EMEA-001082-PIP02-11-M03

Key facts

Invented name
Holoclar
Active substance
Ex vivo expanded autologous human corneal epithelium cells containing stem cells
Therapeutic area
Ophthalmology
Decision number
P/0066/2022
PIP number
EMEA-001082-PIP02-11-M03
Pharmaceutical form(s)
Living tissue equivalent
Condition(s) / indication(s)
Treatment of limbal stem cell deficiency due to ocular burns
Route(s) of administration
Ophthalmic use
Contact for public enquiries
Holostem Terapie Avanzate S.r.l.

 +39 3492403930

regulatory@holostem.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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