Raplixa
human fibrinogen / human thrombin
Table of contents
Overview
The marketing authorisation for Replixa has been withdrawn at the request of the marketing authorisation holder.
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List item
Raplixa : EPAR - Summary for the public (PDF/546.23 KB)
First published: 04/05/2015
Last updated: 10/10/2018
EMA/55672/2015 -
List item
Raplixa : EPAR - Risk-management-plan summary (PDF/571.38 KB)
First published: 04/05/2015
Last updated: 10/10/2018
Authorisation details
| Product details | |
|---|---|
| Name |
Raplixa
|
| Agency product number |
EMEA/H/C/002807
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Hemostasis, Surgical
|
| Anatomical therapeutic chemical (ATC) code |
B02BC30
|
Additional 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
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.