Heparesc

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human heterologous liver cells

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

Overview

On 25 June 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Heparesc, intended for the treatment of urea cycle disorders. The company that applied for authorisation is Cytonet GmbH Ci KG.

The applicant had 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 October 2015.

This EPAR was last updated on 04/04/2016

Application details

Product details
Name
Heparesc
Active substance
Human heterologous liver cells
International non-proprietary name (INN) or common name
human heterologous liver cells
Therapeutic area (MeSH)
Urea Cycle Disorders, Inborn
Anatomical therapeutic chemical (ATC) code
A16
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Application details
Marketing-autorisation applicant
Cytonet GmbH KG
Date of opinion
21/10/2015
Date of refusal of marketing authorisation
20/12/2015

Assessment history

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