EMEA-000575-PIP01-09-M03 - paediatric investigation plan

ciclosporin

Key facts

• Active substance:
  ciclosporin
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0142/2015
• PIP number:
  EMEA-000575-PIP01-09-M03
• Pharmaceutical form(s):
  Eye drops, emulsion
• Condition(s) / indication(s):
  • Treatment of keratoconjunctivitis sicca
  • Treatment of vernal keratoconjunctivitis
• Route(s) of administration:
  Ocular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/07/2015
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000575-PIP01-09-M03
• Compliance opinion date:
  29/04/2016
• Compliance outcome:
  Positive

Decision

P/0142/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ciclosporin (EMEA-000575-PIP01-09-M03)

Adopted Reference Number: EMA/398291/2015