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.
Ruconest : EPAR - Summary for the public (PDF/81.58 KB)
First published: 08/11/2010
Last updated: 06/02/2017
Ruconest : EPAR - Risk-management-plan summary (PDF/229.13 KB)
First published: 18/05/2020
|Agency product number||
Recombinant human C1-inhibitor
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Pharming Group N.V.
|Date of issue of marketing authorisation valid throughout the European Union||
NL-2333 CR Leiden
01/02/2021 Ruconest - EMEA/H/C/001223 - N/0060
- 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.
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Drugs used in hereditary angioedema
Other hematological agents
Ruconest is indicated for treatment of acute angioedema attacks in adults with hereditary angioedema (HAE) due to C1-esterase-inhibitor deficiency.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020 (updated)27/03/2020
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 201611/11/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 201626/02/2016