Reasanz

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serelaxin

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
C01
Application details
Marketing-autorisation applicant
Novartis Europharm Ltd
Date of opinion
22/05/2014
Date of refusal of marketing authorisation
05/08/2014

Assessment history

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