Ceprotin
human protein C
Table of contents
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).
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) |
|
Anatomical therapeutic chemical (ATC) code |
B01AD12
|
Publication details | |
---|---|
Marketing-authorisation holder |
Takeda Manufacturing Austria AG
|
Revision |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
15/07/2001
|
Contact address |
Product information
28/10/2020 Ceprotin - EMEA/H/C/000334 - IB/0117
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.