Reason for request

Inclusion

No clinical benefit demonstrated when compared with intravenous patient-controlled analgesia, in the treatment of acute moderate to severe post-operative pain in adult patients

  • ZALVISO has Marketing Authorisation in the treatment of acute moderate to severe post-operative pain in adult patients.
  • The ZALVISO administration device is designed to deliver a single sufentanil 15 micrograms sublingual tablet, on a patient-controlled as needed basis, with a minimum interval of 20 minutes between doses, over a maximum period of 72 hours. No benefit has been demonstrated by comparison with intravenous, patient-controlled analgesia.

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Évaluation des médicaments