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

Table of contents

KeywordsHormone replacement therapy (HRT)
DescriptionThis 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.


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