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Pharmaceuticals - Community Register
List of refusals for human medicinal products
|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|
|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|