EMA — authorised 22 October 2015
- Application: EMEA/H/C/003750
- Marketing authorisation holder: Cytonet GmbH KG
- Local brand name: Heparesc
- Indication: Treatment of urea cycle disorders (UCD).
- Pathway: orphan
- Status: rejected
🇪🇺 Human Heterologous Liver Cells in European Union
EMA authorised Human Heterologous Liver Cells on 22 October 2015
Marketing authorisation
Human Heterologous Liver Cells in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Human Heterologous Liver Cells approved in European Union?
Yes. EMA authorised it on 22 October 2015.
Who is the marketing authorisation holder for Human Heterologous Liver Cells in European Union?
Cytonet GmbH KG holds the EU marketing authorisation.