Medication Guide App

Label Changes for:

Evamist (estradiol transdermal spray)

October 2011

Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011

 

 

BOXED WARNING

  • Unintentional secondary exposure........added

 

WARNINGS AND PRECAUTIONS

Unintentional Secondary Exposure to Estrogen.....added

 

PATIENT COUNSELLING INFORMATiON

Unintentional Secondary Exposure to Estrogen...added

 

PATIENT PACKAGE INSERT

  • extensive changes re: unintentional secondary exposure to estrogen
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