Reason for request

Inclusion on the list of medicines refundable by National Health Insurance and approved for hospital use of a new formulation of the hard capsule presentation (removal of the caffeine, increase in the doses of paracetamol from 300 to 500 mg and of opium from 10 to 25 mg and of the opium/paracetamol ratio from 0.03 to 0.05).

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Clinical Benefit

Substantial

The actual benefit offered by LAMALINE 500 mg/25 mg, hard capsule, is substantial.


Clinical Added Value

no clinical added value

In light of the results of non-inferiority studies, LAMALINE 500 mg/25 mg, hard capsule, does not offer any improvement in actual benefit (IAB V) compared to the other low-potency opioids in the management of acute pain of moderate to severe intensity and/or not responding to the use of peripheral analgesics alone.


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Évaluation des médicaments

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