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BETMIGA (mirabegron), urinary antispasmodic

UROLOGY - Update
Opinions on drugs - Posted on Mar 29 2018

Reason for request

Re-assessment of the actual benefit

Insufficient clinical benefit to justify its inclusion on the list of reimbursable products for overactive bladder syndrome due to a poorly established efficacy/adverse effects ratio.


  • BETMIGA has Marketing Authorisation in the symptomatic treatment of urinary urgency and increased urinary frequency and/or urge incontinence that may occur in adults with overactive bladder syndrome (OAB).
  • Its efficacy is low compared with placebo. A study was unable to demonstrate the non-inferiority of BETMIGA compared with VESICARE (solifenacin) in terms of mean number of micturitions per day.
  • The cardiovascular tolerance of BETMIGA is still being monitored. 



Clinical Benefit



Therapeutic use


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