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ESMYA (ulipristal), progesterone receptor modulator
GYNAECOLOGY - Focus
Opinions on drugs -
Posted on
Nov 12 2015
Reason for request
Inclusion
Insufficient actual benefit in patients receiving a second 3-month course of treatment in the pre-operative treatment of moderate to severe symptoms of uterine fibroids
Substantial actual benefit in patients receiving a first 3-month course of treatment
- ESMYA has Marketing Authorisation in the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
- The 3-month limitation on the period of treatment has been deleted and a second 3-month period of treatment, if deemed appropriate by the treating doctor, has been authorised. The Marketing Authorisation recommends that treatment should not exceed 2 periods of 3 months because of the lack of long-term safety data.
- There are no data from which an assessment can be made of the efficacy of ESMYA prescribed for two successive periods of 3 months’ treatment at the dosage of the Marketing Authorisation. A second period of 3 months’ treatment therefore has no place in the therapeutic strategy.
Clinical Benefit
| Substantial |
- |
| Insufficient |
Clinical Added Value
| no clinical added value |
- |
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