C1 inhibitor (human)

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Cinryze. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cinryze.

This EPAR was last updated on 10/10/2022

Authorisation details

Product details
Agency product number
Active substance
C1 inhibitor (human)
International non-proprietary name (INN) or common name
C1 inhibitor (human)
Therapeutic area (MeSH)
Angioedemas, Hereditary
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional 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
Takeda Manufacturing Austria AG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Industriestrasse 67
1221 Vienna

Product information

06/10/2022 Cinryze - EMEA/H/C/001207 - IAIN/0095

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Product information documents contain:

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

  • c1-inhibitor, plasma derived
  • Drugs used in hereditary angioedema

Therapeutic indication

Treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (HAE).

Routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.

Assessment history

Changes since initial authorisation of medicine

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