Is Human protein c authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Human protein c: Ceprotin.

Is Human protein c authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 2 products containing Human protein c, including CEPROTIN 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION; CEPROTIN 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION.

Active substance

Human protein c

EMA 1
UK MHRA 2

Open in the medicines table

EMA European Union — centrally authorised medicines

Ceprotin Takeda Manufacturing Austria AG · Authorised · authorised 16 Jul 2001 · ATC B01AD12

Therapeutic indication (EMA)

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.

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
CEPROTIN 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION	PLGB 06009/0033	TAKEDA MANUFACTURING AUSTRIA AKTIENGESELLSCHAFT	POM
CEPROTIN 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION	PLGB 06009/0034	TAKEDA MANUFACTURING AUSTRIA AKTIENGESELLSCHAFT	POM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.