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 24/02/2021

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
Shire Services BVBA
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Rue Montoyer 47
B-1000 Brussels

Product information

01/02/2021 Cinryze - EMEA/H/C/001207 - IAIN/0085


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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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