Raplixa

Withdrawn

This medicine's authorisation has been withdrawn

human fibrinogen / human thrombin

Overview

On 19 March 2018, the European Commission withdrew the marketing authorisation of Raplixa (human fibrinogen / human thrombin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Mallinckrodt Pharmaceuticals Ireland Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Raplixa was granted marketing authorisation in the EU on 19 March 2015 as supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis. The marketing authorisation was initially valid for a 5-year period. 

The European Public Assessment Report (EPAR) for Raplixa is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Raplixa : EPAR - Summary for the public

Reference Number: EMA/55672/2015

Raplixa : EPAR - Risk-management-plan summary

Product information

Raplixa : EPAR - Product Information

Raplixa : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Raplixa
• Active substance:
  • human fibrinogen
  • human thrombin
• International non-proprietary name (INN) or common name:
  • human fibrinogen
  • human thrombin
• Therapeutic area (MeSH):
  Hemostasis, Surgical
• Anatomical therapeutic chemical (ATC) code:
  B02BC30

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002807
• Marketing authorisation holder:
  Mallinckrodt Pharmaceuticals Ireland Limited

  College Business Technology Park; Cruiserath; Blanchardstown; Dublin 15; Ireland

• Marketing authorisation issued:
  19/03/2015
• Withdrawal of marketing authorisation:
  19/03/2018
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Raplixa : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Raplixa : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/747327/2014

CHMP summary of positive opinion for Raplixa

Adopted Reference Number: EMA/CHMP/197/2015