Reason for request

Reassessment of the Actual Benefit

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Clinical Benefit

Substantial

The actual benefit of the proprietary medicinal product ACTIVELLE in hormone replacement therapy (HRT) for oestrogen deficiency symptoms in menopausal women remains substantial in patients for whom menopausal disorders are sufficiently troublesome to impair their quality of life when this proprietary medicinal product is used according to the Committee's recommendations.

The actual benefit of the proprietary medicinal product ACTIVELLE remains substantial in the prevention of postmenopausal osteoporosis in women with an increased risk of osteoporotic fracture and who are intolerant of or contraindicated for other treatments indicated in the prevention of menopausal and recent postmenopausal osteoporosis, after a minor fracture or if there is a low T-score, when this proprietary medicinal product is used according to the committee's recommendations.


Therapeutic use

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