VIPERFAV (fragments F(ab’)2 of European viper antivenom equine immunoglobulin (Vipera aspis, Vipera berus, Vipera ammodytes))

Opinions on drugs - Posted on Jan 09 2025

Reason for request

Initial inclusion

Summary of opinion

Favourable opinion for reimbursement in the treatment of envenomation (grade II or III) by European vipers (Vipera aspis, Vipera berus, Vipera ammodytes), in patients with rapidly spreading oedema and/or systemic signs: vomiting, diarrhoea, abdominal pain and hypotension.

No clinical added value of the new concentrate for solution for infusion form compared to the forms already available.


Clinical Benefit

Substantial

The clinical benefit of VIPERFAV is substantial in the MA indication.


Clinical Added Value

no clinical added value

This medicinal product is a range supplement that does not provide any clinical added value (CAV V) compared to the form already listed.


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