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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.
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Clinical Benefit
| Substantial |
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 |
