Reason for request
First assessment
Key points
Favourable opinion for reimbursement in the relief of moderate to severe acute pain in children from 2 years of age and in adults, which can be adequately managed only with opioid analgesics.
What therapeutic improvement?
No clinical added value in the management of moderate to severe acute pain.
Role in the care pathway?
PALEXIA is a first-line treatment, for which the role compared to other opioid analgesics remains to be specified in the indication.
Clinical Benefit
Substantial |
the clinical benefit of, PALEXIA oral solution is substantial in the MA indication in children.
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Low |
Clinical Added Value
no clinical added value |
PALEXIA oral solution provides no clinical added value (CAV V) in the management of moderate to severe acute pain in children and adults.
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Documents
English version
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Évaluation des médicaments