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Opinions on drugs - Posted on Jun 10 2014

Reason for request

Re-assessment of Actual Benefit and the Improvement in Actual Benefit in response to a request by the Directorate-General for Health and the Social Security Directorate, pursuant to Article R163-19 of the French Social Security Code.


Clinical Benefit


The actual benefit of TROBALT is substantial.

Clinical Added Value

no clinical added value

The TROBALT proprietary medicinal-products as an adjuvant with other anti epileptics do not provide any improvement in actual benefit (level V, non existent) in the therapeutic strategy for partial onset seizures with or without secondary generalisation in patients aged 18 years or older with epilepsy, where other appropriate drug combinations have proved inadequate or have not been tolerated