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COLPRONE (medrogestone) - gynecological
Reason for request
Summary of opinion
Favourable opinion for reimbursement only:
“when the therapeutic alternatives have failed or are contraindicated and in compliance with the recommendations for monitoring by brain imaging (irrespective of age) in the
following indications:
- disorders related to progesterone insufficiency and particularly those observed in the premenopausal period: severe mastodynia associated with mastopathy,
- fibroid-related functional haemorrhages and menorrhagia as preoperative treatment,
- endometriosis”
Unfavourable opinion for reimbursement in the other situations covered by the MA indication.
Clinical Benefit
| Substantial |
The Committee deems that the clinical benefit of COLPRONE 5 mg (medrogestone) is substantial only when the therapeutic alternatives have failed or are contraindicated and in compliance with the recommendations for monitoring by brain imaging (irrespective of age) in disorders related to progesterone insufficiency and particularly those observed in the premenopausal period: severe mastodynia associated with mastopathy.
|
| Insufficient |
The Committee deems that the clinical benefit of COLPRONE 5 mg (medrogestone) is insufficient to justify public funding in the other MA situations. |
Clinical Added Value
| Not applicable |
