Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Ruconest   
Auth. number : EU/1/10/641
Active substance : Conestat alfa
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B06 - Other hematological agents
Pharmacological subgroup: B06A - Other hematological agents
Chemical subgroup: B06AC - Drugs used in hereditary angioedema
Chemical substance: B06AC04 - conestat alfa
(See WHO ATC Index)
Indication: Treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency
Marketing Authorisation Holder: Pharming Group N.V.
Darwinweg 24, 2333 CR Leiden, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
04/11/2010 Centralised - Authorisation EMEA/H/C/1223 (2010)7632 of 28/10/2010
04/11/2010 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1223 (2010)7633 of 28/10/2010
25/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1223/IB/1/G
09/08/2011 Centralised - Variation EMEA/H/C/1223/IB/2
Updated with Decision(2012)1492 of 02/03/2012
06/03/2012 Centralised - Variation (2012)1492 of 02/03/2012
21/03/2013 Centralised - Variation EMEA/H/C/1223/II/10/G
Updated with Decision(2014)1685 of 10/03/2014
25/09/2013 Centralised - Variation EMEA/H/C/1223/IA/13
Updated with Decision(2014)1685 of 10/03/2014
12/03/2014 Centralised - Yearly update (2014)1685 of 10/03/2014
22/09/2015 Centralised - Renewal EMEA/H/C/1223/R/23 (2015)6536 of 18/09/2015
25/02/2016 Centralised - Variation EMEA/H/C/1223/II/32
Updated with Decision(2016)2022 of 31/03/2016
04/04/2016 Centralised - 2-Monthly update EMEA/H/C/1223/II/31 (2016)2022 of 31/03/2016
13/01/2017 Centralised - Variation EMEA/H/C/1223/X/34 (2017)183 of 11/01/2017
28/08/2017 PSUSA - Modification EMEA/H/C/PSUSA/873/201610 (2017)5934 of 24/08/2017
30/11/2017 Centralised - Variation EMEA/H/C/1223/IA/42
10/04/2018 Centralised - Notification EMEA/H/C/1223/N/46