Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tovanor Breezhaler   
Auth. number : EU/1/12/790
INN : glycopyrronium bromide
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R03 - Anti-asthmatics
Pharmacological subgroup: R03B - Other anti-asthmatics, inhalants
Chemical subgroup: R03BB - Anticholinergics
Chemical substance: R03BB06 - Glycopyrronium bromide
(See WHO ATC Index)
Indication: maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, 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
03/10/2012 Centralised - Authorisation EMEA/H/C/2690 (2012)6964 of 28/09/2012
30/07/2013 Centralised - Variation EMEA/H/C/2690/N/2
Updated with Decision(2014)4267 of 19/06/2014
18/12/2013 Centralised - Variation EMEA/H/C/2690/WS/456
Updated with Decision(2014)4267 of 19/06/2014
23/06/2014 Centralised - Modification EMEA/H/C/2690/PSUV/4 (2014)4267 of 19/06/2014
26/06/2014 Centralised - Variation EMEA/H/C/2690/N/8