Raplixa

Withdrawn

This medicine's authorisation has been withdrawn

human fibrinogen / human thrombin

Overview

The marketing authorisation for Replixa has been withdrawn at the request of the marketing authorisation holder.

Raplixa : EPAR - Summary for the public

Reference Number: EMA/55672/2015

Raplixa : EPAR - Risk-management-plan summary

Product information

Raplixa : EPAR - Product Information

Latest procedure affecting product information: IB/0021/G

19/03/2018

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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
• 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

AdoptedReference Number: EMA/CHMP/747327/2014

CHMP summary of positive opinion for Raplixa

AdoptedReference Number: EMA/CHMP/197/2015