Cinryze

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C1 inhibitor (human)

Authorised
This medicine is authorised for use in the European Union.

Overview

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 12/04/2018

Authorisation details

Product details
Name
Cinryze
Agency product number
EMEA/H/C/001207
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
B06AC01
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
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
15/06/2011
Contact address
Rue Montoyer 47
B-1000 Brussels
Belgium

Product information

20/03/2018 Cinryze - EMEA/H/C/001207 - IAIN/0060

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

Other haematological agents

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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