EMEA-001007-PIP02-15 - paediatric investigation plan

ciclosporin

Key facts

• Active substance:
  ciclosporin
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0234/2015
• PIP number:
  EMEA-001007-PIP02-15
• Pharmaceutical form(s):
  Eye drops, solution
• Condition(s) / indication(s):
  Treatment of dry eye disease
• Route(s) of administration:
  Ocular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/10/2015
• Compliance check done:
  No

Decision

P/0234/2015: EMA decision of 27 October 2015 on the granting of a product-specific waiver for ciclosporin (EMEA-001007-PIP02-15)

Adopted Reference Number: EMA/619832/2015