Label Changes for:
Prempro 0.3 mg/1.5 mg and 0.45 mg/1.5 mg(conjugated estrogens/medroxyprogesterone acetate tablets)
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