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

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Current effective version

Revision 1 - Adopted guideline

Reference numberCPMP/EWP/021/97 Rev. 1
Published13/10/2005
Effective from01/05/2006
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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