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U.S. Department of Health and Human Services

Safety

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Copegasus-ß (ribavirin) 200 mg tablets in combination with Pegasys-ß (peginterferon alfa-2a)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Brand (Generic) Name

Sections Modified

Copegasus-ß (ribavirin) 200 mg tablets in combination with Pegasys-ß (peginterferon alfa-2a)

Label approved 04/15/2009 is not available on Drugs@FDA

 

ADVERSE REACTIONS

  • Postmarketing Experience
    • addition of serous retinal detachment

 

MEDICATION GUIDE

  • to include FDA's telephone number, 1-800-FDA-1088, for reporting of side effects information
  • provides an additional reporting telephone number for Hoffmann-Roche

 

 
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