Refused
This medicine was refused authorisation for use in the European Union.
Overview
On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Reasanz, intended for the treatment of acute heart failure. The company that applied for authorisation is Novartis Europharm Ltd.
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 22 May 2014.
This EPAR was last updated on 01/09/2014
Application details
Product details | |
---|---|
Name |
Reasanz
|
Active substance |
Serelaxin
|
International non-proprietary name (INN) or common name |
serelaxin
|
Therapeutic area (MeSH) |
Heart Failure
|
Anatomical therapeutic chemical (ATC) code |
C01DX21
|
Application details | |
---|---|
Marketing-authorisation applicant |
Novartis Europharm Ltd
|
Date of opinion |
22/05/2014
|
Date of refusal of marketing authorisation |
05/08/2014
|
Assessment history
-
List item
Reasanz : EPAR - Public assessment report (PDF/2.72 MB)
Adopted
First published: 01/09/2014
Last updated: 01/09/2014
EMA/303748/2014 -
List item
Questions and answers on refusal of the marketing authorisation for Reasanz (PDF/91.56 KB)
Adopted
First published: 24/01/2014
Last updated: 01/09/2014
EMA/299385/2014 -
News
-
23/05/2014
-
21/02/2014
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 201424/01/2014