This is a summary of the European public assessment report (EPAR) for Holoclar. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Holoclar. For practical information about using Holoclar, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns. A minimum of 1-2 mm2 of undamaged limbus is required for biopsy.
Therapeutic Area (MeSH)
ATC Code
S01XA19
ATC Item
limbal stem cells, autologous
Pharmacotherapeutic Group
Ophthalmologicals
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| ex vivo expanded autologous human corneal epithelial cells containing stem cells | N/A | Ex vivo expanded autologous human corneal epithelial cells containing stem cells |
EMA Name
Holoclar
Medicine Name
Holoclar
Aliases
N/ANo risk management plan link.
