Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 10 May 2019


Medicinal product no longer authorised

Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis.
Raplixa must be used in combination with an approved gelatin sponge.

Raplixa is indicated in adults over 18 years of age.


Full Prescribing information

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Category Value
Agency product number EMEA/H/C/002807
Orphan designation No
Date First Approved 19-03-2015
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Mallinckrodt Specialty Pharmaceuticals Ireland Ltd
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions