Drug information for PREFEST

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET; ORAL	1MG,1MG;N/A,0.09MG	Prescription	AB (Reference Drug)	ESTRADIOL; NORGESTIMATE	Estradiol	TEVA WOMENS	21040 2005-08-02 Review 2004-07-21 Label 2004-07-21 Letter 2004-06-10 Letter 2004-02-10 Label 2004-02-10 Label 2004-02-10 Label 2004-02-10 Label 2004-02-10 Label 2003-12-23 Letter 2003-12-23 Letter 2003-12-23 Letter 2003-12-23 Letter 2003-12-23 Letter 1999-10-22 Letter 1999-10-22 Label

Drug Adverse Effects information for PREFEST

Role code	Indications	Reaction	# Reports
SS	HORMONE REPLACEMENT THERAPY	BREAST CANCER FEMALE	3
C	ACUTE MYELOID LEUKAEMIA	BACTERIAL INFECTION	6
C	ACUTE MYELOID LEUKAEMIA	PLEURAL EFFUSION	6
C	PAIN	BACTERIAL INFECTION	2
C	PAIN	PLEURAL EFFUSION	2
C	PYREXIA	BACTERIAL INFECTION	2
C	PYREXIA	PLEURAL EFFUSION	2

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