HOLOCLAR

This brand name is authorized in Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom

Active ingredients

The drug HOLOCLAR contains one active pharmaceutical ingredient (API):

1 Autologous human corneal epithelial cells
UNII RH2309K129 - AUTOLOGOUS HUMAN LIMBAL STEM CELL

The mechanism of action of limbal stem cells implantation is the replacement of corneal epithelium and lost limbal stem cells in patients in which the limbus has been destroyed by ocular burns. During the corneal repair process, the administered stem cells are intended to partially multiply, differentiate and migrate to regenerate corneal epithelium, as well as maintaining a reservoir of stem cells that can continually regenerate the corneal epithelium.

Read about Limbal stem cells

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
HOLOCLAR Living tissue equivalent European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
S01XA19 S Sensory organs → S01 Ophthalmologicals → S01X Other ophthalmologicals → S01XA Other ophthalmologicals
Discover more medicines within S01XA19

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: EE Ravimiamet Identifier(s): 1677775
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 114987001
Country: FR Base de données publique des médicaments Identifier(s): 62223501
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 348816
Country: IT Agenzia del Farmaco Identifier(s): 043909011
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1075840
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100339008

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