EMEA-001729-PIP01-14-M01 - paediatric investigation plan

recombinant human nerve growth factor

Key facts

• Active substance:
  recombinant human nerve growth factor
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0280/2016
• PIP number:
  EMEA-001729-PIP01-14-M01
• Pharmaceutical form(s):
  Eye drops, solution
• Condition(s) / indication(s):
  Treatment of neurotrophic keratitis
• Route(s) of administration:
  Ocular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/10/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001729-PIP01-14-M01
• Compliance opinion date:
  10/11/2017
• Compliance outcome:
  Positive

Decision

P/0280/2016: EMA decision of 12 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant human nerve growth factor (EMEA-001729-PIP01-14-M01)

Adopted Reference Number: EMA/657489/2016