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Implications of the Pharmacovigilance Risk Assessment Committee recommendations for the treatment of genitourinary
George G Buttigieg1,2, Kirill Micallef-Stafrace3
1Department of Obstetrics and Gynaecology, University of Malta, Malta.
Abstract:
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has issued statements regarding limiting the use of high-dose oestradiol creams by women experiencing the genitourinary syndrome of menopause, and such statements carry much medicolegal weight. Although a low dose is most often used, some clinicians opt to use higher dose creams with close monitoring of the patient. The committee should publish the evidence behind these statements or amend its official position.
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