Ceprotin

RSS

human protein C

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

This EPAR was last updated on 07/12/2018

Authorisation details

Product details
Name
Ceprotin
Agency product number
EMEA/H/C/000334
Active substance
human protein C
International non-proprietary name (INN) or common name
human protein C
Therapeutic area (MeSH)
  • Purpura Fulminans
  • Protein C Deficiency
Anatomical therapeutic chemical (ATC) code
B01AD12
Publication details
Marketing-authorisation holder
Baxter AG
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
15/07/2001
Contact address
Industriestrasse 67
A-1221 Vienna
Austria

Product information

13/09/2018 Ceprotin - EMEA/H/C/000334 - II/0104

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Ceprotin is indicated in purpura fulminans and coumarin-induced skin necrosis in patients with severe congenital protein C deficiency. Furthermore Ceprotin is indicated for short-term prophylaxis in patients with severe congenital protein C deficiency if one or more of the following conditions are met:

  • surgery or invasive therapy is imminent;
  • while initiating coumarin therapy;
  • when coumarin therapy alone is not sufficient;
  • when coumarin therapy is not feasible.

Assessment history

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