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RELISTOR (methylnaltrexone bromide) - Opioid-induced constipation
Reason for request
Summary of opinion
Favourable opinion for reimbursement in the MA indication.
No clinical added value of the new forms compared to the RELISTOR 12 mg/0.6 mL solution for injection (methylnaltrexone bromide) forms already available.
Clinical Benefit
| Substantial |
The Committee considers that the clinical benefit of RELISTOR 12 mg/0.6 mL solution for injection (methylnaltrexone bromide), remains substantial in the indication “Treatment of opioid-induced constipation in palliative care patients with advanced illness when response to usual laxative therapy has not been sufficient”. |
| Low |
The Committee considers that the clinical benefit of RELISTOR 12 mg/0.6 mL solution for injection (methylnaltrexone bromide), remains low in the indication “Treatment of constipation in non-palliative care patients without advanced illness treated with opioids, when response to usual laxative therapy has not been sufficient”. |
Clinical Added Value
| no clinical added value |
These medicinal products are range supplements that do not provide any clinical added value (CAV V) compared to the RELISTOR 12 mg/ 0.6 mL solution for injection (methylnaltrexone bromide) forms already listed. |
