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 |
|
International non-proprietary name (INN) or common name |
|
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
-
List item
Labazenit : EPAR - Refusal public assessment report (PDF/3.35 MB)
Adopted
First published: 10/10/2013
Last updated: 10/10/2013
EMA/465765/2013 -
List item
Questions and answers on refusal of the marketing authorisation for Labazenit (PDF/79.86 KB)
Adopted
First published: 22/03/2013
Last updated: 28/06/2013
EMA/177112/2013