Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Firazyr   
Auth. number : EU/1/08/461
Active substance : icatibant
Orphan market exclusivity for "treatment of angioedema" (based on designation EU/3/03/133) started on 15/07/2008
   10 years of market exclusivity
   This orphan market exclusivity will expire on 15/07/2018
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: B06AC02 - Icatibant
(See WHO ATC Index)
Indication: Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).
Marketing Authorisation Holder: Shire Orphan Therapies GmbH
Friedrichstraße 149, D-10117 Berlin, Deutschland
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
15/07/2008 Centralised - Authorisation EMEA/H/C/899 (2008)3717 of 11/07/2008
27/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/899/II/1
22/12/2008 Centralised - Variation EMEA/H/C/899/IB/3
Updated with Decision(2009)6188 of 29/07/2009
27/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/899/II/2
28/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/899/II/4
26/06/2009 Centralised - Variation EMEA/H/C/899/IA/5
Updated with Decision(2010)1821 of 15/03/2010
31/07/2009 Centralised - Variation (2009)6188 of 29/07/2009
17/03/2010 Centralised - Variation (2010)1821 of 15/03/2010
19/07/2010 Centralised - Variation EMEA/H/C/899/IB/7
Updated with Decision(2011)1206 of 21/02/2011
23/07/2010 Centralised - Variation EMEA/H/C/899/IB/6
Updated with Decision(2011)1206 of 21/02/2011
24/02/2011 Centralised - Variation (2011)1206 of 21/02/2011
04/03/2011 Centralised - Variation EMEA/H/C/899/II/9 (2011)1509 of 28/02/2011
21/04/2011 Centralised - Variation EMEA/H/C/899/II/10 (2011)2858 of 18/04/2011
19/08/2011 Centralised - Variation EMEA/H/C/899/IA/12/G
Updated with Decision(2012)1626 of 08/03/2012
28/10/2011 Centralised - Variation EMEA/H/C/899/IA/14
Updated with Decision(2012)1626 of 08/03/2012
12/03/2012 Centralised - Variation (2012)1626 of 08/03/2012
27/08/2012 Centralised - Variation EMEA/H/C/899/II/15 (2012)6006 of 23/08/2012
29/10/2012 Centralised - Variation EMEA/H/C/899/II/17/G (2012)7726 of 25/10/2012
15/11/2012 Centralised - Variation EMEA/H/C/899/II/20
Updated with Decision(2013)1652 of 13/03/2013
15/03/2013 Centralised - Renewal EMEA/H/C/899/II/20, EMEA/H/C/899/R/22 (2013)1652 of 13/03/2013
20/02/2014 Centralised - Variation EMEA/H/C/899/II/24/G
Updated with Decision(2015)753 of 06/02/2015
10/02/2015 Centralised - Yearly update (2015)753 of 06/02/2015
17/06/2015 Centralised - Variation EMEA/H/C/899/IAIN/29/G
Updated with Decision(2016) 3287 of 26/05/2016
30/05/2016 Centralised - Yearly update (2016) 3287 of 26/05/2016
23/03/2017 Centralised - Variation EMEA/H/C/899/II/36/G