Clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women - Scientific guideline

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This document provides recommendations for the development of medicinal products intended for the treatment of oestrogen deficiency symptoms in post-menopausal woman. It applies to products containing as an active substance an oestrogen alone, an oestrogen in combination with a progestogen or a progestogen to be given with an oestrogen.

Keywords: Hormone replacement therapy (HRT)

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