Label Changes for:

Prempro 0.3 mg/1.5 mg and 0.45 mg/1.5 mg(conjugated estrogens/medroxyprogesterone acetate tablets)

May 2009

Changes have been made to the PATIENT PACKAGE INSERT sections of the safety label.

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

PATIENT PACKAGE INSERT

    What are the ingredients in Prempro and Premphase?

  • incorporates information on the reformulated Prempro 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets
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