Pharmaceuticals - Community Register


List of refusals for human medicinal products


Product name: Labazenit
Active substance: 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.
- 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 6/09/2013