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.

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Clinical Benefit

Insufficient

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 proprietarymedicinal products must be regarded as insufficient for reimbursement by National Health Insurance.


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Évaluation des médicaments

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