Holoclar

RSS

ex vivo expanded autologous human corneal epithelial cells containing stem cells

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 06/07/2017

Authorisation details

Product details
Name
Holoclar
Agency product number
EMEA/H/C/002450
Active substance
ex vivo expanded autologous human corneal epithelial cells containing stem cells
International non-proprietary name (INN) or common name
ex vivo expanded autologous human corneal epithelial cells containing stem cells
Therapeutic area (MeSH)
  • Stem Cell Transplantation
  • Corneal Diseases
Anatomical therapeutic chemical (ATC) code
S01XA19
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

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

Publication details
Marketing-authorisation holder
Chiesi Farmaceutici S.p.A.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
17/02/2015
Contact address
Via Palermo 26/A
43122 Parma
Italy

Product information

22/06/2017 Holoclar - EMEA/H/C/002450 - II/0012/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

OPHTHALMOLOGICALS

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.

Assessment history

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