SELEXID (pivmecillinam), related to beta-lactams

INFECTIOUS DISEASES - Update
Opinions on drugs - Posted on Oct 25 2017

Reason for request

Re-assessment of the actual benefit and of the improvement in actual benefit

No clinical benefit demonstrated when compared with available alternatives in the treatment of urinary tract infections in adult women, in second-line in the therapeutic strategy.

 

  • SELEXID has Marketing Authorisation in the treatment of urinary tract infections in adult women.
  • It is a second-line therapeutic option in adult women in the treatment of acute uncomplicated cystitis and cystitis at risk of complication (including cystitis in pregnancy) as well as in the treatment of urinary tract colonisation in pregnancy.
  • Its efficacy has been demonstrated only in the case of acute uncomplicated cystitis in adult women. In other clinical situations, no studies are available.
  • The new dosages and indications are based on therapeutic recommendations in the field of urinary tract infections.

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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