Labazenit

RSS

budesonide / salmeterol

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Labazenit, intended for the treatment of asthma. The company that applied for authorisation is Laboratoires SMB s.a.

The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 27 June 2013.

This EPAR was last updated on 22/03/2013

Application details

Product details
Name
Labazenit
Active substance
  • budesonide
  • salmeterol
International non-proprietary name (INN) or common name
budesonide / salmeterol
Therapeutic area (MeSH)
Asthma
Anatomical therapeutic chemical (ATC) code
R03AK06
Application details
Marketing-authorisation applicant
Laboratoires SMB S.A.  
Date of opinion
27/06/2013
Date of refusal of marketing authorisation
06/09/2013

Assessment history

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