Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement in the following indications:

  • CONTRAMAL 50 mg hard capsules: “Treatment of moderate to severe pain in adults” (adults and adolescents over 15 years of age)
  • CONTRAMAL LP 100 mg, 150 mg and 200 mg prolonged-release tablets: “Treatment of moderate to severe pain in adults” (adults and adolescents over 12 years of age)

No clinical added value of the new forms in non-pre-cut blister strips compared to the forms already available in individual pre-cut heat-formed blister strips.


Clinical Benefit

Substantial

The Committee considers that the clinical benefit of CONTRAMAL 50 mg hard capsules, and CONTRAMAL LP 100 mg, 150 mg and 200 mg prolonged-release tablets is substantial in the MA indication.

 


Clinical Added Value

no clinical added value

These medicinal products are a range supplement that do not provide any clinical added value (CAV V) compared to the forms already listed.


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