conestat alfa

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Ruconest. 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 Ruconest.

This EPAR was last updated on 11/03/2021

Authorisation details

Product details
Agency product number
Active substance
Recombinant human C1-inhibitor
International non-proprietary name (INN) or common name
conestat alfa
Therapeutic area (MeSH)
Angioedemas, Hereditary
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Pharming Group N.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Darwinweg 24
NL-2333 CR Leiden
The Netherlands

Product information

01/02/2021 Ruconest - EMEA/H/C/001223 - N/0060

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


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

  • Drugs used in hereditary angioedema
  • Other hematological agents

Therapeutic indication

Ruconest is indicated for treatment of acute angioedema attacks in adults with hereditary angioedema (HAE) due to C1-esterase-inhibitor deficiency.

Assessment history

Related content

How useful was this page?

Add your rating
3 ratings
1 rating