Label Changes for:

Copegus (ribavirin) tablet

March 2010

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2010

ADVERSE REACTIONS

Postmarketing Experience
  • Additionally, pure red cell aplasia (PRCA) has been reported with Copegus in combination with Pegasys.
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