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GESTODENE/ETHINYLESTRADIOL WINTHROP

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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.

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Actual benefit

Insuffisant

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


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