Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 25 July 2017

Indication(s)

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.

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Fluid Management

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Category Value
Agency product number EMEA/H/C/002450
Orphan designation Yes
Date First Approved 17-02-2015
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Chiesi Farmaceutici S.p.A.