EMEA-001082-PIP02-11-M03 - paediatric investigation plan
Ex vivo expanded autologous human corneal epithelium cells containing stem cells
PIPHuman
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 date
Decision
P/0066/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ex vivo expanded autologous human corneal epithelium cells containing stem cells (Holoclar), (EMEA-001082-PIP02-11- M03)