Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Oslif Breezhaler   
Auth. number : EU/1/09/586
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: Oslif 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/1210 (2009)9773 of 30/11/2009
07/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1210/IA/2
01/02/2010 Centralised - Variation EMEA/H/C/1210/IB/3
Updated with Decision(2010)2026 of 23/03/2010
25/03/2010 Centralised - Variation EMEA/H/C/1210/II/1 (2010)2026 of 23/03/2010
16/06/2010 Centralised - Variation EMEA/H/C/1210/IA/4
Updated with Decision(2010)6251 of 06/09/2010
09/09/2010 Centralised - Variation (2010)6251 of 06/09/2010
23/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1210/WS/24
25/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1210/IA/25/G
20/12/2010 Centralised - Variation EMEA/H/C/1210/IB/5
Updated with Decision(2011)5947 of 10/08/2011
13/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1210/IG/32/G
31/05/2011 Centralised - Notification EMEA/H/C/1210/N/6
Updated with Decision(2011)5947 of 10/08/2011
12/08/2011 Centralised - Variation (2011)5947 of 10/08/2011
25/07/2012 Centralised - Variation EMEA/H/C/1210/II/14 (2012)5346 of 23/07/2012
28/08/2013 PSUSA - Maintain EMEA/H/C/1210/PSU/8 (2013)5601 of 26/08/2013
21/11/2013 Centralised - Variation EMEA/H/C/1210/WS/455
Updated with Decision(2014)6791 of 18/09/2014
22/09/2014 Centralised - Renewal EMEA/H/C/1210/R/29 (2014)6791 of 18/09/2014
13/10/2014 Centralised - Variation EMEA/H/C/1210/IG/488