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Opinions on drugs - Posted on Jul 03 2013

Reason for request

Extension of the indication


Clinical Benefit


Substantial AB

Clinical Added Value


Given the efficacy of VOTUBIA (everolimus) in reducing renal angiomyolipoma volume associated with tuberous sclerosis complex in adult patients, VOTUBIA provides a substantial improvement in actual benefit (IAB III) in the treatment of patients not requiring immediate surgery (nephrectomy or embolisation).

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