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MIFFEE (mifepristone), progesterone receptor modulator
GYNAECOLOGY - Update
Opinions on drugs -
Posted on
May 10 2017
Reason for request
Re-assessment of the actual benefit
No new clinical efficacy data.
Data on its prescribing conditions, efficacy and safety must be provided within a maximum of one year.
- MIFFEE has marketing authorisation for medical termination of developing intrauterine pregnancy, in sequential use with a prostaglandin analogue, up to 63 days of amenorrhoea.
- The data provided by the pharmaceutical company after 2 years of marketing do not answer the Transparency Committee’s questions about prescribing methods for MIFFEE (dose administered) and the associated prostaglandin (type, dose administered and route of administration) in France.
Clinical Benefit
| Substantial |
- |
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