Heparesc
human heterologous liver cells
Table of contents
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.
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-authorisation applicant |
Cytonet GmbH KG
|
Date of opinion |
22/10/2015
|
Date of refusal of marketing authorisation |
21/12/2015
|