MHRA-100370-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • EX VIVO EXPANDED AUTOLOGOUS HUMAN CORNEAL EPITHELIAL CELLS CONTAINING STEM CELLS
Invented Name
  • Holoclar
  • Holoclar
  • Holoclar
PIP Number MHRA-100370-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Living tissue equivalent
Therapeutic area
Therapeutic area:
  • Ophthamology
Conditions / Indications
Conditions / Indications:
  • Treatment of limbal stem cell deficiency due to ocular burns
Route(s) of administration
Route(s) of administration:
  • Ophthalmic use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):EX VIVO EXPANDED AUTOLOGOUS HUMAN CORNEAL EPITHELIAL CELLS CONTAINING STEM CELLS.pdf
Published Date 27/09/2022