Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Cinryze   
Auth. number : EU/1/11/688
Active substance : C1 inhibitor, human
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: B06AC01 - C1-inhibitor, plasma derived
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Shire Services BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België
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
20/06/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1207 (2011)4349 of 15/06/2011
20/06/2011 Centralised - Authorisation EMEA/H/C/1207 (2011)4350 of 15/06/2011
16/04/2012 Centralised - Variation EMEA/H/C/1207/IB/2/G
Updated with Decision(2012)3464 of 22/05/2012
25/05/2012 Centralised - Variation EMEA/H/C/1207/II/1 (2012)3464 of 22/05/2012
17/08/2012 Centralised - Variation EMEA/H/C/1207/IB/7
Updated with Decision(2012)7733 of 25/10/2012
17/09/2012 Centralised - Variation EMEA/H/C/1207/IAin/10
Updated with Decision(2012)7733 of 25/10/2012
29/10/2012 Centralised - Variation EMEA/H/C/1207/II/3 (2012)7733 of 25/10/2012
19/09/2013 Centralised - Variation EMEA/H/C/1207/II/14
Updated with Decision(2014)7153 of 30/09/2014
20/02/2014 Centralised - Variation EMEA/H/C/1207/IB/18/G
Updated with Decision(2014)7153 of 30/09/2014
02/10/2014 PSUSA - Modification EMEA/H/C/1207/PSUV/23 (2014)7153 of 30/09/2014
27/07/2015 Centralised - Variation EMEA/H/C/1207/IB/32/G
Updated with Decision(2016) 3279 of 26/05/2016
03/12/2015 Centralised - Variation EMEA/H/C/1207/IG/603/G
Updated with Decision(2016) 3279 of 26/05/2016
30/05/2016 Centralised - Renewal EMEA/H/C/1207/R/40 (2016) 3279 of 26/05/2016
20/10/2016 Centralised - Variation EMEA/H/C/1207/IA/47/G
Updated with Decision(2017) 537 of 26/01/2017
30/01/2017 Centralised - 2-Monthly update EMEA/H/C/1207/II/45 (2017) 537 of 26/01/2017
14/09/2017 Centralised - Variation EMEA/H/C/1207/II/48
20/03/2018 Centralised - Variation EMEA/H/C/1207/IAIN/60