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RAPLIXA, sealant powder based on human fibrinogen and thrombin
SURGERY - New medicinal product
Opinions on drugs -
Posted on
Jan 18 2016
Reason for request
Inclusion
No clinical benefit demonstrated in the current surgical treatment to improve haemostasis in combination with gelatin sponge when standard surgical techniques are inadequate.
- RAPLIXA has restricted Marketing Authorisation as an adjuvant treatment to improve haemostasis in surgery when standard surgical techniques are inadequate.
- This sealant powder must be used in combination with gelatin sponge bearing the CE marking.
- RAPLIXA used in combination with gelatin sponge alongside standard methods in elective surgery has been found to reduce the median time to intraoperative haemostasis by a maximum of about 2 minutes compared with gelatin sponge alone.
- Its contribution in reducing morbidity and mortality – in particular transfusions, repeat surgical procedures, operating time, duration of hospitalisation, deaths – has not been demonstrated.
- In the absence of any comparison between RAPLIXA and an adjuvant treatment other than gelatin sponge, it is not possible to assess its therapeutic benefit versus alternatives in routine use, particularly a different fibrin sealant or thrombin product.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
- |
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