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Label Changes for:

PegIntron (peginterferon alfa-2b) in combination with Rebetol (ribavirin)

December 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- December 2008


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.

Summary View


Sections Modified


... revised to include the risk of cerebrovascular complications due to stroke.