Detailed SMPC and OD register data for: Holoclar
Data as extracted from Orphan Designation Register
Product (OD)
Holoclar
PL number (OD)
PLGB 58508/0001
OD Designation ID (OD)
OD1
Active substance (OD)
Ex-vivo expanded autologous human corneal epithelium containing stem cells
Data as extracted from SMPC. (PS: More information at bottom of the page)
Product (SMPC)
PL Number (SMPC)
Composition/ Active Substance (SMPC)
Dose form (SMPC)
Marketing Authorisation holder details (SMPC)
AI match to EMA Substance Dictionary
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SMPC composition / active substance
Matched EMA substance
EMA SMS ID
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Further information for:
Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.
OD Indication (OD)
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.
Full Designation Number(OD)
PLGB 58508/0001/OD1
Orphan Condition(OD)
Corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns
All Indications (SMPC)
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Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
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Container description (SMPC)
Handling/Disposal (SMPC)
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