Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Hirobriz Breezhaler   
Auth. number : EU/1/09/594
Active substance : indacaterol
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R03 - Anti-asthmatics
Pharmacological subgroup: R03A - Adrenergics, inhalants
Chemical subgroup: R03AC - Selective beta-2-adrenoceptor agonists
Chemical substance: R03AC18 - Indacaterol
(See WHO ATC Index)
Indication: Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom
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
02/12/2009 Centralised - Authorisation EMEA/H/C/1211 (2009)9775 of 30/11/2009
07/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1211/IA/2
01/02/2010 Centralised - Variation EMEA/H/C/1211/IB/3
Updated with Decision(2010)2170 of 26/03/2010
30/03/2010 Centralised - Variation EMEA/H/C/1211/IB/3 (2010)2170 of 26/03/2010
16/06/2010 Centralised - Variation EMEA/H/C/1211/IA/4
Updated with Decision(2010)6012 of 26/08/2010
31/08/2010 Centralised - Variation (2010)6012 of 26/08/2010
23/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1211/WS/24
25/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1211/IA/25/G
21/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1211/IG/32/G
03/01/2011 Centralised - Variation EMEA/H/C/1211/IB/5
Updated with Decision(2011)5065 of 07/07/2011
11/07/2011 Centralised - Notification EMEA/H/C/1211/N/7
Updated with Decision(2011)5065 of 07/07/2011
11/07/2011 Centralised - Variation (2011)5065 of 07/07/2011
07/08/2012 Centralised - Variation EMEA/H/C/1211/II/15 (2012)5683 of 03/08/2012
29/08/2013 PSUSA - Modification EMEA/H/C/1211/PSU/8 (2013)5617 of 26/08/2013
21/11/2013 Centralised - Variation EMEA/H/C/1211/WS/455
Updated with Decision(2014)6794 of 18/09/2014
22/09/2014 Centralised - Renewal EMEA/H/C/1211/R/30 (2014)6794 of 18/09/2014
13/10/2014 Centralised - Variation EMEA/H/C/1211/IG/488
Updated with Decision(2015)6274 of 08/09/2015
10/09/2015 Centralised - Yearly update (2015)6274 of 08/09/2015
23/02/2017 Centralised - Variation EMEA/H/C/1211/WS/1102