MELIANE - MONEVA - PHAEVA - MELODIA
Opinions on drugs - Posted on Feb 06 2013
Reason for request
Re-assessment of the actual benefit of third-generation oral contraceptives in response to a request by the Directorate-General for Health dated 27 December 2011.
In 2012 the Transparency Committee considers that, taking into account both the increased risk of venous thromboembolic events and the lack of demonstrated benefit in terms of clinical safety in women exposed to third-generation oral contraceptives compared with second- or first-generation oral contraceptives, the actual benefit of these proprietary medicinal products MELIANE, MONEVA, PHAEVA et MELODIA must be regarded as insufficient for reimbursement by National Health Insurance.
Évaluation des médicaments