Raplixa

RSS

human fibrinogen / human thrombin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

Authorisation details

Product details
Name
Raplixa
Agency product number
EMEA/H/C/002807
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
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Mallinckrodt Pharmaceuticals Ireland Limited
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
19/03/2015
Contact address
College Business Technology Park
Cruiserath
Blanchardstown
Dublin 15
Ireland

Product information

19/03/2018 Raplixa - EMEA/H/C/002807 - IB/0021/G

Contents

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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.

Assessment history

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