Reason for request
Extension of indication
Clinical Benefit
| Substantial |
The actual benefit of BERINERT is substantial in th is extension of the indication to the short-term pre-procedure prevention of acute HAE episodes. |
Clinical Added Value
| no clinical added value |
For the short-term pre-procedure prevention of acute HAE episodes, BERINERT does not provide any improvement in actual benefit (IAB V, non-existent) over other treatments already available. |
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
ESDvSsLCDFJTe6x4
