EMA
withdrawal
· 2016-04-04
EMA Refused: Heparesc (human heterologous liver cells) — Cytonet GmbH KG
Summary
The EMA refused the marketing authorization for Heparesc (human heterologous liver cells) by Cytonet GmbH KG for urea cycle disorders, Inborn, in 2015.
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Diseases / indications
Drugs mentioned
Snippet
Status: Refused. Therapeutic area: Urea Cycle Disorders, Inborn. MAH: Cytonet GmbH KG. Decision date: 22/10/2015. Orphan medicine