectiion
Company: Hoffman La-Roche
Application No.: 125164
Approval Date: 11/14/2007

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Officer/Employee List (PDF)  

• Office Director Memo (PDF)  

• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Proprietary Name Review(s) (PDF) 
• Administrative Document(s) & Correspondence 
  Part 1 (PDF)  
  Part 2 (PDF)  

Date created: March 17, 2008

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