Overview

Ceprotin is a medicine used in patients with severe congenital protein C deficiency, a condition that increases the risk of blood clots. It is used to treat and prevent:

  • purpura fulminans (extensive clotting of blood within the blood vessels, which causes the death of the tissues just beneath the skin, often leading to organ failure and amputations);
  • coumarin-induced skin necrosis (a complication of medicines used to prevent blood clotting such as warfarin, which causes skin death);
  • venous thromboembolism (problems due to the formation of blood clots in the veins).

Ceprotin contains the active substance human protein C.

Ceprotin treatment should only be started by a doctor who has experience in this type of therapy and in a setting where it is possible to measure protein C activity. Ceprotin is given by injection into a vein. It should only be given in a facility with life-supporting facilities as allergic reactions are possible.

The medicine can only be obtained with a prescription. For more information about using Ceprotin, see the package leaflet or contact your doctor or pharmacist.

Ceprotin contains human protein C, extracted and purified from human plasma (the liquid part of the blood). In the body, protein C controls the generation of thrombin, one of the substances (factors) involved in blood clotting. Protein C slows down the production of thrombin, and therefore slows down further clotting. An injection of Ceprotin gives an immediate but temporary increase in levels of protein C. Replacement of protein C in protein C-deficient patients should control or prevent clotting problems in these patients.

An analysis of 79 patients, 22 of whom had severe forms of congenital protein C deficiency, looked at how well Ceprotin treatment could bring the patients’ levels of protein C and other substances involved in clotting to normal levels and improve their skin lesions. In patients with severe congenital protein C deficiency, Ceprotin was effective at treating all 16 cases of purpura fulminans and all six episodes of coumarin-induced skin necrosis.

In addition, a study in 18 patients with severe congenital protein C deficiency showed that Ceprotin was effective at treating all of the 24 episodes of purpura fulminans, coumarin-induced skin necrosis and venous thromboembolism that occurred in a total of 11 patients. When used for short or long-term prevention, no purpura fulminans, coumarin-induced skin necrosis or venous thromboembolism occurred.

Hypersensitivity (allergic reactions), including severe reactions, can occur with Ceprotin. 

Ceprotin must not be used in people who may be hypersensitive (allergic) to human protein C, mouse protein or to heparin, except in life-threatening complications.

For the full list of all side effects of Ceprotin, see the package leaflet.

Studies have shown that Ceprotin can treat and prevent purpura fulminans, coumarin-induced skin necrosis and venous thromboembolism, which are major complications in patients with severe congenital protein C deficiency. Safety data have also shown that the side effects of the medicine are rare and manageable.

The Agency therefore concluded that Ceprotin’s benefits are greater than its risks for patients with severe congenital protein C deficiency and recommended and recommended that it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ceprotin have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Ceprotin are continuously monitored. Suspected side effects reported with Ceprotin are carefully evaluated and any necessary action taken to protect patients.

Ceprotin was granted a marketing authorisation valid throughout the EU on 16 July 2001.

Ceprotin : EPAR - Summary for the public

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Ceprotin : EPAR - Risk-management-plan summary

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Product information

Ceprotin : EPAR - Product Information

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Latest procedure affecting product information: H/C/000334

03/07/2023

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This medicine’s product information is available in all official EU languages.
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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).

Ceprotin : EPAR - All Authorised presentations

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Product details

Name of medicine
Ceprotin
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

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

CEPROTIN is indicated for prophylaxis and treatment of  purpura fulminans  coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein C deficiency.

Authorisation details

EMA product number
EMEA/H/C/000334
Marketing authorisation holder
Takeda Manufacturing Austria AG

Industriestrasse 67
1221 Vienna
Austria

Marketing authorisation issued
16/07/2001
Revision
19

Assessment history

Ceprotin : EPAR - Procedural steps taken and scientific information after authorisation

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CHMP post-authorisation summary of positive opinion for Ceprotin (II-127)

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Ceprotin : EPAR - Assessment report

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Ceprotin : EPAR - Procedural steps taken before authorisation

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Ceprotin : EPAR - Scientific discussion

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