Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement in the symptomatic treatment of moderate to severe pain.

The use of IXPRIM and ZALDIAR should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol.

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


Clinical Benefit

Substantial

The clinical benefit of IXPRIM 37.5 mg/325 mg film-coated tablets and ZALDIAR 37.5 mg/325 mg film-coated tablets (tramadol/paracetamol) is substantial in the MA indication.


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 forms already listed.


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