Pharmaceuticals - Community Register

  

List of refusals for human medicinal products

Labazenit

Product name: Labazenit
INN: budesonide/salmeterol
Indication: Labazenit is indicated in the regular treatment of asthma in adults where use of a combination medicinal product (inhaled corticosteroid and long-acting β2-agonist) is appropriate:
- Patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting β2-agonists.
or
- Patients already adequately controlled on both inhaled corticosteroids and long-acting β2-agonists.
Marketing Authorisation Holder: LABORATOIRES SMB SA

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
10/09/2013 Centralised - Refusal of marketing authorisation EMEA/H/C/2201 (2013)5840 of 06/09/2013